Thu. Jan 27th, 2022


© Reuters. FILE PHOTO: A bottle labeled with the Pfizer-BioNTech coronavirus vaccine (COVID-19) is seen in this illustrated image taken on March 19, 2021. REUTERS / Dado Ruvic / Illustration

By Carl O’Donnell and Manas Mishra

(Reuters) – The US drug regulator agreed on Monday to fully approve the drug deal Pfizer (NYSE 🙂 Inc. / BioNTech Vaccine SE COVID-19, becoming the first to ensure this validation by the Food and Drug Administration, as health authorities struggle to beat vaccine skeptics during a relentless pandemic.

The FDA, which granted emergency use authorization for two-dose vaccines in December, went one step further based on updated data from the company’s clinical trial and fully approved it. for use in persons over 16 years of age. Public health officials hope the action will convince unvaccinated Americans that Pfizer’s shooting is safe and effective.

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

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

Shortly after the FDA announcement, the Pentagon said it was preparing to make the vaccine mandatory for U.S. military personnel. U.S. health officials hope full FDA approval will also drive more state and local governments, as well as private entrepreneurs, to impose vaccine warrants.

“While millions of people have already received COVID-19 vaccines safely, we recognize that for some, FDA vaccine approval may now instill additional confidence to get vaccinated,” said Janet Woodcock, commissioner. in FDA functions.

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

Shares of Pfizer rose nearly 4% and those of BioNTech rose nearly 10%.

(For the Pfizer stock chart in a logbook: https://fingfx.thomsonreuters.com/gfx/mkt/gdpzyymekvw/PFIZER%20SHARES.JPG)

The FDA issued an emergency use authorization for the vaccine for people over the age of 16 in December, making it the first shot to get that support in the United States, and then gave another emergency use authorization to persons 12 years of age or older in May. The FDA is awaiting additional data before deciding to fully approve the Pfizer vaccine in children ages 12 to 15.

Woodcock said the FDA does not recommend children under the age of 12 to be vaccinated at this time, with more data needed to ensure it is safe for them.

The other two COVID-19 vaccines received an emergency use authorization (made by Modern (NASDAQ 🙂 Inc. and Johnson & Johnson (NYSE :): have not yet received full FDA approval.

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

US HIT HARD

The United States leads the world in reported cases and deaths of COVID-19. 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 over the age of 12 (the population eligible to receive COVID-19 vaccines) have received at least one dose and 60.2% are fully vaccinated. For the entire population, including children up to the age of 11 for whom no vaccine has yet been approved, 60.7% of Americans have received at least one dose and 51.5% of them are fully vaccinated. .

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

“We will move forward by making this vaccine mandatory,” Pentagon spokesman John Kirby (NYSE 🙂 told reporters, adding that the timetable was still being worked out. “Right now we are preparing the guide for the force.”

FDA approval extends the shelf life of Pfizer shots from six to nine months. It also confirms that the shot increases the risk of heart inflammation, especially among young men the week after the second shot.

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

“Based on the long-term monitoring data we presented, today’s approval for those over 16 states the efficacy and safety profile of our vaccine at a time when it is urgently needed.” , said Albert Bourla, CEO of Pfizer, in a statement. .

The vaccine will now be marketed under the name Comirnaty.

On August 13, the FDA authorized a third dose of the Pfizer / BioNTech and Moderna vaccines for people with compromised immune systems who were likely to have weaker protection from two-dose regimens. The Pfizer feature is not yet authorized for more widespread use as a booster.

A third dose of Pfizer vaccine has significantly improved protection against infections and serious illnesses among people aged 60 and over in Israel compared to those who received two shots, according to a study published at https://www.reuters .com / world / middle-east / israel-finds-covid-19-vaccine-booster-significantly-reduces-the-risk-of-infection-2021-08-22 on Sunday showed.



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