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FDA Grants Full Approval To Pfizer COVID-19 Vaccine
What Happened: On Monday, The Food and Drug Administration granted full approval to Pfizer-BioNTech’s COVID-19 vaccine for people aged 16 and up. This is the first COVID-19 vaccine to move out of emergency use status in the United States.
In order to get approval, Pfizer claims it provided the F.D.A. with data from 44,000 clinical trial participants in United States, the European Union, Turkey, South Africa and South America. Pfizer claims their data shows the vaccine was 91 percent effective in preventing infection.
“The public and medical community can be confident that although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the U.S.,”
Dr. Peter Marks, the F.D.A.’s top vaccine regulator
FDA regulators are still in the process of reviewing Moderna’s application for full approval which could take several weeks. Further, Johnson & Johnson is expected to apply for full approval soon as well.
Our own investigation suggests vaccine efficacy is much more complicated than Pfizer claims, and a more nuanced understanding is required to inform the public of what efficacy truly looks like. You can see our investigations here and here.
Some people who have looked through the FDA's document about this approval are misinterpreting a paragraph which states:
"This product has not been approved or licensed by FDA, but has been authorized for emergency use by FDA, under an EUA to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 12 years of age and older; and.."
This refers to the older vaccine doses that were distributed under the EUA and old name. New, licensed doses are fully approved, and Pfizer selected the name "COMIRNATY" for its approved vaccine.
The FDA document claims the new product is "legally different" yet the same when it comes to "safety and effectiveness." What is legally different? We don't know. We know the name is different, but other than that Pfizer has not made this clear.
The EUA also still applies to vaccine doses for 12 - 15 year olds.
Nonetheless, the vaccine has been approved.
Why It Matters: Now that full FDA approval is in place, we're likely to see vaccine requirements and mandates take off intensely. Hospitals, colleges, corporations and other organizations will now likely look to mandate their workers be vaccinated, while still offering reasonable accommodation via religious or medical exemption.
Authors anecdote with regards to reasonable accommodation: In my investigations and conversations with people and healthcare workers, I have been told on numerous occasions that doctors have been weary to grant medical exemption to patients.
For example, The Pentagon, who said it would mandate the shots for the country’s 1.3 million active-duty troops once the Pfizer approval came through, will no longer be held back from mandating the shot.
For those who are choosing to hold off on vaccination because they feel it is not necessary for their health, pressure will now rise and companies will have more lee-way in mandating the vaccine for workers.
Rumblings of this upcoming approval may be why Montana recently banned vaccine requirements for employees, which effectively makes it very difficult for those who are unvaccinated to be discriminated against for their choices.
Of course, there are a multitude of reasons, beyond basic personal choice, as to why vaccine mandates and passports are being pushed back against. We explored them in a recent report here.
Update Aug 24, 2021, 8AM: Added insight into the false claims being spread that this vaccine wasn't actually approved.