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Drug that treats COVID with nearly 90% efficacy gets FDA green light

Pfizer markets the pill to patients who are at high risk of becoming seriously ill from the disease caused by coronavirus

The first pill to treat COVID-19 received approval from U.S. regulators on Wednesday, giving way to a new pandemic therapy that can be deployed to adults and children ages 12 and older. 

Under the U.S. Food and Drug Administration’s emergency use authorization, the medication from Pfizer has an 89% efficacy rate in treating patients who are at high risk of being hospitalized or dying from the disease caused by coronavirus. 

“This authorization provides a new tool to combat COVID-19 at a crucial time in the pandemic as new variants emerge and promises to make antiviral treatment more accessible to patients who are at high risk for progression to severe COVID-19,” said Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research. 

Unlike vaccines, used to prevent illness in those exposed to COVID-19, the pill treats those already infected — and the FDA and other top health officials still urge everyone eligible to get vaccinated. 

Pfizer has previously touted the pill’s efficacy against the Omicron variant, which now accounts for nearly three-quarters of new cases in the country. 

In a 2,250-person study, the drug was administered twice daily for five days shortly after the onset of symptoms. The study results showed a roughly 89% reduction in hospitalizations and deaths for high-risk adults. 

Patients could experience side effects like impaired sense of taste, diarrhea, high blood pressure and muscle aches, the FDA said, and drug interaction, including those used to treat HIV, is another concern. Dubbed Paxlovid, the Pfizer drug also is not recommended for those with severe kidney or liver conditions. 

Paxlovid works by inhibiting a protein in the novel coronavirus, stopping it from replicating with a drug called nirmatrelvir. Another drug, ritonavir, slows the breakdown of nirmatrelvir so it stays potent for a longer amount of time. 

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Previously authorized therapies for COVID-19 include monoclonal antibody treatments that have to be administered intravenously and an antiviral treatment, remdesivir, which is given via injection. 

That makes the Pfizer pill the first at-home treatment to fight against the disease.

More than 800,000 people have died from COVID-19. Recent surges have been the product of the Delta and Omicron variants, which have higher rates of transmissibility than the wild-type virus that first sparked the global pandemic. 

“Today’s authorization of Paxlovid represents another tremendous example of how science will help us ultimately defeat this pandemic, which, even two years in, continues to disrupt and devastate lives across the world,” Albert Bourla, chairman and chief executive officer of Pfizer, said in a statement. “Pfizer stands ready to begin delivery in the U.S. immediately to help get Paxlovid into the hands of appropriate patients as quickly as possible.”

In November, when Pfizer’s pill was still experimental, the Biden administration announced that it had preordered millions of doses to prepare for FDA authorization. 

“To make sure that we are ready, my Administration has already placed an order for enough of these pills to treat 10 million Americans,” President Joe Biden said on December 14. “The combination of widespread vaccinations and boosters, testing, and effective pills for those who become ill will help us further reduce the impact of COVID-19 on our lives and our economy as we continue to build back better.”

Drugmaker Merck has been developing a separate COVID-19 pill, which was authorized in November for emergency use by the European Union’s regulators. A panel of FDA advisers recommended the treatment in late November with a 13-10 vote. Data shows the Merck pill reduces hospitalizations and deaths by 30% in high-risk adults, down from the 50% efficacy the company initially touted. 

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Michael J. Ermarth/FDA

Unlike vaccines, used to prevent illness in those exposed to COVID-19, the pill treats those already infected.