Pfizer Asks for Formal Approval of Drug Paxlovid Amid ‘COVID Rebound’ Reports

A Pfizer technician handles the company's COVID-19 pill, known as Paxlovid, in a file photograph. Pfizer via AP

Pharmaceutical giant Pfizer asked federal officials to formally approve its Paxlovid treatment for COVID-19 although the Centers for Disease Control and Prevention (CDC) last month issued an alert to health care providers that the drug can cause “COVID rebound” symptoms.

Pfizer confirmed on Thursday that it submitted a new drug application Paxlovid to the U.S. Food and Drug Administration (FDA) for the treatment of COVID-19 in vaccinated and unvaccinated individuals who are at a high risk of developing severe symptoms. The medication is currently being administered via an emergency use authorization across the United States.

“As the COVID-19 pandemic continues to evolve and be highly unpredictable, we must remain vigilant in protecting those who are at greatest risk of getting very sick from COVID-19, as they remain vulnerable to potential hospitalization or even death,” claimed Pfizer CEO Albert Bourla in a statement, adding that the company believes Paxlovid is an “option for mild-to-moderate COVID-19.”

Pfizer’s stock on Thursday rose about 3 percent after submitting the application to the FDA, although it dropped 1.6 percent during Friday morning’s session.

More than 1.6 million courses of Paxlovid have been administered in the United States, according to data from the Department of Health and Human Services. The medication is authorized in about 65 other countries, the company said Thursday.

‘COVID Rebound’

The development comes as White House medical adviser Anthony Fauci, who has received four COVID-19 vaccine doses, revealed on Tuesday that he is taking Paxlovid and dealing with a rebound of symptoms from the Pfizer drug.

“After I finished the five days of Paxlovid, I reverted to negative on an antigen test for three days in a row,” Fauci stated during a virtual meeting. “And then on the fourth day, just to be absolutely certain, I tested myself again. I reverted back to positive.”

Fauci then said that “over the next day or so, I started to feel really poorly, much worse than in the first go around,” adding, “So, I went back on Paxlovid and right now I am on my fourth day of a five-day course.”

The CDC last month issued an alert to health care providers, public health departments, and other officials about the possible recurrence of symptoms, which it described as “COVID-19 rebound.”

“Paxlovid continues to be recommended for early-stage treatment of mild to moderate COVID-19 among persons at high risk for progression to severe disease,” said the agency in the notice, but it stipulated that “COVID-19 rebound has been reported to occur between 2 and 8 days after initial recovery and is characterized by a recurrence of COVID-19 symptoms.”