Pfizer / BioNTech vaccine fully approved in US: what it means

The American vaccine campaign has just taken a new step on Monday, August 23, after the United States Medicines Agency, the Food and Drug Administration (FDA) announced that it had fully approved the Pfizer / BioNTech serum for people aged 16 years. and more. In total, of the more than 170 million people fully vaccinated in the United States (or 51.5% of the population), more than 92 million have been vaccinated with the Pfizer / BioNTech alliance vaccine.

It’s about “first vaccine” to obtain this full approval, according to the FDA, while all the others – as was the case until then with Pfizer / BioNTech – have only obtained temporary emergency authorization. So what does this decision by the US health authorities mean, and what does it change?

On the one hand, the Pentagon very quickly announced on Monday that the Covid-19 vaccine would become mandatory in the US military after the final approval of the serum from Pfizer / BioNTech. “Now that Pfizer’s vaccine has been approved, the ministry will issue a directive requiring all staff hired to be vaccinated.”military spokesman John Kirby said.

In early August, the US Department of Defense had already announced that all members of the US armed forces – 1.3 million soldiers – should be vaccinated once full authorization was announced.

On the other hand, as noted by CNN, this new step taken by the two laboratories, Monday, could encourage some recalcitrant patients to take the step of vaccination, reassured by the FDA. Thereby, “a small number of people” were waiting for the US health authorities to confirm the full approval of Pfizer / BioNTech and “this could make them switch to vaccination” the chief medical officer of the United States, Vivek Murthy, estimated for the American media.

“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”, confirmed the acting chief of the FDA, Janet Woodcock, quoted in the press release released Monday.

The measure “should give more confidence that this vaccine is safe and effective”Joe Biden added in a tweet.

This new level will also allow many companies, universities or local authorities to impose vaccination, since the FDA’s decision is federal and final and eliminates the fear of legal recourse. the New York Times specifies that many public and private entities were waiting for the FDA to give its full authorization to one of the vaccines to take the step of the vaccination obligation.

New York City said school staff, including teachers, should have received at least one dose of vaccine by September 27. The measure affects nearly 150,000 employees. At the moment, only 63% of educational staff are vaccinated.

Thanks to the decision of the American health authorities, the country is also moving a little closer to the hypothesis of a generalized third dose. Because the federal government announced last week that all American adults who received the Pfizer and Moderna vaccines could request a third injection eight months after the second, from the week of September 20. But the decision is subject to approval by the FDA, which has just fully validated the vaccine from Pfizer / BioNTech, therefore.

Finally, this Monday’s stage is very likely heralding another: the final approval, by the American regulator, of at least another vaccine. Because the remedies of Pfizer / BioNTech and Moderna had been authorized urgently only a week apart, in December 2020, resulting in the first injections of vaccines in the United States.

Full authorization of the vaccine 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.