Pfizer seeks conditional EU authorization for COVID-19 pill

THE HAGUE, Netherlands — The European cause regulator said Monday it has started evaluating an exertion by Pfizer for its pill to dainty the effects of COVID-19.

The announcement comes arsenic countries successful overmuch of the 27-nation bloc are reporting soaring numbers of infections arsenic the highly transmissible omicron variant sweeps crossed the continent.

The European Medicines Agency said successful a connection that it could determine wrong weeks whether to o.k. Pfizer’s exertion for a conditional selling authorization for the cause Paxlovid, “depending connected whether the information submitted are sufficiently robust and whether further accusation is required to enactment the evaluation.”

Late past month, U.S. wellness regulators authorized the pill that patients volition beryllium capable to instrumentality astatine location to ward disconnected the worst effects of the virus. At the time, Pfizer said it had 180,000 attraction courses disposable worldwide, with astir 60,000 to 70,000 allocated to the U.S. The institution said it expected to person 250,000 disposable successful the U.S. by the extremity of January.

Pfizer’s exertion to the EMA covers usage of the pill to dainty mild to mean COVID 19 successful patients aged 12 years and older who are astatine hazard of processing terrible symptoms of the disease.

The EMA past period issued proposal connected usage of the drug to EU nations that wanted to statesman utilizing it earlier authoritative authorization. The bureau said it based its proposal connected a survey of non-hospitalized, unvaccinated patients who had COVID-19 and astatine slightest 1 underlying information that enactment them astatine hazard of processing terrible COVID-19 symptoms.

“These information showed that Paxlovid reduced the hazard of hospitalization and decease erstwhile attraction started wrong 5 days of the commencement of symptoms,” the bureau said.