pfizer – Ӱ America's Education News Source Fri, 17 Jun 2022 16:13:26 +0000 en-US hourly 1 https://wordpress.org/?v=6.7.2 /wp-content/uploads/2022/05/cropped-74_favicon-32x32.png pfizer – Ӱ 32 32 FDA Authorizes Moderna and Pfizer Vaccines for Kids as Young as 6 Months /article/fda-advisory-panel-backs-moderna-and-pfizer-vaccines-for-kids-under-5/ Wed, 15 Jun 2022 22:06:27 +0000 /?post_type=article&p=691595 Updated, June 17

The Federal Food and Drug Administration on Friday authorized both Moderna’s and Pfizer-BioNTech’s vaccines for children as young as 6 months old — meaning COVID shots for the last age group of Americans without access may be just days away.

The vaccines now await sign-off from the Centers for Disease Control and Prevention, the final step before children under 5 can begin rolling up their sleeves. The White House expects providers to begin administering doses on Tuesday, immediately after the federal Juneteenth holiday.

On Wednesday, an FDA panel of experts — made up of pediatricians, infectious disease experts and vaccine researchers — voted 21-0 in favor of both vaccine options.

“There are so many parents who are absolutely desperate to get this vaccine, and I think we owe it to them to give them the choice,” said committee member Jay Portnoy, a professor of pediatrics at Children’s Mercy Hospital in Kansas City, Missouri.

Philip Chan, medical director for the Rhode Island Department of Health, called the panel’s unanimous vote a “major milestone in COVID prevention.” His state is ready to distribute the shots as soon as they receive the all clear, he said.

“We’ve pre-ordered thousands of [doses], and we expect them to ship within 24 or 48 hours after the FDA issues the EUA” (emergency use authorization), he told Ӱ Wednesday. With EUA now granted, the COVID shots should soon be on their way.

Parents who are eager to finally vaccinate their young children took advantage of the public comment period at the FDA’s Wednesday committee meeting to urge advisors to recommend authorization. Michael Baker, the father of a 1 and a 3 year old, described the tough choices he has had to make to protect his children from the virus. He shared a slide of all the events they have missed out on during the pandemic, including weddings, holidays and funerals.

“All I am asking is now that … I have the choice to vaccinate my children, [that] I have the choice to do it in the most timely fashion possible,” he said to the committee.

FDA/YouTube

Parents like Baker awaiting vaccines for their little ones have been on a months-long rollercoaster that has repeatedly raised their hopes only to later send them crashing down. In late February, Pfizer-BioNTech first submitted a request asking the FDA to grant emergency authorization for a two-dose regimen of their vaccine for children 6 months to 4 years old, only to then withdraw the application just five days later. Then in April, when Moderna was on the verge of submitting its EUA application for the age group, the FDA postponed the committee review process until Pfizer’s shots were also ready.

Just 29% of children 5 to 11 years old and 59% of youth 12 to 17 years old have so far received two vaccine doses, according to data from the American Academy of Pediatrics. 

However, Katelyn Jetelina, creator of Your Local Epidemiologist, wrote in her hyper-popular newsletter that parents of young kids should still take COVID seriously and vaccinate their children.

“The rate of severe disease is lower compared to adults, but this is an inherently flawed comparison because kids don’t die as often as adults. Since the beginning of the pandemic, 442 children aged 0-4 years old have died from COVID-19. If we compare to other vaccine preventable diseases among children, deaths due to COVID19 are highest. We cannot become numb to these deaths,” she explained.

FDA

COVID cases across the U.S. are finally leveling off after a springtime surge fueled by an Omicron subvariant spurred bumps in pediatric infections and hospitalizations through the final weeks of the school year.

You can view the FDA’s and watch the full recording of its June 15 vaccine advisory committee’s virtual meeting:

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COVID Vaccinations for Toddlers to Start After Juneteenth, White House Predicts /article/covid-vaccinations-for-toddlers-to-start-after-juneteenth-white-house-predicts/ Fri, 03 Jun 2022 18:51:00 +0000 /?post_type=article&p=690560 Coronavirus vaccinations for children under 5 years old are likely to begin June 21, after the federal Juneteenth holiday, a top White House official said.

In a press conference Thursday, White House COVID Response Coordinator Ashish Jha outlined the possible timeline for when young children, the last group in the U.S. still ineligible for immunizations, could begin rolling up their sleeves.


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Here are the key dates:

—June 1, Pfizer-BioNTech formally asked the Food and Drug Administration to grant emergency use authorization to their doses for kids under 5. Moderna submitted its application in late April for kids 6 months to 6 years old.

—June 3, states became able to order vaccine doses for kids under 5. A total of 10 million are currently available, the White House said.

—June 14 & 15, the FDA’s vaccine advisory committee is scheduled to meet to review the Moderna and Pfizer-BioNTech doses. Should the committee vote in favor of authorization, the White House expects the FDA to greenlight the vaccines in the days immediately after the meeting.

—June 18-20, if the FDA has authorized shots, doses will begin to arrive at doctors’ offices. The White House can begin sending vaccine shipments immediately following FDA authorization.

—June 21, after the long holiday weekend, if the previous steps proceed without setbacks, kids under 5 may begin receiving vaccine doses. The Centers for Disease Control and Prevention must also recommend the shots, but the agency typically follows the guidance of the FDA.

The White House has asked states to first provide vaccines to sites that can handle large volumes of supply, such as children’s hospitals. But as soon as Atlanta-based pediatrician Jennifer Shu receives the green light from local officials, she will order doses for her office.

“Parents have been asking me about vaccine availability for kids under 5 for several months. I plan to order them as soon as I get the notice from our health department,” she wrote in a message to Ӱ.

The White House also stressed that providers should offer vaccinations outside traditional working hours.

“We want to make this as easy as possible for working parents and their families,” said Jha.

The Department of Health and Human Services did not immediately respond to a question from Ӱ asking how many doses have been ordered so far and by which states.

With COVID case counts once again high amid a second Omicron surge, the updated vaccine timeline for young kids appeared as a light at the end of the tunnel to many pandemic-weary parents.

“I teared up in the car today thinking about being able to get my kid vaccinated,” Marisol LeBrón, professor at UC Santa Cruz, wrote on Twitter.

Parents of young children awaiting vaccines for little ones have been on a months-long roller coaster that has repeatedly raised their hopes only to later send them crashing down. In late February, Pfizer-BioNTech first submitted a request asking the FDA to grant emergency authorization for a two-dose regimen of their vaccine for children 6 months to 4 years old, only to then withdraw the application just five days later.

Then in April, when Moderna was on the verge of submitting its EUA application for the age group, Politico reported that the FDA might postpone the review process until Pfizer’s shots were also ready, a reveal that angered many parents and spurred a congressional letter asking the agency to explain the reported delay. The FDA’s current timeline appears to confirm those speculations of a simultaneous review.

The Moderna and Pfizer-BioNTech doses have several differences. Moderna’s shots are a two-dose regimen spaced four weeks apart, while the Pfizer-BioNTech vaccine requires three doses each spaced three weeks apart. The Pfizer-BioNTech shots were 80% effective in clinical trials, while Moderna’s were 51% protective in toddlers 6 months to 2 years old and 37% protective in youngsters 3 to 5 years old.

Researchers believe both vaccines offer a strong defense against severe illness and hospitalization in the age group.

In a clip from the Thursday press conference that has circulated widely on Twitter, White House Press Sec. Karine Jean-Pierre cut off Jha before he could respond to a reporter’s question asking whether “all schools will and must be open this coming fall.”

Any speculations that the Biden administration would advise school closures next year, however, starkly contrast with the administration’s prior actions and messaging. Biden has continually underscored his commitment to keeping schools open and oversaw a push to 99% of schools offering in-person learning in his first months in office. Although early in the pandemic an in-person learning divide existed between red and blue states, virtually all school systems reopened their classrooms for the 2021-22 school year, regardless of their partisan leaning.

But with toddler vaccines possibly rolling out in just a few weeks, many older children have not yet been immunized. Just 29% of children 5 to 11 years old and 59% of youth 12 to 17 years old had received two vaccine doses as of June 1, according to data from the American Academy of Pediatrics. The rates that have remained nearly stagnant for months.

The winter’s massive Omicron surge demonstrated the importance of youth vaccination, said Shu, the Atlanta pediatrician. Children under 5 were hospitalized with the virus at five times the rate they were during the Delta surge, a study from the CDC recently found. And in February, the agency’s data revealed that 3 in 4 kids under 18 had been infected by the virus.

“The kids who are ending up in the hospital are more likely not to be vaccinated,” the doctor told Ӱ in May.

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Three Pfizer Shots 80% Effective Against Omicron in Toddlers, Trial Data Show /article/three-pfizer-shots-80-effective-against-omicron-in-toddlers-trial-data-show/ Mon, 23 May 2022 20:07:09 +0000 /?post_type=article&p=589775 Pfizer-BioNTech’s new three-dose coronavirus vaccine for children under 5 years old is 80% effective at staving off infection, including from the Omicron variant, the companies announced Monday.

It’s a major boost in efficacy compared to data from Moderna, which announced in March that its two-dose regimen is 51% protective in toddlers 6 months to 2 years old and 37% protective in youngsters 3 to 6 years old.

Researchers believe both vaccines offer a strong defense against severe illness and hospitalization in the age group.


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The U.S. Food and Drug Administration on Monday its vaccine advisory committee will meet June 15 to review Moderna’s and Pfizer-BioNTech’s emergency use authorization requests for kids ages 6 months to 5 years old and 6 months to 4 years old, respectively. Pfizer and BioNTech have not yet submitted an EUA request, but plan to do so by the end of the week, BioNTech CEO Ugur Sahin said in a .

The agency’s advisory committee will make a recommendation on whether to approve the shots at the end of the meeting, which the FDA typically follows. Many experts hope the agency will greenlight shots soon after the mid-June meeting.

“I have some optimism that this will go well at [the] FDA advisory meeting and we might begin immunizing under 5 beginning next month,” Peter Hotez, co-director of Texas Children’s Hospital’s Center for Vaccine Development, wrote on .

Children under 5 years old remain the last Americans without access to COVID vaccines, and parents are eager to protect their children, especially as cases once again rise, said Atlanta-based pediatrician Jennifer Shu.

Dr. Jennifer Shu (Children’s Medical Group, P.C.)

On Monday, as the Pfizer news was announced, multiple parents of young children asked whether they could get their kids on a waiting list for the forthcoming vaccines.

“I assure them that we will make availability for everyone who wants [the shots],” said Shu, explaining that her practice has received ample pediatric vaccine supply every time they have placed an order. “I don’t think that access is going to be an issue.”

The news from Pfizer and BioNTech comes on the heels of a months-long saga that has repeatedly raised the hopes of parents anxious to vaccinate their toddlers against COVID only to later send them crashing down. In late February, Pfizer-BioNTech first submitted a request asking the FDA to grant emergency authorization for a two-dose regimen of their vaccine for children 6 months to 4 years old, only to then withdraw the application just five days later.

Then in April, when Moderna was on the verge of submitting its EUA application for the age group, that the FDA might postpone the review process until Pfizer’s shots were also ready, a reveal that angered many parents and spurred a congressional letter asking the agency to explain the reported delay. The announcement of the June 15 committee meeting appears to confirm those speculations of a simultaneous review.

The trial results released Monday clarified what experts have hinted at since February — that Pfizer’s two-dose regimen never offered the full intended protectiveness for young children.

“It was always a three-dose vaccine,” said Hotez.

The news comes as reported U.S. coronavirus cases are up 53% since two weeks ago and youth infections are also rising, though less steeply. With the increased prevalence of at-home testing, those numbers may fail to capture the full scope of new case totals, said Shu.

During the winter’s massive Omicron surge, children under 5 were hospitalized with the virus at five times the rate they were during the Delta surge, a from the Centers for Disease Control and Prevention recently found. And in February, the agency’s data revealed that kids under 18 had been infected by the virus.

Still, repeat infections remain a threat, and can happen of each other. Children who have not yet been vaccinated are more likely to get sick and, in turn, more likely to experience severe outcomes than immunized peers, said Shu.

“The kids who are ending up in the hospital are more likely not to be vaccinated,” she told Ӱ.

Just 28% of children 5 to 11 years old and 58% of youth 12 to 17 years old have received two vaccine doses, rates that have remained nearly stagnant for months.

Aside from recommending that kids roll up their sleeves as soon as they’re eligible, the pediatrician believes schools should consider reinstating universal face-covering rules while infections multiply. While a few schools and districts have made that jump, the vast majority continue to keep masks optional, though some have upped their language recommending masks.

Shu, however, knows of some children who have chosen to mask up at school as they’ve watched their peers get sick. It’s prom and graduation season, the pediatrician noted, and young people don’t want to miss out.

