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FDA panel gives green light to pediatric COVID-19 vaccines

Vaccines for those under 5 could be shipped to states as soon as next week

A Moderna COVID-19 vaccine awaits administration at a vaccination clinic in Los Angeles. A CDC advisory panel on Thursday recommended boosters designed to better respond to newer variants of the coronavirus.
A Moderna COVID-19 vaccine awaits administration at a vaccination clinic in Los Angeles. A CDC advisory panel on Thursday recommended boosters designed to better respond to newer variants of the coronavirus. (Frederic J. Brown/AFP via Getty Images)

Food and Drug Administration vaccine advisers took a crucial step Wednesday toward opening COVID-19 vaccines to all Americans by recommending the agency authorize the life-saving shots for kids under 5 — the last age group to receive access.

The agency’s independent vaccine advisers unanimously agreed, 21-0, that the benefits of both the Pfizer and Moderna vaccines outweigh the risks, although some raised concerns with aspects of the Pfizer shot.

The FDA is expected to issue the long-awaited emergency authorization for both companies’ vaccines within hours of the advisers issuing their recommendations, and toddlers could roll up their sleeves as soon as next week. Roughly 20 million children under age 5 in the United States may be eligible for vaccination.  

The two vaccines being considered during Wednesday’s meeting are not identical.

The Pfizer shot, for children 6 months to 4 years old, is a three-dose vaccine with three micrograms per dose. Moderna’s shot, for kids 6 months to 5 years, is a two-dose vaccine with 25 micrograms.  

Moderna’s shot is 36.8 percent effective in preventing symptomatic COVID-19 in kids 2 to 5 years old, and 53.5 percent effective in preventing symptomatic disease in kids ages 6 months to 23 months old.

The shot induced an antibody response in young kids similar to that in people 18 to 25, company representatives told the committee. Fevers were the most common side effect, and high fevers were not common and resolved within a couple of days. 

The Pfizer shot has fewer side effects but is less effective than the Moderna shot.

William Gruber, Pfizer senior vice president for vaccine clinical research and development, told the committee that the company focused on creating an effective shot for toddlers that had few side effects, but as a result it doesn’t provide nearly as much protection as Moderna.   

Two doses of Pfizer’s vaccine results in just a 28.3 percent protection against symptomatic COVID-19.

Third shot

The company said that a third shot would substantially up this protection, as high as 80 percent protection against disease. But that prediction isn’t based on much data, as trials are still ongoing.   

Pfizer representatives told the committee they are confident the third-dose boost seen in adults will replicate in young kids and provide ample protection against the omicron variant.  

Paul Offit, an infectious disease expert at Children’s Hospital of Philadelphia, said he is concerned the Pfizer shot offers little protection after dose two, and that Pfizer may have underdosed. He worries parents may not fully understand that their child will not be protected after two doses.

“I think it will certainly offer something, but that two-dose data was surprisingly poor,” Offit said.

Archana Chatterjee, dean of the Chicago Medical School, said physicians and families need to be educated about the importance of all three Pfizer shots.  

Kids under 5 were the last group to enter clinical trials for COVID-19 vaccines, and parents, pediatricians and lawmakers have been eager to get them vaccinated.

But as eager as some are, there are skeptics. As few as 20 percent of parents plan to vaccinate their toddlers right away, according to the Kaiser Family Foundation.  

A larger portion of parents, nearly 40 percent, say they’ll wait and see how the vaccine is working for others. Another 40 percent don’t plan to get their child vaccinated, with 11 percent only doing so if required.  

Even though vaccines for kids 5 to 11 have been available since November 2021, fewer than 30 percent in that age group are fully vaccinated.  

Peter Marks, head of the FDA Center for Biologics Evaluation and Research, kicked off the meeting by encouraging vaccine advisers not to become numb to pediatric deaths because of all the adult COVID-19 deaths the country has seen during the pandemic. As of May 28, there were 442 COVID-19 deaths in children under age 6. He said that the FDA has issued vaccines for diseases that cause similar amounts of illness and death in kids.  

In an unusual move, Rep. Louie Gohmert, R-Tex., took part in the public comment section of the meeting and reiterated a litany of anti-vaccine talking points. He called the pediatric vaccination effort a “dystopian experiment.”  

Gohmert said he is working on a bill he hopes to introduce if Republicans win the House majority in November that would allow civil and criminal liability for vaccine providers, despite emergency use authorization.  

“I’m deeply concerned that the push to vaccinate these children is nothing more than a dystopian experiment with unknown consequences,” Gohmert said.   

Centers for Disease Control and Prevention vaccine advisers plan to meet Friday and Saturday to discuss and vote on the vaccines. If they recommend the shots and CDC Director Rochelle Walensky signs off on the measure, the administration will begin shipping doses to states.