“Today, FDA approved the first COVID-19 vaccine for the prevention of #COVID19 disease in individuals 16 years of age and older,” per an official U.S. Food & Drug Administration (FDA) tweet.
Acting FDA Commissioner Janet Woodcock, M.D. said, “The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic. While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product.”
Today’s full approval by the FDA removes one of the stumbling blocks that supposedly kept some Americans from getting the vaccine shot, that it “wasn’t fully studied and approved.”
As Peter Marks, M.D., Ph.D., director of FDA’s Center for Biologics Evaluation and Research said, “Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine. We evaluated scientific data and information included in hundreds of thousands of pages, conducted our own analyses of [its] safety and effectiveness, and performed a detailed assessment of the manufacturing processes, including inspections of the manufacturing facilities.”
Of course, some people still won’t be satisfied. They’ll wonder if FDA considered the ‘research’ and ‘findings’ of that random guy who posted on Facebook. If not, then they will deem the FDA determination to be lacking credibility.
However, for rational readers, FDA detailed the basis for the approval process, stating “Specifically, in the FDA’s review for approval, the agency analyzed effectiveness data from approximately 20,000 vaccine and 20,000 placebo recipients ages 16 and older who did not have evidence of the COVID-19 virus infection within a week of receiving the second dose. The safety of Comirnaty [the new name for the Pfizer-BioNTech vaccine] was evaluated in approximately 22,000 people who received the vaccine and 22,000 people who received a placebo 16 years of age and older.”
No doubt, some Trumpsters and COVID skeptics will ask why the study didn’t include hydroxychloroquine and bleach – and now ivermectin, in addition to placebos and the vaccine, in order to be absolutely thorough. If not, they may still need to do their “own research.”
FDA found that “Based on results from the clinical trial, the vaccine was 91% effective in preventing COVID-19 disease.” It also stated that “More than half of the clinical trial participants were followed for safety outcomes for at least four months after the second dose. Overall, approximately 12,000 recipients have been followed for at least 6 months.”
The full FDA approval should make it even easier for companies and localities to require vaccinations for employees and those seeking to enter their businesses or facilities. It will be interesting to see whether pro-COVID governors like DeSantis, Abbott, and Ducey will use this development as a basis to relax their anti-vaccine mandate/consequences positions, which have caused them considerable political fall-out.
Hardcore wackos likely will still not be persuaded by the FDA’s action. Look for them to assert their “freedoms” by promoting new COVID relief measures, like guano (to prove to their comrades that they’re batshit crazy, too) and meadow muffins (to show that they really do swallow the bullshit). For sane Americans, however, the FDA full approval of the vaccine is welcome news, indeed.