Pfizer Inks $5.29 Billion Pact With U.S. to Supply COVID-19 Antiviral

The U.S. government will pay Pfizer $5.29 billion for 10 million treatment courses of its experimental COVID-19 antiviral, Paxlovid (PF-07321332; ritonavir), to be delivered later this year and into 2022.

Earlier this week, Pfizer filed for Emergency Use Authorization (EUA) of the oral pill as a treatment for mild-to-moderate COVID-19 and announced a deal with the Medicines Patent Pool enabling the organization to strike deals with other drugmakers to make generic versions of Paxlovid available in 95 developing countries.

And Paxlovid is expected to nab FDA authorization. The company’s EUA submission was supported by interim phase 2/3 data showing the drug cut the risk of hospitalization and death by 89 percent vs. placebo, and the trial was stopped early due to the antiviral’s clear efficacy.

The drug is also on track to become the first authorized antiviral of its kind, a 3CL protease inhibitor, that could be prescribed as an at-home treatment to high-risk patients at the first sign of COVID infection (DID, Nov. 17).

But Pfizer is facing competition from Merck and Ridgeback Biotherapeutics, co-developers of another COVID-19 antiviral, molnupiravir, that snagged a UK authorization earlier this month and will be reviewed by an FDA advisory panel on Nov. 30. In addition, the U.S. government has secured approximately 3.1 million treatment courses of molnupiravir for an estimated $2.2 billion through early 2022, pending authorization (DID, Nov. 5).

In other Pfizer news, the company is awaiting the granting of an updated EUA allowing its COVID-19 booster for all adults aged 18 and older. The drugmaker filed the request with the FDA just last week and an authorization is imminent.

On Wednesday, Moderna also announced that it has filed for emergency authorization of its COVID-19 booster shot. A Centers for Disease Control and Prevention expert panel is set to meet today and could take up recommendations for general booster use of the messenger RNA-based shots, provided the FDA authorizes the shots.

Pfizer was previously granted an amended emergency authorization in late September, allowing a booster for individuals over age 65 and those 18 and up who are at high risk of severe infection due to existing comorbidities or due to their place of work (DID, Sept. 23).

Last month, the FDA authorized boosters of the Moderna and Johnson & Johnson COVID-19 vaccines for the same populations, and the use of a “mix and match” approach allowing people to receive a booster with a different vaccine than the one they received in their initial inoculation (DID, Oct. 21). ― Jason Scott