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Pfizer agrees to license generic versions of its COVID-19 pill — in some countries

Updated November 16, 2021 at 3:11 PM ET

Pfizer has signed a licensing deal to allow dozens of lower-income countries to benefit from generic versions of its new COVID-19 pill. The agreement covers 95 nations, but it omits some hard-hit countries.

The antiviral pill is not yet available to the public. On Tuesday, Pfizer announced that it is seeking federal authorization for emergency use of the medication in the U.S. The medication is meant to treat patients with mild to moderate COVID-19 cases who are at higher risk of hospitalization or death.

Pfizer said earlier this month that the medicine, called Paxlovid, had shown promising results in clinical trials.

Effective COVID-19 pills are seen as potential game-changers in the pandemic, because they could be administered at home early after an infection, reducing both the coronavirus' toll and the potential for a single patient to spread it.

"This license is so important because, if authorized or approved, this oral drug is particularly well-suited for low- and middle-income countries and could play a critical role in saving lives" and quelling the pandemic, Charles Gore, executive director of the U.N.-backed Medicines Patent Pool organization, said in a joint news release with Pfizer.

The licensing deal applies to 95 countries, covering up to approximately 53% of the world's population, according to Pfizer and the MPP.

The generic drug will be legal in many countries that are classified as either low-income, lower middle-income or upper middle-income territories. But it will not be available in Russia, Turkey, Brazil, or Romania — all of which are in the world's top 10 countries for COVID-19 case numbers and are also considered upper middle-income countries by the World Bank.

While the list of approved countries includes many nations in Latin America, neither Mexico nor Argentina are among them.

In response to the deal, Doctors Without Borders warned that its limits mean many countries and by extension millions of people will not benefit. It also noted that the drug has an expected price tag of around $700 per treatment course in high-income countries, with lower amounts set for lower-income nations.

"We are disheartened to see yet another restrictive voluntary license during this pandemic while cases continue to rise in many countries around the world," said Yuanqiong Hu, senior legal policy advisor for MSF's Access Campaign, in a statement sent to NPR.

The Pfizer antiviral pill is aided by co-administering a low dose of ritonavir, a drug used in HIV/AIDS treatment regimens. Ritonavir helps protease inhibitors like the Pfizer drug persist longer in the human body, making them more effective in fighting a virus.

Noting that ritonavir's patent has lapsed and the new Pfizer drug does not yet have a patent, Doctors Without Borders urged drugmakers in countries that are excluded by the deal to explore producing the generic medicine themselves.

"The world knows by now that access to COVID-19 medical tools needs to be guaranteed for everyone, everywhere if we really want to control this pandemic," Hu said.

Copyright 2022 NPR. To see more, visit https://www.npr.org.

Bill Chappell is a writer and editor on the News Desk in the heart of NPR's newsroom in Washington, D.C.