FDA Authorizes Pfizer Antiviral Pill for COVID-19

Date:

Dec. 22, 2021 – The FDA on Wednesday granted emergency use authorization of a new antiviral pills to treat people with symptomatic COVID-19.

Pfizer’s ritonavir, name brand Paxlovid, can now be taken by patients age 12 and up who weigh at least 88 pounds.

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

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

Possible side effects of include reduced sense of taste, diarrhea, high blood pressure and muscle aches.

The authorization arrives as the U.S. faces a surge in Omicron case numbers, evidence points to waning effectiveness of some monoclonal antibody treatments and as Americans struggle to maintain some sense of tradition and normalcy around the holidays.

Paxlovid joins remdesivir (as available antivirals to treat COVID-19. Remdesivir is fully approved by the FDA but is only given via I.V. in the hospital.

The pill form of COVID-19 antivirals come with some obvious advantages – including greater convenience for consumers, including 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 has been highly anticipated, and news of its impending authorization circulatied on social media on Tuesday. Eric Topol, MD, called the development an “exciting step forward.” Topol is editor-in-chief of Medscape, WebMD’s sister site for health care professionals. .

Topol, and many others, however, also expected the FDA to grant emergency use authorization for an antiviral from Merck. There was no immediate word Wednesday if that was still going to happen.

An Accelerated Authorization?

FDA’s authorization for Pfizer’s antiviral comes about 5 weeks after the company submitted an application to the FDA. In its submission, the company said a study showed the pill reduced by 89% the rate of hospitalization and death for people with mild-to-moderate COVID-19 illness.

In April 2021, Pfizer announced its antiviral pill for COVID-19 could be available by year’s end. In September, an official at the National Institutes of Allergy and Infectious Diseases seconded the prediction.

Merck filed its EUA application with the FDA in October 2021. The company included results of its Phase 3 study showing the treatment associated with a 50% reduction in COVID-19 hospitalizations.

Interestingly, in September 2021, Merck announced the findings of laboratory studies suggesting that molnupiravir would work against variants of coronavirus because the agent does not target the virus’ spike protein. At the time, Delta was the dominant variant in the U.S..

Faith-Based Purchasing

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

Last month it announced intentions to purchase $1 billion worth of Merck’s molnupiravir, adding to the $1.2 billion worth of the pills the U.S. ordered in June 2021. Also in November, the government announced it would purchase 10 million courses of the Pfizer pill at an estimated cost of $5.3 billion.

The government pre-orders of the antiviral pills for COVID-19 are separate from the orders for COVID-19 vaccines. Most recently, the Biden Administration announced it will make 500 million tests for coronavirus infection available to Americans for free in early 2022.

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