F.D.A. Panel Meets Pfizer Vaccine for Young Children

Federal officials hope the pediatric dose can help close a major gap in the nation’s vaccine campaign that has worried parents, educators and public health leaders.,


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An F.D.A. panel is meeting on whether Pfizer-BioNTech’s vaccine should be authorized for young children.

It is unclear how many U.S. parents would quickly vaccinate their elementary schoolers with the Pfizer-BioNTech coronavirus vaccine if given the chance.Credit…LM Otero/Associated Press

Oct. 26, 2021Updated 9:29 a.m. ET

A key federal advisory committee began discussing Tuesday whether to recommend that a pediatric dose of the Pfizer-BioNTech coronavirus vaccine be offered to 5- to 11-year-olds, setting in motion a string of decisions that could lead to children getting shots as early as the end of next week.

Federal officials hope that the pediatric dose can help close a major gap in the nation’s vaccine campaign that has worried parents, educators and public health leaders. If the Food and Drug Administration grants authorization, about 28 million children will become eligible for shots. Only the youngest, those under 5, would remain uncovered.

Dr. Peter Marks, who heads the F.D.A. division that oversees vaccines, said that 1.9 million children aged 5 to 11 have been infected with the virus and more than 8,300 of them have been hospitalized, a third of whom needed intensive care. Nearly 100 have died, making Covid-19 one of the top 10 causes of death during the pandemic in this age group.

Children in this age range are “far from being spared from the harm of Covid-19,” he said.

The F.D.A.’s advisory committee of experts will hear from officials at the Centers for Disease Control and Prevention, who will discuss how Covid-19 has affected children and data on whether coronavirus vaccines are safe for them. Representatives from Pfizer will discuss the company’s clinical trial, involving more than 4,400 children.

The committee’s recommendations on whether to authorize vaccines are not binding, but the F.D.A. typically follows them in the days after the vote. The meeting is being streamed on YouTube.

It is unclear how many parents would quickly vaccinate their elementary schoolers if given the chance. Polling has showed that roughly a third of these parents are eager to do so right away, while a third prefer to wait. Since federal regulators cleared a full dose of the Pfizer-BioNTech vaccine for children 12 to 15 in May, 46 percent of that age group has been fully vaccinated, compared with about 69 percent of those 18 and older.

The dose for younger children would be one-third of the strength given to people 12 and older, with two shots given three weeks apart. Pfizer and BioNTech are asking the F.D.A. to authorize distribution on an emergency basis.

The process may go more smoothly than when the vaccine manufacturers sought authorization of booster shots for adults — an issue that preoccupied and divided the agency’s regulators and its outside experts for much of the past two months.

All recipients of Johnson & Johnson’s one-dose vaccine are eligible for a booster at least two months afterward. Recipients of the Pfizer-BioNTech and Moderna vaccines are eligible for boosters six months after their second injection if they fit the following broad categories: older adults, as well as younger adults with certain medical conditions or in risky jobs or living situations.

Pfizer has provided the F.D.A. with safety data on two study cohorts of children ages 5 to 11, both of roughly equal size. The first group was followed for about two months, the second for about two and a half weeks. Pfizer cited efficacy data only for the first group of about 2,200 children, saying its vaccine had an efficacy rate of 91 percent against symptomatic Covid-19.

What to Know About Covid-19 Booster Shots

The F.D.A. has authorized booster shots for millions of recipients of the Pfizer-BioNTech, Moderna and Johnson & Johnson vaccines. Pfizer and Moderna recipients who are eligible for a booster include people 65 and older, and younger adults at high risk of severe Covid-19 because of medical conditions or where they work. Eligible Pfizer and Moderna recipients can get a booster at least six months after their second dose. All Johnson & Johnson recipients will be eligible for a second shot at least two months after the first.

Yes. The F.D.A. has updated its authorizations to allow medical providers to boost people with a different vaccine than the one they initially received, a strategy known as “mix and match.” Whether you received Moderna, Johnson & Johnson or Pfizer-BioNTech, you may receive a booster of any other vaccine. Regulators have not recommended any one vaccine over another as a booster. They have also remained silent on whether it is preferable to stick with the same vaccine when possible.

The C.D.C. has said the conditions that qualify a person for a booster shot include: hypertension and heart disease; diabetes or obesity; cancer or blood disorders; weakened immune system; chronic lung, kidney or liver disease; dementia and certain disabilities. Pregnant women and current and former smokers are also eligible.

The F.D.A. authorized boosters for workers whose jobs put them at high risk of exposure to potentially infectious people. The C.D.C. says that group includes: emergency medical workers; education workers; food and agriculture workers; manufacturing workers; corrections workers; U.S. Postal Service workers; public transit workers; grocery store workers.

Yes. The C.D.C. says the Covid vaccine may be administered without regard to the timing of other vaccines, and many pharmacy sites are allowing people to schedule a flu shot at the same time as a booster dose.

On Friday, F.D.A. regulators said in an analysis of Pfizer’s pediatric trial data that the benefits of staving off Covid-19 with the vaccine generally outweighed the risks of the most worrisome side effects for young children.

Regulators modeled scenarios that involved varying levels of spread of the virus, and assumed the rate of two vaccine-associated heart conditions would be the same in the younger children vaccinated with a one-third dose as in adolescents aged 12 to 15 who received a full dose.

Federal health officials have said that cases of those heart conditions — myocarditis, or inflammation of the heart muscle, and pericarditis, inflammation of the lining around the heart — after the second dose of a vaccine tend to be mild and resolve quickly.

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