The European Medicines Agency (EMA) has recommended that Pfizer's coronavirus antiviral drug be authorised for use in the 27-nation European Union, the first time the agency has recommended a pill for treating Covid-19.
In a statement on Thursday, the EU drug regulator said giving the green light to Pfizer’s Paxlovid could help people infected with Covid-19 to avoid more serious disease and being admitted to hospital.
The EMA’s expert committee recommended the pill be given to adults who do not require oxygen and who are at higher risk of severe disease.
The drug was cleared by regulators in the US and the UK in late December, although authorities noted that supplies would be extremely limited.
An antiviral pill from Merck is also expected to be authorised, but Pfizer's drug is all but certain to be the preferred option because of its mild side effects and superior effectiveness as suggested by studies, including a nearly 90 per cent reduction in hospital admissions and deaths among patients most likely to become severely ill.
The pills from Pfizer and Merck are expected to be effective against the Omicron variant because they do not target the spike protein where most of the variant's mutations reside.
Pfizer has 180,000 treatment courses available worldwide, with roughly 60,000 to 70,000 allocated to the US. The company said it expects to have 250,000 available in the US by the end of January. Its Ringaskiddy plant in Cork will play a key role in the manufacturing process.
The EMA said its decision was based on a review of the drug’s use in people who were mostly infected with the Delta variant, but it believed it would also be helpful in curbing the surge caused by the ultra-contagious Omicron variant.
“Based on laboratory studies, Paxlovid is also expected to be active against Omicron and other variants,” the regulator said. It said the drug’s safety profile was “favourable” and that side effects were generally mild.
Peter Liese, the European Parliament's spokesperson for health, called the decision a "real ray of hope" for a return to normality after the pandemic, but he cautioned that there were no guarantees from the European Commission or member countries that the drug would be delivered quickly.
In a statement, he said he had recently sent Pfizer’s chief executive “an urgent appeal” following EU negotiations to obtain the drug. – AP