The Food and Drug Administration granted full approval for Pfizer’s Covid antiviral pill Paxlovid for high-risk adults, nearly a year and a half after the drug received an emergency use authorization, as hospitalization and death rates continue to decline.
The FDA announced its approval of the oral pill in a statement Thursday, giving doctors more flexibility to prescribe the pill for adults with mild to moderate Covid-19 who are at high risk of developing severe Covid, being hospitalized by the virus or dying.
The approval comes as demand for Paxlovid, which was granted an emergency approval in December 2021, declines as hospitalization and death rates drop in the U.S. and as the World Health Organization ended its global health emergency status for Covid after more than three years.
The FDA last July allowed pharmacists to prescribe Paxlovid to eligible patients 12 years and older at high risk of developing more severe Covid.
Paxlovid sales in the first three months of 2023 bounced back to surpass analysts’ expectations, with $4.1 billion in sales. Pfizer had previously estimated sales of Paxlovid on the year to only reach $8 billion, as demand for Covid vaccines and treatment wanes and the World Health Organization said the pandemic is nearing a “transition” point.
In a statement, Patrizia Cavazzoni, the director of the FDA’s Center for Drug Evaluation and Research, said the full approval demonstrates Paxlovid “remains an important treatment option for people at high risk for progression to severe Covid-19.”
9,186. That’s how many people in the U.S. were hospitalized for Covid in the week ending May 11, according to the Centers for Disease Control and Prevention’s final batch of weekly Covid-19 data, marking a 4.9% drop from the previous week.
Paxlovid, one of the only available Covid-19 oral antiviral pills in the U.S., had been lauded as a potential game-changer to combat surging coronavirus cases and the rise of the more virulent omicron variant when it given its emergency use authorization in December 2021. It also received praise from the Biden Administration, which pushed for its increased use last April, doubling the number of locations to receive the pill, amid lingering supply issues. White House officials also lamented at the time it was being underused, even as those supply issues dissipated.
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On Wednesday, the U.S. Food and Drug Administration (FDA) granted full approval to Pfizer and partner BioNTech’s pill to prevent Pfizer’s two-dose COVID-19 vaccine, known as Paxlovid.
Paxlovid is the first FDA-approved pill to prevent the effects of COVID-19 for people 12 and older who’ve been fully vaccinated. It is a single-dose tablet that can be taken within 24 hours after the first dose of the Pfizer-BioNTech COVID-19 vaccine.
The pill contains a monoclonal antibody, known as PAZ-C201. Monoclonal antibodies are antibodies that are specific to a particular strain of a virus, and they can help neutralize the virus.
The FDA examined data from a clinical trial of 2,260 people in three arms: placebo, 250 mg of Paxlovid, and 500 mg of Paxlovid. The study found that overall, the groups that took Paxlovid had greater protection than those in the placebo group.
The majority of people who took Paxlovid experienced mild or moderate side effects, such as headache, muscle pain, abdominal pain, nausea, and fatigue.
Pfizer and BioNTech’s pill is a much-needed tool to help protect people against the virus, especially in the short term following vaccination.
“We understand the urgency of providing this monoclonal to the public, and are dedicated to continuing to supply and support its use in clinical settings,” said Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases. “This approval adds another option to help protect people at risk of COVID-19 infection.”
The pill is officially approved for those 12 and older, although the FDA says it may be used in younger age groups on an individual basis. The pill is expected to be widely available in the coming weeks.