The European Union’s health regulator gave its nod for the use of Pfizer’s COVID-19 anti-viral pill on Thursday.
In a statement, the European Medicines Agency (EMA) said it had “recommended authorising Paxlovid for treating COVID-19 in adults who… are at increased risk of the disease becoming severe.”
Paxlovid has so far been authorised for people aged 12 and older in a handful of countries including the United States, Canada and Israel.
The European Union had allowed member states to use it ahead of formal approval as an emergency measure against Omicron, reports news agency AFP.
The drug, which comprises two types of tablet, is the first COVID-19 therapy which can be taken at home.
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It is usually prescribed to high-risk patients from getting so sick that they need to be hospitalised.
It is taken twice a day for five days in combination with a second medicine called ritonavir, a generic antiviral.
Unlike vaccines, it does not target the ever-evolving spike protein which the coronavirus uses to invade cells.
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The company in its preliminary lab studies concluded that the pill, in theory, is more variant-proof than the vaccines.
In a Pfizer study involving more than 2,200 people at high risk for developing serious COVID-19, it was found that Paxlovid reduced the risk of hospitalisation or death by 89 per cent, compared with a placebo, when taken within three days of first symptoms of illness.
When taken within five days, the drug reduced the risk of hospitalisation and death by 88 per cent, the study conducted by the company claimed.
(With inputs from agencies)