WASHINGTON (AP) – U.S. health regulators on Wednesday approved the first drug against COVID-19, a Pfizer drug that Americans can take at home to combat the worst effects. most of the virus.
The long-awaited milestone comes as US cases, hospitalizations and deaths all rise and health officials warn that a new tsunami of infections from the omicron variant could overwhelm. hospitals.
The drug Paxlovid is a faster, cheaper way to treat an early COVID-19 infection, although initial supplies will be very limited. All drugs previously authorized to fight the disease require intravenous or injection.
An antiviral pill from Merck is also said to be gaining approval soon. But Pfizer’s drug is certainly the preferred choice because of its mild side effects and remarkable effectiveness, including a nearly 90% reduction in hospitalizations and deaths in patients most likely to have severe illness.
“Highly effective, with few side effects and is an oral drug. It checks all the boxes,” said Dr. Gregory Poland of the Mayo Clinic. “You’re looking at a 90% reduction in the risk of hospitalization and death in the high-risk group – that’s amazing.”
The Food and Drug Administration has authorized Pfizer for adults and children 12 years of age and older with a positive COVID-19 test and early symptoms, who are most at risk for hospitalization. That includes older adults and people with conditions like obesity and heart disease. Children to be eligible for the drug must weigh at least 88 pounds (40 kg).
Drugs from both Pfizer and Merck are expected to be effective against omicrons because they do not target the mutant protein that resides most of the variant’s worrisome mutations.
Pfizer currently has 180,000 treatment courses available worldwide, with about 60,000 to 70,000 allocated to US Federal health officials who expect to distribute shipments soon to hard-hit areas. best of the country. Pfizer says the small supply is due to the lead time – currently around nine months. The company says it could halve its production time next year.
The US government has agreed to buy enough Paxlovid to treat 10 million people. Pfizer says it is on track to produce 80 million courses globally next year, under contracts with the UK, Australia and other countries. ‘
Health experts agree that vaccination is still the best way to protect against COVID-19. But with about 40 million American adults still unvaccinated, effective drugs will be crucial to stemming the current and future wave of infections.
The United States is currently reporting more than 140,000 new infections daily, and federal officials warn that the omicron variant could cause the number of cases to soar. Federal officials confirmed Omicron across the country to be the dominant strain earlier this week.
Against this backdrop, experts warn that Paxlovid’s initial impact may be limited.
For more than a year, biotechnologically engineered antibody drugs have been the leading treatment for COVID-19. But they are expensive, difficult to manufacture, and require injections or infusions, often given in a hospital or clinic. In addition, laboratory testing showed that two leading antibody drugs used in the US were not effective against omicrons.
Pfizer’s drug comes with its own set of challenges.
Patients will need to test positive for COVID-19 to be prescribed. And Paxlovid has only been shown to be effective if taken within five days of symptoms appearing. As testing supplies stretch, experts worry that it’s impractical for patients to be able to self-diagnose, test, see a doctor, and get a prescription within that narrow window.
“If you go outside that period, I fully expect the effectiveness of this drug to drop,” said Andrew Pekosz, a virologist at Johns Hopkins University.
The FDA made its decision based on the company’s results from a trial of 2,250 patients that showed the drug cuts hospitalization and death rates by 89% when used for people with COVID- 19 is mild to moderate within three days of symptoms. Less than 1% of patients taking the drug were hospitalized and there were no deaths at the end of the 30-day study period, compared with 6.5% of patients hospitalized in the dummy group, which included 9 cases. case of death.
Pfizer’s drug is part of a decades-old line of antiviral drugs called protease inhibitors that have revolutionized the treatment of HIV and hepatitis C. The drug blocks one. important enzyme that the virus needs to multiply in the human body.
The US will pay about $500 for each Pfizer treatment, which includes three pills taken twice a day for five days. Two of the pills are Paxlovid and the third is another antiviral that helps increase the levels of the main drug in the body.
https://kdvr.com/news/coronavirus/pfizer-pill-becomes-1st-us-authorized-home-covid-treatment/ Pfizer Pill Becomes First US-Authorized Home Treatment for COVID