Pfizer Asks FDA To Authorize Its COVID Antiviral Pill
By Bill Galluccio
November 16, 2021
Pfizer has asked the U.S. Food and Drug Administration to authorize its experimental new COVID-19 antiviral drug, Paxlovid. The pharmaceutical company said that clinical trials showed the drug can reduce the chances of hospitalization and death when given to unvaccinated people within three days of showing symptoms of COVID-19.
The treatment consists of three pills, taken twice a day for five days. The current authorization request would only make the treatment available for people who are not fully vaccinated.
"With more than 5 million deaths and countless lives impacted by this devastating disease globally, there is an urgent need for life-saving treatment options. The overwhelming efficacy achieved in our recent clinical study of PAXLOVID, and its potential to help save lives and keep people out of the hospital if authorized, underscores the critical role that oral antiviral therapies could play in the battle against COVID-19," Albert Bourla, chairman and CEO of Pfizer, said in a statement.
The request comes just hours after Pfizer announced it had worked out an agreement with the United Nations-backed Medicines Patent Pool to allow other companies to manufacture the drug for low- and middle-income countries.
Pfizer joins Merk as the second company to ask for FDA authorization for a COVID antiviral treatment. The FDA will review Merk's treatment, which has been authorized by health officials in the United Kingdom, on November 30.