F.D.A. Panel Endorses Pfizer-BioNTech Vaccine for Children 5 to 11

A major Food and Drug Administration advisory committee voted overwhelmingly to recommend the use of Pfizer-BioNTech’s coronavirus vaccine in 5- to 11-year-olds, bringing the vaccine a big step closer to about 28 million children. The recordings could be offered as early as next week.

The panel approved to give the age group one-third the dose given to people 12 years and older in two shots, three weeks apart. The committee’s recommendations on whether or not to authorize vaccines are not binding, but the FDA usually follows them up in the days following the vote.

That will turn the matter over to the CDC, which has its own panel of experts scheduled to weigh in next week.

FDA outside experts voted after regulators claimed 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. Seventeen committee members voted for the pediatric dose; one abstained.

During a long debate beforehand, some committee members questioned whether every child in the age group really needed the vaccine or whether it should be limited to those at high risk of severe Covid-19.

dr. Paul Offit, a panelist who heads the Vaccine Education Center at the Children’s Hospital in Philadelphia, said it was “nervous” to make public health decisions that affect millions of children based on studies involving just a few thousand participants. .

But he said: “The question is when do you know enough? And I think we know for sure that there are a lot of kids between the ages of 5 and 11 who are susceptible to this disease who could very well be sick and be hospitalized or die from it.”

dr. Peter Marks, head of the department overseeing vaccine approval, told the committee that Covid-19 is now one of the top 10 causes of death among children aged 5 to 11. Nearly two million in that age group have been infected and 8,300 have been admitted. in the hospital, a third of whom needed intensive care, he said.

Federal officials hope the pediatric dose could help close a major gap in the US vaccine campaign that worries parents, educators and public health leaders. If the FDA grants approval, approximately 28 million children will be eligible. Only the youngest, children under 5, would be left uncovered.

dr. Fiona Havers, a viral disease specialist at the CDC, said children ages 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 get infected, she said. She said there appear to be many more cases of infection than have been publicly recorded.

Covid hospitalization rates in the 5 to 11 age group are three times higher for black, Hispanic or Native American children than for white children, she said. More than 2,000 schools with more than a million students had to close between early August and October due to outbreaks, she said.

The CDC also presented blood test data indicating that 42 percent of young children had antibodies, raising the question of whether many of them were infected and developed natural immunity. dr. Havers warned, however, that the children tested were already under clinical care and may not represent the general population.

“Clearly there are still many susceptible children who are vulnerable to serious illness,” she said.

It’s unclear how many parents would quickly vaccinate their primary school students if given the chance. Polls show that about a third of these parents would like to do so right away, while a third would rather wait. Since federal regulators approved Pfizer injections for children ages 12 to 15 in May, 46 percent of that age group have been fully vaccinated, compared with about 69 percent of adults.

Panelists were recently inundated with messages in an organized email campaign urging them to vote against recommending authorization, said Dr. off.

What you need to know about Covid-19 booster shots

Who is eligible for a booster shot?

The FDA has authorized booster shots for millions of recipients of the Pfizer-BioNTech, Moderna and Johnson & Johnson vaccines. Recipients of Pfizer and Moderna who are eligible for a booster include people 65 and older and younger adults at high risk of severe Covid-19 due to medical conditions or where they work. Eligible Pfizer and Moderna recipients can receive a booster at least six months after their second dose. All Johnson & Johnson recipients are eligible for a second injection at least two months after the first.

Can I exchange Covid vaccines for a booster?

Yes. The FDA has updated its authorizations to allow medical providers to incentivize people with a different vaccine than the one they were initially given, a strategy known as “mix and match.” Whether you’ve been given Moderna, Johnson & Johnson, or Pfizer-BioNTech, you can get a booster from any other vaccine. Regulators have not recommended one vaccine over another as a booster. They have also kept quiet about whether it is preferable to stick with the same vaccine if possible.

What underlying medical conditions are eligible for a booster injection?

The CDC has said the conditions that qualify a person for a booster injection are: 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 (ex-)smokers are also eligible.

Which professions are eligible for boosters?

The FDA approved boosters for workers whose jobs put them at high risk of exposure to potentially infectious people. The CDC says that group includes: medical workers; education workers; food and agricultural workers; factory workers; corrections employees; US Postal Service workers; employees in public transport; grocery store workers.

Can I get a flu shot at the same time as a Covid vaccine or booster vaccination?

Yes. The CDC says the Covid vaccine can be administered without regard to the timing of other vaccines, and many pharmacies allow people to schedule a flu shot at the same time as a booster dose.

dr. Marks said he wanted to acknowledge the “strong feelings” for and against authorization, but stressed that the only question for the experts was whether to allow shots, not whether to oblige them.

But dr. H. Cody Meissner, a panelist and chief of the Division of Pediatric Infectious Diseases at Tufts Children’s Hospital, said he was concerned that consent would soon be followed by vaccine requirements for schoolchildren.

A. Oveta Fuller, an infectious disease expert at the University of Michigan, said, “If I were a parent of a child in this age group, I’d like to have the choice and they can’t have the choice unless the vaccine is available .” But she wondered whether the government would adequately detect any adverse side effects.

Pfizer officials described safety data on two study cohorts of children ages 5 to 11, both of approximately 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, and said the vaccine had a 91 percent efficacy rate against symptomatic Covid-19.

FDA scientists reviewed their own analysis showing that the benefits of averting Covid-19 with a pediatric dose generally outweighed the risks of the most worrisome side effects. Hong Yang, an FDA scientist, said that even in a scenario where the infection risk is low like in June, the benefits of vaccination outweigh the risks of potential side effects. That’s because people hospitalized with Covid-19 tend to be sicker and taller than people with certain heart conditions linked to the vaccine.

Federal health officials have said that cases of heart disease the FDA considered — myocarditis, or inflammation of the heart muscle, and pericarditis, inflammation of the lining around the heart — tend to be mild and resolve quickly after the second dose of a vaccine. None of the children involved in Pfizer’s clinical trial developed those conditions, but that was to be expected given the small trial size and the rarity of those diseases.

Comments are closed.