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Here's What the FDA's New Approval of Pfizer's Vaccine Really Means

It could help convince so-called 'skeptics.'

Here's What the FDA's New Approval of Pfizer's Vaccine Really Means
A doctor preparing a vaccine, with a coronavirus model in background. kovop58 / iStock

Now it's up to everyone.

Pfizer/BioNTech received full approval from the Food and Drug Administration for recipients aged 16 and older on Monday, which will both enable more people than ever to get the jab, in addition to compellign those who don't want it to do so, according to a post on the FDA's official website.

However, conflicting opinions on the vaccine efficacy, the prospect of ongoing booster shots, and concern about the delta variant remain a challenge for health officials.

The FDA's full approval for Pfizer's vaccine will enable booster shots

Vaccines for the COVID-19 coronavirus from Pfizer/BioNTech, Moderna, and Johnson & Johnson saw deployment throughout the population of the U.S. following emergency use authorizations, which is an early-stage fast-track approval process for drugs, vaccines, or medical treatment amid a public health emergency, which is what happened in 2020. When government agencies slam this proverbial red button, it can only happen after clinical trials have proved that intervention is both adequately effective and reasonably safe, but it takes more empirical work to confirm a vaccine is viable for full approval from the FDA. But, since 200 million people are already vaccinated, the FDA has decided to grant Pfizer's mRNA vaccine full approval.

"While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated," said FDA Acting Commissioner Janet Woodcock in the Monday statement. But with full approval, vaccine manufacturers acquire a green light to not only sell the product, but also advertise it, and go on selling it after the public health emergency has subsided. Notably, this also means doctors can use vaccines for uses beyond the conventional immunization round of one or two shots, and potentially administer a third or fourth shot, for booster purposes.

Full COVID-19 vaccine approval might convince so-called 'skeptics'

Crucially, this latest approval might serve to boost the public's confidence in the vaccines, despite conflicting sentiments from various detractors to the treatment. In other words, full approval solidifies the brand of vaccines in the minds of those who remained hesitant about a vaccine that was designed, developed, tested, completed, and distributed to the entire country's population in one year, for the first time. People who had doubts about the vaccine might feel skeptical "because they know there will be much more data available at the time of an approval [...] three times as much data on safety and three times as much data on effectiveness," said Founder and Senior Advisor Sidney Wolfe of Public Citizen's health research group, according to a Vox report.

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And yes, this means more employers will compel employees to get an approved COVID-19 vaccine. Additionally, the FDA's full approval for the jabs might strengthen confidence in them in other countries still looking to the U.S. and its federal agencies for leadership. But this means spokespeople in the government, from the president all the way down to local doctors need to have a single, legitimate, and cohesive message. And this will be more necessary than ever to convince the chronically stubborn to protect themselves and others from the coronavirus as we move into the winter months, when the delta variant may loom large in the country.

This was a breaking story and was regularly updated as new information became available.

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