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Pfizer Moves to Get US Authorization for Antiviral Covid Pill

Pfizer pill
Pfizer has filed to have its antiviral Covid pill authorized for use in the U.S. Credit: Dr. Janos Korum, CC BY-SA 2.0

Pfizer announced on Tuesday that it has filed for U.S. authorization of the company’s new antiviral Covid-19 pill.

The pill, called Paxlovid, has yielded impressive results in clinical trials, reducing hospitalization or death by 89%. If approved, the drug could prove to be a gamechanger for those most vulnerable to severe illness, as well as helping countries with a less vaccinated population.

Pfizer has officially completed its application for emergency use authorization from the FDA, but it has not yet been announced when the administration will make a decision about the drug. Merck & Co and Ridgeback Biotherapeutics submitted their antiviral pill molnupiravir earlier last month. Their drug will be reviewed by a panel of advisers on November 30, similar to the process conducted for the Covid vaccines.

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“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 Pfizer’s CEO Albert Bourla in a press release on the Paxlovid.

The company also announced on Tuesday that its officials had inked a licensing agreement which will enable less wealthy nations to distribute its antiviral drug Paxlovid in the form of generic anti-Covid pills.

The New York City based pharmaceutical company agreed to allow generic drug manufacturers to produce their own Paxlovid pills at a much lower price than the original drug.

“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, a United Nations-backed public health organization, agreed with the pharmaceuticals behemoth that Paxlovid will be made available to 95 low- to middle-income countries which are home to 53% of the entire population of the world.

Generic anti-Covid pills a “game changer,” according to CEO Dr. Albert Bourla

The anti-Covid pill, also known as PF-07321332, will be given to patients alongside an older antiviral drug called ritonavir, according to a report from CNN.

In an interview with CNBC, Thessaloniki-born Bourla said that the drug had the power to save millions of lives:

“This is a fantastic demonstration of the power  of science — and in fact it’s coming exactly a year to the day after we announced the results of the previous breakthrough of the vaccine, which has 95% efficacy. That was November 9th; this is November 5th.

“I think this medicine will change the way things are happening right now and save millions and millions of lives.”

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