This image provided by Pfizer in October 2021 shows Pfizer’s COVID-19 Paxlovid pills, which U.S. health regulators authorized Wednesday as the first pill against COVID-19.
AP photo
Columbus Regional Health is expecting to receive a limited supply of the first pill that U.S. regulators have authorized to prevent the worst effects of COVID-19, though the time table, as well as number of doses the local hospital system will get, remain uncertain.
The drug, Paxlovid, was authorized Wednesday by U.S. health regulators, a long-awaited milestone that 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, The Associated Press reported.
Paxlovid has been billed as a faster way to treat early COVID-19 infections, though initial supplies will be extremely limited, according to wire reports. All of the previously authorized drugs to treat the disease require an IV or an injection.
“We are signed up to receive the medication,” said Dr. Slade Crowder, CRH vice president of physician enterprise operations and associate chief medical officer. “We anticipate a very limited supply in the first several months. We are prepared to use it when it does become available.”
The Food and Drug Administration authorized Pfizer’s drug for adults and children ages 12 and older with a positive COVID-19 test and early symptoms who face the highest risks of hospitalization, according to wire reports. That includes older people and those with conditions such as obesity and heart disease, though the drug is not recommended for patients with severe kidney or liver problems. Children eligible for the drug must weigh at least 88 pounds.
Pfizer currently has 180,000 treatment courses available worldwide, with roughly 60,000 to 70,000 allocated to the U.S. Federal health officials are expected to ration early shipments to the hardest-hit parts of the country, according to the AP. 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.
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.
Currently, it unclear how the pill will distributed in Indiana, CRH officials said.
“We are being briefed about the medication from the Indiana State Department of Health,” Crowder said. “The distribution process for this new medication has not been fully spelled out to us at this time.”
An antiviral pill from Merck also won authorization Thursday. 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 severe disease.
However, health experts agree that vaccination remains the best way to protect against COVID-19. But with roughly 40 million American adults still unvaccinated — including some 31,000 eligible Bartholomew County residents — effective drugs will be critical to blunting the current and future waves of infection.
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, according to wire reports. Omicron has already whipped across the country to become the dominant strain, federal officials confirmed earlier this week.
Against that backdrop, experts warn that Paxlovid’s initial impact could be limited.
“We are hopeful it is as effective as initial reports show, but it depends on early detection and treatment (as well as being available),” Crowder said. “Therefore, preventing the disease with vaccine, booster, mask, etc. is still the best approach.”
The Associated Press contributed to this report.
