The Pfizer laboratory’s COVID-19 pill was urgently authorized by the United States Medicines Agency (FDA) on Wednesday, an important step in the fight against the pandemic that could allow millions of patients to access treatment .
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“This authorization provides a new tool to fight COVID-19 at a crucial time in the pandemic, where new variants are emerging,” said FDA official Patrizia Cavazzoni, quoted in a statement.
This antiviral drug can be given to high-risk patients aged 12 and over, says the FDA.
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 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 in people at risk by nearly 90% when taken in the first days after the 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.
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.
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.
The European Medicines Agency has also authorized Paxlovid on an emergency basis.
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.
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