New COVID-19 pill reduces risk of death in hospitals by 90%.
WASHINGTON (AP) – Pfizer Inc. said Friday that its experimental antiviral pill for COVID-19 reduced hospitalization and death rates by nearly 90% as the drugmaker joins the race to bring the first easy-to-use drug. against the coronavirus to the country. American market.
Currently, all COVID-19 treatments used in the US require an IV or injection. 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 UK became the first country to approve it.
Pfizer said it will ask the FDA and international regulators to authorize its pill as soon as possible after independent experts recommended stopping the company’s study based on the robustness of its results. Once Pfizer submits the application, the FDA could make a decision in weeks or months.
Researchers around the world have been quick to find a COVID-19 pill that can be taken at home to ease symptoms, speed recovery, and reduce the crippling burden on hospitals and doctors.
Pfizer released the preliminary results of its study of 775 adults on Friday. Patients who took the company’s drug along with another antiviral had an 89% reduction in their combined rate of hospitalization or death after one month, compared to patients who took a dummy pill.
Less than 1% of the patients taking the drug had to be hospitalized and no one died. In the comparison group, 7% were hospitalized and there were seven deaths.
“We were hoping to have something extraordinary, but it’s rare to see great drugs with almost 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 for five days.
Pfizer reported few details on side effects, but said the rates of problems were similar between the groups at about 20%.
An independent group of medical experts monitoring the trial recommended stopping it early, 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.
Top US health officials continue to emphasize that vaccination will continue to be the best way to protect against infection. But with tens of millions of adults still unvaccinated, and many more globally, effective and easy-to-use treatments will be critical to curbing future waves of infections.
The FDA has scheduled a public meeting later this month to review Merck’s pill, known as molnupiravir. The company reported in September that its drugs reduced hospitalization and death rates by 50%. Experts caution against comparing preliminary results due to differences in studies.
Although Merck’s pill is further advanced in the US regulatory process, Pfizer’s drug could benefit from a more familiar safety profile to regulators with fewer red flags. While pregnant women were excluded from the Merck trial due to the potential risk of birth defects, the Pfizer drug had no similar restrictions.
The Merck drug works by interfering with the genetic code of the coronavirus, a novel approach to disrupting the virus.
The Pfizer drug is part of a family of antiviral drugs known as protease inhibitors, which revolutionized the treatment of HIV and hepatitis C. The drugs block a key enzyme that viruses need to multiply in the human body.
The drug, which has not yet been named, was first identified during the SARS outbreak that originated in Asia during 2003. Last year, company researchers decided to reactivate the drug and study it for COVID-19, given the similarities between the two coronaviruses.
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The United States approved another antiviral drug for COVID-19, remdesivir, and authorized three antibody therapies that help the immune system fight the virus.
But they have to be given intravenously or by injection in hospitals or clinics, and the latest surge in the delta variant depleted limited supplies.