Dec 23, 2021: Health regulators in the United States have approved the first oral pill against COVID-19, a Pfizer drug that users will be able to take at home to combat the worst effects of the coronavirus.

The long-awaited milestone was announced Wednesday by the US Food and Drug Administration (FDA). The approval comes as cases of the corona virus have risen worldwide, including in the United States, and health officials have warned of a tsunami of new Omicron-type infections that could overwhelm hospitals.

Data from Pfizer’s clinical trial show that his antiviral method was 90% effective in preventing hospital admissions and deaths in high-risk patients with severe illness. Recent laboratory data show that the drug maintains its effectiveness against Omicron. The drug, Paxlovid, is a quick, inexpensive way to treat early COVID-19 infections, although early supplies will be extremely limited. All of the previously approved medications against the disease require IV or injection.

Dr Gregory Poland of the Mayo Clinic commented on the efficacy saying, “The efficacy is high, the side effects are low and it’s oral. It checks all the boxes, you’re looking at a 90 percent decreased risk of hospitalisation and death in a high-risk group — that’s stunning.”

The FDA says it has authorized the emergency use of the drug to treat mild to moderate illness in adults 12 and older and children weighing at least 40 kilograms (88 pounds) and who are at risk of developing severe symptoms of COVID-19. This includes the elderly and people with conditions such as obesity and heart disease.

The agency said 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 company said it is ready to begin immediate delivery in the United States and has increased production estimates from 80 million to 120 million treatment courses in 2022.

The US government contracts for 10 million Pfizer medicine courses cost $ 530 per course. Patients will need a positive COVID-19 test to obtain a prescription. And Paxlovid is only effective if given within five days of the onset of symptoms. With a shortage of testing supplies, experts fear that it may be unrealistic for patients to self-diagnose, get tested, see a doctor and get a prescription in this narrow window.

A rival pill from Merck & Co., which is under FDA review, has shown less efficacy than Pfizer’s treatment. Merck’s drug, Molonoperavir, reduced hospital admissions and mortality in high-risk patients by about 30%. Both Pfizer and Merck tablets are expected to be effective against Omicron because they do not target spike proteins where most of the different types of worrying mutations reside.

But while nearly 40 million American adults have not yet been vaccinated, effective medications will be important to stem the current and future wave of infections.

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