It is an important step in the fight against the pandemic which could allow millions of patients to access treatment. The Pfizer laboratory’s Covid-19 pill was urgently authorized, Wednesday, December 22, by the United States Medicines Agency (FDA).
“This authorization provides a new tool to fight Covid-19, at a crucial moment in the pandemic where new variants are emerging”, FDA official Patrizia Cavazzoni was quoted as saying in a statement. This antiviral drug can be given to high-risk patients 12 years of age and older, the FDA said.
Pfizer’s treatment, marketed as Paxlovid, consists of a combination of two pills taken twice a day for five days, upon diagnosis and within five days of symptom onset, the FDA adds.
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 in people at risk by nearly 90% when it is taken in the first days after onset of symptoms, according to 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.
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A key complement to vaccines
Antivirals work by decreasing the ability of a virus to replicate, thereby slowing down the disease. These treatments represent a key complement to vaccines to protect against Covid-19, in particular because they are very easy to administer, being able to be taken simply at home with a large glass of water. Paxlovid supplements the arsenal available against Covid-19 but does not replace vaccines, which remain the first line of defense against this pandemic, the FDA reminded us.
“This innovative treatment (…) will change the way we treat Covid-19 and, I hope, help reduce the significant pressure on our health and hospital systems ”, rejoiced Albert Bourla, CEO of Pfizer, in a press release.
In 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. The European Medicines Agency has also authorized Paxlovid temporarily, pending final authorization.
Another pill has also been filed with the FDA for authorization, the one from the Merck laboratory, known as MSD outside 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. The pills from Merck and Pfizer don’t fight the coronavirus in the same way, and the second doesn’t cause as much concern.