EU’s Drug Regulator Gives Emergency-Use Approval to Pfizer’s COVID-19 Pill

The pill, named Paxlovid, should be administered as soon as possible after a diagnosis of COVID-19, as per the EMA.

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The European Union’s (EU's) drug regulator has approved Pfizer's antiviral COVID-19 pill for emergency use, though a formal approval is pending.

This comes days after Pfizer said that the pill displayed 90 percent efficacy against hospitalisations and deaths in high-risk patients, and even proved effective against the new and possibly more contagious Omicron variant.

The European Medicines Agency (EMA) said in a statement, "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 pill, named Paxlovid, should be administered as soon as possible after a diagnosis of COVID-19 and within five days of the start of symptoms, as per the EMA.

The EMA added, “The two active substances of the medicine, PF-07321332 and ritonavir, which are available as separate tablets, should be taken together twice a day for 5 days.”

The approval has been given in light of rising infections across the EU, and in order to support national authorities who might decide to use it in emergency situations.

The most common side effects reported during treatment and up to 34 days after the last dose of Paxlovid were taste disturbance, diarrhoea, and vomiting.

It is also not recommended during pregnancy.

Meanwhile, a “rolling review” of the medicine has been launched, as the pharma-giant waits for a formal approval for market authorisation.