European Union Medical Body Approves Pfizer Covid Pill For Emergency Use
Pfizer said this week that the pill -- a new type of treatment that should withstand the new Omicron variant -- reduced hospitalisations and deaths in at-risk people by almost 90 percent.
The EU's drug regulator on Thursday allowed member states to use Pfizer's new Covid pill ahead of its formal approval, as an emergency measure to curb a new wave of the disease.
The US pharma giant said this week that the pill -- a new type of treatment that should withstand the new Omicron variant -- reduced hospitalisations and deaths in at-risk people by almost 90 percent.
"The medicine, which is not yet authorised 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," the European Medicines Agency (EMA) said in a statement.
"EMA issued this advice to support national authorities who may decide on possible early use of the medicine... for example in emergency use settings, in the light of rising rates of infection and deaths due to COVID-19 across the EU."
The treatment, dubbed Paxlovid, is a combination of a new molecule, PF-07321332, and HIV antiviral ritonavir, that are taken as separate tablets.
"Paxlovid should be administered as soon as possible after diagnosis of COVID-19 and within five days of the start of symptoms," the EMA said, adding that the pills should then be taken for five more days.
The most common side effects were a disturbance of the sense of taste, diarrhoea and vomiting. The drug should not be used by pregnant women, and breastfeeding should be interrupted while it is being taken, it added.
The Amsterdam-based watchdog said it was at the same time launching a "rolling review" of the Pfizer pill that could lead to its eventual approval in a matter of months.
The EMA has already issued a similar emergency use approval for a pill by Pfizer's rival Merck.
The US pharma giant said this week that the pill -- a new type of treatment that should withstand the new Omicron variant -- reduced hospitalisations and deaths in at-risk people by almost 90 percent.
"The medicine, which is not yet authorised 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," the European Medicines Agency (EMA) said in a statement.
"EMA issued this advice to support national authorities who may decide on possible early use of the medicine... for example in emergency use settings, in the light of rising rates of infection and deaths due to COVID-19 across the EU."
The treatment, dubbed Paxlovid, is a combination of a new molecule, PF-07321332, and HIV antiviral ritonavir, that are taken as separate tablets.
"Paxlovid should be administered as soon as possible after diagnosis of COVID-19 and within five days of the start of symptoms," the EMA said, adding that the pills should then be taken for five more days.
The most common side effects were a disturbance of the sense of taste, diarrhoea and vomiting. The drug should not be used by pregnant women, and breastfeeding should be interrupted while it is being taken, it added.
The Amsterdam-based watchdog said it was at the same time launching a "rolling review" of the Pfizer pill that could lead to its eventual approval in a matter of months.
The EMA has already issued a similar emergency use approval for a pill by Pfizer's rival Merck.
AI Disclaimer: An advanced artificial intelligence (AI) system generated the content of this page on its own. This innovative technology conducts extensive research from a variety of reliable sources, performs rigorous fact-checking and verification, cleans up and balances biased or manipulated content, and presents a minimal factual summary that is just enough yet essential for you to function as an informed and educated citizen. Please keep in mind, however, that this system is an evolving technology, and as a result, the article may contain accidental inaccuracies or errors. We urge you to help us improve our site by reporting any inaccuracies you find using the "Contact Us" link at the bottom of this page. Your helpful feedback helps us improve our system and deliver more precise content. When you find an article of interest here, please look for the full and extensive coverage of this topic in traditional news sources, as they are written by professional journalists that we try to support, not replace. We appreciate your understanding and assistance.