EU reviewing Pfizer’s COVID antiviral pill for emergency use

The European Union’s drug regulator has announced that the EU is reviewing Pfizer’s antiviral pill. The review follows the application by Pfizer for approval of the drug, which the European Medicines Agency says will include looking at whether permission can be given for use in emergency situations prior to formal authorisation.

On Friday, the European Medicines Agency said it was looking at the effectiveness of Pfizer’s antiviral pill when given to people infected with COVID-19, but who have yet to be hospitalised but are at risk of developing severe symptoms. According to the data provided by Pfizer, the pill reduces the risk of hospitalisation or death when compared with people who receive a placebo. Those participating in the trials were treated within three to five days of developing COVID-19 symptoms. Pfizer has said that the pill cuts the risk of hospitalisation or death by up to 90%, with few side effects no more than have been experienced with their jab currently in use.

The regulator has indicated a more comprehensive evaluation will start soon, however “this current review will provide EU-wide recommendations in the shortest possible timeframe so they can be used by national authorities who wish to take evidence-based decisions on the early use of the medicine.”

Independent medical experts monitoring the trial of Pfizer’s antiviral pill recommended that it be stopped early, which is standard procedure when interim results show a clear benefit. At this stage no data has been made available for external review, a normal process for authorising new medical research. Competitor Merck’s COVID-19 pill has already been authorised for use in the UK.

Europe has become the epicenter of the COVID-19 pandemic, with numerous countries facing a surge in the disease amid flagging vaccination rates. On Friday, Austrian Chancellor Alexander Schallenberg announced the country would go into a national lockdown and that COVID-19 vaccinations would be mandatory by next year.

Researchers worldwide have been racing to develop effective remedies. Pfizer, one of the first to develop a vaccine, hopes that its antiviral pill will shortly be cleared for emergency use and in time full authorisation.

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