“If you miss some of these things, you can’t make them up,” said Shu.

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Districts Recommend Masks — But Don’t Require Them — as COVID Counts Rise /article/districts-recommend-masks-but-dont-require-them-as-covid-counts-rise/ Tue, 17 May 2022 19:07:55 +0000 /?post_type=article&p=589472 Coronavirus cases are rising nationwide but, so far, upticks have spurred only a few school districts to reinstate mask mandates.

Nationwide, reported infections are up 57% since two weeks ago and 4 percent of counties, including large clusters in the Northeast, are categorized as high risk by the Centers for Disease Control and Prevention’s . Another 14 percent are at the medium risk level.

Still, only are requiring students and staff to wear face coverings, according to the latest analysis from Burbio, a data service that has surveyed K-12 policies through the pandemic. 

An outlier, Pittsburgh Public Schools in Pennsylvania recently opted to less than two weeks after having made masks optional districtwide. And Portland, Maine on May 12 also , but clarified that it would not enforce the rule at end-of-year events like graduation and prom.

Much more common, school and health officials are announcing guidance that residents wear masks indoors as case counts rise, but have fallen short of issuing mandates. New York City leaders are residents to wear masks indoors, but the nation’s largest school district has made no changes to its face-covering policy thus far. The Cambridge, Massachusetts superintendent put forward a May 9, “​​encouraging our entire school community to mask, particularly when we are indoors,” but added that “we are NOT reinstating a requirement.”

“While a small number of districts are reinstating mask mandates, what we are seeing more often is district superintendents more forcefully recommending use of masks while not requiring them,” Burbio co-founder Dennis Roche told Ӱ.

The vast majority of U.S. counties remain at low risk for COVID, while clusters in the Northeast have reached the high-risk level. (CDC)

Mia Miron, 13, is weeks from graduating middle school in Pomona, California. Recently, she’s noticed far more students and staff catching the virus, she said. 

Her friend in science class got infected. And the school called her to the cafeteria last week to notify her of a possible exposure in history class, though she has since tested negative for the virus. Los Angeles County, where Pomona Unified School District is located, has seen a 48% increase in cases over the last two weeks.

“This shot up out of nowhere,” she told Ӱ.

Though the district does not require students or staff to wear face coverings, teachers in most classes now remind Miron and her peers that COVID is spreading and that they should mask up and frequently wash their hands, she said.

The eighth grader has worn a mask in school all year long and continues to now, but few of her classmates have heeded educators’ warnings, she said. 

“It’s kinda like 50-50” in terms of who wears face coverings in the classroom, she said.

Ameera Eshtewi, a Portland, Oregon high schooler who attends the Oregon Islamic Academy, a private school, said her school never dropped its universal face-covering requirement. She’s glad: mask-wearing gives her a “level of safety and security,” she told Ӱ.

Across the country, reported pediatric COVID infection counts have steadily increased over the past month, but remain far below levels from the worst of the first Omicron surge. For the seven-day period ending May 12, the country reported about 94,000 youth cases compared to over 1.1 million over the same time span in late January, according to data from the .

While pediatric COVID cases are increasing, counts remain far below the level of the first Omicron surge. (American Academy of Pediatrics)

On Tuesday, the U.S. Food and Drug Administration to Pfizer-BioNTech’s booster shots for children aged 5 to 11. The agency has hearings to review Moderna’s vaccines for children 5 and younger.

Meanwhile, as the U.S. surpasses the grim milestone of 1 million lives claimed by COVID, just of youth aged 12 to 17 and 28% of children 5 to 11 have received two vaccine doses. The latest wave of infection includes many people who have been both fully immunized and boosted, leading to a belief that schools cannot realistically take a zero-COVID approach to virus mitigation.

Still, masking requirements should return on a short-term basis in school districts where virus risk is high, believes Benjamin Linas, professor of medicine at Boston University. He serves on an advisory panel for his children’s Brookline, Massachusetts school system and advocated for a temporary reimplementation of universal masking, though on May 11 officials instead opted to “,” but not require, face coverings.

“Unless we’re willing to say, ‘That’s it, we’re 100% done, there’s absolutely nothing we can do to mitigate [COVID spread],’ — and I’m not ready to say that — … then we’re at a point where we should be using masks,” he told Ӱ.

The doctor, who was among the first in his liberal suburb to advocate for off-ramps from mask mandates earlier in the spring, added that “once-in-a-lifetime, big events, where interacting with humans and walking around and seeing each other smiling is mission critical to what the event is,” such as prom, should not enforce face-covering rules.

His stance on classroom masking comes less out of concern for curbing community spread, he explained, and more for a desire to keep students from missing school. Face coverings reduce virus transmission in K-12 settings, multiple academic studies have demonstrated, which can prevent young people from quarantine. 

“The reason we want people to wear masks is to protect our own education, now” while cases are up, said Linas.

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Congress Wants FDA to Explain Reported Delay in Moderna Toddler Vaccine Review /congress-wants-fda-to-explain-reported-delay-in-reviewing-moderna-toddler-vaccine/ Mon, 25 Apr 2022 21:25:39 +0000 /?p=588253 Updated, May 2

The Food and Drug Administration April 29 that it will reserve the dates June 8, 21 and 22 for its vaccine advisory committee to review the emergency use authorization requests of Moderna’s and Pfizer-BioNTech’s coronavirus shots for toddlers. While the dates remain subject to change, they provide an indication of when doses may be available to those under 5, as the FDA typically follows the recommendation of the committee in the weeks following its meeting.

Members of Congress sent a to the U.S. Food and Drug Administration Monday asking whether the agency intended to delay reviewing Moderna’s coronavirus vaccine for children 5 years old and younger and for “the scientific basis and any other rationale” for such an action.

The move comes after White House officials told last week that young kids, the last age group not yet eligible for coronavirus vaccines, will likely have to wait until the summer for immunizations — a longer timeline than previously expected.


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Although Moderna completed the trial for its toddler vaccine in late March and submitted a on Thursday, Anthony Fauci said that the FDA is considering reviewing the pharmaceutical company’s application at the same time as Pfizer-BioNTech’s, which has not yet been submitted.

“[The] two products … are similar but not identical, particularly with regard to the dose. And what the FDA wants to do is to get it so that we don’t confuse people to say, ‘this is the dose. This is the dose regimen for children within that age group of 6 months to 5 years,'” President Biden’s chief medical advisor on Thursday.

“Such a decision could delay the potential authorization and administration of the Moderna vaccine by several weeks,” points out Rep. James Clyburn, chair of the House Subcommittee on the Coronavirus Crisis, in its letter to the FDA. The committee asked for a staff briefing on the subject by May 9.

In early February, Pfizer-BioNTech submitted data on a two-dose vaccine series for children under 5 to the FDA, but in a highly unusual move withdrew their application just 10 days later. The two shots, which are 10 times less potent than the companies’ adult doses, were safe for all age groups, but did not provide enough protection against the Omicron variant for 3- and 4-year-olds. Pfizer-BioNTech now plans to request that the FDA authorize a three-dose regimen for children under 5, the companies have said.

The Moderna series currently submitted for review includes two shots that are each one-quarter the dose adults received. Trial data showed shots to be 44% and 38% effective in preventing illness among children 6 months to 2 years old and 2 years to under 6 years old, respectively.

But despite the relatively low efficacy, many parents of young children are anxious for a base level of protection for their kids, especially as mask mandates and social distancing requirements continue to fall across the country. 

For some, the idea that the FDA would delay the Moderna shots on parents’ behalf — ostensibly to avoid confusion — struck the wrong chord.

“If I sign a waiver saying ‘I don’t find this confusing at all,” can I go ahead and get the vaccine for my four-year-old?” parent and New York Times writer Whet Moser .

Meanwhile, a Tuesday report from the Centers for Disease Control and Prevention revealed that more than half of Americans have been infected by the coronavirus, including . Rates of prior infection nearly doubled over the course of the Omicron surge, the agency found.

Jennifer Shu, an Atlanta-based pediatrician, agrees that if doses are ready for emergency use authorization, Washington should not delay the rollout. After all, vaccines from separate companies were approved at different times for other age groups, she pointed out.

“If it’s ready to go, if the science has proven that the vaccine is safe and effective, then why not let the parents educate themselves on it?” she told Ӱ, adding that health professionals like herself can help families make an informed choice.

Parents of kids under 5 may feel they’re being “thrown under the bus” as pandemic precautions dwindle and the BA.2 Omicron subvariant threatens, said Shu.

But despite thousands of families eager to vaccinate their toddlers, still more are likely to pass on the opportunity when it becomes available. 

Immunization rates remain relatively low for older kids and teens with 28% of 5- to 11-year-olds and 58% of 12- to 17-years-old fully vaccinated as of April 20, according to the . New immunizations have slowed nearly to a halt, with vaccine coverage having increased only 1 percentage point in each age group since mid-March.

Even as vaccination rates are flatlining, Pfizer-BioNTech is planning to seek authorization for a third booster shot for kids 5- to 11-years old after trials found that it offers added protection against the Omicron variant.

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Masks Optional in NYC Schools Starting Monday, Mayor Says /nyc-mayor-we-are-lifting-the-indoor-mask-requirement-for-doe-schools/ Fri, 04 Mar 2022 18:12:30 +0000 /?p=585953 On Monday March 7, masks will be optional in New York City’s K-12 classrooms, Mayor Eric Adams announced Friday during an address held in Times Square.

“Our schools have been some of the safest places,” said Adams, citing a COVID positivity rate this week of 0.18 percent in schools. “We are lifting the indoors mask requirement for DOE schools.”


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“We want to see the faces of our children. We want to see their smiles,” he said.

The seismic move in the country’s largest school district was in accordance with plans the mayor signaled on Sunday, days after the Centers for Disease Control and Prevention lifted their universal masking guidance for schools in areas with low to moderate transmission.

After a tumultuous two years in which the teachers union and City Hall were often at odds over COVID protocols, United Federation of Teachers President Michael Mulgrew endorsed the change in a brief emailed statement.

“Our doctors agree with the city’s medical experts that this is the right time to safely move from a mask mandate to an optional mask system,” he said. “This is the responsible, thoughtful way to make our next transition.”

Face-covering requirements will stay in place for those younger than 5 in pre-kindergarten and child care settings, Adams said, noting that age group is not yet eligible for vaccination. That distinction will set up a scenario in some city schools with pre-K programs that certain grade levels can go mask-free while others cannot.

In February, Pfizer and BioNTech postponed their request that the U.S. Food and Drug Administration authorize their COVID shots for toddlers, pushing the timeline back several months for that age group.

Over three-quarters of all New York City residents have received at least two vaccine doses, including 87 percent of adult residents, according to . Studies show that three doses of the COVID vaccine are at preventing hospitalization, even against the Delta and Omicron variants.

However, student vaccination rates vary widely from school to school, from just under 10 percent coverage in some places to above 90 percent at others, reveal. Schools in wealthier areas tended to have higher rates of immunization, leading some to worry that lifting the face-covering mandate will lead to a disproportionate toll on underserved families who have suffered outsized death tolls through the pandemic.

On Wednesday, parents took to the steps of Tweed Courthouse to protest the city’s plans to drop universal masking in an event organized by the parent advocacy group . They rallied under the hashtag #MaskingForAFriend to emphasize the need to protect the most vulnerable, including the immunocompromised and the elderly, they said.

“I know there’s some who state that they still want their children to wear their masks,” acknowledged Adams. “You can.”

He himself will continue masking in crowded venues from time to time, he said, and wants to ensure that no child is ostracized for their decision to cover up.

Monday will also mark the end of proof-of-vaccination requirements for gyms, restaurants and movie theaters, though individual businesses may keep their rules in place if they so choose, the mayor said.

Meanwhile, his administration has indicated that they are interested in creating a virtual learning option for families who prefer to keep their children out of the classroom, but has provided no concrete details on a timeline, frustrating parents who have advocated for that possibility since . In January, at the height of the Omicron surge, Adams told officials that the process could take as long as six months.

The mayor closed his Friday address on a rejoiceful note.

“This is a celebratory moment,” he said. “We’ve been waiting for this day for so long. And it’s here.”

Watch the full address:

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Pfizer Postpones Request that FDA Authorize Doses for Kids Under 5 /pfizer-postpones-request-that-fda-authorize-vaccine-doses-for-kids-under-5/ Fri, 11 Feb 2022 21:59:29 +0000 /?p=584837 Vaccines for children under 5, the last age group still ineligible for coronavirus shots, will not be available in the coming weeks as previously anticipated.

On Friday, Pfizer-BioNTech that they will postpone their request that the Food and Drug Administration authorize their vaccine for children 6 months to 4 years old, saying they will wait for the data on a three-dose series.


