United States Fully Authorizes Pfizer-BioNTech Vaccine

The United States on Monday fully approved a first vaccine against COVID-19, that of Pfizer-BioNTech, a decision that could help to convince some hesitant, but also to push more institutions to impose vaccination, in a country where the Delta variant is raging.

First visible consequence: the Pentagon announced in the wake that all members of the American armed forces should be vaccinated.

The U.S. Medicines Agency, the FDA, has approved the German-American alliance formula for people 16 and older, she said in a statement. It continues to be available to adolescents aged 12 to 15 under emergency authorization.

“Even though millions of people have already been safely vaccinated against COVID-19, we recognize that for some, this authorization may give more confidence in the vaccination,” said Acting Chief of the FDA Janet Woodcock, cited in the press release. The measure “should give more confidence that this vaccine is safe and effective,” Joe Biden added on Twitter . The American president is due to speak in the afternoon on the vaccination campaign, announced the White House.

According to a Kaiser Family Foundation poll in June, about one in 10 unvaccinated American adults said they would be more likely to receive an injection if any of the formulas were fully approved by health authorities. “One of the arguments of the anti-vaccine movement, which wrongly claimed that it was an experimental vaccine, has been swept  aside,” said AFP to Dr. Amesh Adalja, of the center. Johns Hopkins for Health Safety.

Towards compulsory vaccination?

This decision by the health authorities may also allow certain authorities to impose vaccination without fear of legal recourse.

Full authorization also allows doctors, as with any drug, to prescribe a remedy outside of the recommendations. This could therefore lead some professionals to decide to administer the vaccine to fragile children under 12 for whom it is not yet authorized, even in an emergency. However, this practice should remain rare, knowing that clinical trial data are expected quickly for this population.

Pfizer announced in March that it had started trials on thousands of children aged 6 months to 11 years, which are ongoing. If the results prove conclusive, Pfizer hopes to be the first to file an emergency authorization request for the vaccine for 5-11 year olds in September.

More than 200 million people, or nearly 61% of the US population, have received at least one dose of the vaccine – most of them from Pfizer-BioNTech.

If the rate of vaccinations had slowed down sharply between early April and early July, the curve of daily injections has been on the rise for several weeks. The number of immunizations is growing especially in states with the highest number of daily cases – an outbreak due to the highly contagious Delta variant.

“Hundreds of thousands of pages” of analyzes

The FDA’s clearance is based on clinical trials involving approximately 20,000 people aged 16 and over who received the vaccine, and 20,000 who received a placebo.

About 12,000 people were followed for a minimum of six months, the agency said. “We have evaluated the scientific data and information included in hundreds of thousands of pages” and “conducted our own analysis of the safety and efficacy” of the vaccine, detailed Peter Marks, chief scientist at the FDA. . He said the vaccine production process had also been verified, including through factory visits.

The authorization includes a warning about an increased risk of myocarditis, an inflammation of the heart muscle, after vaccination. This risk is higher in young men, within seven days of the second injection.


New York – New York on Monday announced making the vaccine mandatory for staff in its public schools, including teachers and principals. Mayor Bill de Blasio said all education department employees should receive at least one dose of the COVID-19 vaccine by September 27. “We know this will help make sure everyone is safe,” he told reporters. About 63% of education staff are vaccinated, while 75.6% of adults in New York City have received at least one dose of the vaccine, according to official figures. Before New York, Chicago and Los Angeles also made vaccination compulsory for teachers. The “Big Apple”, which tries to find a normal life,

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