WASHINGTON, Pfizer Inc. announced Friday that the company's experimental antiviral pill, COVID-19, reduced hospitalizations and deaths by almost 90% among high-risk adults. The drugmaker is now joining the race to bring an easy-to-use coronavirus medication to the U.S.
All COVID-19 treatment in the United States require either an injection or IV. After showing promising initial results, the Food and Drug Administration is currently reviewing Merck's COVID-19 pills. The United Kingdom was the first to approve it on Thursday.
After independent experts suggested that Pfizer stop its study due to the strength of its results, Pfizer stated it would ask the FDA and other international regulators for authorization. The FDA may make a decision in weeks or months after Pfizer has applied. The company could sell the drug under Paxlovid if it is approved.
Researches around the world have been trying to find a way to prevent COVID-19 from spreading to others.
Friday's preliminary results from a study of 775 adults by Pfizer were released. The company's drug was given to patients who presented with COVID-19 symptoms within a month. They experienced an 89% decrease in hospitalizations and deaths compared with patients who were treated with a placebo pill. The drug was not required to be administered to more than 1% of patients. No one died. In comparison, 7 % were admitted to the hospital and seven people died.
"We had hoped that we would have something extraordinary," stated Dr. Mikael Dolsten (Pfizer's chief scientist officer) in an interview.
Participants in the study were unvaccinated and had mild-to-moderate COVID-19. They were also considered high-risk for hospitalization because of health issues like diabetes, obesity, heart disease, or diabetes. The treatment began within three to five working days of the initial symptoms and lasted five days. Patients who were treated earlier had slightly better results. This highlights the importance of quick testing and treatment.
Pfizer did not provide any details about side effects, but stated that the rates of problems between the groups were approximately 20%.
A group of independent medical experts that monitored the trial recommended it be stopped early. This is standard procedure if interim results prove to show a clear benefit. Although the data are not yet available for review by outsiders, this is the usual process to approve new medical research.
Top U.S. officials insist that vaccinations will continue to be the best way to prevent infection. However, with millions of people still not vaccinated and many more worldwide, effective, simple-to-use treatment options will be crucial to preventing future outbreaks.
Merck's pill, molnupiravir, has been scheduled for review by the FDA. In September, Merck reported that its drug had reduced hospitalizations and deaths by half. Experts advise against comparing preliminary results due to differences in studies.
Merck's pill is still in the U.S. regulatory process. However, Pfizer could have a safer profile that is familiar to regulators and raises fewer red flags. Merck's trial excluded pregnant women due to the possibility of birth defects. Pfizer's drug had no such restrictions. Merck's drug interferes with the genetic code of the coronavirus, which is a novel way to stop the virus.
Pfizer's drug is one of a long-standing family of antiviral drugs called protease inhibitors. These drugs have revolutionized HIV treatment and hepatitis C treatment.
It was discovered for the first time during the 2003 SARS epidemic that broke out in Asia. Company researchers revived the drug and studied it for COVID-19 last year due to the similarity between the coronaviruses.
The United States has approved remdesivir as an antiviral drug for COVID-19 and three antibodies therapies to help the immune system fight this virus. They must be administered by intravenous injection or in hospitals and clinics. Supplies were limited by the recent surge in the delta variant.
Pfizer shares rose more than 9% Friday morning before the opening bell.
