U.S. health regulators on Wednesday authorized the first pill against COVID-19, a Pfizer drug that Americans will be able to take at home to head off the worst effects of the virus. The long-awaited milestone comes as U.S. cases, hospitalizations and deaths are all rising and health officials warn of a tsunami of new infections from the omicron variant that could overwhelm hospitals.
President Joe Biden said the pill marks a “significant step forward in our path out of the pandemic” and said his administration will work with states to ensure equitable distribution.
The drug, Paxlovid, is a faster way to treat early COVID-19 infections, though initial supplies will be extremely limited. All of the previously authorized drugs against the disease require an IV or an injection.
JUST IN: FDA authorizes first oral antiviral for treatment for Covid-19: Paxlovid, a pill made by Pfizer.
— Ana Cabrera (@AnaCabrera) December 22, 2021
An antiviral pill from Merck also is expected to soon win authorization. But Pfizer’s drug is all but certain to be the preferred option because of its mild side effects and superior effectiveness, including a nearly 90% reduction in hospitalizations and deaths among patients most likely to get the virus.
Breakthrough: First anti-COVID pill (Paxlovid) approved by FDA
3 pills, twice a day, for 5 days
Works against Omicron and Delta
Not a substitute for the vaccinehttps://t.co/Gn5zDUNBTM
— Faheem Younus, MD (@FaheemYounus) December 22, 2021
Federal health officials are expected to ration early shipments to the hardest-hit parts of the country. Pfizer said the small supply is due to the manufacturing time — currently about nine months. The company says it can halve production time next year.
So Pfizer's Paxlovid has 1 – just 1 of IVM's 20 mechanisms of action, plus its expensive, plus its mixed with dangerous AIDS drug Ritonavir plus it doesnt have the 40 year safety profile, yet one is approved right away and the other is trashed. $cience=genocide.
— Daniel Horowitz (@RMConservative) December 21, 2021
The U.S. government has agreed to purchase enough Paxlovid to treat 10 million people, and it will be provided free to patients. Pfizer says it’s on track to produce 80 million courses globally next year, under contracts with the U.K., Australia, and other nations.
— Bloomberg Quicktake (@Quicktake) December 22, 2021
Patients will need a positive COVID-19 test to get a prescription. And Paxlovid has only proven effective if given within five days of symptoms appearing. With testing supplies stretched, experts worry it may be unrealistic for patients to self-diagnose, get tested, see a physician and pick up a prescription within that narrow window.
👉Big breaking coming in from US
👉America approves easy-to-use Paxlovid pill to TREAT covid
👉It's a 5 day dose that saves people from developing severe Covid
👉Cuts risk of hospitalization/DEATH by 89%
👉Unlike others, it's not a repurposed pill but made specially for Covid
— Saahil Murli Menghani (@saahilmenghani) December 22, 2021
The U.S. is now reporting more than 140,000 new infections daily and federal officials warn that the omicron variant could send case counts soaring. Omicron has already whipped across the country to become the dominant strain, federal officials confirmed earlier this week.