(WASHINGTON) — Pfizer Inc. said Friday that its experimental antiviral pill for COVID-19 cut rates of hospitalization and death by nearly 90% in high-risk adults, as the drugmaker joins the race to bring the first easy-to-use medication against the coronavirus to the U.S. market.
All COVID-19 treatment in America requires an injection or IV. Competitor Merck’s COVID-19 pill is already under review at the Food and Drug Administration after showing strong initial results, and on Thursday the United Kingdom became the first country to OK it.
Pfizer said it will ask the FDA and international regulators to authorize its pill as soon as possible, after independent experts recommended halting the company’s study based on the strength of its results. 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 raced to develop a home remedy for COVID-19 to reduce symptoms and speed up recovery.
Pfizer announced Friday preliminary results from its 775-person study. Patients who received the company’s drug along with another antiviral shortly after showing COVID-19 symptoms had an 89% reduction in their combined rate of hospitalization or death after a month, compared to patients taking a dummy pill. The drug was not required to be administered in a hospital setting, and less than one percent of the patients had to go there. In comparison, 7 % were admitted to the hospital and seven people died.
“We were hoping that we had something extraordinary, but it’s rare that you see great drugs come through with almost 90% efficacy and 100% protection for death,” said Dr. Mikael Dolsten, Pfizer’s chief scientific officer, in an interview.
The study participants had unvaccinated mild-to moderate COVID-19 and were high-risk patients for being hospitalized due to obesity, diabetes, heart disease, or other health conditions. Within three to five working days, treatment was initiated and lasted five days. The treatment results were slightly more favorable for patients who had received the drug sooner, which highlights the necessity of rapid testing and treatment.
Pfizer provided few details regarding side effects. However, they said that rates of problem were comparable between all groups (around 20%).
A group of independent medical experts that monitored the trial advised against stopping it before interim results showed a benefit. Data have yet to be published outside for external review as is standard procedure for reviewing new medical research.
U.S. officials in health continue to emphasize that vaccination is the best protection against infection. But with tens of millions of adults still unvaccinated — and many more globally — effective, easy-to-use treatments will be critical to curbing future waves of infections.
The FDA has set a public meeting later this month to review Merck’s pill, known as molnupiravir. In September, Merck reported that the drug had reduced hospitalizations and deaths by half. Experts advise against comparing preliminary data due to differences in the studies.
Although Merck’s pill is further along in the U.S. regulatory process, Pfizer’s drug could benefit from a safety profile that is more familiar to regulators with fewer red flags. While pregnant women were excluded from the Merck trial due to a potential risk of birth defects, Pfizer’s drug did not have any similar restrictions. The Merck drug works by interfering with the coronavirus’ genetic code, a novel approach to disrupting the virus.
Pfizer’s drug is part of a decades-old family of antiviral drugs known as protease inhibitors, which revolutionized the treatment of HIV and hepatitis C. The drugs block a key enzyme which viruses need to multiply in the human body.
This drug was identified for the first times during SARS’s 2003 outbreak in Asia. Company researchers revived the drug and studied it last year for COVID-19 because of the similarity between these coronaviruses.
One other antiviral drug has been approved by the U.S. for COVID-19. Three antibody treatments have also been authorized to help fight the virus. However, they must be administered intravenously or by injection in clinics or hospitals. The supply was limited due to the latest surge of the delta virus.
Pfizer shares rose more than 9 percent before Friday’s opening bell.