AMSTERDAM — Before it is formally approved, the European Union’s medicines authority has begun studying Pfizer Inc.’s coronavirus pill to determine if it can be used in emergency situations.
The European Medicines Agency said in a statement Friday that it is reviewing evidence on the efficacy of Pfizer’s antiviral tablet in persons infected with COVID-19 who are not yet hospitalized but are at risk of developing severe illness.
When patients were treated within three to five days after acquiring COVID-19 symptoms, early data show Pfizer’s medication lessens the risk of hospitalization or mortality when compared to persons who got a dummy pill, the FDA said.
Although a more thorough review is expected to begin soon, the regulator stated that “this current review will provide EU-wide recommendations in the shortest possible timeframe so that they can be used by national authorities who wish to make evidence-based decisions on the early use of the medicine.”
The COVID-19 pandemic is centered in Europe, with outbreaks in a number of countries due to low vaccination rates. Austrian Chancellor Alexander Schallenberg declared on Friday that the country will enter a state of emergency and that COVID-19 vaccines would be required by next year.
Pfizer recently announced that their tablet reduced the chance of hospitalization or death by up to 90%. The corporation provided limited information on side effects but indicated that the rates of difficulties were roughly 20% in both groups.
When intermediate findings reveal such an obvious benefit, an independent committee of medical professionals overseeing the study suggested discontinuing it early, as is customary protocol. The data has not yet been made public for outside assessment, as is customary when new medical research is being evaluated.
The majority of COVID-19 therapies necessitate the use of an IV or injection. Britain has already approved competitor Merck’s COVID-19 tablet, while the US Food and Drug Administration is considering Pfizer’s medication.
Researchers have been rushing to develop a tablet to treat COVID-19 that can be used at home to relieve symptoms, expedite recovery, and keep people out of the hospital since the epidemic began last year.