FDA grants full approval to Pfizer COVID-19 vaccine

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FDA grants full approval to Pfizer COVID-19 vaccine
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FDA grants full approval to Pfizer COVID-19 vaccine
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“Today, I’m calling on more countries — more companies, I should say — in the private sector to step up with vaccine requirements that will reach millions more people,” Biden said. “If you’re a business leader, a nonprofit leader, a state or local leader, who has been waiting for full FDA approval to require vaccinations, I call on you now to do that, require it.”

The full approval will likely give legal cover to many organizations who want to require vaccinations for their employees as the delta variant surges nationwide. The U.S. has so far vaccinated 71% of the eligible population, but under-vaccinated areas like the Southeast have proven that the virus will continue to spread wherever there is not ample protection.

“Let me say this loudly and clearly, if you’re one of the millions of Americans who said that they will not get the shot until it has full and final approval of the FDA, it’s now happened,” Biden said during remarks at the White House. “The moment you’ve been waiting for is here.”

It indicates that Pfizer has shown enough effectiveness and safety data to meet the stringent Biologics License Application (BLA) requirements, which includes at least six months of safety data from a majority of the volunteers in a large, final stage clinical trial.

“Based on the longer-term follow-up data that we submitted, today’s approval for those aged 16 and over affirms the efficacy and safety profile of our vaccine at a time when it is urgently needed,” Albert Bourla, Pfizer CEO said in a statement to ABC News. “Hundreds of millions of doses of our vaccine already have been administered in the U.S. since December 2020, and we look forward to continuing to work with the U.S. government to reach more Americans.”

You can read the rest of ‘s article at ABCnews.com

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