The FDA has approved the Pfizer antivirus pill for COVID-19

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December 22, 2021 – The FDA on Wednesday approved the emergency use of a new antiviral pill to treat people with symptomatic COVID-19.

Pfizer ritonavir, a Paxlovid brand name, can now be taken by patients aged 12 and over who are at least 88 pounds.

The antiviral drug is only intended for people who are coronavirus positive and who are at high risk of severe COVID-19 disease, including hospitalization or death. It is only available by prescription and should be taken as soon as possible after diagnosis and within 5 days of the onset of symptoms.

Paxlovid is taken as three tablets together orally twice a day for 5 days, for a total of 30 tablets.

Possible side effects include decreased taste sensation, diarrhea, high blood pressure, and muscle aches.

The power comes as cases of the Omicron variant in the U.S. grow, some monoclonal antibody treatments become less effective and as Americans struggle to maintain a sense of tradition and normalcy around the holidays.

Paxlovid joins remdesivir as an available antiviral drug for the treatment of COVID-19. Remdesivir is fully FDA approved, but is only given as IV in a hospital.

COVID-19 antiviral pills come with some obvious benefits, including greater convenience for consumers – such as home use – and the potential to expand treatment for people in low- and middle-income countries.

‘An exciting step forward’

The EUA for Pfizer’s new drug was long overdue, and news of its imminent authorization circulated on social media on Tuesday. Eric Topol, MD, called the development an “exciting step forward”. Topol is the editor-in-chief of Medscape, WebMD’s sister site for healthcare professionals.

He and many others also expected the FDA to grant emergency approval for Merck’s antiviral drug. But there was no immediate news Wednesday as to whether this would happen anyway.

Expedited authorization?

FDA approval for Pfizer’s antiviral drug comes approximately 5 weeks after the company submitted a request agency. In its submission, the company said the study showed a pill reduced by 89% hospitalization and death rates for people with mild to moderate disease COVID-19.

In April 2021, Pfizer announced that its antivirus pill for COVID-19 could be available by the end of the year. In September, an official of the National Institute of Allergies and Infectious Diseases supported the prediction.

Merck applied to the EUA FDA in October. The company included the results of its phase III study showing that treatment is related to 50% reduction in COVID-19 hospitalizations.

Interestingly, in September Merck published the results of laboratory studies that suggest that molnupiravir work against variants coronavirus because the agent does not target the spiky protein of the virus. At the time, the Delta was the dominant variant in the United States

Faith-based buying

The U.S. government has already recognized the potential of these oral therapies, at least in terms of reservations.

Last month, it announced its intention to buy Merck’s molnupiravir worth $ 1 billion, adding to the $ 1.2 billion tablets ordered by the U.S. in June 2021. The government also announced in November that it would buy 10 million servings of Pfizer pills at an estimated cost. cost $ 5.3 billion.

Government pre-orders of antiviral pills for COVID-19 are separate from orders for COVID-19 vaccines. The Biden administration recently announced that it would do so 500 million tests for coronavirus infection available to Americans for free in early 2022.

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