A key advisory committee to the Food and Drug Administration on Tuesday recommended a lower dose of Pfizer and BioNTech’s Covid-19 vaccine for children aged 5 to 11 is spreading.
Approval by the Agency’s Advisory Committee on Vaccines and Related Biological Products is now under review by the FDA, which could make a final decision in a matter of days. The vote was almost unanimous with 17 votes in favor and one abstention.
The agency does not always follow the advice of its independent committee, but it often does. A vaccine advisory group from the Centers for Disease Control and Prevention is expected to make its own recommendation next week. If there is confirmation and CDC Director Dr. Rochelle Walensky signs, recordings for young children could start immediately.
The Biden government said it plans to distribute the doses once it has been approved by the FDA and CDC, which is expected to happen early next month. The government said it had procured enough vaccine to vaccinate all 28 million 5-11 year olds in the US and will be distributing it in smaller doses and with smaller needles to make it easier for pediatricians and pharmacists to administer to children.
Many parents say they are eagerly awaiting approval of the vaccine as schools are now open in the US and the Delta variant is causing an increase in child cases.
Children ages 5-11 make up about 9% of all reported Covid cases in the US, according to data the FDA presented to the committee on Tuesday. The number of new Covid cases in children remains exceptionally high with more than 1.1 million new child cases in the past six weeks, according to the American Academy of Pediatrics.
Still, some parents and advocacy groups argue that Covid vaccinations are unnecessary for children, as studies show children are less likely to have symptoms of the disease even though they become infected at rates similar to adults.
Some committee members said Tuesday that vaccinating younger groups would help the US move towards the “endemic” phase of Covid, where the virus is still floating around but at a lower level than it is now. Others noted that there are still unknowns like the rate of myocarditis in young children, but still emphasized that the benefits of injections outweigh the risks. One member wondered if they should make recommendations only for children at risk.
“We do not want children to die of Covid, even if there are far fewer children than adults and we do not want them in the intensive care unit,” said member Dr. Amanda Cohn before the vote.
Before the vote, Dr. Peter Marks, the FDA’s chief vaccine regulator, urged committee members to keep today’s debate “civil”, saying there are strong sentiments on both sides.
“To be clear, today’s discussion will be about the scientific data that is being presented, and not about vaccine mandates that are left to other agencies outside of the FDA,” Marks said at the beginning of the meeting. “I ask that we keep our discourse civil today and focus on the science on this topic so that we can have a productive discussion.”
Pfizer asked the FDA on October 7th to approve its vaccine for children ages 5 to 11. The company released data showing that a two-dose regimen of 10 micrograms – a third of the dose used for adolescents and adults – is safe and has a strong immune response in a clinical trial in young children. The syringes are well tolerated and have caused an immune response and side effects that are comparable to those observed in a study with 16 to 25 year olds.
Dr. Doran Fink, an assistant director of the FDA’s vaccines division, said Tuesday a “small army” of FDA staff had been working around the clock for the past month to ensure that the data on children they presented today were as accurate as possible.
FDA staff released an analysis late Friday stating that lower doses of the Pfizer vaccine appear safe and highly effective in young children. They noted the increased risk of myocarditis and pericarditis, but said the benefits of the syringes, including preventing serious illness, hospitalizations, and deaths, would generally outweigh the risk of the rare inflammatory heart disease.
As of October 6, 1,640 cases of myocarditis had been reported in people under the age of 30 who had received the Covid vaccines from Pfizer or Moderna, said Dr. Mathew Oster, a CDC official, the FDA’s vaccines committee. Only 877 met the CDC case definition for myocarditis. He added the agency had not found increased rates of the disease in children ages 12-17.
This is a developing story. Please check again for updates.