FDA ends emergency use authorization for COVID-19 drug Evusheld

Jan. 27 (UPI) -- The Food and Drug Administration on Thursday withdrew emergency use authorization for the COVID-19 drug Evusheld because of its lack of effectiveness against some of the more widespread coronavirus variants.

The FDA said that while the effectiveness of the drug has dropped, its side effects, including some recipients having an allergic reaction to the virus, can be "potentially serious."


"Data show Evusheld is unlikely to be active against certain SARS-CoV-2 variants," the FDA said in a statement. "According to the most recent CDC Nowcast data, these variants are projected to be responsible for more than 90% of current infections in the U.S."

The FDA noted the availability several other treatments including Paxlovid, remdesivir and molnupiravir which it said are expected to combat the variants.

It also recommended that facilities and providers hold onto their stock of Evusheld in the event that COVID-19 variants that it is effective against become more widespread in the future.

It was just the latest action the FDA has taken this week in downgrading what appears to be now ineffective COVID-19 treatments in the face of emerging variants. On Thursday, an FDA advisory committee approved a proposal to phase out the Pfizer and Moderna vaccines used in the original round of nationwide vaccinations.


In turn, that committee said those should be replaced with the newest shot for the Omicron variant.

The Vaccines and Related Biological Products Advisory Committee voted 19-2 in favor of the proposal.

The committee's decision was seen as an effort to simplify vaccinations by eliminating old vaccines in favor of the bivalent omicron vaccines, which have proven to be effective in guarding against the worst outcomes of infection from newer strands of the virus.

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