Washington, Dec. 22 (BUS): US health regulators on Wednesday approved the first pill against COVID-19, a drug produced by Pfizer that Americans will be able to take at home to avoid the worst effects of the virus, the Associated Press reported.
The long-awaited breakthrough comes as the number of cases, hospitalizations and deaths soars in the United States and health officials warn of a tsunami of new omicron infections that could overwhelm hospitals.
Paxlovid is a faster and cheaper way to treat early COVID-19 infections, although initial supplies will be very limited. All pre-approved anti-disease medications require an intravenous infusion.
An anti-virus pilot from Merck is also expected to obtain a license soon. But Pfizer is by far the preferred choice due to its mild side effects and superior efficacy, including a nearly 90% reduction in hospitalizations and deaths among patients at high risk of developing severe disease.
“The efficacy is high, the side effects are low and it is taken orally. It checks all the boxes,” said Dr. Gregory Poland of the Mayo Clinic. “You look at a 90% reduction in the risk of hospitalization and death in a high-risk group — and that’s amazing. “
The US Food and Drug Administration has allowed Pfizer to be used by adults and children 12 years of age or older with a positive COVID-19 test and early symptoms who face the highest risk of hospitalization. This includes the elderly and those with medical conditions such as obesity and heart disease. Children eligible for the drug must weigh at least 88 pounds (40 kilograms).
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 of the variant are located.
Pfizer currently has 180,000 courses of treatment available worldwide, with roughly 60,000 to 70,000 earmarked for US federal health officials and early shipments expected to be legalized to hardest-hit areas of the country.
Pfizer said the short supply was due to manufacturing time – currently about nine months. The company says it could cut production time in half next year.
The US government has agreed to purchase enough baxlovid to treat 10 million people. Pfizer says it is on track to produce 80 million courses globally next year, under contracts with the United Kingdom, Australia and other countries.
Health experts agree that vaccination remains the best way to prevent COVID-19. But with nearly 40 million American adults still unvaccinated, effective drugs will be critical in fending off current and future waves of infection.
The US is now reporting more than 140,000 new infections per day and federal officials are warning that the Omicron variant could drive the number of cases up. Federal officials confirmed earlier this week that the Omicron has already roamed around the country to become the dominant breed.
Against this background, experts warn that the initial effect of baxlovid can be limited.
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