Pfizer COVID-19 pill approved by the US for home use | Coronavirus pandemic News

Test data show that 90 percent of the oral pill is effective in preventing deaths and hospitalizations of high-risk patients.

U.S. health regulators have authorized the first oral pill against COVID-19, a Pfizer drug users can take it home to deal with the worst effects of coronavirus.

The long-awaited milestone was announced on Wednesday by the U.S. Food and Drug Administration (FDA). Recognition is growing as the coronavirus case rises worldwide, including in the U.S., and health officials have warned that it is a tsunami of new infections. Omikron variant which can overwhelm hospitals.

Pfizer’s clinical trial data show that the anti-virus regimen is 90 percent effective prevention of hospitalizations and deaths in patients at high risk of serious illness. Recent laboratory data suggest that the drug remains effective against Omicron.

The drug, Paxlovid, is a faster and cheaper way to treat early COVID-19 infections, even if the initial supply will be very limited. All previously prescribed medications for the disease require an IV or injection.

“The effectiveness is high, the side effects are small and it is oral. He checks all the boxes, “said Dr. Gregory Poland of the Mayo Clinic in the United States.” You’re seeing a 90 percent reduction in the risk of hospitalization and death in a high-risk group.

The FDA said it had approved the use of the drug for emergencies to treat mild to moderate adult and pediatric illnesses. 12-year-old patients and the elderly who weigh at least 40 kg (88 lb) are at high risk for severe COVID-19. It includes the elderly and those with conditions such as obesity and heart disease.

“This permit provides a new tool to deal with COVID-19 at a crucial time in the pandemic new variants are created and is committed to making anti-virus treatment more accessible to patients at high risk of progression to severe COVID-19, “said Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research.

The drug is only available by prescription and should be started as soon as possible after the diagnosis of COVID-19 and within five days of the onset of symptoms, the agency said.

Pfizer’s drug is part of a family of antiviral drugs known as protease inhibitors, which revolutionized the treatment of HIV and hepatitis C. Drugs block the essential enzymes that viruses need to reproduce in the human body.

The company said it was ready to start shipping to the U.S. immediately and its production projection rose to 120 million treatments in 2022 from 80 million.

The U.S. government has signed a $ 530 contract with Pfizer for $ 530 per course.

The Pfizer pill has its challenges.

Patients will need a positive COVID-19 test to obtain a prescription. And Paxlovid has been shown to be effective if symptoms appear within five days. With extended test supplies, experts are concerned that patients should be self-diagnosed, tested, see a doctor, and take a prescription to be realistic in that narrow window.

“If you go out of that time window I fully expect the effectiveness of this drug to go down,” said Andrew Pekosz, a virologist at Johns Hopkins University.

A pill against Merck & Co., Which the FDA is reviewing, has shown lower efficacy compared to Pfizer treatment. Merck’s drugs, molnupiravir, hospitalizations and deaths were reduced by 30 percent in a clinical trial with high-risk patients.

Pfizer and Merck tablets are expected to be effective Against Omicron because they do not target the tip protein in which most of the disturbing mutations in the variant live.

Most health experts say the vaccine remains the best way to protect against COVID-19. But with about 40 million Americans still unaccounted for, effective drugs will be essential to alleviate current and future waves of infection.