Pfizer Makes Progress on Multiple Fronts with COVID-19 Treatment Candidate
January 24, 2022
Building on the announcement of clinical trial results, Pfizer’s oral COVID-19 treatment has been authorized by the U.S. Food and Drug Administration (FDA) as well as numerous other governments around the world. Pfizer has also sought to broaden access, increase production and announced its largest advance purchase commitment to date of PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets) with the U.S. government.
Receiving FDA Emergency Use Authorization
The company received Emergency Use Authorization (EUA) in December 2021 from the U.S. FDA for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older) who are at high risk for progression to severe COVID-19, including hospitalization or death. The authorization is based on results from Pfizer’s Phase 2/3 study of PAXLOVID, which showed an 88% reduced risk of COVID-19-related hospitalization or death from any cause compared to placebo in patients treated within five days of symptom onset.
The oral COVID-19 treatment has also demonstrated in vitro efficacy against circulating variants of concern, including the Omicron variant.
“All of us at Pfizer are incredibly proud of our scientists, who designed and developed this molecule, working with the utmost urgency to help lessen the impact of this devastating disease on patients and their communities,” said Mikael Dolsten, MD, PhD., Chief Scientific Officer and President, Worldwide Research, Development and Medical of Pfizer.
For more detail, read our press release on the FDA EUA.
Providing 20 million treatment courses to the U.S. government
The company also announced a commitment by the US Government to purchase 20 million treatment courses by the end of 2022. Approximately 10 million PAXLOVID treatment courses have been accelerated for delivery by the end of June, with the remaining 10 million to follow by the end of September.
Pfizer has also entered into agreements with several other countries and has initiated bilateral outreach to approximately 100 countries around the world.
For more detail, read our press release.
A commitment to access
Pfizer entered into an agreement for the oral COVID-19 treatment with the Medicines Patent Pool, a United Nations-backed public health organization working to increase access to life-saving medicines.
The agreement will help expand access, pending regulatory authorization or approval, in 95 low- and middle-income countries that account for approximately 53% of the world’s population.
“This license is so important because, if authorized or approved, this oral drug is particularly well-suited for low- and middle-income countries and could play a critical role in saving lives, contributing to global efforts to fight the current pandemic,” said Charles Gore, Executive Director of MPP
For more detail, read our press release.
The first of its kind
The oral COVID-19 treatment, taken as part of a 5-day treatment course that includes a total of 30 pills, could be prescribed as an at-home treatment to reduce illness severity, hospitalizations and death. Treatment-emergent adverse events were comparable between PAXLOVID and placebo.
Nirmatrelvir [PF-07321332], which originated in Pfizer laboratories, is designed to block the activity of the Mpro, an enzyme that the coronavirus needs to replicate.