EU reviewing Pfizer’s COVID antiviral pill for emergency use

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FILE – This Feb. 5, 2021, file photo shows the Pfizer logo displayed at the company’s headquarters in New York. Pfizer says its experimental pill for COVID-19 cut rates of hospitalization and death by nearly 90% among patients with mild-to-moderate infections. The company announced Friday, Nov. 5, it will soon ask the U.S. Food and Drug Administration and international regulators to authorize its pill, which is taken twice a day for five days. (AP Photo/Mark Lennihan, File)

AMSTERDAM (AP) — The European Union’s drug regulator said it has started evaluating the coronavirus pill made by Pfizer Inc. to see if it might be used in emergency situations before it is officially authorized.

In a statement Friday, the European Medicines Agency said it is looking at data on the effectiveness of Pfizer’s antiviral pill when given to people infected with COVID-19 who are not yet hospitalized but are at risk of developing severe disease.

Early results suggest Pfizer’s pill reduces the risk of hospitalization or death, compared with people who received a dummy pill, when they were treated within three to five days of developing COVID-19 symptoms, the agency said.

Although a more comprehensive evaluation will likely start soon, “this current review will provide EU-wide recommendations in the shortest possible timeframe so they can be used by national authorities who wish to take evidence-based decisions on the early use of the medicine,” the regulator said.

Europe is the epicenter of the COVID-19 pandemic, with numerous countries facing surges of disease amid lagging vaccination rates. On Friday, Austrian Chancellor Alexander Schallenberg announced the country would go into a national lockdown and that COVID-19 vaccinations would be mandatory by next year.

Pfizer said earlier this month that its pill cut the risk of hospitalization or death by up to 90%. The company reported few details on side effects but said 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 a clear benefit. The data has not yet been published for outside review, the normal process for vetting new medical research.

Most COVID-19 treatments require an IV or injection. Competitor Merck’s COVID-19 pill has already been authorized by Britain, and Pfizer’s pill is under consideration by the U.S. Food and Drug Administration.

Since the beginning of the pandemic last year, researchers worldwide have been racing to find a pill to treat COVID-19 that can be taken at home to ease symptoms, speed recovery and keep people out of the hospital.


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