On Thursday, 16 December, European Medicines Agency (EMA) approved an antiviral pill Paxlovid developed by Pfizer for emergency treatment of Covid-19 infection in member states of the European Union.
EMA mentioned in its statement that the pill, which is not yet approved for use in the EU, can be used in treatment of Covid-19 patients who do not require oxygen treatment and who are at a high risk of the infection developing into a severe stage.
On Tuesday, 14 December, Pfizer announced that clinical trials proved the developed pill can reduce the risk of hospitalisation by nearly 90% and death in risk groups.
Paxlovid pill should prove effective against mutations observed with Omicron variant of Covid-19, the company reported.
More than 2 200 volunteers participated in clinical trials of Paxlovid antiviral pill.
«EMA 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,» EMA explained in its statement.
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.
This means the pill is only effective at early stages of infection. Once Covid-19 has progressed into severe phase of infection the virus no longer multiplies and patients suffer from excessive immune response.
As EMA stresses Paxlovid should be used immediately after initial Covid-19 infection and within five days after symptoms appear. EMA notes pills should be used for five days.
The most common side-effects from Paxlovid include dysgeusia (taste disturbance), diarrhoea and vomiting.
Pills are not recommended during pregnancy. Young mothers should cease breastfeeding after starting using Paxlovid pills.
EMA announced having started rapid evaluation of the pills so that their use can be approved officially in a couple of months.
EMA previously issued similar permission for emergency use of antiviral medicine for Covid-19 treatment produced by company Merck.
EMA approves Paxlovid for emergency treatment of Covid-19 infection
