Comirnaty is the trade name for the Pfizer BioNTech COVID-19 vaccine. With full FDA approval of Pfizer Comirnaty official, it’s time to add it to the spell check on our phones. Fierce Pharma says the name is a potpourri that mashes several concepts together. Those thoughts are community, immunity, mRNA and COVID. And so there’s an echo of a feeling of a world community somewhere in it.
The Process From Emergency to Full Use Authorization
U.S. Food and Drug Administration FDA provisionally approved Comirnaty for emergency use in December 2020. This was after the agency determined the benefits outweighed potential risks during a public health emergency, according to New York Times.
However, this provisional nod added to brewing public uncertainty concerning the safety of vaccinations generally. To many, this was a fair question. If the Pfizer vaccine was safe, why not say simply so. So what changed?
The trials did not end in December 2020. Monitoring of primary and secondary outcomes continued according to Wikipedia. But the primary survey ended as scheduled in August 2021. And it demonstrated conclusively the vaccine was effective against severe COVID-19 symptomatic disease.
However, monitoring for the second outcome will continue through to January 2023. This will assess the overall efficacy of Comirnaty against non-severe COVID-19 too. The scientific logic behind these trials is complex. There’s a link to Annals of Internal Medicine if you would like to explore this further.
Will Hesitancy Diminish with Full FDA Approval of Pfizer Comirnaty?
We sure hope it does, for the sake of everybody. The FDA’s full approval rests on data from approximately 44,000 people, that showed 91% primary efficacy. Although much of this data came from the pre-delta period.
Acting FDA commissioner, Janet Woodcock has said the public ‘can be very confident the vaccine meets high safety, effectiveness and manufacturing quality standards.’ This approval is thus essentially permanent.
It’s been evident for some time many are holding back from vaccinations because of uncertainty over safety. Let’s hope the full FDA approval of Pfizer Comirnaty convinces more people to have their shots. So we can get on with the deadly serious business, of ending this pandemic that’s stealing lives.
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