U.S. FDA gives full approval to Pfizer-BioNTech COVID-19 vaccine

(Reuters) – The U.S. drug regulator on Monday granted full approval to the Pfizer Inc/BioNTech SE COVID-19 vaccine, making it the first to secure such Food and Drug Administration validation as health authorities struggle to win over vaccine skeptics during a relentless pandemic.

The FDA, which gave the two-dose vaccine emergency-use authorization in December, went a step further based on updated data from the company’s clinical trial and fully approved it for use in people age 16 and older. Public health officials hope the action will convince unvaccinated Americans that Pfizer’s shot is safe and effective.

There is entrenched vaccine skepticism among some Americans, particularly conservatives. COVID-19 cases, driven by the highly infectious Delta variant, have surged in parts of the United States with lower vaccination levels.

“This FDA approval should give added confidence that this vaccine is safe and effective,” President Joe Biden, who has sought to increase vaccination levels, wrote on Twitter.

Shortly after the FDA’s announcement, the Pentagon said it is preparing to make the vaccine mandatory for U.S. military personnel. U.S. health officials expect that the FDA’s full approval also will prompt more state and local governments, as well as private employers, to impose vaccine mandates.

“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 FDA’s acting commissioner.

The approval also makes it easier for physicians to prescribe a third dose of Pfizer’s vaccine off-label for people who may benefit from additional protection against COVID-19.

Pfizer shares were up nearly 4% and BioNTech shares were up nearly 10%.

(For graphic on Pfizer’s shares on a record run – )

The FDA gave emergency-use authorization to the vaccine for people age 16 and older in December – making it the first shot to gain such backing in the United States – and then gave further emergency-use authorization for people age 12 and up in May. The FDA is awaiting additional data before deciding on fully approving Pfizer’s vaccine in children ages 12 to 15.

Woodcock said the FDA was not recommending children below 12 years of age get the vaccine at this time, with more data needed to ensure it is safe for them.

The two other COVID-19 vaccines given emergency-use authorization – made by Moderna Inc and Johnson & Johnson – have not yet received full FDA approval.

More than 204 million people in the United States already have received the Pfizer/BioNTech vaccine.

U.S. HIT HARD

The United States leads the world in reported COVID-19 cases and deaths. More than 625,000 Americans have died from the disease, including an average of more than 600 daily in recent weeks.

According to the Centers for Disease Control and Prevention (CDC), 71% of Americans age 12 and older – the population eligible to receive COVID-19 vaccines – have gotten at least one dose and 60.2% are fully vaccinated. For the entire population, including children up to age 11 for whom no vaccines are yet approved, 60.7% of Americans have received at least one dose and 51.5% of them are fully vaccinated.

The FDA’s approval should signal that the vaccine is “safe, effective, and has been manufactured consistently,” said Dr. Paul Offit of the University of Pennsylvania, a member of the FDA’s vaccine advisory panel.

“We’re going to move forward making that vaccine mandatory,” Pentagon spokesman John Kirby told reporters, adding that the timetable was still being worked out. “We’re preparing the guidance to the force right now.”

The FDA’s approval extends the shelf life of Pfizer shots from six months to nine months. It also confirms that the shot increases risk of heart inflammation, particularly among young men in the week following their second shot.

In Pfizer’s clinical trial, approximately 12,000 recipients of the vaccine have been followed for at least six months.

“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,” Pfizer CEO Albert Bourla said in a statement.

The vaccine will now be marketed under the name Comirnaty.

The FDA on Aug. 13 authorized a third dose of the Pfizer/BioNTech and Moderna vaccines for people with compromised immune systems who are likely to have weaker protection from the two-dose regimens. Pfizer’s shot has not yet been authorized for more widespread use as a booster.

A third dose of Pfizer’s vaccine has significantly improved protection from infection and serious illness among people age 60 and older in Israel compared with those who received two shots, a study published here on Sunday showed.

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