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.

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.

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:

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.

Get stories like this delivered straight to your inbox. Sign up for ����Ӱ�� Newsletter

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.

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.

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.��

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.

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��.

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 .

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.

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.

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.

Their shots, delivered as two 25-microgram doses spaced four weeks apart, produced a similar immune response in young children as two larger doses did in adults. In a 6,700-participant randomized trial the vaccines triggered no safety concerns such as myocarditis or multisystem inflammatory syndrome, the company said in a .

“We now have clinical data on the performance of our vaccine from infants six months of age through older adults,” said Moderna CEO Stéphane Bancel. “Given the need for a vaccine against COVID-19 in infants and young children we are working with the U.S. FDA and regulators globally to submit these data as soon as possible.”

The update offers a glimmer of hope to many parents frustrated that their young children remain ineligible for immunizations more than two years into the pandemic, and who expressed dismay following a dramatic reversal last month from Pfizer-BioNTech, which withdrew its request for FDA approval of shots for children under 5 just days after submission.��

“As an [infectious disease] doc and dad, I’ve been eagerly awaiting these data for 15 months now — sounds like we’ll see them soon. Fingers firmly crossed,” Roby Battacharyya on Twitter.

Trial data show shots were 43.7% and 37.5% effective in preventing illness among children 6 months to 2 years old and 2 years to under 6 years old, respectively. No immunized children in the study suffered severe disease or death, but neither did any youngsters in the control group who received no vaccine doses.��

Jacqueline Miller, Moderna’s senior vice president for infectious diseases, hypothesized that the lower efficacy reflected the Omicron variant’s ability to evade immune defenses. Regardless, she said, the shots convey a level of protection.

“What I will say is 37.5% and 43.7% are higher than zero,”, . “If I were the parent of a young child, I would want there to be some protection on board, especially if we see another wave of infections.”

The news comes as school mask mandates continue to drop across the country. Some 92% of the largest 500 school districts did not require face coverings as of March 23 compared to only 58% at the beginning of the month and 35% at the beginning of February, according to the .

On Tuesday, New York City Mayor Eric Adams announced that on April 4 the nation’s largest school district will be dropping its mask rule for toddlers 2- to 4-years old, which had stayed in place even after the city lifted its K-12 mandate.

Meanwhile, COVID cases in Europe are , fueled by the more transmissible Omicron subvariant BA.2. Even as infections continue to , many experts warn that the increases across the pond could foreshadow a coming wave in America.

As of March 16, 27% of children 5- to 11-year old and 57% of children 12- to 17-years old had completed their two-dose vaccine series, according to the .

“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.”

“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:

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.��

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 .

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.��

“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.

“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.”

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. 

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.”

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.

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.

“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.”

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.

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.

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.”

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.

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.

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 .

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.��

Get stories like this delivered straight to your inbox. Sign up for ����Ӱ�� Newsletter

“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.”

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.”

Get stories like this delivered straight to your inbox. Sign up for ����Ӱ�� Newsletter

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

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.”

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.

Get stories like this delivered straight to your inbox. Sign up for ����Ӱ�� Newsletter

“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.”

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.”

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.

Get stories like this delivered straight to your inbox. Sign up for ����Ӱ�� Newsletter

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:

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.