WASHINGTON — Pfizer says its experimental pill for COVID-19 cuts the risk of hospitalization or death by nearly 90% in patients treated within three days of developing symptoms.
The company announced Friday it would soon ask the U.S. Food and Drug Administration (FDA) and international regulators to authorize its pill, which it calls Paxlovid.
In Pfizer's press release, the company said patients took the pill twice a day for five days. In addition to lowering the risk for hospitalization, in the overall study population, no patients who took the drug died, while 10 people who received a placebo drug died, based on an interim analysis.
"Today's news is a real game-changer in the global efforts to halt the devastation of this pandemic," Albert Bourla, Pfizer's chairman and CEO, said in a statement. "...given the continued global impact of COVID-19, we have remained laser-focused on the science and fulfilling our responsibility to help healthcare systems and institutions around the world while ensuring equitable and broad access to people everywhere."
“We know that some of the people that have gotten vaccinated and even boosted are immunocompromised or they’re at high medical risk of having severe COVID, so it’d be these people that once you have symptom onset, you could treat them and potentially keep them out of the hospital," said Dr. Michael Teng, an Associate Professor at USF Health.
Dr. Teng explained pills are much easier and cheaper to manufacture. Compared to monoclonal antibody treatments, he shared how this drug could be a good option if approved.
“It requires a lot of resources to put the monoclonal antibodies into you," said Teng. "Somebody has to inject it. You have to get to a site. You have to distribute it. Pills are easy. Pills are in our pharmacies all the time, and you can get a prescription, take it home, take it in the comfort of your own home.”
As for the next steps, Pfizer says at the recommendation of an independent Data Monitoring Committee and in consultation with the FDA, it will stop further enrollment into the study and plans to submit the data as part of its ongoing rolling submission to the FDA for Emergency Use Authorization (EUA) as soon as possible.
”That means the people who monitor the clinical trials think that it’s so effective that there’s no point in continuing the trial and that they should just go forward with trying to get it out there to the public," said Dr. Teng.
A similar pill from competitor Merck is currently under FDA review and was cleared Thursday by U.K. regulators.
Drugmakers around the world have been racing to develop an easy-to-use pill to blunt the effects of COVID-19.
All therapies currently authorized in the U.S. require an IV or injection.