In a statement on Thursday, the EU drug regulator said
giving the green light to Pfizer’s Paxlovoid could help people infected with
COVID-19 avoid more serious disease and being hospitalized. EMA’s expert
committee recommended the pill be given to adults who don’t require oxygen and
who are at higher risk of severe disease.
The drug was cleared by regulators in the U.S. and Britain
in late December, although authorities noted that supplies would be extremely
limited.
An antiviral pill from Merck also is expected to soon be
authorized. But Pfizer’s drug is all but certain to be the preferred option
because of its mild side effects and superior effectiveness as suggested by
studies, including a nearly 90% reduction in hospitalizations and deaths among
patients most likely to get severely ill.
The pills from both Pfizer and Merck are expected to be
effective against omicron because they do not target the spike protein where
most of the variant’s worrisome mutations reside.
Pfizer currently has 180,000 treatment courses available worldwide,
with roughly 60,000 to 70,000 allocated to the U.S. The company said it expects
to have 250,000 available in the U.S. by the end of January.
The European Medicines Agency said its decision was made
based on a review of the drug’s use in people who were mostly infected with the
delta variant of COVID-19, but they believed it would also be helpful in
curbing the current surge caused by the ultra-contagious omicron variant.
“Based on laboratory studies, Paxlovid is also expected to
be active against omicron and other variants,” the regulator said. It said the
drug’s safety profile was “favorable” and that side effects were generally
mild.
Peter Liese, the European Parliament’s spokesperson for
health, called the decision a “real ray of hope” for a return to normality
after the pandemic. But he cautioned that there were no guarantees from the
European Commission or member countries that the drug would delivered quickly.
In a statement, Liese said he had recently sent Pfizer’s CEO
“an urgent appeal” following EU negotiations to obtain the drug.
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