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Pfizer asks FDA to grant emergency authorization for its COVID-19 pill


Pfizer has asked federal regulators to approve its experimental COVID-19 pill, which the company claims can protect people from the disease's most severe symptoms.

Pfizer announced on Tuesday that it is requesting an Emergency Use Authorization from the Food and Drug Administration for the antiviral pill Paxlovid. Earlier this month, the company announced that Paxlovid reduced the risk of hospitalization and death in people with mild to moderate coronavirus infections by nearly 90%.

The Pharmaceutical jobs giant, which also makes a coronavirus vaccine, announced earlier on Tuesday that it has signed a deal with a United Nations-backed group to allow other manufacturers to make the COVID-19 pill, which could make the treatment available to more than half of the world's population.

"The overwhelming efficacy achieved in our recent clinical study of Paxlovid, and its potential to help save lives and keep people out of the hospital if authorized, underscores the critical role that oral antiviral therapies could play in the battle against COVID-19," Pfizer CEO Albert Bourla said in a statement.

Other pharmaceutical companies are also working on a pill to treat COVID-19. An FDA panel is scheduled to meet on November 30 to consider molnupiravir, an antiviral drug developed by Merck and Ridgeback Biotherapeutics that recently received approval in the United Kingdom.

Merck claims that its drug, molnupiravir, has cut the risk of adult COVID-19 patients with underlying health conditions being hospitalized or dying from the disease in half.

Both Merck's and Pfizer's antiviral drugs are taken in capsule form for five days, beginning as soon as higher-risk patients test positive for the virus. Both pills are intended to reduce the risk of severe disease in the days following infection, but they work in different ways.

Pfizer jobs claim that its pill prevents the virus from spreading in a person's body by utilizing a new compound that can bind to a virus enzyme, preventing the virus from replicating inside infected cells. Merck's drug, which is based on a drug developed at Emory University to combat the flu, attempts to use the body's cells to prevent the virus from replicating.

Paxlovid works in the same way as remdesivir, an antiviral drug approved by the FDA last year for the treatment of COVID-19. However, the pills would be easier to administer because remdesivir must be administered intravenously in a hospital or clinic.

Source: CBS News

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