COVID has certainly taken its toll on the U.S. over the last two years. As of May 18, there have been more than 82 million coronavirus cases and close to one million total COVID deaths reported in the country, according to the Centers for Disease Control and Prevention (CDC). And while the situation has improved in many ways, the virus continues to make itself known. In the last week alone, infections have increased by more than 18 percent and hospitalizations have climbed by over 24 percent, per the CDC.
Deaths are not rising at the moment, however. This is likely due to the number of advancements we’ve made in terms of battling the coronavirus, including the development of COVID vaccines and treatments. Pfizer has been praised for its mRNA vaccine, but the company also created an oral antiviral pill called Paxlovid, which was authorized by the U.S. Food and Drug Administration (FDA) in Dec. 2021.
Paxlovid is a COVID treatment designed to be taken at home to prevent those most at risk of severe COVID from getting so ill that they need to be hospitalized, according to Yale Medicine. It’s become increasingly popular over the last few months, having been used by notable figures like Vice President Kamala Harris. It’s even been prioritized over other COVID treatments by the National Institutes of Health (NIH) due to a clinical trial finding that it had a 89 percent effectiveness in reducing the risk of hospitalization and death.
“I think it is the beginning of a ‘game-changer,'” Scott Roberts, MD, a Yale Medicine infectious disease specialist, said. “It’s really our first efficacious oral antiviral all for this virus. It shows clear benefit, and it really can prevent hospitalization and death in people who are at high risk.”
But in recent weeks, a concerning trend has emerged in connection with the antiviral pill. According to Forbes, more and more people are reporting that they’ve had COVID relapses after taking Paxlovid. And it’s even happening to people who are up-to-date on their COVID vaccinations.
Peter Hotez, MD, the dean of the National School of Tropical Medicine at Baylor Medical College who is both fully vaccinated and boosted, recently tweeted that he had recovered from COVID with two negative tests and felt fine after finishing a five-day course of Paxlovid. But five days later on May 17, he said he woke up to a runny nose, sore throat, and a positive COVID test.
“So either this post-Paxlovid relapse is real … or something,” Hotez tweeted. “We’ll eventually figure this out, but still a puzzle. I don’t feel that terrible it’s like a bad cold … will a [second] course of Paxlovid help? Not much of a roadmap.”
Now, the FDA is investigating the possibility of post-Paxlovid COVID relapse. The agency said that it is “aware of the reports of some patients developing recurrent COVID-19 symptoms” after finishing a course of Paxlovid. “In some of these cases, patients tested negative on a direct SARS-CoV-2 viral test and then tested positive again,” the FDA said.
According to the agency, there is currently no evidence that there is any benefit of extending the course of this treatment to 10 days or repeating a course of Paxlovid in patients who experience a COVID relapse after completing an initial treatment course.
But despite reports of relapses, top virus experts still recommend the use of this treatment.
“I would like to reiterate that Paxlovid is now widely available at community pharmacies,” John Farley, MD, director of the Office of Infectious Diseases in the Center for Drug Evaluation and Research of New Drugs at the FDA, said in a statement. “There is strong scientific evidence that it reduces the risk of hospitalization and death in patients with mild-to-moderate COVID-19 at high risk for progression to severe disease.”