EU regulator approves Pfizer’s COVID-19 pill for high-risk groups

On Thursday, the European Union’s drug regulator approved Pfizer’s antiviral pill to combat COVID-19 for high-risk adults as the bloc works to combat the omicron variant. 

The European Medicines Agency (EMA) offered conditional approval for the pill’s use in higher-risk adults, pending the European Commission’s final decision, a press release from Pfizer said. 

The decision will make the pill, known as Paxlovid, the first COVID-19 oral treatment recommended in the EU after the drug was already available after emergency guidance last year. 

EU Health Commissioner Stella Kyriakides told Reuters the region was making positive progress on arranging the treatments. 

“Paxlovid is the first oral antiviral for home use in our portfolio, and has the potential to make a real difference for persons at high risk of progression to severe COVID,” she said.

Italy, Germany and Belgium have already purchased the pill, according to Reuters. 

Merck also has a COVID-19 pill that is under review in the EU, but its approval process is moving slowly after the company submitted revised data in November indicating it was less effective than previously thought, Reuters reported. 

The pills are intended to be taken early on in one’s COVID-19 diagnosis in an effort to prevent hospitalizations and fatalities.

A clinical trial of Pfizer’s Paxlovid showed it was almost 90 percent effective in preventing severe outcomes in patients at high risk of severe illness if taken within three days of the onset of symptoms, according to the company.

Though the trial only included unvaccinated patients, the EMA’s endorsement was not exclusively for unvaccinated people.

“We are proud to have a strong manufacturing footprint in Europe, which will help support the production of up to 120 million courses of Paxlovid globally,” Pfizer Chief Executive Albert Bourla said in a statement.