Pfizer Deal Authorizes Generic Drugmakers to Produce Experimental COVID Pill

2021-11-16

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Pfizer has signed an agreement with a global United Nations-backed public health group to authorize generic drugmakers to produce its experimental COVID-19 pill for 95 countries.

The American drug company said Tuesday it signed a deal with the Geneva-based Medicines Patent Pool to make the pill for low- and middle-income countries comprising about 53% of the world's population.

Pfizer has said the pill reduced the risks of hospitalization and death by nearly 90% in people with mild to moderate coronavirus cases. Independent experts recommended ending Pfizer's study because of its encouraging results.

The deal was reached before the pill was authorized for use, raising hopes it could help end the coronavirus pandemic sooner.

"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," said the Medicines Patent Pool's Esteban Burrone.

Yuanqiong Hu, a senior legal policy adviser at Doctors Without Borders, said the organization is disappointed the agreement does not make the pill available to all countries.

"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," she said.

Pfizer said it would ask the U.S. Food and Drug Administration and other regulators to approve the pill's use as soon as possible.

Pfizer will not receive payments on sales in low-income countries, where fewer than 1% of its COVID-19 vaccine doses have been provided. It also will waive royalties on sales in all countries covered by the deal while COVID-19 remains a public health emergency.

The Medicines Patent Pool announced in October that another U.S. drugmaker, Merck, agreed to allow other companies to make its COVID-19 pill available in 105 poorer countries.

Earlier this month, Britain approved Merck's pill for use. It is pending approval elsewhere.

Despite decisions by Pfizer and Merck to share their COVID-19 drug patents, Pfizer and other vaccine-makers have refused to release their vaccine formulas for broader production.