Among those who have challenged the need for boosters at this point are two senior FDA officials who recently announced they will retire from the agency this fall, a move seen to be motivated by their disagreement with the administration on the booster question. Marion Gruber and Phil Krause, director and deputy director, respectively, of FDA’s Office of Vaccines Research and Review, were also co-authors of a paper published Monday in The Lancet that argued against the need for booster shots for the general public at this time.
The FDA documents assessed questions about the safety of giving a third dose of the vaccine, noting that for some issues, there are no answers. For instance, it is not known if a third dose would trigger elevated rates of myocarditis and pericarditis, a side effect seen mainly in males under the age of 40.
“It is currently not known if there will be an increased risk of myocarditis/pericarditis or other adverse reactions after a booster dose of Comirnaty. These risks and associated uncertainties have to be considered when assessing benefit and risk,” the agency’s scientists wrote. Comirnaty is the brand name of Pfizer’s vaccine.
In the Kaiser data, the efficacy of the vaccine at preventing SARS-CoV-2 infection with the Delta variant dropped from 93% for those vaccinated less than one month to 53% for those vaccinated more than four months ago.
I tried to share information on the meeting when it was first announced, since the public is allowed to both submit comments (which will be provided to the committee) and to make a presentation/speech at the meeting (which will be live streamed to everyone). Unsurprisingly, it was deleted from everywhere but NoNewNormal.win (surviving post here). Even /r/LockdownSkepticism deleted my post.
Most important parts:
Monthly boosters incoming.
The meeting will be streamed to the public, please watch if you are able. Information and meeting materials can be found here: https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-september-17-2021-meeting-announcement
I tried to share information on the meeting when it was first announced, since the public is allowed to both submit comments (which will be provided to the committee) and to make a presentation/speech at the meeting (which will be live streamed to everyone). Unsurprisingly, it was deleted from everywhere but NoNewNormal.win (surviving post here). Even /r/LockdownSkepticism deleted my post.