FDA Authorizes Two Covid Pills

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The US Food and Drug Administration (FDA) has recently approved two oral antiviral pills for the at-home treatment of Covid-19. In an announcement FDA release note said the FDA “issued an emergency use authorization (EUA) for Pfizer’s Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) for the treatment of mild-to-moderate coronavirus disease (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kilograms or about 88 pounds) with positive results of direct SARS-CoV-2 testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death. Paxlovid is available by prescription only and should be initiated as soon as possible after diagnosis of COVID-19 and within five days of symptom onset.”

“Today’s authorization introduces the first treatment for COVID-19 that is in the form of a pill that is taken orally — a major step forward in the fight against this global pandemic. This authorization provides a new tool to combat COVID-19 at a crucial time in the pandemic as new variants emerge and promises to make antiviral treatment more accessible to patients who are at high risk for progression to severe COVID-19.” 

– Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research (source: FDA website)

The efficacy is high, the side effects are low and it’s oral. It checks all the boxes. You’re looking at a 90% decreased risk of hospitalization and death in a high-risk group — that’s stunning.

Dr. Gregory Poland of the Mayo Clinic (source: Associated Press)

Last Thursday, the FDA also issued authorization of second oral antiviral pill Molnupiravir from Merk’s for ill people to take at home, before they get sick enough to be hospitalized.

Dr. Eliav Barr, senior vice president of global medical affairs at Merck, told CNN “The Omicron variant is primarily different from the other types of Covid at the spike protein. Our drug works in completely different part of the virus. So we’re very optimistic that the drug will continue to be effective against Omicron, and we’re studying that right now.”

Covid vaccine shots remain the main protection from Covid infection, however, most health experts agree that “effective drugs will be critical to blunting the current and future waves of infection.”

The FDA emphasized in the statement that “Paxlovid is not for pre- or post-exposure prevention of Covid-19 and “is not a substitute for vaccination in individuals for whom COVID-19 vaccination and a booster dose are recommended.”

Coronavirus-19 vaccination watch

According to the US Centers for Disease Control and Prevention (CDC) COVID vaccination tracker page (as of Dec 23, 9 a.m.) 611,897,975 doses have been distributed and 500,222,330 doses administered. According MDH COVID-19 Response vaccine data (as of Dec 21) a total of 8,564,704 doses of Covid-19 (Pfizer & Moderna) vaccines have been administered in Minnesota. According to the MDH latest tally (as of Dec 23) the confirmed COVID-19 cases in Minnesota are 996,224 (out of 15,882,328 tested) with 10,306 deaths.