Pfizer will seek FDA approval for new COVID pill

Clinical trials of new COVID treatment show positive outcomes.

By Emily Faith Grodin, Staff Writer

Pfizer announced its new oral drug to fight COVID-19 on Nov. 5, claiming the pill could cut the disease's risk of hospitalization or serious illness by 89 percent.

The medication has been given the name Paxlovid, and is similar to a new pill by Merck already seeking approval in the U.K. Pfizer says they will stop enrolling people into more trials and instead send the data they already have to the FDA in hopes of emergency-use authorization. Clinical trials of the drug used participants who were known to be at high risk of serious illness. Volunteers were either given Paxlovid or a placebo within three days of their first symptoms. The group receiving the treatment saw only 0.8 percent of patients hospitalized compared to 7 percent of the group receiving placebo. Of the group that received the placebo, seven people died. No deaths were recorded in the group that received the drug.

“Today’s news is a real game-changer in the global efforts to halt the devastation of this pandemic,” said Pfizer CEO Albert Bourla in a statement released online. "Paxlovid is a protease inhibitor, which means it stops the virus from multiplying in the body. It is co-administered with another drug called Ritonavir that is commonly used in patients receiving treatment for HIV/AIDS. If approved, Paxlovid has the potential to “save patients’ lives, reduce the severity of COVID-19 infections, and eliminate up to 9 out of ten hospitalizations.”

This would be the first major tool the country has had to treat COVID-19. At this time, Remdesivir is the only FDA approved treatment for the virus, but it must be administered intravenously by a medical professional. If Paxlovid is approved, it can be easily prescribed for at-home treatment. Pfizer has already begun advanced purchase agreements with several countries such as the U.K., South Korea, and Australia and is negotiating with more.

As with any new drug, concerns do exist. During clinical trials, volunteers were all individuals with underlying health issues. So it is unclear how Paxlovid will work for the general public. One concern that the company is addressing is affordability. The company plans to price the drug through a tiered pricing approach, which means that lower-income countries pay less for the drug, while higher-income countries pay more.