FDA advisory panel authorizes Pfizer's vaccine for children 5-11

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A key federal advisory committee voted Tuesday to recommend emergency authorization of the Pfizer mRNA COVID-19 vaccines for children between the ages of 5 and 11, a sign that the shot will likely be authorized for this age group in the next week.

Following today’s vote, acting FDA Commissioner Janet Woodcock is expected to shortly deliver the agency’s final determination on whether to authorize the vaccine for this age group. Once the FDA gives final approval, the next step is for a CDC vaccine expert panel, the Advisory Committee on Immunization Practices, to review the vaccine’s safety and efficacy. That group would then vote on whether CDC Director Rochelle Walensky should recommend its use. The CDC committee is scheduled to meet on Nov. 2, and the CDC director will likely announce a final decision within hours, meaning these vaccines could be available as early as Nov. 3.

If approved, the Pfizer vaccine will be the first pediatric COVID-19 vaccine. At a White House briefing last week, the Biden administration said it had a plan to ensure these shots were ready to be administered quickly to up to 28 million American children.

“I do think we need it as a tool in our armamentarium for our children, for equity issues, for parents who really would like to protect their children and because of the long-term, very profound implications of schools being disrupted and the social and educational impact that [COVID-19] is having on our children,” said Mark Sawyer, an infectious disease specialist who was one of 17 members who voted in favor of the vaccine for children 5 to 11. One member of the 18-member committee abstained from Tuesday’s vote, while the 17 others voted to approve.

Although children are less likely to get severely ill from COVID-19, Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said 1.9 million children between the ages of 5 and 11 have been infected, resulting in 8,300 hospitalizations and more than 2,500 cases of multisystem inflammatory disorder.

“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,” Marks said.

According to data presented by Pfizer that was analyzed by the FDA, the mRNA vaccine is more than 90 percent effective against symptomatic disease for children in this age group, and side effects reported in the studies were comparable to those seen in older Americans for which the vaccine has already been approved, the FDA experts said.

After reviewing the safety and efficacy data, the panel of experts recommended that the Pfizer vaccine be given as a series of two doses consisting of 10 micrograms, and administered three weeks apart for children in this age group.

Among some of the concerns brought up by the experts related to vaccinating younger children was the risk of myocarditis, a rare condition that is an inflammation of the heart muscle.

Dr. Matthew Oster, a member of the CDC’s COVID-19 Vaccine Task Force, presented some data on myocarditis to the FDA committee and said so far officials had received 1,640 reports of myocarditis in vaccinated people under 30. The cases include 877 that met the CDC’s case definition for the heart condition, and 637 cases that remained under review.

Myocarditis has been associated with the mRNA vaccines. However, since it has been most commonly reported among young men after the second dose, particularly in ages 18-24, Oster and other experts speculated this might indicate that risk will be smaller for 5- to 11-year-olds than it is for teens.

Another aspect that made the decision difficult for many of the committee members today was the limited data available. The Pfizer trial, which drove the decision, had just 2,268 participants.

"It’s always nerve-racking, I think, when you’re asked to make a decision for millions of children based on studies of only a few thousand children," said Dr. Paul Offit, a vaccine researcher at Children’s Hospital of Philadelphia and a committee member. "The question is, when do you know enough? And I think we certainly know that there are many children between 5 and 11 years of age who are susceptible to this disease who could very well be sick and are hospitalized or die from it,” he added.

Sawyer said deploying the vaccine for these children, however, was the only way to compile this crucial information.

“We are not going to get the data unless we start to use this vaccine,” Sawyer said.

A few things remain unclear based on the data that was presented at the FDA meeting Tuesday. One, it is not clear yet what effects the vaccine will have on transmission for this age group. The Pfizer study wasn’t designed to study this in particular, but Dr. William Gruber, a scientist at Pfizer, said that “real world evidence” has suggested that vaccination reduces transmission in adults, adding that “it’s reasonable to expect that there’ll be some reduction in transmission” for kids.

Another question that remains is whether boosters will later be necessary for these children. According to Pfizer, the company does not have that information at the moment, but expects to know after a six-month follow-up whether antibody levels would decrease in children similarly as they have in vaccinated adults.

Some of the experts also expressed concern about whether the authorization would quickly lead to school vaccination mandates for children 5 to 11. Dr. Cody Meissner, a pediatrician from Tufts University, said school mandates were a major concern given the limited data available.

"I think that would be an error at this time until we get more information about the safety,” Meissner said.

Sawyer added it is important to keep in mind that today’s decision was “going to be a fluid situation,” saying that “an EUA [emergency use authorization] is not a permanent situation and that things could change based on either additional side effects data or depending on what happens with the pandemic.”

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