Pfizer asks FDA to approve its experimental antiviral pill for COVID-19

Pfizer said Tuesday it is asking U.S. regulators to authorize its experimental antiviral pill for COVID-19, setting the stage for a likely launch of the promising therapy in the coming weeks.

The company's filing comes as new infections are rising in the U.S. once again, driven mainly by hot spots in states where colder weather is driving more Americans indoors.

Earlier this month, Pfizer said its clinical trialshowed the pill cut the risk of hospitalization and deathby between 85 and 89 per centin people with mild to moderate coronavirus infectionsif taken within three to five days of symptom onset.

Independent experts recommended halting the company's study based on its promising results.

If authorized by the U.S. Food and Drug Administration (FDA), the drugcould offer an effective way for patients to treat themselves at home.

The only other FDA-authorized treatments for COVID-19require an IV or injection given by a health professional at a hospital or clinic.

WATCH | Learn more about Pfizer's experimental antiviral pill:

Pfizer COVID-19 antiviral pill offers huge hope, says specialist

3 years ago

Duration 4:49

Pfizer's experimental antiviral pill for COVID-19 has great potential to drive down mass hospitalizations and reduce death, says infectious diseases specialist Dr. Zain Chagla. 'There is a lot of optimism,' he said. (Bebeto Matthews/The Associated Press)

"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," said Albert Bourla, Pfizer's CEO, in a news release.

Health officials have stressed that vaccination will remain the best way to protect against COVID-19 infection.

FDA regulators will scrutinize company data on the safety and effectiveness of the drug, which will be calledPaxlovid, before making a decision.

Health Canada would review 'on a priority basis'

Earlier this month, Health Canadasaidit hadnot received a submission from Pfizer for theantiviral drug, but said in an email to CBC News that if it received an application, "it will be reviewed on a priority basis."

As of Tuesday afternoon, the drug was not listed in Health Canada's COVID-19 drug and vaccine applicationsdatabase.

Pfizer's drug is part of a decades-old family of antiviral drugs known as protease inhibitors, which revolutionized the treatment of HIV and hepatitis C. The drugs block a key enzyme that viruses need to multiply in the human body.

That's different than the antiviral pill manufactured by competitor Merck, called Molnupiravir,which causes tiny mutations in the coronavirus until the point that it can't reproduce itself.

Britain authorized Merck's COVID-19 antiviralpillearlier this month, and it is pending approval elsewhere, including in both the U.S. andCanada.

Generic drug companies can make Pfizer's pill

Also on Tuesday,Pfizersigned a deal with a UN-backed group to allow other manufacturers to make its experimental COVID-19 antiviral pill, a move that could make the treatment available to more than half of the world's population.

In a statement issued Tuesday, Pfizer said it would grant a licence for the antiviral pill to the Geneva-based Medicines Patent Pool, which would let generic drug companies produce the pill for use in 95 countries, making up about 53 per centof the world's population.

The deal excludes some large countries that have suffered devastating coronavirus outbreaks. For example, while a Brazilian drug company could get a licence to make the pill for export to other countries, the medicine could not be made generically for use in Brazil.

Still, health officials said the fact that the deal was struck even before Pfizer's pill has been authorized anywherecould help to end the pandemic quicker.

"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 fourbillion people," Esteban Burrone, head of policy at the Medicines Patent Pool, said.

He estimated that other drugmakers would be able to start producing the pill within months, but acknowledged the agreement wouldn't please everyone.

"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.

Under the terms of the agreement, Pfizer will not receive royalties on sales in low-income countries, and will waive royalties on sales in all countries covered by the agreement while COVID-19 remains a public health emergency.

In a similar deal with the Medicines Patent Pool announced in October, Merck agreed to let other drugmakers make itsMolnupiravir pillavailable in 105 poorer countries.

Doctors Without Borders said it was "disheartened" that the Pfizer deal does not make the drug available to the entire world, noting that the agreement announced Tuesday also excludes countries including China, Argentina and Thailand.

"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," said Yuanqiong Hu, a senior legal policy adviser at Doctors Without Borders.

The decisions by Pfizer and Merck to share their COVID-19 drug patents stands in stark contrast to the refusal of Pfizer and other vaccine-makers to release their vaccine recipes for wider production. A hub set up by the World Health Organization in South Africa intended to share messenger RNA vaccine recipes and technologies has not enticed a single pharmaceutical company to join.

Fewer than one per cent of Pfizer's COVID-19 vaccineshots have gone to poorer countries.