Pfizer said Tuesday that it has asked the U.S. Food and Drug Administration to approve its medication for people at increased risk of hospitalization or death due to COVID-19. Earlier Tuesday, Pfizer and Medicines Patent Pool, a public health organization that advocates for drug access, said the drugmaker signed an agreement to share its license for its oral antiviral COVID-19 treatment.
The treatment, called Paxlovid, is a combination of the drug PF-07321332 and ritonavir, a drug used to treat HIV. The treatment was found to reduce the risk of hospitalization or death due to COVID-19 by 89% in a clinical trial, Pfizer said.
There is not yet a timeline for when the FDA will consider Paxlovid, but an independent committee of the FDA will meet on November 30 to discuss approval of.
Earlier in the day, Pfizer announced a voluntary licensing agreement on Paxlovid that will provide qualified manufacturers around the world with the formula of the drug, enabling them to produce and distribute the antiviral drug to 95 countries and about 53% of the world’s population, according to a news release .
Pfizer said it will not receive royalties on sales in low-income countries and will waive royalties in all countries covered by the agreement, while COVID-19 is classified as a “public health emergency of international concern” by the World Health Organization.
Although the drug does not prevent COVID-19, having a pill available to people in countries without access to coronavirus vaccines would be a major step in minimizing deaths due to the pandemic. Only 4.6% of the population in low-income countries have received at least one dose of a COVID-19 vaccine, according to Our World in Data.
Pfizer has not accepted a similar division of its COVID-19 vaccine formula. Pfizer’s vaccine is the only COVID-19 vaccine with full FDA approval, rather than an emergency use permit.
In September, the drug manufacturer signed an agreement with the United States that it would sell 500 million vaccine doses to the government per year.for the country to donate to other nations.
Merck, the maker of another promising COVID-19 antiviral drug, said in October that it agreed to share its license with lower-income countries, also pending local regulatory processes.
“This sets a precedent that if you have a COVID-19 countermeasure, you are licensing it for wider use,” Ellen ‘t Hoen, a member of a drug patent pool expert advisory group, told the Washington Post.
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