Pfizer to allow broader global access to its experimental COVID-19 antiviral pill

Pfizer said Tuesday it signed a licensing agreement to allow broader global access to its experimental COVID-19 pill.

The agreement with the Medicines Patent Pool, a United Nations-backed public health organization, would allow generic manufacturers to make the pill widely available in 95 low- and middle-income countries covering 53% of the world's population, the company said.

The pill, known as PF-07321332 or Paxlovid, is to be given in combination with an older antiviral drug called ritonavir.

Earlier this month Pfizer announced topline results from its trial saying that an interim analysis -- done before the trial was scheduled to end -- showed an 89% reduction in the risk of hospitalization or death from COVID-19 among people given the drug within the first three days of symptom onset.

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"Pfizer will not receive royalties on sales in low-income countries and will further waive royalties on sales in all countries covered by the agreement while COVID-19 remains classified as a Public Health Emergency of International Concern by the World Health Organization," Pfizer said in the statement.

The Medicines Patent Pool, founded by Unitaid 10 years ago, facilitates rapid access to medicines for people in low- and middle-income-countries.

Pfizer has yet to submit the pill for authorization by the US Food and Drug Administration but said it would do so before the end of the month.

Late last month, Merck, Ridgeback Biotherapeutics and the Medicines Patent Pool announced a voluntary licensing agreement to help create broader access to the antiviral molnupiravir in 105 low- and middle-income-countries.

Molnupiravir is an oral Covid-19 antiviral for treatment of mild to moderate Covid-19 by adults who are at risk of severe COVID-19 and hospitalization. It was authorized by the UK Medicines and Healthcare Products Regulatory Agency earlier this month, and the companies have requested authorization from the US FDA.

Merck, Ridgeback Therapeutics and Emory University -- the creators and license holders of the antiviral -- will not receive royalties for these sales for the length of time that COVID-19 remains a Public Health Emergency of International Concern under World Health Organization classifications, they said.