pfizer-biontech – 蜜桃影视 America's Education News Source Fri, 11 Feb 2022 21:59:33 +0000 en-US hourly 1 https://wordpress.org/?v=6.7.2 /wp-content/uploads/2022/05/cropped-74_favicon-32x32.png pfizer-biontech – 蜜桃影视 32 32 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.聽


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Three doses 鈥渕ay provide a higher level of protection in this age group,鈥 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鈥 submission.聽

鈥淲e will provide an update on timing for the advisory committee meeting once we receive additional data on a third dose,鈥 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.聽

鈥淭his rollercoaster that parents under 5 (including me) are forced to ride is an absolute, unacceptable disaster,鈥 Katelyn Jetelina, assistant professor of epidemiology at the University of Texas School of Public Health, on Twitter. 鈥淧fizer 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.鈥

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

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 鈥 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.

鈥淚f 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 鈥 if they have a third dose approved, then they鈥檒l get through this course,鈥 explained Benjamin Linas, professor of medicine at Boston University. 鈥淏ut if they wait until they have all the data for the three-dose course, then they won鈥檛 even be able to get started.鈥

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.

鈥淎bsolutely, it should give families some peace of mind having their children two-dose vaccinated,鈥 he told 蜜桃影视.

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 .

鈥淎s a parent of a 3-year-old, this news does feel like light at the end of (the) tunnel,鈥 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 鈥渨ait and see鈥 before immunizing their kids in the most recent poll administered by the on parents鈥 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 鈥 but that the initial authorization of a two-shot regime allows youngsters to safely get started 鈥 he worries the eventual pivot could erode some parents鈥 faith in the shots. 

鈥淚f you don’t talk about it 鈥 it just creates this opportunity for misinformation, lack of trust, and then people shut down,鈥 he said. 鈥淭his is all about trust right now.鈥

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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.聽


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

The Omicron strain, listed as a 鈥渧ariant of concern鈥 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鈥檚 booster doses, experts say.聽

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鈥檚 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.

鈥溾嬧婽his study gives me great hope that our boosters will help protect against Omicron,鈥 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.

鈥淪ince 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,鈥 said Peter Marks, director of the FDA鈥檚 Center for Biologics Evaluation and Research. 鈥淎 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.鈥澛

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鈥檚 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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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鈥檚 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鈥檚 hospitals and pediatrician鈥檚 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鈥檚 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 鈥 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鈥檚 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鈥 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鈥檚 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鈥檚 Office of Biostatistics and Epidemiology.

鈥淭he benefits clearly outweigh the risks,鈥 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.

鈥淭he school closures and the disruption has been enormous,鈥 said the FDA鈥檚 Jeanette Lee. 鈥淲e have to weigh that against the benefits we would see [from] the vaccine.鈥

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鈥檚 recommendation as a win for school safety.

鈥淭his 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,鈥 she said in a statement. 鈥淓ducators, school staff and healthcare professionals are eager to work together with parents to help get America鈥檚 kids vaccinated in the places they trust, including public schools and community centers.鈥

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. 

鈥淚鈥檓 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,鈥 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鈥檚 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 鈥渞ight away鈥 once they were eligible, according to a Sept. 30 , while a third said they would 鈥渨ait and see鈥 and a quarter said they would 鈥渄efinitely not鈥 vaccinate their younger children. A by 鈥嬧媡he 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鈥檚 vote, Ashish Jha, dean of the Brown University School of Public Health, .

鈥淭hey got it right,鈥 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鈥 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 鈥 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 鈥渞obust鈥 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鈥檚 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鈥檚 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.

鈥淲hile we鈥檙e 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鈥 questions and ease concerns about the vaccines,鈥 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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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 鈥渞obust鈥 antibody response, including immunity and side effects comparable to that produced by the larger dose in 16- to 25-year-old patients.聽


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鈥淲ith 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,鈥 Pfizer Thursday.