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Three doses “may provide a higher level of protection in this age group,” the companies wrote.

In early February, Pfizer and BioNTech sent a rolling submission to the FDA for authorization of a two-dose round of shots, hoping to jumpstart the process of vaccines for little ones as early as the end of the month, while continuing to monitor whether a third dose may eventually be needed. But that timeline will now be halted until after researchers examine data from the three-dose regimen.

The FDA, in turn, pushed back its scheduled Feb. 15 advisory committee meeting to review the companies’ submission.

“We will provide an update on timing for the advisory committee meeting once we receive additional data on a third dose,” said the federal agency in a .

Pfizer and BioNTech expect to have numbers on the efficacy of a third shot by early April, the companies said.

Younger children bear the lowest COVID risk out of all age groups and, even when unvaccinated, are less likely to fall seriously ill from the virus than vaccinated adults. But whiplash from the Friday announcement may frustrate many parents who were counting on the arrival of shots for some long-awaited relief after the Omicron surge brought on and widespread .

Health experts, too, expressed frustration with the sudden change in plans, worrying that it could undermine faith in the shots.

“This rollercoaster that parents under 5 (including me) are forced to ride is an absolute, unacceptable disaster,” Katelyn Jetelina, assistant professor of epidemiology at the University of Texas School of Public Health, on Twitter. “Pfizer and the FDA need to get it together so the public knows what the (heck) is going on (and why) so we can continue to be confident in this process.”

Brown University’s Ashish Jha, on the other hand, : “This is good science in action. If we don’t yet have clear evidence of effectiveness, postponing a decision is the right thing to do.” He did, however, acknowledge “I know this will so disappoint parents of kids under 5.”

Pfizer-BioNTech shots for kids 6 months to 4 years old contain three micrograms of the vaccine, while the shots for teens and adults contain 10 micrograms and 30 micrograms, respectively.

Just under a quarter of children aged 5 to 11 and 56 percent of youth aged 12 to 17 are fully vaccinated against COVID-19, according to data from the .

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Pfizer Requests FDA Authorize COVID Shots for Kids Under 5 /pfizer-expected-to-request-fda-authorize-covid-shots-for-kids-under-5/ Tue, 01 Feb 2022 19:40:13 +0000 /?p=584170 Updated

Children under 5 years old may be eligible for coronavirus shots as soon as the end of February — much earlier than previously expected.

On Tuesday, Pfizer and BioNTech that they requested the Food and Drug Administration authorize a two-dose regimen of their vaccine for children under 5. Meanwhile, the companies will continue to research the efficacy of a third shot.


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In December, disappointing trial data showing that two smaller doses were safe for youngsters but, in children ages 2 to 4, threatened to extend the timetable before which young children would be eligible for COVID vaccines. But the FDA urged Pfizer-BioNTech to submit their initial trial data so that regulators could begin the review process, then to later submit numbers on a third shot once those become available, The Washington Post . Results from the study of a three-dose regimen are expected to arrive in late March at the earliest.

“If they get the two-dose approved, then they can get going. And by the time the first round of two-dose people are ready to boost … if they have a third dose approved, then they’ll get through this course,” explained Benjamin Linas, professor of medicine at Boston University. “But if they wait until they have all the data for the three-dose course, then they won’t even be able to get started.”

Even if three shots prove to be the optimal vaccination level for the age group, the Massachusetts doctor reassures parents that two doses provide far more protection than zero.

“Absolutely, it should give families some peace of mind having their children two-dose vaccinated,” he told Ӱ.

The news may bring some long-awaited relief to parents of children under 5 for whom the Omicron surge has been particularly frightening and stressful between spikes in and widespread .

“As a parent of a 3-year-old, this news does feel like light at the end of (the) tunnel,” said Jorge Burmicky, assistant professor at Howard University, in a sharing The Washington Post story.

But nationwide, rates of pediatric vaccination remain low. As of Jan. 26, just 20 percent of children ages 5 to 11 were fully immunized, while 55 percent of those ages 12 to 17, who have been eligible for shots for longer, had received two doses, according to data published by the .

As of November, nearly a third of parents of children ages 5 to 11 said they would “wait and see” before immunizing their kids in the most recent poll administered by the on parents’ vaccine attitudes.

For this decision around immunizations for children 6 months to 4 years old, Linas believes federal agencies must be upfront about the expected authorization process. Without clear messaging that young kids may ultimately need to receive three shots — but that the initial authorization of a two-shot regime allows youngsters to safely get started — he worries the eventual pivot could erode some parents’ faith in the shots. 

“If you don’t talk about it … it just creates this opportunity for misinformation, lack of trust, and then people shut down,” he said. “This is all about trust right now.”

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Youth Ages 16 & 17 Now Eligible for Pfizer Booster Dose, FDA Says /youth-ages-16-17-now-eligible-for-pfizer-booster-dose-fda-says/ Thu, 09 Dec 2021 19:23:01 +0000 /?p=581949 Young people ages 16 and 17 may now receive a third dose of the Pfizer-BioNTech coronavirus vaccine six months after their second shot, the U.S. Food and Drug Administration announced Thursday.

The news comes as the number of average daily COVID cases in the U.S. has in the past two weeks, and as fears for spread of the Omicron variant have motivated a to a level not seen since late May.


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“With both the Delta and Omicron variants continuing to spread, vaccination remains the best protection against COVID-19,” said Acting FDA Commissioner Janet Woodcock in a .

The Omicron strain, listed as a “variant of concern” by the World Health Organization in late November, currently makes up a miniscule fraction of U.S. infections, but features a combination of mutations that worries scientists. It is known to have infected more than , the director of the Centers for Disease Control and Prevention told the Associated Press Wednesday.

The first look at how vaccines hold up against the Omicron variant bodes well for the efficacy of Pfizer-BioNTech’s booster doses, experts say.

Lab data published Tuesday analyzing how effectively blood from vaccinated South Africans neutralized the new strain found that the virus did evade the immune defenses more craftily than previous versions of COVID. However, blood from individuals who had a previous infection and then received two vaccine doses did a good job staving off Omicron. It’s the best proxy so far for the immunity of those who have received three doses, scientists say, because South Africa has not yet authorized booster shots.

“​​This study gives me great hope that our boosters will help protect against Omicron,” Katelyn Jetelina, an assistant professor of epidemiology at the University of Texas School of Public Health, wote in a explaining the new lab results.

In authorizing third doses for 16- and 17-year olds, the FDA expanded its already existing emergency use authorization for the Pfizer-BioNTech vaccines to include older teens. Before shots can be officially administered to the newly eligible group, they need to receive the green light from the CDC, an authorization that is expected to come swiftly. The federal agency cleared boosters for all adults 18 and older in early November.

“Since we first authorized the vaccine, new evidence indicates that vaccine effectiveness against COVID-19 is waning after the second dose of the vaccine for all adults and for those in the 16- and 17-year-old age group,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research. “A single booster dose of the vaccine for those vaccinated at least six months prior will help provide continued protection against COVID-19 in this and older age groups.” 

Meanwhile, as many Americans are still wrapping their minds around first, second and third doses, Pfizer CEO Albert Bourla said late Wednesday that the Omicron variant could mean will be necessary in under 12 months.

New Mexico appears to be the first state to require that certain workers receive booster shots, including a vaccinate-or-test rule for K-12 staff. So far, about 9 percent of school employees statewide have submitted documentation of having received a third dose.

Ensuring that staff and eligible students up their immunity as Omicron threats loom may be of particular importance given that temporary school closures have continued through the fall. Roughly 10 percent of the nation’s schools have experienced a disruption this school year alone. Some closures have been due to outbreaks, but others have been caused by teacher burnout and staffing shortages.

As of Dec. 1, some 4.3 million children ages 5 to 11, representing 15 percent of the age group, had received a vaccine dose. The same was true for ages 12 to 17, and over half had completed the full two-dose series, according to data published by the American Academy of Pediatrics.

Across all ages, more than people in the U.S are now fully vaccinated, about 60 percent of the population.

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NM Requires K-12 Staff Booster Shots as Omicron Fears Fuel Vaccination Spike /article/new-mexico-requires-school-staff-booster-shots-as-omicron-fears-fuel-nationwide-vaccination-spike/ Mon, 06 Dec 2021 22:57:36 +0000 /?post_type=article&p=581720 Updated Dec. 7

In what may be a national first, New Mexico issued a requiring that all school staff receive coronavirus booster shots or submit to weekly testing.

The state was already enforcing a vaccinate-or-test rule for K-12 workers and other state employees, but due to concern surrounding the recently identified Omicron variant, the state announced that it will require school staff to up their immunity with an extra shot of the vaccine by Jan. 17, 2022. 


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Booster shots, infectious disease specialists believe, are the against the new strain.

“We recognize the gravity of the situation,” Nora Sackett, press secretary for Gov. Michelle Lujan Grisham, told Ӱ. “For folks who are fully vaccinated, they are now required to get their booster shot, if they’re eligible.”

As of Nov. 29, 85 percent of school staff had been fully vaccinated, according to the state Public Education Department. K-12 employees who are unvaccinated, or who have two doses but choose not to receive a third, must undergo weekly testing for the virus, she explained. If staff are non-compliant with the testing regimen, individual school districts will decide on repercussions. 

Only about 9 percent of school staff reported having received a booster shot as of Dec. 7, meaning the vast majority of vaccinated K-12 employees still must submit documentation of a third dose by Jan. 17 in order to avoid the state’s weekly testing regimen.

Outside of schools, the order requires third doses with no testing opt-out for New Mexico’s health care workers. It’s the first booster mandate in the nation that the data team behind the has identified.

“We haven’t seen it anywhere else,” Burbio co-founder Dennis Roche told Ӱ. 

While numerous districts, including Chicago, gave teachers a day off to get their third shots, he said, “we have not seen [boosters] mandated until we saw it in New Mexico.” 

Sackett, also, said she was not aware of any other states having such a policy on the books.

The published by the governor’s office includes multiple paragraphs outlining the threats posed by the Omicron variant, which seem to have motivated the announcement.  The new COVID strain has been detected in at least , with cases continuing to increase, according to the Centers for Disease Control and Prevention. 

In late November, the World Health Organization named the Omicron strain a “variant of concern” just days after it was first identified. Its high number of mutations — including more than the Delta strain on the protein used to latch onto cells — raises alarm for officials. But scientists have yet to determine whether the new version of the virus is indeed more transmissible or better able to evade the protections provided by existing vaccines. More clarity will arrive in the , experts say. For now, the Delta variant remains the dominant coronavirus strain in the U.S. and is responsible for the vast majority of cases, hospitalizations and deaths.

The CDC last Monday on booster doses to recommend that all adults “should,” rather than “may,” receive a third shot six months after their second. A day later, Pfizer CEO and Chairman Albert Bourla announced that his pharmaceutical company from the Food and Drug Administration to extend eligibility for third doses to 16- and 17-year olds.

Alarm over possible threats from the Omicron strain may be translating into more demand for coronavirus immunizations. On Thursday, nearly doses were administered, according to CDC data, a level not seen since late May.

It remains unclear, however, who exactly has been rolling up their sleeves. Counts published by the American Academy of Pediatrics indicate that the number of youth getting vaccinated against the coronavirus had in the seven-day period ending Dec. 1, but the nationwide spike in doses has mostly come after that window.

On Thursday, President Joe Biden announced a spate of new policies designed to enhance school safety and boost youth vaccination rates. He introduced measures including the and a requirement that Medicaid pay health care providers for vaccine consultations with families. 

“​​We’re going to fight this variant with science and speed, not chaos and confusion,” said the president.

Biden also indicated that the CDC would soon release updated guidance on “test-to-stay” programs for schools that allow students potentially exposed to the virus to avoid quarantine if they test negative before the school day. This fall, the practice has grown increasingly popular nationwide as schools seek to keep healthy students learning in person. Test-to-stay schemes would likely expand further should the federal government recommend their implementation.

In California, the state that so far has taken the most aggressive approach to vaccinating its public school students, a federal appeals court on Sunday delivered a win to San Diego Unified School District, against the implementation of its student COVID immunization mandate. Students 16 and up in the state’s second-largest school system will have until Dec. 20 to receive their second vaccine doses if they wish to attend school in person after Jan. 24, when the policy is set to take effect. 

“This latest decision recognizes that we have both the responsibility to protect students and the authority to do so by implementing a vaccine mandate, which is really our best hope as a country to get this deadly disease under control,” Board President Richard Barrera said in a statement.

The case, however, may be ongoing according to Paul Jonna, the attorney representing the lawsuit’s plaintiff, a 16-year-old high school junior who sued the district over its mandate in October, citing religious objections.

“We will seek emergency relief from the U.S. Supreme Court as soon as possible,” Jonna said in a statement.

