Pfizer, BioNTech seek FDA clearance for updated COVID-19 booster in children

Pfizer and BioNTech on Monday announced that they’ve asked the Food and Drug Administration to clear their two-pronged, or “bivalent,” vaccine as a booster shot for children between the ages of 5 and 11. 

The FDA authorized updated vaccines from Pfizer and Moderna in August, aiming to have them available ahead of an anticipated surge of COVID-19 cases in the winter. Both shots have components that target the ancestral strain of the coronavirus, as well as widely circulating sub-strains of the omicron variant. But those clearances only applied to people 12 and older, in Pfizer’s case. Moderna’s authorization was only for those 18 and up.  

Pfizer and Moderna have since focused on making teenagers and children eligible for the new shots. Currently, for instance, kids between 5 and 11 are only eligible to receive a third shot of Pfizer’s original vaccine. Children between 6 and 11 can get a booster of Moderna’s original shot.  

Both have now made formal requests to the FDA. On Friday, Moderna asked the FDA to make its bivalent shot available to kids as young as 6 years old. With its request on Monday, Pfizer is right behind. 

As with their authorization requests for adults, both developers are seeking clearances without completing human trials that prove the new vaccines are more effective than the old ones. Pfizer, for instance, is relying on preclinical data on the bivalent shot and human data from studies of a different omicron booster shot. Upon clearing the bivalent shots in adults, the FDA cited its process for annually updating flu vaccines, for which strain changes can be made without affecting safety. 

Still, the decisions have drawn criticism. Paul Offit, director of a vaccine center at the Children’s Hospital of Philadelphia and a member of the FDA advisory committee that reviews new shots, wrote an op-ed last week arguing regulators should be careful of “overselling” the new booster without supportive clinical data. The Centers for Disease Control and Prevention “risks eroding the public’s trust,” Offit wrote.

Already, uptake of the bivalent vaccines has been slow. According to CDC data, less than 2% of those eligible had received the new booster as of last week. Vaccination rates have been even lower in younger children. As of Sept. 14, only 31% of children aged 5 through 11 had received a primary vaccination. 

Pfizer is starting human trials for its new booster in children ages 6 months to 11 years years old. The study is similar to the tests that led to clearance, in kids, for its original vaccine. 

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