EU drug regulator gives go-ahead for Pfizer Covid pill's emergency use

The European Medical Agency on Thursday gave go-ahead for emergency use of Pfizer's Covid pill. Formal approval is still pending. The initial go-ahead has been given to curb Omicron infection.

Pills made by Pfizer and Merck are being hailed as groundbreaking because as compared to injections, they can be made accessible readily.

Pfizer said this week that its Paxlovid pill reduced hospitalisations and deaths in vulnerable 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 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."

Pfizer CEO Albert Bourla welcomed the development. He said that the decision "signifies the strength of our data for Paxlovid in the treatment of high-risk adults diagnosed with Covid-19."

"If authorised, Paxlovid has the potential to help save lives and reduce hospitalisations," he said in a statement.

The Pfizer pill is a combination of a new molecule, PF-07321332, and HIV antiviral ritonavir, that are taken as separate tablets.

The Amsterdam-based EMA said it should be taken as soon as possible after a diagnosis and within five days of the start of symptoms, with the treatment lasting five days.

'Combined effect'

Possible side effects were taste changes, diarrhoea and vomiting. Pregnant women should not use the drug.

The EMA said it also launching a "rolling review" of the Pfizer pill that could lead to its full approval in months. 

Merck's pill received EMA emergency approval in November. It is already authorised in Britain and is in the process of being approved in the United States.

Denmark on Thursday became the first EU country to approve its use.

However the full results of a clinical trial released by Merck were disappointing as they showed a much lower efficacy than earlier reports based on interim data.

(With inputs from agencies)