Nov. 16, 2021 -- Pfizer on Tuesday submitted its application to the FDA for emergency authorization of its experimental COVID-19 pill. 

The pill, called Paxlovid, would be the first oral antiviral of its kind should the FDA approve it for emergency use, the company said. The pill reduces the risk of hospitalization and death by 89% among people with mild to moderate COVID-19 infections, Pfizer said in a statement.

“With more than 5 million deaths and countless lives impacted by this devastating disease globally, there is an urgent need for life-saving treatment options. The overwhelming efficacy achieved in our recent clinical study of PAXLOVID, and its potential to help save lives and keep people out of the hospital if authorized, underscores the critical role that oral antiviral therapies could play in the battle against COVID-19,” Albert Bourla, the chairman and chief executive officer at Pfizer, said in a statement. “We are moving as quickly as possible in our effort to get this potential treatment into the hands of patients, and we look forward to working with the U.S. FDA on its review of our application, along with other regulatory agencies around the world.”

The news came just hours after the company said it has signed a deal to allow other manufacturers to make its experimental COVID-19 pill, possibly opening up access to treatment to countries across the world.

On Tuesday, the company said it would give a license for the pill to the Medicines Patent Pool, a U.N.-backed group based in Geneva, Switzerland. The agreement would allow generic drug companies to produce the pill for use in 95 countries, which would cover about 53% of the world’s population, according to a news release.

“It’s quite significant that we will be able to provide access to a drug that appears to be effective and has just been developed, to more than 4 billion people,” Esteban Burrone, head of policy at the Medicines Patent Pool, told The Associated Press.

Drugmakers could start producing the pill within months, Burrone said.

But the deal has some caveats and excludes some large countries from making the pill. Under the agreement, Pfizer won’t receive royalties on sales in low-income countries and will waive royalties in all countries included in the agreement while COVID-19 remains a public health emergency, the AP reported.

“We try to strike a very delicate balance between the interests of the (company), the sustainability required by generic producers and most importantly, the public health needs in lower and middle-income countries,” Burrone said.

Researchers have worked to develop a pill to treat COVID-19 so people can take it easily at home and stay out of hospitals, the AP reported. Most COVID-19 treatments must be given as an IV or a shot under medical supervision.

Earlier this month, Britain authorized a COVID-19 pill made by Merck, which is pending approval in other countries. In October, the company signed a similar deal with the Medicines Patent Pool to make its pill, called molnupiravir, available in 105 countries.

After Pfizer’s announcement, Doctors Without Borders told the AP that it was “disheartened” that the deal doesn’t make the pill available to all countries. Notably, the agreement doesn’t include countries such as Argentina, Brazil, China, Russia, and Thailand. The Merck agreement also excludes countries such as Brazil, China, and Russia.

“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,” Yuanqiong Hu, PhD, a senior legal policy adviser at Doctors Without Borders, told the AP.

Show Sources

The Associated Press: “Pfizer agrees to let other companies make its COVID-19 pill.”

Pfizer: “Pfizer and the Medicines Patent Pool (MPP) Sign Licensing Agreement for COVID-19 Oral Antiviral Treatment Candidate to Expand Access in Low- and Middle-Income Countries,” “Pfizer’s Novel COVID-19 Oral Antiviral Treatment Candidate Reduced Risk of Hospitalization or Death by 89% in Interim Analysis of Phase 2/3 EPIC-HR Study.”

© 2021 WebMD, LLC. All rights reserved. View privacy policy and trust info