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US approves COVID-19 pills that reduce the risk of hospitalization by 90%

 


US health regulators approved the first tablet for COVID-19 on Wednesday. This is a Pfizer drug that Americans can take at home to avoid the worst effects of the virus.

The long-awaited milestone comes with an increase in all US cases, hospitalizations and deaths, and health officials warning about a tsunami of new infections from Omicron variants that could overwhelm hospitals.

The drug Paxlovid is a faster and cheaper way to treat early COVID-19 infections, but early supply is very limited. All previously approved medications for this disease require infusions or injections.

Merck’s antivirals will soon be licensed. However, Pfizer’s medications are almost certainly the preferred option due to its mild side effects and excellent efficacy, including a nearly 90% reduction in hospitalization and mortality in patients most likely to suffer from severe illness. ..

Jody Ford, an ICU nurse, is taking care of a COVID-19 patient at the Willis-Nighton Medical Center in Shreveport, Louisiana, in this August 17, 2021 photo. The United States has approved the first home-based drug for COVID-19. This reduces the risk of hospitalization for patients most likely to have a serious illness by 90%. (Gerald Herbert / Associated Press)

Both drugs are awaiting approval in Canada and the federal government It is said that it is a preliminary consultation Purchased a round of treatment for Canadians with Pfizer and Merck. Health Canada is considering drugs “priority,” a spokesman for Health Canada told CBC News in an email Wednesday, and still receives relevant data from two companies.

“It’s highly effective, has low side effects, and is taken orally. Check all check boxes,” said Dr. Gregory Poland of the Mayo Clinic. “We have found that the risk of hospitalization and death is reduced by 90% in the high-risk group, which is surprising.”

Approved medicines for adults and children over 12 years of age

The Food and Drug Administration has approved Pfizer’s medicines for adults and children over the age of 12 who are positive for COVID-19 and have early symptoms at the highest risk of hospitalization. This includes the elderly and those with symptoms such as obesity and heart disease. Children eligible for the drug should weigh at least 88 pounds.

Both Pfizer and Merck tablets are expected to be effective against Omicron because they do not target peplomer, which contains most of the nasty mutations in the mutant.

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Pfizer currently has 180,000 treatment courses available worldwide, and approximately 60,000 to 70,000 assigned to US federal health authorities will distribute early shipments to the country’s most devastated areas. According to Pfizer, the low supply is due to the manufacturing period and is currently about 9 months. According to the company, production time can be halved next year.

The US government has agreed to buy enough Paxlovid to treat 10 million people. Pfizer says it plans to produce 80 million courses worldwide next year under contracts with the United Kingdom, Australia and other countries.

Health experts agree that vaccination will continue to be the best way to protect against COVID-19. However, as approximately 40 million American adults have not yet been vaccinated, effective drugs are essential to slow the wave of current and future infections.

The United States is currently reporting over 140,000 new infections daily, and federal officials have warned that Omicron variants could spike the number of cases. Omicron has already circulated nationwide to become the dominant stock, US officials confirmed earlier this week.

Against such a background, experts warn that the initial impact of Paxrovid may be limited.

For over a year, antibody drugs designed by biotechnology have been the reliable treatment for COVID-19. However, they are expensive, difficult to manufacture, and require injections and infusions that are usually given in hospitals and clinics. Laboratory tests also suggest that the two major antibody drugs used in the United States are ineffective against Omicron.

Pfizer tablets have their own challenges.

Patients will need a positive COVID-19 test to get a prescription. And Paxlovid has proven to be effective only when given within 5 days of the onset of symptoms. With the growth of testing supplies, experts are worried that it may be impractical for patients to self-diagnose, be tested, see a doctor, and receive prescriptions within that narrow range.

Andrew Pekosi, a virologist at Johns Hopkins University, said:

Less than 1% of patients receiving the drug were hospitalized

The FDA has shown that administration of pills to people with mild to moderate COVID-19 within 3 days of symptoms reduces hospitalization and mortality by 89%, based on the results of a study of 2,250 patients. Did. Less than 1% of patients taking the drug were hospitalized and none died at the end of the 30-day study period, whereas 6.5% of patients admitted to the group were dummy pills containing 9 deaths. I took.

Pfizer’s drugs are part of a decade-old family of antiviral drugs known as protease inhibitors that have revolutionized the treatment of HIV and hepatitis C. These drugs block important enzymes that the virus needs to multiply in the human body.

The United States pays approximately US $ 500 for each course of Pfizer treatment. It consists of 3 tablets taken twice daily for 5 days. Two of the tablets are Paxrovid and the third is another antiviral that helps raise the level of the main drug in the body.

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