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Pfizer has asked the United States to authorize its anti-COVID-19 drug

Pfizer announced on Tuesday that it had requested emergency authorization in the United States for its anti-COVID pill, a highly anticipated treatment because it can easily be taken at home in the first days after the onset of symptoms in the event of an infection.

The pharmaceutical giant has filed this request with the US agency responsible for drugs (FDA), he said in a statement. Earlier on Tuesday, Pfizer announced a global deal to allow generic manufacturers to produce the drug for delivery to 95 of the world’s poorest countries.

This antiviral treatment, which will be marketed as Paxlovid, has been shown to be 89% effective against hospitalizations and deaths from COVID-19 in clinical trials, when taken within three days of symptom onset.

These trials were conducted by the company on people at high risk of developing a severe case of COVID-19. They ingested the drug every 12 hours for five days.

“The overwhelming efficacy achieved in our clinical study of Paxlovid, and its ability to help save lives and keep people out of hospital if authorized, underscores the critical role that antiviral therapies can play in battle against COVID-19, ”said Pfizer boss Albert Bourla, quoted in the press release.

Antivirals work by reducing 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.

the Washington Post reported Tuesday that the US government planned to announce the purchase of 10 million treatments this week.

Pfizer has said it plans to invest up to $ 1 billion to manufacture and distribute Paxlovid.

Manufacture by other companies

A voluntary license agreement was also announced Tuesday between Pfizer and the Medicines Patent Pool (MPP), a group supported by the UN. This agreement should allow generic manufacturers to produce the drug for supply to 95 countries with middle and lower income. A decision that could make treatment accessible to more than half of the world’s population.

The deal excludes some large countries that have suffered devastating coronavirus outbreaks. For example, while a Brazilian pharmaceutical company could obtain a license to make the tablet and export it to other countries, the drug could not be made generically for use in Brazil.

Health officials have nonetheless said that the fact that the deal was reached even before Pfizer’s drug was cleared somewhere could help end the pandemic faster.

“It is quite significant that we are able to provide access to a drug which appears to be effective and which has just been developed to more than 4 billion people,” said Esteban Burrone, head of the Patent Pool’s drug policy.

He estimated that other drug makers could start producing the tablet within a few months.

Under the terms of the agreement, Pfizer will not collect royalties on sales in low-income countries and will waive royalties on sales in all countries covered by the agreement as long as COVID-19 remains a public health emergency. .

In data | To know everything about COVID-19

Doctors Without Borders said it was “disheartened” that the Pfizer deal does not make the drug available worldwide, noting that the deal announced on Tuesday excludes countries like China, Argentina and Thailand. “The world now knows that access to medical tools to fight COVID-19 must be guaranteed for everyone, everywhere, if we are truly to control this pandemic,” said Yuanqiong Hu, senior legal policy adviser at Doctors. without limits.

The decisions of Pfizer and Merck to share their drug patents stand in stark contrast to the refusal of Pfizer and other vaccine makers to release their vaccine formulations for wider production. Less than 1% of Pfizer’s COVID-19 vaccines went to poorer countries.

The American laboratory Merck has also developed an antiviral treatment against COVID-19, molnupiravir, authorized in early November in a first country, the United Kingdom. In a similar deal with the MPP announced in October, Merck agreed to let other drugmakers offer its pill in 105 poorer countries.

An FDA committee is due to meet on November 30 to decide on Merck’s US drug approval request. Washington has already purchased 3.1 million treatments from Merck.

With Maria Cheng (Associated Press)

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