An FDA advisory committee voted Wednesday to recommend both the Pfizer-BioNTech and Moderna COVID-19 vaccines for children as young as six months old.
Late Wednesday afternoon, the U.S. Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee unanimously voted to recommend both Pfizer-BioNTech‘s and Moderna’s COVID-19 vaccines for children as young as six months old.
The Pfizer-BioNTech vaccine for children six months through four years of age would be a series of three shots, the first two given three weeks apart, with a third dose eight weeks after the second vaccine. The Moderna two-shot vaccine would be for kids six months through five years.
This follows Tuesday’s decision by the same committee when the members voted unanimously to recommend emergency use authorization (EUA) for Moderna’s COVID-19 vaccine for children ages six to 17.
The next steps will include the agency deciding whether to amend the existing EUAs to include those ages. If they do, an advisory committee of the U.S. Centers for Disease Control and Prevention (CDC) will decide whether to make their recommendations on their usage. This vote will occur on Friday or Saturday.
Although younger children are less likely to become infected and have severe symptoms from COVID-19 than adults, there is still a risk. In particular, the Omicron variant and its subvariants have proved to be more infectious and more able to evade immunity, even from previous infections and vaccines.
FDA representatives told the advisory committee that deaths in the U.S. from COVID-19 in children under the age of five has been relatively small, but it “compared terribly” to the 78 deaths cited during the swine flu pandemic of 2009-2010.
“I think we have to be careful that we don’t become numb to the number of pediatric deaths because of the overwhelming number of older deaths,” Dr. Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, said in a statement.
Paul Offit, M.D. of Children’s Hospital of Philadelphia raised the question of why the Pfizer-BioNTech and Moderna COVID-19 vaccines, which had been approximately equivalent, do not seem to be in the youngest children. Two doses of the Moderna vaccine offer some protection to children 23 months and younger, but it’s not clear if two doses of the Pfizer-BioNTech shots work the same way.
The panel indicated it was difficult to answer the question with the data available. The Pfizer-BioNTech data appears to be preliminary and not completely clear, or in the words of Doran Fink, M.D., Ph.D., deputy director in the office of vaccines at the FDA, “preliminary, imprecise, and potentially unstable.”
Still, levels of neutralizing antibodies appear to show the Pfizer-BioNTech vaccine is sufficient enough to protect the children to justify an EUA. This is why Pfizer and BioNTech recommended a three-dose series for the youngest age group.
In their studies, Pfizer and BioNTech indicated that their three-dose vaccine for kids ages six months through four years was 80% effective at preventing disease from the Omicron variant. The children are given three micrograms, one-tenth the dose given to adults. But the efficacy was only 14.5% seven days after the second dose.
In this regard, Pfizer and BioNTech recommended three shots would be the primary dose, instead of a third shot as a booster. One problem is that the 80% figure is based on only seven cases in the placebo group and three in the vaccine group. Still, the advisory panel apparently believed that the data on efficacy and safety, and the general need for vaccines for this age group justified an EUA.
Dr. Jay Portnoy, M.D., professor of pediatrics at Children’s Mercy Hospital in Kansas City, Mo., told The New York Times, “I know that the death rate from COVID and young children may not be extremely high. It’s absolutely terrifying to parents to have their children be sick. There are so many parents who are absolutely desperate to get this vaccine, and I think we owe it to them to give them the choice.”