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

Pressed on what issues will be on the table during that meeting and how soon afterward authorization might be granted, a spokesperson responded to 蜜桃影视 that the 鈥淔DA cannot comment on its interactions with manufacturers about their investigational products.鈥

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 蜜桃影视 last month.

鈥淲ith the vaccine, you鈥檙e very well protected from the bad outcomes.鈥

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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 鈥 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 鈥渋ndividual benefits and risks,鈥 the CDC said.


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鈥淚f 鈥 you’re a frontline worker, like a health care worker or a teacher, you can get a free booster now,鈥 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鈥檚 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鈥檚 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鈥檚 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鈥檚 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.

鈥淧rincipals and superintendents have been reaching out consistently to tell us that they are concerned about not having enough staff come Tuesday morning, Sept. 28,鈥 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鈥檚 Center on Reinventing Public Education show that the majority of school districts do not require teachers to be vaccinated, said Director Robin Lake.

鈥淭hat is a major unresolved problem,鈥 she wrote in an email to 蜜桃影视. 鈥淲hy do we keep giving teachers priority access to the vaccine without requiring they all do their part to protect kids?鈥

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

鈥淲e have the tools to beat COVID-19,鈥 he said. 鈥淕et vaccinated.鈥

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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. 鈥 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鈥檚 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.

鈥淲e 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,鈥 said Dr. Ugur Sahin, BioNTech鈥檚 CEO and co-founder.

鈥嬧婸fizer 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 鈥 like chronic illness or death 鈥 still remain 鈥vanishingly rare,鈥 health experts told 蜜桃影视 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鈥檚 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 蜜桃影视 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 蜜桃影视 conducted in early September.

Authorization of shots for younger learners 鈥渟tarts to open the door鈥 for wider student vaccine requirements, Benjamin Linas, professor of medicine at Boston University, told 蜜桃影视.

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

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.

鈥淚t鈥檚 going to be an uphill battle addressing [vaccine] hesitancy in schools,鈥 said Linas.

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

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After Pfizer Approval, New School Vax Rules; All NYC Educators Have Til Sept. 27 /new-vaccination-mandates-for-teachers-as-fda-grants-full-approval-to-pfizer-nyc-announces-all-education-employees-must-get-first-shot-by-sept-27/ Mon, 23 Aug 2021 17:44:04 +0000 /?p=576643 Eight months after the Food and Drug Administration first granted emergency use authorization of the Pfizer-BioNTech COVID-19 Vaccine, for all Americans 16 and older.

鈥淲hile millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated,鈥 said Acting FDA Commissioner Janet Woodcock .


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鈥淭oday鈥檚 milestone puts us one step closer to altering the course of this pandemic in the U.S.鈥

Surrounding the approval were several announcements of new vaccine requirements across the country from school districts, colleges, corporations and government agencies. In New York, school officials announced that New York City will require all 148,000 department of education employees to receive a first dose of the vaccine by Sept. 27. In Washington, D.C., the defense department will be mandating vaccinations for the nation鈥檚 1.4 million service members.

The FDA published a full news release Monday (see below); the agency also livestreamed its morning conference call with the media:

The Pfizer vaccine also continues to be available for younger students between the ages of 12 and 15 through the emergency use authorization approved last May.

A few of our recent reports on student vaccines and school safety going into the fall:

鈥擝ringing Vaccines to Schools: How NYC is aiming to make it easier for teens to access COVID vaccinations (Read more)

鈥擟DC Changes Definition of 鈥楥lose Contacts鈥 in Classrooms: Health experts now say properly protected students needn鈥檛 quarantine (Read more)

鈥擣补肠迟-颁丑别肠办: Are 90 percent of teachers really already vaccinated? The numbers say otherwise (Read more)

鈥擟ollege COVID Safe Zones: Open letter from former government officials 鈥 How higher education leaders can accelerate America鈥檚 vaccination push (Read more)

Click to read Monday鈥檚 full guidance from the FDA:

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