F.D.A. Panel Considering 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.,
Federal officials emphasize to a F.D.A. panel the benefits that Pfizer-BioNTech’s pediatric vaccine would bring.
Federal officials on Tuesday stressed the importance of a pediatric coronavirus dose to a key advisory panel, arguing that thousands of children between the ages of 5 and 11 have been hospitalized with Covid 19 and nearly 100 have died over the course of the pandemic.
The advisory panel to the Food and Drug Administration is scheduled to vote later Tuesday on whether to recommend authorization of Pfizer-BioNTech’s vaccine for that age group, setting in motion a string of decisions that could lead to children getting shots as early as the end of next week.
Younger children are “far from being spared from the harm of Covid-19,” Dr. Peter Marks, who heads the agency’s division that oversees vaccine approvals, told the committee. He said Covid-19 is now one of the top ten causes of death among children 5 to 11. Nearly two million in that age group have been infected and 8,300 have been hospitalized, a third of whom have needed intensive care, he said.
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 F.D.A. grants authorization, about 28 million children will become eligible for shots. Only the youngest Americans, children under 5, would remain uncovered. (You can watch the meeting here.)
The panel heard from F.D.A. and the Centers for Disease Control and Prevention experts about the risks and benefits of a pediatric dose, followed by a presentation from Pfizer on the results of its clinical trial involving about 4,500 children.
The committee’s recommendations on whether to authorize vaccines are not binding, but the F.D.A. typically follows them. The vote is expected to go more smoothly than a series of votes over recent weeks about whether to recommend authorization of boosters for adults, an issue that divided regulators and the outside experts that advise them.
Dr. Fiona Havers, a specialist in viral diseases at the Centers for Disease Control and Prevention, said that children aged 5 to 11 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. She said there appear to be many more cases of infection than are publicly recorded.
Covid 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. 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, she said.
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 adults.
Panelists were recently deluged by messages in an organized email campaign urging them to vote against recommending authorization, according to Dr. Paul Offit, a panelist who heads the Vaccine Education Center at Children’s Hospital of Philadelphia.
As of early Tuesday, nearly 140,000 public comments had been formally submitted to the agency on the issue. By contrast, only 66 comments were submitted before the panel recommended boosters for adult recipients of the Moderna and Johnson & Johnson vaccines.
As the meeting began, Dr. Marks said he wanted to acknowledge the “strong feelings” for and against authorization across the country, but stressed that the only question before the experts was whether to allow shots, 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.
Pfizer officials described 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. The company said the children tolerated the vaccine well, and no major safety concerns emerged.
Pfizer presented 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.
F.D.A. scientists reviewed their own analysis that found the benefits of staving off Covid-19 with a pediatric dose generally outweighed the risks of the most worrisome side effects. Hong Yang, an F.D.A. scientist, said that even in a scenario where the risk of infection is low as it was in June, vaccination’s benefits may outweigh the risks of possible side effects. That’s because people hospitalized with Covid-19 tend to be sicker, and for longer, than those with certain heart conditions tied to the vaccine.
She and other F.D.A. analysts modeled scenarios that involved varying levels of virus spread. They assumed the rate of two rare heart conditions would be the same in the younger children vaccinated with a one-third dose as in adolescents ages 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. None of the children involved in Pfizer’s clinical trial developed those conditions, but that was expected given the rarity of those diseases.
Pfizer said the pediatric doses would be in vials with orange caps instead of purple, and the vials would come in orange-colored packages in order to reduce the risk that providers would mistakenly give young children doses meant for those ages 12 and older.