The US Meals and Drug Administration says the potential advantages of the Pfizer/BioNTech vaccine outweigh the dangers for 16- and 17-year-olds, Dr. Peter Marks, director of FDA’s Middle for Biologics Analysis and Analysis, mentioned throughout a information briefing on Saturday.
FDA has an extended historical past of evaluating pediatric vaccines and extrapolating information from adults to youngsters, he mentioned.
“Based mostly on all the pieces we noticed from trying on the information, we’re very snug that the protection profile that was noticed in 17- and 16-year-olds was acceptable,” Marks mentioned, even when the research group wasn’t as massive because it was for older folks.
Though teenagers hardly ever develop into significantly unwell from Covid-19, Marks acknowledged some do develop into very sick and die. And, teenagers are in a position to transmit the virus “fairly simply” – even when they’re asymptomatic.
“Since a few of these 16- and 17-year-olds, not less than that I do know of, are on the market as checkout folks, or interacting with communities, it might be smart that we’re in a position to vaccinate them,” Marks mentioned. “So we predict the identified and potential advantages outweigh the identified and potential dangers.”
It can take a couple of months earlier than it’s clear how the vaccine impacts transmission of the virus, Marks mentioned.
On pregnant ladies: Selections about whether or not pregnant ladies ought to take Pfizer and BioNTech’s Covid-19 vaccine ought to be thought of on a person foundation, Marks mentioned.
“Covid-19 in a pregnant girl will not be an excellent factor, so somebody may determine that they wish to be vaccinated, however that is not one thing that we’re recommending right now. That is one thing we’re leaving as much as the person,” Marks mentioned.
Marks mentioned that the scientific trials of the vaccine, which didn’t enroll pregnant ladies however included ladies who grew to become pregnant through the trials, didn’t yield sufficient information to make a dedication for that inhabitants.
“For pregnant ladies and the immunocompromised – simply at this level – it will likely be one thing that suppliers might want to contemplate on a person foundation for sufferers,” mentioned Marks.