U.S. health regulators on Wednesday authorized the first pill against COVID-19, a Pfizer drug that Americans can take at home to ward off the virus’ worst effects.
The long-awaited milestone comes as cases, hospitalizations and deaths in the United States all rise and health officials warn of a tsunami of new infections from the omicron variant that could overwhelm hospitals.
The drug, Paxlovid, is a faster and cheaper way to treat early-onset COVID-19 infections, although initial supplies are severely limited. All previously authorized drugs for the disease require an IV or injection.
Superior efficacy and mild side effects
An antiviral pill from Merck is also expected to get clearance soon. But Pfizer’s drug is almost certainly the preferred option because of its mild side effects and superior efficacy, including an almost 90% reduction in hospitalizations and deaths in patients most at risk for serious illness.
“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. “You envision a 90% decrease in the risk of hospitalization and death in a high-risk group, it’s mind-boggling. “
The Food and Drug Administration has cleared Pfizer’s drug for adults and children aged 12 and older with a positive COVID-19 test and early symptoms who face the highest risk of hospitalization. This includes the elderly and those with conditions such as obesity and heart disease. Children eligible for the drug must weigh at least 88 pounds.
Should be effective against Omicron
The pills from Pfizer and Merck are expected to be effective against omicron because they do not target the spike protein where most of the worrisome mutations in the variant reside.
Pfizer currently has 180,000 treatment courses available worldwide, with approximately 60,000 to 70,000 allocated in the United States. Federal health authorities should ration early shipments to the hardest-hit areas of the country. Pfizer said the low supply is due to time to manufacture – currently around nine months. The company says it can cut production time in half next year.
The US government has agreed to purchase enough Paxlovid to treat 10 million people. Pfizer says it is on track to produce 80 million courses worldwide next year, under contracts with the UK, Australia and other countries.
Health experts agree that vaccination remains the best way to protect yourself against COVID-19. But with an estimated 40 million U.S. adults still unvaccinated, effective drugs will be essential in easing current and future waves of infection.
The United States is now reporting more than 140,000 new infections a day, and federal officials are warning that the omicron variant could spike the number of cases. Omicron has already crossed the country to become the dominant strain, federal officials confirmed earlier this week.
Against this background, experts warn that the initial impact of Paxlovid may be limited.
For more than a year, drugs based on antibodies derived from biotechnology have been the gold standard treatments for COVID-19. But they are expensive, difficult to produce, and require an injection or infusion, usually given in a hospital or clinic. In addition, laboratory tests suggest that the two main antibody-based drugs used in the United States are not effective against omicron.
Limited supplies available
The Pfizer pill has its own challenges.
Patients will need a positive COVID-19 test to get a prescription. And Paxlovid has only been shown to work if it is given within five days of symptom onset. With testing supplies running out, experts fear it may be unrealistic for patients to self-diagnose, get tested, see a doctor and take a prescription in this narrow window.
“If you go outside that window of time, I would expect the effectiveness of this drug to decrease,” said Andrew Pekosz, virologist at Johns Hopkins University.
The FDA based its decision on the company’s results from a 2,250-patient trial that showed the pill reduced hospitalizations and deaths by 89% when given to people with mild COVID-19 to moderate 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 to 6.5% of hospitalized patients in the dummy pill group, which included nine death.
Pfizer’s drug is part of a decades-old family of antiviral drugs known as protease inhibitors, which have revolutionized the treatment of HIV and hepatitis C. The drugs block a key enzyme including viruses need to multiply in the human body.
The United States will pay approximately $ 500 for each treatment of Pfizer, which consists of three tablets taken twice a day for five days. Two of the pills are Paxlovid and the third is a different antiviral which helps to increase the levels of the main drug in the body.