This authorization provides a new tool to fight COVID-19 at a crucial time in the pandemic where new variants are emerging, welcomed an official of the FDA, Patrizia Cavazzoni, quoted in a press release.
This antiviral drug can be administered to high-risk patients aged 12 and over, says the FDA, which, unlike usual, has not convened a committee of independent experts to review the data provided before authorization.
Pfizer’s treatment, marketed as Paxlovid, consists of a combination of two pills taken twice a day for five days upon diagnosis or within five days of onset of symptoms, the FDA says.
The pill from the American laboratory, whose vaccine against COVID-19 is also authorized in the United States, makes it possible to reduce hospitalizations and deaths by 88% in people at risk when taken within the first five days after the onset of symptoms , according to pharmaceutical clinical trials involving more than 2,200 people.
No deaths were recorded in these trials among the patients who received the treatment. Participants were unvaccinated and at high risk of developing a severe case of COVID-19.
Pfizer also announced that its antiviral treatment should remain effective against Omicron. This new, highly transmissible variant has led to an increase in cases in the United States, as in many other countries around the world.
This innovative treatment […] will change the way we treat COVID-19 and hopefully help reduce the significant strain on our healthcare and hospital systems, rejoiced Albert Bourla, CEO of Pfizer, in a press release.
Paxlovid complements the arsenal available against COVID-19, but does not replace vaccines, which remain the first line of defense against this pandemic, the FDA stressed.
Antivirals work by reducing the ability of a virus to replicate, thereby slowing down the disease. These treatments represent a key complement to vaccines, in particular because they are very easy to administer, which can be taken simply at home with a full glass of water.
As early as November, the United States had ordered Pfizer 10 million treatments of its anti-COVID pill, for $ 5.29 billion, President Joe Biden then assuring that they would be distributed free of charge.
Another pill has also been filed with the FDA for clearance, the one from the Merck Laboratory, known as MSD outside of the United States.
This other treatment, Molnupiravir, received a positive opinion from an independent committee despite less efficacy than initially anticipated and concerns about pregnant women.
Molnupiravir has already been authorized in the UK and Denmark.