BREAKING FDA Gives Green Light to Pfizer’s Antiviral Covid-19 Pill

 Could this be a game-changer as Omicron spreads across the United States?  A milestone in the fight against the pandemic as the first at-home treatment Covid-19 treatment gets FDA authorization.

Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for Pfizer’s Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) for the treatment of mild-to-moderate coronavirus disease (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kilograms or about 88 pounds) with positive results of direct SARS-CoV-2 testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death. Paxlovid is available by prescription only and should be initiated as soon as possible after a diagnosis of COVID-19 and within five days of symptom onset.

In clinical trials, Pfizer’s treatment reduced the risk of hospitalization and death by 89 percent when taken three days after the onset of symptoms. Individuals eligible for the pill need a prescription and should begin taking the treatment as soon as possible within five days of the start of symptoms, the FDA said in a statement Wednesday. The FDA said the Pfizer pill is not a substitute for vaccination in individuals eligible for Covid-19 shots and boosters.

“Today’s authorization introduces the first treatment for COVID-19 that is in the form of a pill that is taken orally — a major step forward in the fight against this global pandemic,” said Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research. “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.”

Paxlovid is not authorized for the pre-exposure or post-exposure prevention of COVID-19 or for initiation of treatment in those requiring hospitalization due to severe or critical COVID-19. Paxlovid is not a substitute for vaccination in individuals for whom COVID-19 vaccination and a booster dose are recommended, the FDA said.

Emergency Use Authorization is different than FDA approval. At this stage, the agency has determined that the known and potential benefits of Paxlovid, when used consistent with the terms and conditions of the authorization, outweigh the known and potential risks. The FDA also said that at this time, there are no adequate, approved, and available alternatives to Paxlovid for the treatment of COVID-19.

The safety and effectiveness of Paxlovid for the treatment of COVID-19 continue to be evaluated, the FDA said.

The federal government has already purchased 10 million doses of Pfizer’s pill and will begin delivering them over the next several months.

FDA authorizes Pfizer oral antiviral COVID-19 treatmenthttps://t.co/syWtYsr9Xe

— FOX Business (@FoxBusiness) December 22, 2021

 

Not surprisingly, U.S. stocks picked up momentum in afternoon trading after the Food and Drug Administration approved Pfizer’s COVID-19 pill for use in adults and children ages 12 and older.