Pfizer COVID-19 vaccine gets full FDA approval

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Lara Adejoro

The Food and Drug Administration has approved the Pfizer-BioNTech COVID-19 vaccine, which is the first vaccine to be granted approval by the FDA.

The two-dose vaccine is fully approved to prevent COVID-19 in individuals aged 16 years and older.

In a release posted on its website, Pfizer said the vaccine has been available in the U.S. under Emergency Use Authorisation since December 11, 2020, as the Pfizer-BioNTech COVID-19 vaccine.

For FDA approval, Pfizer and BioNTech submitted a comprehensive data package that included longer-term follow-up data from the Phase three trial, where the vaccine’s high efficacy and favorable safety profile were observed up to six months after the second dose. 

Chairman and Chief Executive Officer, Pfizer, Albert Bourla said “Based on the longer-term follow-up data that we submitted, today’s decision by the FDA affirms the efficacy and safety profile of our vaccine at a time when it is urgently needed. 

“About 60 per cent of eligible Americans are fully vaccinated, and infection, hospitalization and death rates continue to rise rapidly among unvaccinated populations across the country.

“I am hopeful this approval will help increase confidence in our vaccine, as vaccination remains the best tool we have to help protect lives and achieve herd immunity. 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 now that we have FDA approval.”

CEO and Co-founder of BioNTech, Ugur Sahin, M.D. added that the approval by the FDA underlines the vaccine’s high efficacy and favorable safety profile. 

“Our companies have shipped more than one billion doses worldwide, and we will continue to work tirelessly to broaden the access to our vaccine and to be prepared for potential emerging escape variants,” Sahin said.

The final approval also means the Pfizer vaccine gets a brand name called Comirnaty.

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