The Hague: The European Medicines Agency (EMA) has issued advice on the emergency use of Pfizer’s Covid-19 pill called Paxlovid.
The European Union (EU) drug regulator on Thursday December 16 said the medicine, which is not yet authorized in the EU, can be used to treat adults with Covid-19 who do not require supplemental oxygen and who are at increased risk of progressing to severe disease.
Paxlovid should be administered as soon as possible after diagnosis of Covid-19 and within five days of the start of symptoms, it added.
EMA said it issued this advice to support national authorities who may decide on possible early use of the medicine prior to marketing authorization, for example in emergency use settings, in the light of rising rates of infection and deaths due to Covid-19 across the EU, Xinhua news agency reported.
Data showed that Paxlovid reduced the risk of hospitalisation and death when treatment started within five days of the start of symptoms, according to EMA.
Test results showed that about one per cent of patients who took Paxlovid within five days of the start of symptoms were hospitalised within 28 days of starting treatment, compared with 6.7 per cent of patients given placebo. None of the patients in the Paxlovid group died compared with 10 patients in the placebo group, EMA added.
Paxlovid is an oral antiviral medicine that reduces the ability of SARS-CoV-2 (the virus that causes Covid-19) to multiply in the body.