More than eligible San Diego students are fully vaccinated, the San Diego Union-Tribune reports. 

Just north in Los Angeles, where a student immunization rule will also soon go into effect, the district published figures Nov. 22 showing that of eligible youth had received at least one coronavirus shot or were medically exempt. L.A. Unified’s mandate applies to all students ages 12 and up.

California is also the only state in the nation to adopt a statewide student COVID mandate, which will likely kick in next school year. But already, a small district in San Diego County has said that it will allow unvaccinated students to continue learning in separate, off-campus buildings, .

“For whatever reason, if the parent chooses not to vaccinate [their child], I still believe that a student deserves every opportunity to reach their potential,” schools Superintendent Rich Newman said.

On the other side of the country, New York City will up the stakes on vaccination even for its youngest residents, requiring restaurants and movie theaters by Dec. 14 to of children ages 5 to 11, Mayor Bill de Blasio announced Monday.

Back in New Mexico, bracing for the possible threats of the Omicron variant, acting Health Secretary David Scrase shared his reasoning on the state’s new booster requirement.

“New Mexico isn’t an island,” he said, “and we can’t prevent the new variant from arriving here. So we must defend ourselves with the tools we know to work.”


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Photo Story: Inside a Local Pharmacy Offering Vaccines to Kids /article/photo-story-inside-a-vaccine-site-for-kids-a-brooklyn-pharmacy-becomes-a-comforting-spot-for-covid-shots/ Tue, 09 Nov 2021 00:37:00 +0000 /?post_type=article&p=580416

Early Monday morning, a steady stream of Brooklyn families showed up at one neighborhood pharmacy for childrens’ COVID vaccines — even as hundreds of other New York City kids confronted uncertainty and long lines at school sites.

At Neergaard Pharmacy in Park Slope, Heath Griffths, 5, was soon 10 micrograms of Pfizer vaccine richer — departing for a happily delayed school day equipped with a stuffed bear from the pharmacy shop.

Elsewhere in the city, in lines hundreds deep. On the opening day for school-based vaccine pop-up sites, operated by the city and Department of Education, many were turned away as demand overwhelmed supply.

On 5th Avenue in Park Slope on Monday, Neergaard began its first official day of vaccinating kids, administering about 200 doses, preparing to offer hundreds of vaccines to 5- to 11-year-olds this week.

Vaccines have been a staple for Neergaard, an independent Brooklyn institution .  

About 15 minutes into a child’s screams from a fear of needles, one pharmacist told Ӱ families choose them for their “more personalized touch — people come in and feel like they’re comforted.” He added, “that kid’s been here a long time.” 

Pharmacists had a deep bag of tricks: “Are you a righty or a lefty?” and “count down from 10 with me” were repeated throughout the morning to help calm kids’ anxieties about the dreaded needles.  

One Neergaard pharmacist said over the last two weeks, the shop has seen droves of parents walk in, seeking shots ever since the Centers for Disease Control and Prevention news broke. Appointment sign-ups for 5- to 11-year-olds almost crashed Neergard’s website. 

“I definitely prefer to go here than a place far away … this felt a lot better,” Ava, 10, told Ӱ after receiving her vaccine.

Meanwhile, as he waited to get his shot, Heath Griffiths silently looked to his mother, Rachel. Confident and on a mission, Heath never took off his scooter helmet. Time was of the essence — he didn’t want to miss any more school than he had to at P.S. 282 on nearby 6th Avenue.

For the Griffiths, the pediatric vaccine means indoor playdates and family visits are back on the table. Once Heath and his 8-year-old brother finish their sequences, the Griffiths will fly to Arizona for the first time since the pandemic began.

“We’re following the CDC guidance and are really excited. I hope everyone decides to do it,” Rachel Griffiths said, adding that the excitement’s been constant since authorization was announced on Nov. 2. Dancing erupted in their kitchen when Heath and his brother learned the news. 

Excitement was an understatement for Neergaard regulars Luke and Parker Trautmann, 10 and 8 years old, respectively. “Relieved,” they jointly agreed. 

“Right when the message came out that kids can be vaccinated, she was on the case,” Parker said of his mom, Amanda.

When first-week, city-run appointment slots filled up, Amanda looked to pharmacies. She said her boys needed the in-person connections vaccines afforded, and the sooner the better. 

And Ava’s mother, Allison, said what was on a lot of parents’ minds: 

“We just hope that a lot of kids are going to be protected,” she said, looking forward to the days when visiting friends and family will “feel a little bit safer, for us and for them.” 

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COVID-19 Vaccines Roll Out for Young Children in NYC, Early-Bird Families All Sm /article/covid-19-vaccines-roll-out-for-young-children-in-nyc-early-bird-families-all-smiles/ Sat, 06 Nov 2021 14:01:00 +0000 /?post_type=article&p=580373 Brooklyn 10-year old Freya Graff did not mince words describing how she felt after receiving her first dose of the coronavirus vaccine Friday morning.

“Happy, excited,” she said, throwing her arms up to celebrate.


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Her 5-year old sister, Mayari, who also got the shot, jumped in a circle to show off her “happy vaccine dance” outside the Brooklyn Children’s Museum, where both siblings got immunized.

Then the sisters, hand in hand with their father, skipped down the street back to their car.

Days after Rochelle Walensky, director of the Centers for Disease Control and Prevention, gave the final sign-off late Tuesday night to Pfizer-BioNTech’s pediatric coronavirus vaccine for use in children ages 5 to 11, shots are now rolling out and kids are — gleefully — pushing up their sleeves.

Mayari Graff shows off her “happy vaccine dance,” as her dad and sister look on. (Marianna McMurdock)

The Brooklyn Children’s Museum, located in the borough’s Crown Heights neighborhood, is one of to offer pediatric shots. Before the site’s 9 a.m opening, a modest line of roughly a dozen parents and children gathered by the front doors. A larger crowd came for shots afterschool on Thursday, when the museum first had doses available for the age group.

“It’s emotional,” said Kira Halevy, who was bringing her 6- and 8-year-old boys to get immunized. The pandemic has taken up about a quarter of her younger son’s lifetime, and the family jumped at the first opportunity to vaccinate their kids. 

“We’ve been waiting for this,” she said.

Leading up to the shots, her family used the event as a real-world lesson in biology and medicine, explaining the mechanics of the doses.

“The first shot tells your body what corona is,” recited Zeke, Halevy’s older son. “The second shot is telling your body how to fight it.” 

Kobi Halevy, Zeke’s younger brother, with the fidget spinner he received post-shot. (Marianna McMurdock)

In New York City, nearly ages 12 to 17 have been vaccinated, well above the national rate reported by the American Academy of Pediatrics for that group. 

Now with shots available for the younger age group, a speedy and thorough rollout could significantly lower COVID’s hospitalization and death toll in the U.S. over the coming months and dull the impact of future variants, according to recent . Polling indicates, however, that nationwide will “definitely not” vaccinate their kids and others will “wait and see.” 

But the early-bird crowd on Friday was gung-ho.

“I was literally jumping up and down,” said Jenna Sternbach, describing the feeling when she received the email telling her she could sign her 11-year-old daughter Adlai up for a vaccine appointment. Now, having received the first dose and with a second soon to come, Adlai will soon be able to play soccer without a mask, which she looks forward to. 

The elder Halevy son, Zeke, can see himself very soon back at his friends’ houses, trading  Pokemon cards, he said.

And Wesley Francois, 15, who has been eligible for vaccines since the spring but was finally persuaded to receive the shot by a requirement for his basketball team, was excited to soon be able to ease up on masking.

“I’ll be a little more free,” he told Ӱ.

Plus, the pain was only a 1 on a scale of 1 to 5, Mateo Vasquez, 7, estimated after his shot.

Wesley Francois, 15, with his mother Tiffany Grinnage. (Marianna McMurdock)

The nation’s largest school district is doing its part to encourage the vaccination effort. On Monday, New York City officials are setting up pop-up vaccine clinics at across the five boroughs.

Efforts to boost accessibility to the shots is key, said pediatrician Maria Molina, who practices in Manhattan and the Bronx.

“Now that we have a vaccine,” she told Ӱ, “we have to make sure that every child has the same opportunity to get it.”

That extends to cultural factors as well, she noted. “I not only share the language of my patients, but I share the culture,” said Molina, who immigrated to the U.S. from the Dominican Republic and is now a member of SOMOS Community Care, a network of city health providers from diverse linguistic backgrounds. “It’s coming from someone who looks similar to them.”

The Brooklyn Children’s Museum is administering Pfizer’s pediatric coronavirus doses to children ages 5 to 11. (Marianna McMurdock)

The city has extended its for new vaccine recipients to youngsters as well, including those who receive shots at school. After first doses, families will receive an email explaining how to select between a prepaid $100 debit card, tickets to sporting events  or other perks.

“We really want kids to take advantage, families to take advantage of that,” said Mayor Bill de Blasio.

Young folks told Ӱ that they had wide-ranging plans for their newfound cash: some planning to save or donate it to school fundraisers sending holiday gifts abroad, others are planning to splurge on the aforementioned Pokemon cards or Heelys sneakers, which come with wheels in the sole.

The mayor has not stipulated whether there is a student vaccination threshold at which schools would drop universal masking rules for the classroom — a move made by at least a dozen major districts across the country in recent weeks, with mixed opinions from health experts.

Parents at the Brooklyn Children’s Museum vaccination site on Friday said that they would prefer schools wait to scrap mask mandates until vaccination rates reach as many as 90 percent of students. 

“We’d rather have any form of protection,” said Kira Halevy.

Elsewhere in the U.S., Chicago Public Schools announced Thursday that it will cancel school Friday, Nov. 12 for the nation’s first “” in an effort to boost immunization rates.

It’s an “opportunity for parents and guardians to take their children five years of age and older to get vaccinated at their pediatrician’s office, at a healthcare provider, or at a CPS school-based site or community vaccination event,” schools CEO Pedro Martinez wrote to parents.

For those wary of vaccination, other effective safety measures against the virus may soon be on the way. Pfizer announced Friday that their new antiviral pill cuts the risk of COVID hospitalization or death by in vulnerable adults. That development, alongside President Joe Biden’s recently announced vaccine mandate deadlines for large workplaces, led Pfizer board member Scott Gottlieb to tell CNBC on Friday that the pandemic “” by early January. Other health experts have their doubts, citing the possibility of new mutations of the virus.

Winona Winkel, 9, is excited to hug her friends when she’s fully vaccinated. (Marianna McMurdock)

Back in Brooklyn, Winona Winkel, 9, got her first vaccine dose Friday and is already counting the days to her second. 

“Then I can hug my friends,” she said. 

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COVID Shots for Children Usher in New Wave of Vaccine Hesitancy /article/with-nearly-half-of-parents-expected-to-forgo-child-covid-shots-schools-brace-for-new-wave-of-vaccine-hesitancy/ Thu, 04 Nov 2021 16:01:00 +0000 /?post_type=article&p=580267 This fall in the Elmbrook School District outside Milwaukee, elementary school classrooms come in two flavors: mask-required and mask-recommended. Students in each group, chosen by their parents, rarely interact with one another, except outdoors at recess or in required small-group settings.

“We keep cohorts together during lunch, so if you’re in a mask-required classroom, you’re eating as a group — socially distanced,” said Superintendent Mark Hansen. “We’re keeping those bubbles pretty tight.”


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Until now, elementary schoolers couldn’t get a COVID-19 vaccine. No longer. Centers for Disease Control and Prevention Director Dr. Rochelle Walensky on Tuesday endorsed the unanimous vote of a CDC vaccine advisory panel recommending Pfizer-BioNTech’s pediatric coronavirus vaccine for use in children ages 5 to 11. That means as many as 28 million children can begin receiving shots this week. 

Mark Hansen (Elmbrook School District)

But just as parents split on masks, they’re also divided on vaccines: Nearly half say they may pass on vaccinating their children for now, mostly because they aren’t especially worried their children will get seriously sick from coronavirus — even as doctors warn the virus will become endemic and virtually unavoidable in coming years, much like the annual flu.

That could set up a tense confrontation in coming months between schools and parents as public health officials push to make the shots part of mandatory school vaccine regimens. And as with the divide over masking, social distancing, and other practices, it could also change how schools operate, as pro-vaccine parents insist on keeping their kids apart from unvaccinated classmates.

Even requiring the vaccine for enrollment might not settle the dispute: An Oct. 23 poll found that 46 percent of parents simply wouldn’t send their child to school if COVID vaccinations are required.

In southern California’s ABC Unified School District near Los Angeles, Superintendent Mary Sieu said many cautious families are already hesitant to send their children back to school — about 700 have remained in remote instruction programs this fall. Overall, she said, the district has lost more than 1,400 students over the past two years, forcing her to consider closing one of her schools next year.

