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FDA panel meets to consider COVID-19 shots for ages 5-11

FDA panel meets to consider COVID-19 shots for ages
5-11 1

Advisers to the Food and Drug Administration are debating Tuesday whether to recommend the COVID-19 vaccine from Pfizer-BioTech for emergency use in 5- to 11-year-olds, setting the stage for shots to become available to 28 million school-aged children by the start of November.

An authorization will spark a heated debate, as some parents are more worried about potential side effects from a vaccine than a virus that has killed about 100 in this age group out of 737,000 deaths overall. Green-lighting the vaccine for kids also will accelerate fights over mandates in schools.

“There are strong feelings that have clearly been expressed by members of the pubic both for and against the use of the Pfizer-BioNTetch under emergency use authorization for this age group of 5- to 11-year-old children,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research. “To be clear, today’s discussion is going to be about the scientific data that are presented, and it’s not about vaccine mandates, which are left to other entities outside of FDA.”

“I ask that we keep our discourse today civil and focus on the science related to this issue so we can get through a productive discussion,” Dr. Marks said.

The panel will hear from the Centers for Disease Control and Prevention on how COVID-19 has impacted this age group, and Pfizer scientist William Gruber will discuss its trial involving 4,400 children. Enrollment was far less than the tens of thousands in initial trials in adults, though the company and regulators use a technique known as “immuno-bridging” to measure antibody responses versus older groups and draw inferences about the vaccine’s ability.

Whether children are likely to see similar rates of myocarditis, an inflammation of the heart muscle, as older age groups — especially young adult males — will be a prominent topic of discussion.

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The meeting, which is being streamed online, will feature comments from the public and a vote on whether to recommend the vaccine for 5- to 11-year-olds.

If the advisory panel recommends the vaccine, acting FDA Commissioner Janet Woodcock will decide whether to accept the decision and issue an emergency use authorization. The agency typically makes a decision within days of the advisory meetings.

A separate panel of CDC advisers will meet next week to discuss the vaccine and issue recommendations on how the FDA authorization should be applied in the real world. CDC Director Rochelle Walensky will decide whether to accept or reject their guidance.

From there, the Biden administration says it will be ready to distribute the vaccines to pediatrician offices and pharmacies once the vaccines are approved, hoping to fill a gap in the vaccination program as only 57% of the population is fully vaccinated.

The vaccines for children use a smaller dose than the ones given to adults. Federal officials said they worked with Pfizer to make sure packages of the childhood vaccines are clearly labeled and provide smaller vials and needles.

“Children are not simply small adults,” said FDA presenter Doran Fink, a deputy director in the clinical division.

Yet a wide swath of parents will be leery and weigh whether potential side effects outweigh their fear of the virus.

Doctors reported an uptick in child cases as the delta variant took hold and society opened up, though younger people have tended to avoid the worst outcomes from COVID-19, with 5- to 11-year-olds accounting for roughly 0.01% of reported deaths in the U.S.

Dr. Marks said that while children have seen better outcomes than older groups, they are “far from being spared.”

The age group has seen 1.9 million cases and 8,300 hospitalizations, about a third of which required intensive care unit stays, and there have been 2,500 reports of a multi-system inflammatory disorder from the virus.

“And there have also been close to 100 deaths, making it one of the top 10 causes of death in this age range during this time,” he said. “In addition, infections have caused many school closures and disrupted the education and socialization of children.”

Only 34% of parents said they would get their 5- to 11-year-old children vaccinated “right away” once the shots are available, according to a Kaiser Family Foundation poll released at the end of September.

That’s up from 26% in July, however, and the bulk of September interviews were conducted before Pfizer announced positive results from its trial in 5- to 11-year-olds.

Another 32% of parents said they would “wait and see” whether to bring forward a child in that age group. About 24% said they would “definitely not” get their kids in the group vaccinated, and 7% said they would do it only if required.

California Gov. Gavin Newsom recently announced he will mandate the COVID-19 vaccine for schools once it is fully licensed for relevant age groups.

The Democrat expects the approvals to track within two grade spans — seventh through 12th grade, and kindergarten through sixth grade. Given the expected timeline, the mandate might not take full effect until fall 2022.

Roughly 57% of the U.S. population is fully vaccinated, but the rate rises to two-thirds of Americans when looking at those who are eligible, meaning age 12 and older.

Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said recent papers show children transmit the virus as readily as adults in the “delta era” so vaccinating them could play a role in reaching sufficient immunity levels to control the virus within households and communities.

CDC presenters said 5- to 11-year-olds started to account for a greater share of cases when the delta variant hit over the summer. They made up about 10.6% of all cases in the week of Oct. 10 while making up 8.7% of the population in the most recent census.

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