FDA Grants Full Approval to Pfizer COVID Vaccine

The full approval, following an emergency one in December, 'affirms the efficacy and safety profile of our vaccine at a time when it is urgently needed,' Pfizer CEO says

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A syringe with a first dose of the Pfizer Covid-19 vaccine at a mobile vaccination clinic in Los Angeles, California.
A syringe with a first dose of the Pfizer Covid-19 vaccine at a mobile vaccination clinic in Los Angeles, California.Credit: Patrick T. FALLON / AFP

The U.S. Food and Drug Administration on Monday gave full approval to the COVID-19 vaccine made by Pfizer Inc and German partner BioNTech SE for use in people over the age of 16, in first such approval of a COVID-19 shot.

The vaccine has been authorized for emergency use since December and more than 204 million people in the United States have received it, based on Sunday's data. But none of the three authorized COVID-19 vaccines had previously received full FDA approval. The new authorization does not give final approval for those between ages 12 and 15.

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U.S. health officials also expect that the full approval will prompt more state and local governments, as well as private employers, to employ vaccine mandates.

Pfizer shares were up around 5 percent and BioNTech shares were up more than 9 percent.

According to the U.S. Centers for Disease Control and Prevention, 71 percent of Americans age 12 and older- the population eligible to receive COVID-19 vaccines - have received at last one dose and 60.2 percent are fully vaccinated.

For the entire population, including children up to age 11 for whom no vaccines are yet approved, 60.7 percent of Americans have received at least one dose and 51.5 percent of them are fully vaccinated.

The FDA's approval is based on updated data from the company's clinical trial. Overall, in follow-ups to Pfizer's original late stage study, approximately 12,000 recipients of the vaccine have been followed for at least six months.

In Israel, a booster shot campaign is underway, with close to 1.5 million people, out of the country's population of 9.3 million people, have received a third shot. 

Kira Lundell, 16, receives a coronavirus disease (COVID-19) vaccine in Worcester, Pennsylvania, U.S., April 29, 2021.Credit: REUTERS/Hannah Beier

So far, 5,445,968 Israelis have received two doses of the coronavirus vaccine.

Public health officials hope it will convince more unvaccinated Americans that Pfizer's shot is safe and effective.

Vaccine hesitancy among some Americans has hindered the United States response to the novel coronavirus.

"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 Janet Woodcock, the U.S. Food and Drug Administration's acting commissioner.

"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, CEO of Pfizer, said in a statement.

The Pfizer-BioNTech vaccine will now be marketed under the name Comirnaty, the FDA said.

Some U.S. cities including New York and San Francisco have already imposed rules requiring vaccination to dine at restaurants or work in government offices, among other activities.

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