“I just feel that a lot of people are afraid of coming back to school,” she said.

While suggests that children remain at a lower risk than most adults of contracting serious illness due to the virus, outbreaks happen. In , conducted in early October, nearly one in three parents said their child’s schooling had been disrupted by COVID-19.

“Look at your ZIP code and see what your vaccination rates are, and your infection rates are,” said Daniel Domenech, executive director of the American Association of School Administrators. “That’s going to tell you the quality of education that those kids are getting in those schools. If a child isn’t in school consistently, they’re not going to be getting the quality education that they need. That’s the bottom line.”

Domenech, a former superintendent in Fairfax County, Va., said he fears that the vaccination gap taking shape between districts could replicate the existing achievement gap. Recent research in has found, for instance, that communities with high poverty rates had COVID-19 infection rates in 2020 that were two to three times as high as those in wealthier areas.

“What we’ve seen is that the areas that are suffering the most in terms of lack of a vaccine and high infection rates are exactly [high-poverty] areas, where families of color are afraid to get their kids vaccinated and are afraid to send their kids to school,” Domenech said. 

‘Ripe for a contentious situation’

Though they typically get a raft of vaccinations just to attend school, children’s COVID-19 vaccination rates have already shown evidence of parental hesitation. In September, the CDC said just of children ages 12 to 17 had gotten at least one shot and 32 percent had completed the two-shot dose by July 31. That’s more than two months after the FDA granted it emergency use authorization — and more than seven months after it first approved the vaccine for adolescents aged 16 to 17. 

In Marshalltown Community School District, northeast of Des Moines, Iowa, as many as 90 percent of school employees are vaccinated, said Superintendent Theron Schutte. But just 40 to 50 percent of eligible students have been vaccinated so far. For the youngest eligible students, ages 12 to 13, the vaccination rate is closer to 40 percent. “My guess is that a lesser percentage of the younger kids’ parents will probably get them vaccinated,” he said. “I’m hoping that more of them do.”

Dr. William Raszka, a professor of pediatrics at the University of Vermont’s Larner College of Medicine, said the risk-benefit analysis for vaccination “is just so overwhelming. I have trouble understanding why someone wouldn’t get vaccinated at this point in time.”

So far, he said, life-threatening illnesses associated with the vaccines “are awfully rare.” One of the most common reactions to Pfizer’s vaccine — the only one approved for emergency use in children — is “a sore arm,” he said.

From the beginning of the pandemic, said Schutte, “We operated on the premise that we know COVID’s going to come into the school. There’s no way we can know whether it is or isn’t coming in – but what we can control is its opportunity to spread.”

He couldn’t immediately predict how his school board would respond to the recent FDA approval of childhood COVID vaccines. “They’re a reflection of our community. So if our community is split on whether we should or shouldn’t require vaccinations, I think it’s always going to be ripe for a contentious situation.”

Mandates are years off

Once COVID vaccines earn full FDA approval, states could move quickly to mandate them for school attendance — California Gov. Gavin Newsom has he plans to add it to the list of vaccinations required to attend school in-person for middle and high school grades, as with vaccines for measles, mumps, rubella, and the like. “We want our kids back in school without episodic closures,” on Oct. 27.

Speaking after he received a COVID booster shot in Oakland, Newsom said children already receive 10 other vaccinations in order to attend school. “The politics around this are disturbing to me. Lives are quite literally at risk.”

A child in Hartford, Connecticut, covers her face as she waits for her turn to receive the Pfizer-BioNTech COVID-19 Vaccine for kids on Tuesday. (Joseph Prezioso / Getty Images)

Leaders in four of the state’s — Los Angeles, Sacramento, San Diego and Oakland — have already said students must get a first shot of the vaccine or attend school virtually from home in January.

But former FDA commissioner Dr. Scott Gottlieb in October predicted that any COVID vaccination mandate for school attendance would be “a couple of years away, perhaps a little longer,” for children ages 12 to 17, and even further for children ages 5 to 11. Appearing on CBS’s , Gottlieb said CDC has typically taken several years to add most childhood vaccines to their immunization schedule. 

That will leave the decision for now to parents like Debra Garrett, a mother of four children, all of them under 12, in Troy, N.Y. 

Garrett said she’s vaccinated, but added, “I’m not really sure about my kids getting it done right now.” Parents need more information about how the vaccines affect children, she said. “It’s all brand new. We don’t know how anybody’s going to respond to it.”

That sensitivity is heightened, Garrett said, because she grew up Black in a country with a history of mistreating Black research subjects in the name of medicine. “I just don’t want my child to be looked at as ‘the tester,’” she said.

Debra Garrett and her four children, all between the ages of 5 and 12. Garrett, who is vaccinated, says she’s “not really sure about my kids getting it done right now.” (All In Media & Productions)

Garrett’s four children all attend , part of the Uncommon Schools network of charter schools in six Northeastern cities. She said the school has given parents of students 12 and up the choice to vaccinate. 

But if Uncommon makes vaccination mandatory, “that’s when it’s going to be tricky — and it’s going to get tough for the school, and for parents. I just feel like there is going to be some kind of push and pull on both ends. I can’t say whether one is right or wrong, but what I do know for certain is that we have to educate people in order for them to be able to fully get it and fully feel like, ‘They’re not just pricking my kid.’”

Many parents will likely find themselves agreeing with Garrett. In a June survey , as the more-contagious Delta variant began to take hold in the U.S., the parents of just 51 percent of students under age 18 said they’d “probably” or “definitely” have their child vaccinated, with vaccine hesitancy much higher for parents of younger children. They’re far less likely to say they’ll vaccinate their kids compared to parents of high schoolers — 46 percent vs. 59 percent. 

Political party affiliation also plays a role: Republican-identifying parents of 35 percent of children say they’ll vaccinate their kids, while that figure is much higher for Democrats at 66 percent.

A September Gallup poll suggests that of parents of children under 12 would get them an available vaccine. Parents’ own vaccination status strongly predicted their attitude toward their kids: 82 percent of parents who were fully vaccinated against COVID-19 said they’d vaccinate their child, while just 1 percent who don’t plan to get vaccinated themselves planned to vaccinate their kids. 

Dr. Benjamin Lee, a pediatric infectious disease specialist and associate professor at the University of Vermont Children’s Hospital, said the findings are cause for concern.

Dr. Benjamin Lee (University of Vermont Medical Center)

It’s discouraging to me to see how many parents have already sort of expressed that they don’t want to get their children vaccinated as soon as vaccines are available,” he said.

While it’s natural for parents to hold out a high threshold for vaccine safety, he said, no vaccine carries zero risk. “And that includes all of the vaccines that we use routinely” for both children and adults. “In all scenarios, the data are so overwhelming that risks from vaccination are far lower than the risks of natural infection.”

Schutte, the Iowa superintendent, said it’s true that children are less likely than adults to get seriously ill due to COVID, but he urged parents to see the bigger picture: Even if kids don’t get sick, they could take the virus home. “We have a lot of multi-generation (families) living under the same roof in our community,” he said. “So it’s not only the parents, but the grandparents, and maybe in some cases, the great-grandparents.” 

The longer it takes to get most people vaccinated, he said, “the longer the situation is going to stretch out.”

In reality, said Lee, the Vermont pediatrician, SARS-CoV-2 “is going to be with us from now on. Any chance to completely eradicate this virus is long gone. And this will become an endemic virus,” like the annual flu, sticking around for years. Because it’s so contagious, he said, “what we should recognize is that all of us are going to get this virus. And the question is: Under what conditions or terms do we want to catch it?”

So far, the only statistically significant side effect of the vaccine is a mild case of myocarditis, or inflammation of the heart muscle, in adolescent males. But it’s enough to prompt physicians in a few countries to give young people of the Pfizer-BioNTech vaccine, offering at least partial protection from the virus without this side effect. 

“We should acknowledge that that is a known risk of vaccination,” Lee said. “However, when you look at the risk of myocarditis from vaccine versus the risk of myocarditis from COVID-19, the risks are far higher of catching myocarditis if you catch COVID-19 than from the vaccine itself.” 

Also, he noted, “almost without exception” the myocarditis associated with the vaccine is “a very, very mild illness that completely resolves.” COVID-19, by contrast, carries a higher risk of severe outcomes. 

Lee also warned against taking to heart the many unsupported claims about the vaccines’ quick development and emergency approval, claims that might turn parents, like Garrett, off to vaccination. “When all is said and done, these will end up being the most heavily scrutinized vaccines in terms of safety perhaps ever, compared to any vaccine that we’ve ever used.”

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FDA Panel Recommends Authorization of Pfizer Shots for Kids Ages 5 to 11 /fda-panel-recommends-authorization-of-pfizer-shots-for-kids-ages-5-to-11/ Tue, 26 Oct 2021 22:49:38 +0000 /?p=579774 Updated, Nov. 2

Centers for Disease Control and Prevention Director Dr. Rochelle Walensky on Tuesday evening the unanimous vote of a CDC vaccine advisory panel recommending Pfizer-BioNTech’s pediatric coronavirus vaccine for use in children ages 5 to 11. Her sign-off means shots can begin Wednesday for some 28 million children in this younger age group. The CDC approval comes after the Food and Drug Administration on Friday for emergency use in 5- to 11-year-olds. Children’s hospitals and pediatrician’s offices across the country told CNN that they have and would be ready to administer shots to children as soon as they got the green light. “As a mom, I encourage parents with questions to talk to their pediatrician, school nurse or local pharmacist to learn more about the vaccine and the importance of getting their children vaccinated,” Walenksy said.

Members of a federal advisory panel voted overwhelmingly Tuesday evening to recommend the authorization of a pediatric dose of Pfizer-BioNTech’s coronavirus vaccine for children ages 5 to 11, setting in motion a process that could make shots available for the age group by next week.

The 17-0 vote, with one abstention, represents a key step toward vaccine access for approximately 28 million U.S. children — and means that virtually all K-12 students could soon be eligible for shots.


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The Food and Drug Administration panel endorsed giving children one-third the dosage for adults in two shots spaced three weeks apart. The group’s vote is non-binding, but the FDA typically in the days after a decision, according to The New York Times.

Next, the Centers for Disease Control and Prevention has Nov. 2 and 3 meetings scheduled for their own panel of experts to weigh in on the matter, after which emergency use authorization could soon be issued.

FDA committee members cast their votes after considering the efficacy data of the Pfizer-BioNTech shots and the cumulative toll of COVID-19 on children and families.

Shots for kids were 91 percent effective at preventing infection, the pharmaceutical companies’ trial showed. Only three out of over 3,000 inoculated children experienced breakthrough infections, compared to over a dozen who had received the placebo.

Only three inoculated children out of over 3,000 experienced breakthrough infections in the Pfizer-BioNTech trial. (FDA via YouTube)

Immunity and side effects for 5- to 11-year-olds were comparable to those produced by the larger dose in 16- to 25-year-old patients, the data showed. No new safety problems or cases of heart inflammation were observed in the trial. Israeli studies have found myocarditis to occur in less than , so it’s possible the condition would have been too rare to have been detected in the main study.

However, even in worst-case scenarios where adverse cases run on the high side of what officials expect, the benefits of shots for kids still supersede the potential dangers, according to modeling presented by Hong Yang, senior advisor at the FDA’s Office of Biostatistics and Epidemiology.

“The benefits clearly outweigh the risks,” she said.

Over the course of the pandemic, nearly 2 million children between the ages of 5 and 11 have fallen ill with the virus, 8,300 have been hospitalized, and close to 100 have died, making COVID-19 one of the top 10 causes of death among the age group, said Peter Marks, who heads the FDA division that oversees vaccine approvals.

In addition to preventing cases and hospitalizations, minimizing learning disruptions was a key consideration for advisory committee members. 

Since August, over 1 million K-12 students have been affected by school closures due to COVID, Dr. Fiona Havers, a viral diseases specialist at the CDC told committee members during the Tuesday hearing.

“The school closures and the disruption has been enormous,” said the FDA’s Jeanette Lee. “We have to weigh that against the benefits we would see [from] the vaccine.”

Over 1 million students have been affected by COVID school closures this year. (FDA via YouTube)

Randi Weingarten, president of the American Federation for Teachers, celebrated the panel’s recommendation as a win for school safety.

“This is huge news in our ongoing effort to keep our kids safe from COVID-19. For nearly two years, parents have been living in fear, worried that their child could get sick at school, day care, or in daily life, but now they finally have FDA-approved protection to add to the long list of vaccines we use to keep our children protected from transmissible diseases,” she said in a statement. “Educators, school staff and healthcare professionals are eager to work together with parents to help get America’s kids vaccinated in the places they trust, including public schools and community centers.”

