Pfizer signs $3.2 billion deal with the U.S. for 105 million COVID-19 doses

Pfizer and BioNTech SE have signed a $3.2 billion agreement with the U.S. government for 105 million doses of their COVID-19 vaccine.

The deal includes new versions of the shots, and they will be delivered by the fall, pending a decision by the Food and Drug Administration. Federal officials say the deal includes the option to purchase a total of 300 million vaccine doses.

Pfizer said Thursday that it is seeking full approval for its oral COVID antiviral treatment Paxlovid by the FDA.

The drug would be used for the treatment of COVID 19 in vaccinated and unvaccinated people at high risk for serious illness.

Paxlovid is currently approved for use in adults and kids ages 12 years and older, with positive results from direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID 19.

According to the Centers for Disease Control and Prevention, 50 - 60% of the U.S. population is estimated to have one or more risk factors for developing severe COVID- 19 illness.

As the COVID 19 pandemic continues to evolve and be highly unpredictable, we must remain vigilant in protecting those who are at greatest risk of getting sick from COVID 19 as they remain vulnerable to possible hospitalization or even death, Albert Bourla, Pfizer's chairman and CEO, said in a statement. Data from our clinical development program and the more than 1.7 million patients around the world who have been given our oral treatment to date strengthen Paxlovid as an important treatment option for mild to moderate COVID 19 in patients at greater risk of progression to severe symptoms, regardless of vaccine status. We look forward to working with the FDA to get full regulatory approval for Paxlovid. The submission was supported by non-clinical and clinical data for Paxlovid, including results from a Phase 2 3 EPIC-HR study on COVID- 19 in High-Risk patients, which found that treatment with Paxlovid reduced the risk of hospitalization or death from any cause by 88% in non-hospitalized, high-risk adult patients treated within five days of symptom onset, in comparison to placebo.

The final clinical study showed an 86% reduction in relative risk.

Pfizer said that the data analyses included data from both vaccinated patients with and unvaccinated patients with no risk factors for severe COVID - 19.

The data was supportive of the efficacy and safety data observed in EPIC-HR for use in patients with an increased risk of progression to severe COVID 19 illness, while the novel primary endpoint of self-reported, sustained alleviation of all symptoms for four consecutive days was not met.

More than 12 million treatment courses of Paxlovid were shipped to more than 40 countries by Pfizer at the end of May.

More than 1.6 million courses of Paxlovid have been administered in the U.S. according to data from the Department of Health and Human Services.