Pfizer Inc. said Friday that its experimental antiviral pill against COVID-19 reduces the rate of hospitalization and death by nearly 90% in high-risk adults. The pharmaceutical company thus enters the race to market the first easy-to-use drug against the coronavirus.
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Currently, all COVID-19 treatments used in the United States require an IV or injection. Its competition, the pill made by Merck, is under review by the Food and Drug Administration (FDA) after showing strong initial results. Britain became the first country to give the go-ahead on Thursday.
Pfizer said it will ask the FDA and international regulators to authorize its pill as soon as possible, after independent experts recommended stopping the study based on the strength of its results. Once Pfizer submits your application, the FDA could make a decision in a matter of weeks or months.
Researchers around the world have been racing to find a COVID-19 pill that can be taken at home that will ease symptoms, speed recovery, and reduce the enormous burden on hospitals and doctors.
Having pills to fight COVID-19 as early as possible “would be a very important advance,” said Dr. John Mellors, head of the department of infectious diseases at the University of Pittsburgh, who was not involved in the Pfizer study.
“If someone develops symptoms and tests positive, we can ask the local pharmacy for a prescription, as we do with many, many infectious diseases,” he added.
Pfizer released the preliminary results of its study on 775 adults on Friday. People who took their drug with another antiviral experienced an 89% reduction in their combined rate of hospitalization or death after one month, compared to patients who received placebo. Less than 1% of the patients who took the new pill had to be hospitalized and there were no deaths. In the control group, 7% were hospitalized and seven deaths were recorded.
“We were hoping to have something extraordinary, but it’s rare that you see great drugs with nearly 90% efficacy and 100% protection against death,” said Dr. Mikael Dolsten, Pfizer’s chief scientific officer, in an interview.
Study participants were unvaccinated, had mild to moderate COVID-19, and were considered at high risk for hospitalization due to health problems such as obesity, diabetes, or heart disease. Treatment began three to five days after the initial symptoms, and lasted five days. Patients who received the drug earlier showed slightly better results, underscoring the need to speed up testing and treatment.
Pfizer reported few details about side effects, but said the rates of problems were similar between the groups, around 20%.
An independent group of medical experts who oversaw the trial recommended stopping it before the initial deadline, which is standard procedure when interim results show such clear benefit. The data has not yet been released for external review, the normal process for examining new medical research.