At least one committee member, Cody Meissner, who ultimately voted to recommend the vaccine for authorization, expressed hesitation about how greenlighting shots for 5- to 11-year-olds may play out for school policy. 

“I’m just worried that if we say yes, that the states are going to mandate administration of this vaccine to children in order to go to school and I do not agree with that. I think that would be an error at this time,” he said during the Tuesday hearing.

Vaccine mandates have become a flashpoint in the ongoing culture wars now consuming school boards nationally. Only a handful of school districts, mostly in California, have enacted coronavirus vaccine requirements for eligible students. The Golden State’s two largest school systems, Los Angeles and San Diego, are currently defending their policies in court

California is also the only state to mandate shots for eligible students, though the policy will .

A third of parents with children ages 5 to 11 said they would get their child vaccinated “right away” once they were eligible, according to a Sept. 30 , while a third said they would “wait and see” and a quarter said they would “definitely not” vaccinate their younger children. A by ​​the COVID-19 Vaccine Education and Equity Project reported that two-thirds of parents with children in the age group said they would immunize them once the shots are authorized.

Vials of the pediatric vaccine will be colored orange, to differentiate from adult doses. (FDA via YouTube)

When shots do ultimately roll out for children, vials will be colored differently to avoid confusion with the more potent adult formula, said William Gruber, senior vice president of Pfizer Vaccine Clinical Research and Development.

Immediately after the FDA panel’s vote, Ashish Jha, dean of the Brown University School of Public Health, .

“They got it right,” he said.


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Pfizer Shot 91% Effective at Preventing COVID in Children Ages 5-11 /pfizer-biontech-vaccine-over-90-effective-at-preventing-covid-in-children-ages-5-11/ Fri, 22 Oct 2021 17:38:47 +0000 /?p=579574 The Pfizer-BioNTech coronavirus vaccine is 91 percent effective at preventing COVID infection in youth ages 5 to 11, the pharmaceutical companies’ data released Friday reveal.

The protection provided by the shots, the companies say, supports authorization of the vaccine for the 28 million U.S. children in that age group. The Food and Drug Administration has a hearing scheduled Tuesday with expert advisors to review the case for authorization. 

Two weeks ago, Pfizer and BioNTech submitted their formal request to the FDA for the green light to deliver doses to 5- to 11-year olds. 

If the review timeline spans a similar length as that of vaccines for 12- to 15-year olds, the agency could grant authorization ahead of the Thanksgiving holiday — meaning that the vast majority of K-12 students may soon be eligible for immunizations.

The vaccine efficacy numbers come from a Pfizer and BioNTech provided to the FDA, released Friday morning by the federal agency. In their trial, the companies tested a 10 microgram dose of the vaccine, one-third the size of the shot for teenagers and adults, and found that it produced a “robust” antibody response. Immunity and side effects, they said, were comparable to those produced by the larger dose in 16- to 25-year-old patients. 

No new safety problems or cases of heart inflammation were observed in the trial, which tested 2,268 participants. Israeli studies have found myocarditis to occur in , so it’s possible the condition would have been too rare to have been detected in the main study. 

The news comes as children make up over , amounting to about a quarter of all reported infections per week nationwide, according to mid-October data published by the American Academy of Pediatrics. Over have closed so far this year due to outbreaks of the virus, according to Burbio, an organization that has tracked schools through the pandemic, though COVID-related school closures have slowed considerably in recent weeks as and schools hone their protocols to curb spread.

The White House has made it clear that immunizing children will be a priority once shots are authorized for 5- to 11-year olds. The Biden administration will match schools with COVID-19 vaccine providers, the White House Wednesday. The Department of Health and Human Services will also enlist community-based clinics, doctor’s offices, hospitals and faith-based organizations in rapidly distributing vaccines.

Two-thirds of parents of children aged 5 to 11 years say they will immunize their children against COVID-19 once shots are authorized for the age group, according to by the COVID-19 Vaccine Education and Equity Project.

“While we’re encouraged to see that a majority of parents intend to vaccinate their children against COVID-19 once they are eligible, there is clearly more work to be done to help address parents’ questions and ease concerns about the vaccines,” Beth Battaglino, CEO of the nonprofit HealthyWomen, one of the partner organizations behind the polling, said in a .

Pfizer-BioNTech vaccinations have been fully approved by the FDA for individuals ages 16 and above, and have emergency use authorization for teenagers ages 12 to 15. Shots for kids younger than five may arrive .

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COVID Shots Required for School Staff in 36% of Top Districts /covid-shots-required-for-school-staff-in-36-of-top-districts/ Tue, 12 Oct 2021 21:25:27 +0000 /?p=579102 Updated

With the vast majority of U.S. students once again learning in classrooms, 180 of the largest 500 U.S. school districts have enacted requirements for their staff to be vaccinated against COVID-19, according to an analysis published Monday by Burbio, an organization that has tracked school safety policies through the pandemic.

It’s a safety measure that health experts say represents a key step toward improved coronavirus safety in school — especially as younger students remain ineligible for shots likely until November. Although children rarely fall seriously ill from the virus, young people still make up of new cases in the U.S. and school-based outbreaks have triggered some already in 2021-22.


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“Most pediatricians that I’ve spoken with … absolutely support vaccine mandates for teachers,” Kristina Deeter, professor of pediatric medicine at University of Nevada, Reno School of Medicine, told Ӱ. “It’s the right thing to do.”

In 11 states, coronavirus vaccines are mandated for teachers statewide, the University of Washington’s Center on Reinventing Public Education reports, meaning a considerable share of the 180 districts with staff mandates enacted such policies because state law required it.

Still, vaccination rules , with some mandates having already kicked in and others not taking effect until next month.

Some school systems have more lenient policies, such as Philadelphia, which acknowledged that unvaccinated teachers , though they will be subject to twice-weekly testing. Others impose stricter sanctions, like New York City, which is barring unvaccinated teachers from entering school buildings and putting them on unpaid leave until they get the shot.

Even those districts where staff have a choice between vaccination or regular testing are included in the 36 percent tally, Burbio co-founder Dennis Roche confirmed to Ӱ.

The New York City mandate, which took effect Oct. 4 after a brief legal challenge, applies to roughly 150,000 people who work in the nation’s largest school system, and of employees to receive their shots in the weeks before the rule took effect. Some 96 percent of teachers in the district have now been immunized against COVID-19, The New York Times reported.

By contrast, Los Angeles, the country’s second-largest school system, on Monday extended its deadline for employees to receive their shots from Oct. 15 to Nov. 15, fearing that strict enforcement would . Unlike the New York City mandate, the L.A. rule requires two doses before the deadline for educators receiving the Moderna or Pfizer vaccine.

While many teacher mandates are in deep blue states, the San Antonio Independent School District has an immunization requirement set to go into effect Oct. 15. Earlier this month, the district’s rule from Texas Attorney General Ken Paxton when a county judge denied the state’s motion to secure a temporary injunction on the mandate. A ruling on the policy from a higher court is .

Meanwhile, on Monday, Texas Gov. Greg Abbott issued an executive order banning all COVID-19 vaccine mandates in the state, .

“We are reviewing the new executive order and consulting with our legal counsel and Board of Trustees to determine how the district will proceed with its employee vaccine mandate,” a San Antonio ISD spokesperson wrote in an email to Ӱ.

In lieu of mandates, other Texas districts are providing cash incentives for teachers who roll up their sleeves. , and each deliver $500 bonuses to fully vaccinated educators.

Vaccine mandates for students remain much more rare, with only a select few districts having implemented such rules. California districts Los Angeles, Oakland and Culver City as well as Hoboken, New Jersey have each made immunization a requirement for in-person school for vaccine-eligible students, with deadlines in the coming months. Washington, D.C. is .

In early October, California Gov. Gavin Newsom announced that coronavirus vaccines will be required for all eligible students in the state, though the rule will .

Burbio’s count that 36 percent of top districts require teachers to be immunized comes as the rush to embrace such policies has slowed considerably. After eight states moved to enact educator mandates in late August and early September, only one — Delaware — has added a similar rule since then, CRPE reports.

But even as COVID case counts , Deeter, the pediatrics professor, warns that now is not time for the country to let down its guard.

“As the surge goes down … now everybody’s like ‘Yay! [The pandemic] is over.’ It’s not over. It’s not even close to over. We are just prepping for the next wave,” she said. “We have to prepare.”

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Pfizer asks FDA to OK COVID Shots for Kids 5-11, Could Roll Out Pre-Thanksgiving /pfizer-asks-fda-to-greenlight-covid-shots-for-kids-5-11-budget-impasse-could-slow-review/ Thu, 07 Oct 2021 16:33:48 +0000 /?p=578875 Updated Oct. 8

In a key step toward coronavirus vaccine access for over 28 million U.S. children, Pfizer-BioNTech Thursday morning that they have submitted their formal request to federal regulators for authorization to deliver shots to youth ages 5 to 11.

The move comes after the pharmaceutical companies announced positive topline results among that age group in clinical trials in late September. The testing regimen delivered two reduced-potency doses to more than 2,000 youngsters, producing a “robust” antibody response, including immunity and side effects comparable to that produced by the larger dose in 16- to 25-year-old patients.


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“With new cases in children in the U.S. continuing to be at a high level, this submission is an important step in our ongoing effort against COVID-19,” Pfizer Thursday.

The Food and Drug Administration has an Oct. 26 advisory committee meeting to review Pfizer-BioNTech’s request to expand authorization to younger children.

Pressed on what issues will be on the table during that meeting and how soon afterward authorization might be granted, a spokesperson responded to Ӱ that the “FDA cannot comment on its interactions with manufacturers about their investigational products.”

Should the review process follow a similar timeline as it did for 12- to 15-year olds, which stretched just over a month from an April 9 submission to a May 10 authorization, children ages 5 to 11 could receive the greenlight for COVID immunizations by early- to mid-November, sometime between Halloween and Thanksgiving.

Meanwhile, schools are facing a third straight school year disrupted by the virus, which as of last week had even as cases overall have begun to fall. As of Sunday, outbreaks had triggered some across 561 districts since buildings opened their doors for the 2021-22 school year, according to the website Burbio, which has tracked school policies and schedules through the pandemic.

Although children rarely fall seriously ill from the virus, the Delta variant has driven up caseloads among unvaccinated Americans, including youth. Last week, over 173,000 pediatric cases were reported, accounting for nationwide, according to the American Academy of Pediatrics.

Vaccines are currently authorized for youth ages 12 to 15, and fully approved for those 16 and up. As of Sept. 29, of 12- to 17-year olds in the U.S. had received at least one dose of the vaccine, according to the pediatrics academy, while of adults 18 and older are fully vaccinated.

Youth immunization rates, however, vary greatly by locale. In 10 states, ages 12 to 17 have received at least one dose of the vaccine, while in 21 states, the same is true for less than half of youth that age.

Last week, California Gov. Gavin Newsom announced that for all eligible students in the state, though the rule will likely not go into effect until July 2022.

Some districts have moved to implement more immediate mandates for children ages 12 and up including Los Angeles, Oakland and Culver City, all in California; and Hoboken, New Jersey. Washington D.C. is also that would require all students to be fully immunized against the virus by Dec. 15.

Though it may prove a challenge to persuade the parents of K-12 students to receive vaccinations in some districts, COVID shots are the most effective way to defend children against the virus, Benjamin Linas, professor of medicine at Boston University, told Ӱ last month.

“With the vaccine, you’re very well protected from the bad outcomes.”

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Pfizer Sends Vaccine Data for Kids Ages 5-11 to FDA /pfizer-sends-vaccine-data-for-kids-ages-5-11-to-fda-now-days-away-from-formal-authorization-request-ceo-says/ Tue, 28 Sep 2021 19:37:46 +0000 /?p=578325 Updated, Oct. 1

Pfizer-BioNTech has submitted initial data to the Food and Drug Administration that its COVID-19 vaccine is safe and effective for 5- to 11-year olds, the pharmaceutical company Tuesday.

The development represents another key step toward shots for young children, but Pfizer has yet to formally submit a request to the FDA for authorization to inoculate the roughly Americans under 12 years old, which it must do before the federal agency can fully begin the weeks-long review process.

Though younger children are not yet cleared for the vaccine, California Gov. Gavin Newsom on Friday ordered COVID shots for all eligible K-12 students in the state, marking the first such statewide move in the nation. The mandate but depends on when vaccines receive full FDA approval for young people ages 12 and up, the Los Angeles Times reports. Currently, Pfizer shots have full FDA approval for use in individuals 16 or older.

“This is just another vaccine,” Newsom said. Coronavirus shots will be added to “a well-established list that currently includes 10 vaccines and well-established rules and regulations that have been advanced by the Legislature for decades.”


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Pfizer’s submission for emergency use authorization among kids under 12 will come , CEO Albert Bourla told ABC News on Sunday.

