A group of scientists who advise the Food and Drug Administration said the benefits of BioNTech /zigman2/quotes/214419716/composite BNTX +3.17% and Pfizer’s /zigman2/quotes/202877789/composite PFE +2.32% COVID-19 vaccine outweigh the risks for children between the ages of 5 and 11.
The 17-0 vote in favor of the vaccine puts the U.S. one step closer to the first authorization of a shot for this age group. One member abstained.
“Our kids are going to be dealing with this virus for many years to come,” Dr. Jay Portnoy, a pediatrician at Children’s Mercy Hospital in Kansas City and a temporary voting member of the committee, said Tuesday during the FDA advisory committee meeting. “Getting this vaccine is just the first step that they’re going to take toward being able to protect themselves from getting this virus and having bad outcomes.”
The next step is the FDA’s decision. The regulator is not required to follow the recommendation of the committee, but it often does.
The final regulatory stamp of approval has to come from the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices, which is set to meet next Tuesday and Wednesday, and the CDC director herself.
The proposed authorization for elementary school-aged children is different than the one granted for teens and adults. This formulation is also a two-dose vaccine, but the dosage is much smaller, at 10 micrograms dose administered 21 days apart. The regimen for individuals who are at least 12 years old who get the BioNTech/Pfizer vaccine is two 30-microgram doses 21 days apart.
The FDA said Friday that the clinical trial showed that the vaccine had an efficacy rate of 90.7% against symptomatic infection in 2,268 elementary school-age children seven days after they got the second shot. The most common side effects from the study were pain at the injection site, fatigue and headache, and no serious adverse events were associated with the vaccine in the study, according to the FDA.
There are more than 25 million children in the U.S. between the ages of 5 and 11 years old, many of whom are back in classrooms and relying on other mitigation measures like masks and distancing to avoid getting sick.
“We can’t forever have mitigation, particularly in schools,” said Dr. Hayley Gans, a pediatrician at Stanford University Medical Center and one of the committee’s acting chairs. “Children need the more open life as we all do.”
About 6.3 million children have had COVID-19 during the course of the pandemic, making up about 16% of all cases in the U.S., according to the American Academy of Pediatrics .
“COVID-19 is an ongoing threat for the more than 28 million young children in this age group in the U.S.,” Kathrin Jansen, Pfizer’s head of vaccine research and development, said in a statement. “Immunizing children will help to get us closer to herd immunity, with the potential to stem the pandemic sooner.”
Even with committee members all in favor of the FDA authorizing the vaccine for young children, the discussion on Tuesday raised questions about implementing a uniform policy for vaccinating this age group. Some clinicians urged the FDA to think about making a more flexible authorization that could take into account different dosing regimens.
Committee members also asked about safety risks for younger children, including the risk of myocarditis, a type of inflammation of the heart.
This is a very rare but documented side effect that has occurred after a small number of people have received the second shot of the mRNA vaccines developed by BioNTech/Pfizer and Moderna Inc. /zigman2/quotes/205619834/composite MRNA +1.73% .
“We know that this many mothers and fathers and parents are eager to administer this vaccine to children,” Dr. Cody Meissner, director of pediatric infectious disease at Tufts Medical Center in Boston and a committee member, said Tuesday. “This vaccine should be available for those parents who who are very eager to get it for their child and because their child has a comorbidity.”
Meissner went on to say that he is worried that an authorization could lead to states mandating vaccinations for children.
“I think that would be an error at this time until we get more information about the safety,” he concluded.