Until now, it has benefited from a temporary emergency authorization. The Pfizer-BioNTech alliance’s vaccine against Covid-19 is now fully approved by the Food and Drug Administration (FDA), the US drug agency, for people 16 years of age and over, the latter announced in a press release, Monday 23 August.
“Even though millions of people have already received vaccines against Covid-19 safely, we recognize that, for some, this authorization may give more confidence in the vaccination”, said the acting chief of the American regulator, Janet Woodcock, quoted in the press release. “The public can be confident that this vaccine meets the high standards of safety, efficacy and manufacturing quality that the FDA demands of an approved product. ” The vaccine production process had also been checked, including during factory visits. “Today’s stage brings us a little closer to the moment when we can reverse the course of the pandemic in the United States”, can we also read in the press release.
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.
Convince the hesitant
The United States becomes the first country to fully approve the vaccine for those over 16. It continues to be available to children and adolescents between the ages of 12 and 15 under this conditional authorization, the FDA said.
“We hope this decision will help increase confidence in our vaccine, as vaccination remains the best tool we have to protect lives.”Pfizer CEO Albert Bourla said in a statement. The measure “Should give more confidence that this vaccine is safe and effective”, added Joe Biden in a tweet. From the White House on Monday evening, the US president pleaded for “Those who were waiting for this full authorization [aillent] get their dose now ”. He also expressed the wish that “More companies” impose a vaccination obligation on their employees.
According to a Kaiser Family Foundation poll in June, about one in ten unvaccinated American adults said they would be more likely to receive an injection if any of the sera were fully approved by health officials. “One of the arguments of the anti-vaccine movement, which wrongly claimed that it was an experimental vaccine, has been swept aside”, welcomed the Dr Amesh Adalja of the Johns Hopkins Center for Health Safety.
Towards a full vaccination of the US military
In addition to convincing some hesitant, this authorization may also allow certain authorities to impose vaccination without fear of legal recourse. The Pentagon confirmed Monday that all members of the U.S. military will now need to be vaccinated, now that full authorization has been announced. New York City, for its part, announced that school staff, including teachers, should have received at least one dose of the vaccine by September 27. The measure affects nearly 150,000 employees. At the moment, only 63% of educational staff are vaccinated.
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.
The appointments to be vaccinated reached their lowest level in July in the United States. As the Delta variant fills hospital beds, they have just risen again, with one million doses administered per day Thursday, Friday and Saturday. Just over half of the American population is fully vaccinated with one of the three options offered by Pfizer, Moderna or Johnson & Johnson.
