“A medicine that has not yet been approved in the EU can be used to treat adults with Covid-19 who do not need extra oxygen and who are at increased risk of their disease progressing to a more severe stage,” the EZA said in a statement.
Pfizer said on Tuesday that clinical trials had confirmed that its Covid-19 pill prevented hospitalization and death in high-risk groups by nearly 90%.
Paxlovid should also be effective against the mutations in the Covid-19 omicron, the company said.
More than 2,200 volunteers participated in the clinical trials of the new tablet. Their data confirmed the preliminary results announced in November.
The ESA stated that it had issued this recommendation to support national authorities who may decide to use the medicine before it is officially approved.
Pfizer oral medicines are protease inhibitors and block the replication of the virus.
This means that the medicine will only be effective in the early stages of infection. By the time Covid-19 has progressed to a severe illness, the virus has largely stopped replicating and patients are suffering from an excessive immune response.
The ESA also emphasized that Paxlovid should be used immediately after infection with Covid-19 and within five days of the onset of symptoms. The ESA stated that the tablets should be taken for five days.
The most common side effects with Paxlovid are taste disturbances, diarrhea and vomiting. It must not be used during pregnancy and new mothers must stop breast-feeding while taking it.
The ESA has announced that it has begun evaluating the approval of the tablets under an accelerated procedure, which could be formally approved within a few months.
The ESA has already issued a similar emergency use of Merck’s antiviral medicine for the treatment of Covid-19 patients.
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