If Bourla’s company sticks to that timeline, young kids should have access to COVID shots before the end of next month, said Dr. Anthony Fauci.

“I would imagine in the next few weeks [the FDA] will examine that data and hopefully give the OK so we can start vaccinating children hopefully by the end of October,” the nation’s top infectious disease expert told MSNBC’s Morning Joe.

An anonymous source familiar with the authorization process, however, told The Wall Street Journal that if Pfizer delays its submission to the FDA, clearance for young children to receive shots

Dr. Jennifer Shu (Children’s Medical Group, P.C.)

Either way, it’s big news for schools, says Atlanta-based pediatrician Jennifer Shu. Though classrooms have not proven to be the locus of viral spread through the pandemic, circulation of the highly contagious Delta variant this fall has spurred outbreaks forcing some already since buildings opened. In late September, minors made up , the American Academy of Pediatrics reports, though the risk of severe outcomes remains small, doctors say.

“Once kids ages 5 to 11 are eligible for [the] vaccine, attending school during the pandemic will be safer,” Shu wrote in a message to Ӱ.

The Pfizer data included 2,268 participants ages 5 to 11 who were each given a two-dose regimen of the vaccine 21 days apart. Children were given a 10 microgram dose, smaller than the 30 micrograms administered to older children and adults, which the drug company said was a carefully selected dosage for safety, tolerability and effectiveness.

In an internal review of the results last week, Pfizer reported that one month after the second dose, the shots produced a “robust” antibody response, including immunity and side effects comparable to that delivered by the larger dose in 16- to 25-year-old patients.

The FDA said that it will analyze those data as soon as possible, the .

In the Atlanta pediatrician’s practice, patients are eager to have youngsters inoculated — though Shu’s clientele may be the exception, from a nationwide perspective.

“I’m mostly seeing families that are all in,” she said. “​​Children are telling me they can’t wait until they can get the vaccine, since they are often the only ones in their family who haven’t even gotten one dose yet.”

Youth ages 12 and up have been eligible for doses since May, but , according to the AAP. By that measure, inoculating those under 12 years old may prove a challenge.

A Kaiser Family Foundation national poll from mid-August found that only of 5- to 11-year olds would want their child to receive the COVID-19 shot right away after it’s cleared, while another 40 percent said they would “wait and see.” That attitude may be changing, however, as of U.S. parents surveyed in a Gallup poll published Tuesday indicated that they would have their children inoculated against COVID-19 if shots were available.

Getting children under 12 vaccinated “will be an uphill battle,” Rebecca Wurtz, professor of health policy at the University of Minnesota, told Ӱ. “I think parents are even more protective of their younger kids (than their older children).”

In the Kaiser survey, an additional 9 percent of parents said they would get their youngsters vaccinated only if the shots were required. Meanwhile, momentum is building for schools to do just that.

Last week, Oakland Unified School District in California joined Golden State counterparts Los Angeles and Culver City, as well as Hoboken, New Jersey, in in order to attend in-person school.

Los Angeles Unified School District officials chose not to comment when asked by Ӱ last week whether they would extend their student vaccine requirement to learners ages 5 to 11, should shots be approved for that age group.

Whether or not student vaccination mandates continue to expand, Shu believes the real-world outcomes from COVID shots should encourage parents who may be on the fence.

“More than 5.5 billion doses of COVID vaccine have been given worldwide,” she points out. “I hope that builds confidence for parents to give it to their children.”

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CDC Director OKs Booster Shots for Teachers and Other Frontline Workers /cdc-director-oks-booster-shots-for-teachers-and-other-frontline-workers/ Fri, 24 Sep 2021 16:21:08 +0000 /?p=578143 Updated, Sept. 27

In a highly unusual move, Centers for Disease Control and Prevention Director Dr. Rochelle Walensky on Friday overruled a recommendation delivered by an advisory panel of her agency — paving the way for teachers to receive booster shots of the Pfizer-BioNTech coronavirus vaccine.

Teachers and other school workers inoculated with the Pfizer vaccine may now receive third doses at least six months after receiving their second shot. Those under 65 years old should make their decision based on the “individual benefits and risks,” the CDC said.


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“If … you’re a frontline worker, like a health care worker or a teacher, you can get a free booster now,” said President Joe Biden in remarks on Friday.

In addition to essential workers, senior citizens and adults with underlying health conditions are also eligible, meaning a total of some 60 million Americans will soon have access to third doses, including 20 million already eligible because six months have elapsed since their second Pfizer shot.

Walensky’s decision comes as the final play in a days-long drama between the Food and Drug Administration, which on Wednesday in their list of groups recommended for boosters, and the CDC, whose Advisory Committee on Immunization Practices voted on Thursday to leave those in high-exposure occupations off the list.

The CDC director then broke with her agency’s recommendation early Friday morning, endorsing third doses for those working in high-risk fields.

“As CDC Director, it is my job to recognize where our actions can have the greatest impact,” Walensky said in a . “I believe we can best serve the nation’s public health needs by providing booster doses for the elderly, those in long-term care facilities, people with underlying medical conditions, and for adults at high risk of disease from occupational and institutional exposures to COVID-19.”

President Biden delivers remarks on booster shots and his administration’s COVID-19 response from the White House Sept. 24. (Anna Moneymaker/Getty Images)

But while some educators may soon line up for third doses, others are resistant to even get their first or second shot.

An Education Week survey from the summer found that of teachers nationwide do not intend to get vaccinated, while 87 percent reported that they had already been immunized. More recently, a Sept. 24 poll from the American Federation of Teachers found that and that 67 percent favor a vaccine requirement for all school staff. The exact nationwide totals of vaccinated school personnel remain unclear.

In New York City, where teachers had been expected to provide proof of vaccination by Monday, Sept. 27, many schools have dozens of teachers who have not yet complied with the mandate, including some sites with up to 100 staff without proof of immunization, said Mark Cannizzaro, president of the Council of School Supervisors and Administrators, in a Friday press conference.

“Principals and superintendents have been reaching out consistently to tell us that they are concerned about not having enough staff come Tuesday morning, Sept. 28,” he said.

A federal appeals court judge on Friday New York City’s vaccine mandate for Department of Education staff, delaying its enforcement. But late Monday, the federal court Chalkbeat reported, clearing the way for the city to require staff to provide proof of vaccination or be placed on unpaid leave.

Alongside New York City, Los Angeles and Chicago, the second- and third-largest districts in the country, are also requiring teachers to be immunized without providing regular testing as an alternative. The same is true for Washington, Oregon and the District of Columbia. Seven other states require educators to choose between COVID vaccination or regularly undergoing testing for the virus, according to an EdWeek .

But even where mandates are supposedly in place, , meaning that many unvaccinated teachers remain in the classroom, often teaching students who themselves are not yet eligible for shots. Students aged 12 and up are authorized for COVID vaccines, and children aged 5 to 11 may gain access by Halloween.

Further still, data from the University of Washington’s Center on Reinventing Public Education show that the majority of school districts do not require teachers to be vaccinated, said Director Robin Lake.

“That is a major unresolved problem,” she wrote in an email to Ӱ. “Why do we keep giving teachers priority access to the vaccine without requiring they all do their part to protect kids?”

President Biden urged the more than 70 million Americans eligible for shots who have still not received immunizations to reconsider their choice.

“We have the tools to beat COVID-19,” he said. “Get vaccinated.”

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COVID Shots Safe and Effective for Children Ages 5 to 11 /covid-vaccine-authorization-for-children-ages-5-11-possible-within-weeks-after-pfizer-trials-find-shots-produce-robust-immune-response/ Mon, 20 Sep 2021 15:26:00 +0000 /?p=577914 Updated

In a pivotal development for school coronavirus safety, Pfizer-BioNTech announced Monday that its vaccine was for children ages 5 to 11 in trials.

These are the first such results for this age group in the U.S., and data have not yet been peer-reviewed or submitted to the Food and Drug Administration for emergency use authorization. The pharmaceutical company plans to apply for approval to use the shot in children , the New York Times reports, meaning that millions of 5- to 11-year-olds could be inoculated before Halloween if the regulatory review goes as smoothly for this age group as it did for adolescents.


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The trial included 2,268 participants ages 5 to 11 who were each given a two-dose regimen of the vaccine 21 days apart. Children were given a 10 microgram dose, smaller than the 30 micrograms administered to older children and adults, which the drug company said was a carefully selected dosage for safety, tolerability and effectiveness.

One month after the second dose, the shots produced an immune response and side effects comparable to that delivered by the larger dose in 16- to 25-year-old patients, Pfizer said. A company spokesperson confirmed to CNN that there were in the trial, a type of heart inflammation that has been linked with mRNA vaccines in boys and young men.

The results come at a pivotal time, as children now make up and as the highly contagious Delta variant has sent more children into hospitals in the past few weeks than at any other point in the pandemic.

“Since July, pediatric cases of COVID-19 have risen by about 240 percent in the U.S. — underscoring the public health need for vaccination. These trial results provide a strong foundation for seeking authorization of our vaccine for children 5 to 11 years old, and we plan to submit them to the FDA and other regulators with urgency,” said Albert Bourla, Pfizer’s chairman and CEO.

The trial results are a hopeful indication that shots will be available for young children before the winter months, when low temperatures complicate outdoor activities and ventilation across much of the country.

“We are pleased to be able to submit data to regulatory authorities for this group of school-aged children before the start of the winter season,” said Dr. Ugur Sahin, BioNTech’s CEO and co-founder.

​​Pfizer said it is expecting to release trial data for children as young as 6 months “as soon as the fourth quarter of this year.”

Already in the first weeks of the school year, tens of thousands of students have been forced out of class due to infection or exposure to the virus, oftentimes with sparse learning opportunities while they self-isolate. In Mississippi, where the state does not require that masks be worn in school, more than in just one week and over 20,000 students and staff were in quarantine.

Even as quarantines stack up, worst-case outcomes among healthy children — like chronic illness or death — still remain “vanishingly rare,” health experts told Ӱ earlier this month.

But with schools across the country scrambling to regularly test their student bodies as a screening measure against viral spread, the now-likely approval of shots for elementary schoolers before the winter may provide an alternate route for mitigation, and could open the door for more widespread COVID vaccine mandates for students in school.

Earlier this month, Los Angeles Unified became the country’s first major school district to require student vaccinations with a rule dangling full vaccination by the winter holidays as a necessary step to remain learning in person for students 12 and up. Culver City, California and Hoboken, New Jersey made similar moves in late August.

LAUSD officials chose not to comment when asked by Ӱ whether they would extend their student vaccine requirement to learners ages 5 to 11, should shots be approved for that age group.

In late August, the FDA gave full authorization to coronavirus shots for individuals ages 16 and up. Health experts are mixed on whether schools should mandate that 12- to 15-year-old students, who are currently approved for doses under emergency use authorization, receive the vaccine, according to interviews Ӱ conducted in early September.

Authorization of shots for younger learners “starts to open the door” for wider student vaccine requirements, Benjamin Linas, professor of medicine at Boston University, told Ӱ.

“We can and do mandate vaccines (like shots protecting against measles, mumps and rubella) for students all over the place, every day in this country,” he said. “We should treat [the COVID shot] like we treat all vaccines.”

Without mandates, districts may have trouble persuading their younger children to get immunized. Though youth ages 12 and up have been eligible for doses since May, only 43 percent of 12- to 17-year-olds are fully vaccinated, according to the American Academy of Pediatrics. After a high of 1.6 million pediatric vaccinations per week in late May, the rate has since fallen to 273,000 weekly doses in mid-September.

“It’s going to be an uphill battle addressing [vaccine] hesitancy in schools,” said Linas.

Learn more about the vaccine results for 5- to 11-year-olds here:

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Ask the Doctor: Did We Misunderstand the Risk of COVID for Kids? /ask-the-doctor-did-we-miscalculate-the-risk-of-covid-for-kids/ Mon, 13 Sep 2021 13:01:00 +0000 /?p=577546 Not so long ago, it seemed the data on COVID-19 held a degree of comfort when it came to children: not too many of them got infected, fewer still got sick and almost none were hospitalized. As for schools, they were not believed to be super spreaders of the virus, for either adults or students.

And then came the Delta variant.

Pediatric coronavirus cases have now surged above 250,000 for the first time since the start of the pandemic, according to . Hospitalizations of children stricken by the highly transmissible strain are reaching and some of students across the country last week were quarantining away from schools that had just barely begun. With a swiftness that surprised even health experts, the virus has across some 278 districts in 35 states, according to the website Burbio, a data service that tracks school calendars.

As for the adults in schools, at least have died of the virus since mid-August and shut down all its schools earlier this month after two teachers perished in the same week.

