- U.S. health regulators on Wednesday, Dec. 22, 2021, 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 U.S. government has agreed to purchase enough Paxlovid to treat 10 million people, and it will be provided free to patients.
- “It checks all the boxes,” said Dr Gregory Poland of the Mayo Clinic.
The first tablet against COVID-19, a Pfizer medicine that Americans will be able to take at home to prevent the virus’s worst symptoms, was approved by US health regulators on Wednesday as reported by AP News.
New infections
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.
All of the previously authorized drugs against the disease require an IV or an injection.
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 severe disease.
“The efficacy is high, the side effects are low and it’s oral.”
“It checks all the boxes,” said Dr Gregory Poland of the Mayo Clinic.
Equitable distribution
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.
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.
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.
Children eligible for the drug must weigh at least 88 pounds (40 kilograms).
Pfizer currently has 180,000 treatment courses available worldwide, with roughly 60,000 to 70,000 allocated to the U.S. The company said it expects to have 250,000 available in the U.S. by the end of January.
Pfizer said the small supply is due to the manufacturing time — currently about nine months.
Health experts agree that vaccination remains the best way to protect against COVID-19.
Challenges
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.
But they are expensive, hard to produce and require an injection or infusion, typically given at a hospital or clinic.
Also, laboratory testing suggests the two leading antibody drugs used in the U.S. aren’t effective against omicron.
Pfizer’s pill comes with its own challenges.
And Paxlovid has only proven effective if given within five days of symptoms appearing.
“If you go outside that window of time I fully expect the effectiveness of this drug is going to fall,” said Andrew Pekosz, a Johns Hopkins University virologist.
Revolutionized treatment
The FDA based its decision on company results from a 2,250-patient trial that showed the pill cut hospitalizations and deaths by 89% when given to people with mild-to-moderate COVID-19 within three days of symptoms.
Less than 1% of patients taking the drug were hospitalized and none died at the end of the 30-day study period, compared with 6.5% of patients hospitalized in the group getting a dummy pill, which included nine deaths.
Pfizer’s drug is part of a decades-old family of antiviral drugs known as protease inhibitors, which revolutionized the treatment of HIV and hepatitis C. The drugs block a key enzyme that viruses need to multiply in the human body.
The U.S. will pay about $500 for each course of Pfizer’s treatment, which consists of three pills taken twice a day for five days.
Two of the pills are Paxlovid and the third is a different antiviral that helps boost levels of the main drug in the body.
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Source: AP News
