Pfizer BioNTech COVID-19 vaccine gets full FDA approval, and mandates could be on the way
Full approval by the U.S. agency could also go a long way in boosting confidence in the vaccines.
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On Monday, Aug. 23, nine months after receiving emergency authorization from the U.S. Food and Drug Administration (FDA), the Pfizer BioNTech two-shot COVID-19 vaccine became the first of three vaccines to get full approval for usage in the country.
Back in December 2020, the Pfizer vaccine was the first authorized by the FDA for emergency use to combat what was then a dire COVID-19 situation heading into Christmas.
Today, the situation isn’t as dire in all parts of the country, but a rising tide of cases related to COVID-19’s Delta variant could change that reality.
Under the previous emergency use authorization, Pfizer and BioNTech could not market their vaccine directly to potential U.S. consumers, nor would it be able to stay on the market past the declared emergency order, which renewed in July 2021.
In the market, the Pfizer BioNTech vaccine will officially go by Comirnaty.
Full approval for vaccines usually takes upwards of six months as mountains of paperwork and data must be sifted through by FDA scientists to check for inconsistencies.
Pfizer and BioNTech first submitted the necessary paperwork for approval back on May 7, 2021.
Beyond marketing potential and the ability to stay on the market past the emergency order, the full FDA approval will also likely give businesses, organizations and schools more confidence to enforce vaccine mandates.
Many had already done so given the close to 5 billion doses of vaccine given out around the world, but the extra government backing gives companies even more confidence on the legal front that it’s allowed. For the record, it was before too.
That could grow even more vital given the massive rise in COVID-19 cases thanks to the Delta variant.
So far, around 57% of the total U.S. population, or about 190 million people have received one dose of one of the two-shot COVID-19 vaccines. Forty-nine percent, or about 164 million people have been fully vaccinated.
It’s a far cry from the 70% vaccinated goal set by Biden before July 4, but the goal was never met largely because of vaccine hesitancy.
Full FDA approval could also go a long way toward getting more people to trust the vaccine and get it.
If not, potential mandates will have another role to play going forward.
This article is part of Broke in Philly, a collaborative reporting project among more than 20 news organizations focused on economic mobility in Philadelphia. Read all of our reporting at brokeinphilly.org.