After more than seven hours of meeting, the experts of the U.S. regulator’s advisory panel gave the green light to the recommendation, with 17 votes in favor and one abstention. The committee had to vote “yes” or “no” on the question of whether the benefits of administering the two doses of the Pfizer/BioNTech vaccine outweigh the risks in children between 5 and 11 years of age.
The FDA must now issue its own decision on the matter, expected around Nov. 1, and later the Centers for Disease Control and Prevention (CDC) must scrutinize immunization in this age group, which is estimated to encompass as many as 28 million people in the United States.
The CDC’s own advisory committee is scheduled to meet Nov. 2-3 to examine vaccine data in children ages 5-11 before the agency’s director, Rochelle Walenksy, has the final say on the matter.
Tuesday’s vote came after intense debate over the safety of the vaccines in minors, since in some cases they have been linked to a heart condition called myocarditis, which involves inflammation of the heart.
In that regard, some FDA panel members stressed the need for more information before recommending the Pfizer/BioNTech serum for children between the ages of 5 and 11, while others stressed that the data on its efficacy and safety are sufficient to move forward.
Expert Hong Yang, Risk-Benefit Assessment Advisor in the FDA Office of Biostatistics and Epidemiology, discussed several possible scenarios on the evolution of the pandemic and in all of these cases considered that the benefits of immunizing children “clearly” outweigh the risks. Yang acknowledged that there is a theoretical risk of myocarditis, which is more present in those vaccinated, especially in young boys, although for her it is possible that the benefits of immunization are still “strong”.
Children’s Hospital of Philadelphia vaccine expert Paul Offit expressed reservations. “I think it’s always stressful for me to be asked to make a decision for millions of children based on studies done on only a few thousand children,” Offit said. Still, “I think I know enough to go ahead and vote ‘yes,’ but you know, you don’t always know everything, though, when do you know enough?” this expert reflected.
A CDC pediatrician, Matthew Oster, presented data from a study of children aged 12 to 17 years during the session, noting that they have not detected higher rates of vaccine-caused myocarditis in that group. In May, the U.S. gave the green light to Pfizer’s injection for adolescents aged 12 and older.
Oster explained that myocarditis can occur in minors with multisystem inflammatory syndrome caused by covid-19. According to the CDC, although it is not known exactly what causes this syndrome in which several parts of the body become inflamed, it is known that in many cases it occurs in children who have had covid or who were close to a covid-positive child.
For its analysis, the CDC followed the cases of 5,000 children with the covid-related syndrome and, according to Oster, the agency has “not yet seen any signs” connecting it to vaccines. Specifically, the CDC identified 24 volunteers who had been immunized before contracting the syndrome, of whom 18 had been infected with covid. “We have not seen high rates of vaccine-associated MIS-C (as that myocarditis is known) in infants and older children,” Oster said.
These data did not convince everyone, including the advisory committee member who abstained from voting, Michael Kurilla, an infectious disease expert at the National Institutes of Health (NIH). Kurilla felt that the recommendation should be only for those children between the ages of 5 and 11 at risk for severe covid-19, not for this entire age group. He added that if the child has had covid before, he or she may not even need to be immunized.
Prior to Tuesday’s meeting, Pfizer released data four days ago on its vaccine for children aged 5 to 11 years, following a trial involving 2,000 children. According to the pharmaceutical company, its serum against covid-19 is 90.7% effective in children between those ages.
The results of the experiment showed that three of the immunized children became infected, compared to the 16 who contracted the disease in the group of children who received a placebo. The company pointed out that twice as many children received the vaccine as those who were injected with the placebo.
Last October 7, Pfizer and BioNTech applied to the FDA for authorization for the emergency use of their vaccine in children between 5 and 11 years of age. So far, the FDA only authorizes its use from 12 years of age.