Paxlovid For COVID-19 Still Free After FDA's Full Approval
Pfizer's antiviral drug for the treatment of COVID-19, Paxlovid, will remain free for now. The U.S. government will continue to distribute it at no charge despite gaining full approval from the Food and Drug Administration (FDA).
On Thursday, Pfizer, the pharmaceutical company behind the first oral antiviral against COVID-19, issued a statement on its availability following the news that it has been granted full approval for use against the novel coronavirus disease in adults.
"At this time, the U.S. government will continue to oversee the distribution of Paxlovid, and U.S. residents eligible for Paxlovid will continue to receive the medicine at no charge," Pfizer stated.
The treatment is a combination of nirmatrelvir and ritonavir tablets for oral use among patients with mild-to-moderate COVID-19 infection and at high risk for severe illness, hospitalization, or death.
Even before the full approval, Paxlovid was already available for use in adults and teens, but only under emergency use authorization (EUA). Now that it is fully approved for adults, more people could have access to it while undergoing treatment for COVID-19.
"Today's approval demonstrates that Paxlovid has met the agency's rigorous standards for safety and effectiveness, and that it remains an important treatment option for people at high risk for progression to severe COVID-19, including those with prior immunity," Patrizia Cavazzoni, M.D., director of FDA's Center for Drug Evaluation and Research, said.
Children aged 12 to 17 can still get Paxlovid for their treatment, but they should be eligible under the existing EUA. Pfizer said it continues to gather scientific data from ongoing clinical trials involving children, so the drug could get full approval for teens at a future date.
While the Biden administration will continue to manage the distribution of free Paxlovid, CBS News said this setup would only last for at least another few months. Patients would soon be required to pay for them if the drug is not covered by their insurance.
The free courses of Pfizer's Paxlovid treatment for COVID-19 will only be available while supplies last. The government has already paid for them. Thus federal officials previously said that the approval of the drug would not affect its free distribution, at least for now.
Outside of the U.S., Paxlovid is approved or authorized for conditional or emergency use against COVID-19 in 69 other countries across the globe.