The Delta drumbeat of distress is one of the main reasons that President Joe Biden came out Thursday with a new plan of attack, including mandatory vaccinations for some 300,000 school staff members working for federal programs, such as Head Start or schools operated by the Bureau of Indian Education, and grants for districts confronting loss of funding for implementing mask mandates.

It will take some time to tell if Biden’s new strategy will be successful in beating back this latest surge. Right now, many parents and school officials are in a state of anxiety about how to keep their K-12 communities safe and perhaps questioning whether they miscalculated the strength of the COVID-19 enemy.

Complicating the matter further, decisions to implement basic virus mitigation measures in school have in some cases exploded into or even .

Amid the uncertainty and high tensions, and with , Ӱ spoke directly to health experts for clarity on how to understand the virus in this critical stage and tips on how to safely navigate the back-to-school season.

Here’s what they had to say:

1 We’ve seen a surge in pediatric coronavirus cases. Should we abandon the prior wisdom that kids rarely catch COVID, and when they do, it’s not too serious?

Not exactly.

“[The Delta variant] is more infectious, but it’s not a whole new game,” explained Benjamin Linas, professor of medicine at Boston University.

The variant’s high transmissibility has pushed up case counts, including among children, he told Ӱ. But serious illness among young people remains “vanishingly rare,” he said — citing a case fatality rate of .00003 for those under 20.

“This underlying reality that kids are at far less risk of severe COVID-19 than adults remains true, even with Delta.”

Young people do represent a larger share of infections nationwide now than they did at the outset of the pandemic. But that’s likely because far fewer minors than adults are vaccinated, and many remain ineligible for shots, said Kristina Deeter, professor of pediatric medicine at University of Nevada, Reno School of Medicine.

In most cases, “[kids] are not as sick as the adults,” she agreed.

Still, Rebecca Wurtz, professor of health policy at the University of Minnesota, cautions that the risk of infection remains high, particularly for the unvaccinated. The idea that young people couldn’t catch or spread COVID was always silly, she told Ӱ, and the Delta variant means that transmission is now easier than ever before.

“Delta will find you if you are not thoughtfully masking and social distancing,” she said.

2 Does the Delta variant make kids sicker than previous strains?

There is no conclusive evidence that it does, according to the experts.

“The jury’s still out,” said Deeter.

Studies from Canada and Scotland have found that than those infected with previous mutations of the virus.

And while those papers don’t examine virulence specifically among young people, Wurtz believes it could still be “reasonable to extrapolate that to kids.”

Evidence from the U.S., however, seems to contradict the idea that Delta causes more severe infections among youth. Even as pediatric COVID cases have surged, the proportion of children and adolescents hospitalized with severe disease has , points out Amruta Padhye, pediatric infectious disease specialist at the University of Missouri.

The hospitalization rate among unvaccinated adolescents was , recent CDC data reveal.

3 After the Pfizer vaccine’s full approval from the FDA, parents may now theoretically seek “off-label” vaccines for children under 12. Should they do so?

In short, no.

Although the FDA’s full approval of the Pfizer vaccine for those 16 and up means that doctors now have the power to prescribe the shot “” to any individual regardless of age, it would be irresponsible to do so, said Deeter.

The biggest unknown, she explained, is dosage. She prescribes drugs off label every day as a pediatrician, but explained that the COVID vaccine is different because it’s still so new.

“I don’t feel safe even deciding on what dose I might want to prescribe for a child. I have no idea what’s going to work,” she said, explaining that too much vaccine could elevate risks such as myocarditis, already more prevalent in young vaccine recipients than adults, and too little vaccine might not provide adequate protection against the coronavirus.

“There’s a reason that we have the approval process, even in the middle of a crisis,” added Linas. “I don’t recommend going out to get your child vaccinated before the vaccine has actually been approved or emergency authorized for kids.”

Youngsters aged 5 to 11 are expected to become eligible for coronavirus shots , experts say. The process has stretched out over months in part due to federal health regulators efforts to bolster confidence in the shots by in clinical trials.

Once shots are approved for that age group, they will be the most effective way to keep children healthy, said Linas.

“With the vaccine, you’re very well protected from the bad outcomes.”

4 Should schools implement vaccine mandates for staff?

Immunization requirements for school staff have multiplied since the FDA issued full approval for the Pfizer vaccine. ​, , and multiple other states have enacted rules requiring educators to receive the COVID shot or be regularly tested for the virus.

In his Thursday address, which unveiled new vaccination rules covering two-thirds of all U.S. workers, President Biden to help move the needle on teacher immunization from its reported 90 percent level up to 100 percent.

“Vaccination requirements in schools are nothing new,” said the president.

Expecting teachers to be immunized against COVID represents a sound public health policy, says Linas.

“It’s reasonable for school districts … to say to their educators and staff… ‘We have an expectation that if you’re going to come into our buildings where we have our unvaccinated children, we expect you to be vaccinated. And if you won’t do that, then I’m sorry, you can’t teach.’”

That strategy also minimizes learning disruptions, pointed out Janet Englund, professor of pediatrics at the University of Washington School of Medicine.

“When a teacher gets sick, he or she is unable to perform his or her job,” she told Ӱ.

5 What about vaccine mandates for students?

Very few school districts have extended vaccine mandates to students, as 12- to 15-year-olds remain eligible for shots only on an emergency authorization basis, and those under 12 are still ineligible.

On Thursday, however, Los Angeles Unified School District, which serves 600,000 students, became the first major U.S. school district to require that eligible students attending school in person be fully vaccinated against the coronavirus. Students 12 and older in the nation’s second-largest school system will have to receive their second dose of the shot by Dec. 19, officials announced.

Culver City, California and also instituted similar requirements for students in late August. Experts told Ӱ that they expect the vaccination rules to face legal challenges.

Although Englund said she is a believer in many student vaccine mandates — they helped control diseases such as measles and polio, she pointed out — requiring a vaccine that is approved only on an emergency use authorization may be premature.

“It’s not quite time,” she said.

Dr. Anthony Fauci, however, expressed his while speaking on CNN in late August, and the University of Minnesota’s Wurtz told Ӱ that she is “absolutely in favor of mandatory vaccinations for students,” due to the high safety and efficacy of COVID shots.

6 How effective are masks and other safety mitigation measures at slowing the spread of COVID in school?

Experts agree that safety measures to slow the spread of COVID are more effective when implemented in tandem with multiple others than on their own.

“[Masking] has to be a part of a layered protection strategy,” UCLA professor of pediatrics Ishminder Kaur told Ӱ.

That means that classrooms should employ all strategies available to them, she said: universal masking, ventilation, distancing, outdoor activities and rigorous testing to keep infected students out of the classroom.

Doing so can result in schools effectively containing the virus and keeping case rates below those of surrounding communities, academic studies show.

Although quarantining students exposed to the virus can disrupt academics, experts said it is a necessary step to contain transmission. They pointed out that with widespread access to testing, a negative result after five days may allow students to return to the classroom more quickly. On Thursday, Biden announced that the White House will move to make 280 million rapid and at-home tests available using the Defense Production Act and lower the cost of over-the-counter tests from Walmart, Kroger and Amazon.

Some districts’ quarantine protocols are more stringent than those recommended by the CDC, according to a recent survey of 100 districts from the University of Washington’s Center for Reinventing Public Education.

Some observers have recently made the case that the , but Kaur points out that a recent study from Bangladesh with a randomized design — considered the “gold standard” in causal research — finds that , though it cautions that cloth masks may be less effective.

And while masking controversy has turned many school board meetings ugly, including in Broward County, Florida where the board chair said “all hell broke loose” when they required face coverings in defiance of Gov. Ron DeSantis’s order, kids don’t actually seem to mind wearing masks, said Kaur.

“They’re not fidgeting, they’re not touching it,” she said of the youngsters who come into her clinic. “It’s the new normal for them.”

Deeter, who works in a sedation clinic and has to ask kids to remove their masks, has observed the same.

“They get so upset when I try to take it off of them. It’s their buddy,” she said.

7 Outside of school, what’s the best way to navigate playdates and other social activities?

The number one tip, experts say, is to stay outside as much as possible.

“Outdoor activities were not the ones that were spreading these infections, which remains true even for Delta,” said Kaur, although she recommended avoiding overcrowded locations even outside. For example, coaches calling players into a huddle might ask everyone to momentarily mask up.

Even when the weather gets cold, Wurtz recommends limiting indoor hangouts. She suggests some compromises: building a snowman outside then coming indoors for hot chocolate at the end, perhaps.

8 What’s the COVID end-game for schools?

Once all students have had the opportunity to receive COVID vaccinations, it could be time to consider rolling back virus mitigation protocols, Linas said, and beginning the conversation about how to live with a virus that within the global population. But that’s still a long way out.

“We’re not there yet,” he said.

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As FDA Clears Pfizer Vaccine for Teens, Experts Say Young Kids on Track for 2022 /vaccinating-all-students-as-fda-authorizes-pfizer-doses-for-teens-experts-say-kids-younger-than-12-should-be-able-access-vaccines-by-early-2022/ Tue, 11 May 2021 19:39:33 +0000 /?p=571941 Get essential education news and commentary delivered straight to your inbox. Sign up here for Ӱ’s daily newsletter.

Amid Monday’s announcement that the Food and Drug Administration was extending access to the Pfizer-BioNTech COVID-19 vaccine to adolescents (ages 12-15), experts also shared updated timelines regarding the vaccination of younger children in middle schools, grade schools and early education programs.

“We hope to have some data in the 11-and-under [population] by the fall,” Pfizer’s Dr. William Gruber , pointing to the ongoing safety trials involving young children.

“Perhaps as early as the end of the year, we would be in a position where that vaccine could be made available to at least 5- to 11-year olds, if not the younger age groups,” he said. “But certainly by the early part of next year.”

But looking ahead to 2022, when nearly all American students will be eligible for a vaccine, issues of access may be quickly overshadowed by parents’ concerns surrounding safety.

The big question going forward for elementary schools: How many families will choose to have their children vaccinated?

A recent Kaiser Family Foundation survey found that less than a third of parents say they are willing to get their child vaccinated immediately.

While 29% of parents of children 17 and under said they would seek out vaccinations “right away,” 15% said their child would only be vaccinated if a school requires it and 19% said they definitely wouldn’t seek vaccinations. The remaining 32% said they would wait to vaccinate their child until they had seen how the vaccine was working with others in the community.

More data from the safety trials should be available this fall; here’s some of Ӱ’s recent coverage surrounding vaccines, parent perspectives and school safety during the pandemic:

Adolescents: FDA studies show Pfizer vaccine even more effective for children ages 12-15 than for adults (Read more)

School Requirements: Why K-12 districts are unlikely to require student vaccinations this fall (Read more)

Immune Systems: As adults move toward herd immunity, could an unexpected COVID side effect be kids unable to fight off germs long-term? (Read more)

Returning to Normal: One Texas town, two school districts, clashing mask policies (Read more)

Restoring Trust: How 2 D.C. principals restored Black parents’ trust in returning kids to the classroom (Read more)

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COVID Vaccine Approved for 17 Million Adolescents; Studies Show 100% Effective /fda-authorizers-pfizer-vaccine-for-nearly-17-million-adolescents-between-the-ages-of-12-and-15-studies-show-even-greater-effectiveness-for-teens-than-adults/ Tue, 11 May 2021 00:50:54 +0000 /?p=571913 Get essential education news and commentary delivered straight to your inbox. Sign up here for Ӱ’s daily newsletter.

The Food and Drug Administration for the Pfizer-BioNTech COVID-19 vaccine “to include adolescents 12 through 15 years of age.” 

The Centers for Disease Control and Prevention’s vaccine advisory committee has also scheduled a meeting Wednesday to review the data, where the agency is expected to similarly approve this extension of the EUA.

As CBS News reported Monday evening, vaccinations could begin within days of that CDC approval, though recent surveys continue to point to a substantial number of parents who say they’re unlikely to vaccinate young children:

The new age range means that nearly 17 million adolescents are now eligible for the vaccine. Nearly half of that population are children of color, including one in four who are Hispanic, 13.4% are Black and 4.8% are Asian.

Studies conducted by Pfizer showed the vaccine was not only safe for teenagers, but also nearly eliminated all risk of catching COVID-19 — a level of effectiveness that was greater than that of adults. 

“This is a watershed moment in our ability to fight back the COVID-19 pandemic,” Dr. William Gruber of Pfizer told the Associated Press. “We actually had higher antibody responses in the 12- to 15-year-olds, so that gives us real confidence.”

In the FDA statement , the agency broke down the effectiveness data of the recent vaccine trial: “In this analysis, among participants without evidence of prior infection with SARS-CoV-2, no cases of COVID-19 occurred among 1,005 vaccine recipients and 16 cases of COVID-19 occurred among 978 placebo recipients; the vaccine was 100% effective in preventing COVID-19.”

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