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

A key federal advisory committee was discussing on 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 U.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. Only the youngest, those under 5, would remain uncovered.

Dr. Peter Marks, who heads the F.D.A. division that oversees vaccines, said at the meeting 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 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.

Dr. Fiona Havers, a specialist in viral diseases at the Centers for Disease Control and Prevention, said that children in this age group make up 10.6 percent of all cases but only 8.7 percent of the population. Children have higher levels than adults of the neutralizing antibodies that are essential for preventing infection, she said, but are at least as likely as adults to be infected, she said.

Antibody tests of children also suggested there are many more virus cases than are publicly recorded Dr. Havers said.

Hospitalization rates in the 5 to 11 age group are three times as high for Black, Hispanic or Native American children as for white children, she said. She stressed the impact of the pandemic on childhood education, saying that more than 2,000 schools with a total of over one million students were forced to close between early August and October because of outbreaks.

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. (You can watch the meeting here.)

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 Pfizer shots 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.

An organized email campaign against giving the vaccine to younger children got underway over the weekend, with panel members deluged by messages urging to vote against recommending authorization, according to Dr. Paul Offit, a panelist who heads the Vaccine Education Center at Children’s Hospital of Philadelphia.

According to the F.D.A.’s website, as of early Tuesday the agency had received nearly 140,000 comments on the issue from the public so far — a number that federal officials described as strikingly high. As he opened the meeting, Dr. Marks said: “I want to acknowledge the fact that there are strong feelings that have clearly been expressed by members of the public both for and against” authorization. He stressed that the only question before the experts was whether shots should be allowed, not whether to mandate them.

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.

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.

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.

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.

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 rare 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.

Source: NYT > U.S. > Politics

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