The US Food and Drug Administration (FDA)’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) has voted 17-0 with one abstention to recommend Pfizer-BioNTech’s COVID-19 vaccine, Comirnaty, in children aged 5-11.
The panel of experts reviewed data from Pfizer-BioNTech and an analysis from the FDA to balance the risks and benefits of vaccination.
Although the panel looked at the “totality of scientific evidence”, this included results from a phase 2/3 trial of 4,500 children that showed “a favourable safety profile, robust immune responses and a vaccine efficacy rate of 90.7%”, said the companies.
The children aged 5-11 received two 10-µg doses of Comirnaty administered 21 days apart – one-third of the 30-µg dose used for people 12 years and older.
“COVID-19 is an ongoing threat for the more than 28 million young children in this age group in the US,” said Pfizer’s head of vaccine R&D Kathrin Jansen. “About 10% of all weekly US cases occur in children of 5 to under 12 years of age with a potential risk of complications. In addition, immunising children will help to get us closer to herd immunity, with the potential to stem the pandemic sooner.”
The FDA is expected to make a decision quickly, although the vaccines cannot be administered to children until the Centers for Disease Control and Prevention’s advisory committee has given the jab a thumbs up.
The discussions during the VRBPAC meeting showed that some of the experts had concerns about the vaccine being used too widely among younger children.
“The best way to protect the health of some kids would be to do nothing at all because they’re going to be just fine,” said James Hildreth, president of Meharry Medical College in Nashville. “But there are lots and lots of children for whom this vaccine will be the difference between health and even life.”
“The FDA is a regulatory agency… not a recommending body,” added Paul Offit, a vaccine researcher at Children’s Hospital of Philadelphia. “What they do is they allow this vaccine to be distributed in that age range. And how the CDC defines who gets it is not our purview.”
The key concern among the experts was the risk of side effects from the vaccine, specifically the risk of myocarditis and pericarditis, which appear to affect 1 in 10,000 older boys and young men who are vaccinated with Comirnaty.
However, the panel eventually agreed with the FDA’s own analysis that the risk of getting COVID-19 far outstripped the risk of serious side effects, even when the prevalence of the virus was relatively low.
Pfizer and BioNTech have also submitted requests for authorisation of its COVID-19 vaccine in this age group to other regulators around the world, including the European Medicines Agency.