WASHINGTON (AP) – Pfizer Inc. said its experimental COVID-19 antiviral pill has reduced hospital admissions and deaths by nearly 90% among high-risk adults as the drug maker joins the race for an easy-to-use drug to treat the coronavirus.
Currently, most treatments for COVID-19 require intravenous or injection. A pill from rival Merck’s COVID-19 is already under FDA review after showing strong initial results, and the UK became the first country to approve it Thursday.
Pfizer said it will ask the FDA and international regulators to authorize its pill as soon as possible after independent experts recommended that the company’s research be suspended based on its findings. Once the application is filed by Pfizer, the FDA may make a decision within weeks or months.
Since the outbreak of the pandemic last year, researchers around the world have been rushing to find a pill for the treatment of COVID-19 that can be taken at home to relieve symptoms, speed up recovery and keep people from hospitalization.
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Having pills to treat COVID-19 early “would be a very important achievement,” said Dr. John Mellors, head of infectious diseases at the University of Pittsburgh, who was not involved in the Pfizer study.
“If anyone has symptoms and tests positive, we could write a prescription to the local pharmacy, as we do for many, many infectious diseases,” he said.
On Friday, Pfizer released preliminary results from a study of 775 adults. In patients who received the company’s drug along with another antiviral drug shortly after the onset of symptoms of COVID-19, a month later, the combined hospitalization or death rate was 89% lower compared to patients taking the pacifier. Less than 1% of patients taking the drug required hospitalization and no one died. In the comparison group, 7% were hospitalized and there were seven deaths.
“We were hoping we had something extraordinary, but it’s rare to see excellent drugs with almost 90% effectiveness and 100% death protection,” said Dr. Mikael Dolsten, Pfizer’s chief scientist, in an interview.
Study participants were not vaccinated, had mild to moderate COVID-19, and were considered to be at high risk of hospitalization due to health problems such as obesity, diabetes, or heart disease. Treatment began within three to five days after the onset of the first symptoms and lasted for five days. Patients who received the drug earlier showed slightly better results, which emphasizes the need for early testing and treatment.
Pfizer provided few details on side effects, but reported that the incidence of problems in the groups was similar at about 20%.
An independent panel of medical experts overseeing the study recommended that the study be discontinued prematurely when intermediate results show such clear benefit. The data has not yet been released for external review, which is a common process for validating new medical research.
Senior US health officials continue to stress that vaccination will remain the best way to protect against infection. But with tens of millions of adults still unvaccinated – and many more around the world – effective, easy-to-use treatments will be critical in curbing future waves of infections.
Later this month, the FDA called a public meeting to review a Merck pill known as molnupiravir. In September, the company reported that its medications reduced hospital admissions and deaths by 50%. Experts cautioned against comparing preliminary results due to differences in studies, including where they were conducted and what types of variants were circulating.
“It’s too early to say who won the 100m,” Mellors said. “There is a big difference between 50% and 90%, but we have to make sure the populations are comparable.”
While Merck’s tablet is further undergoing regulation in the US, Pfizer’s drug could benefit from a safety profile more familiar to regulators with fewer red flags. While pregnant women were excluded from the Merck study due to the potential risk of birth defects, Pfizer did not have these limitations. Merck’s drug works by interfering with the genetic code of the coronavirus, a novel approach to breaking down the virus.
Pfizer is part of the family of antiviral drugs known as protease inhibitors that are decades old. They revolutionized the treatment of HIV and hepatitis C. The drugs block a key enzyme that viruses need to reproduce in the human body.
The drug was first discovered during the 2003 SARS outbreak in Asia. Last year, company researchers decided to revive the drug and study it for COVID-19, given the similarities between the two coronaviruses.
The US has approved another antiviral drug for COVID-19, remdesivir, and has authorized three antibody therapies that help the immune system fight the virus. But they have to be administered intravenously or by injection in hospitals or clinics, and limited supplies have been limited by the latest surge in the delta option.
Pfizer shares jumped more than 8% in Friday morning trading.