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American Patients Held Hostage Day 71

Summary:
Jeffrey A. Singer The new omicron variant is the most contagious variant of COVID-19 yet to emerge. Cases of omicron are doubling every 1.5 to 3 days, as the virus quickly spreads throughout the U.S. While the delta variant is still the dominant variant in this country, omicron is on track to replace it. The Centers ...

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Jeffrey A. Singer

The new omicron variant is the most contagious variant of COVID-19 yet to emerge. Cases of omicron are doubling every 1.5 to 3 days, as the virus quickly spreads throughout the U.S. While the delta variant is still the dominant variant in this country, omicron is on track to replace it. The Centers for Disease Control and Prevention reported late today that the omicron variant is responsible for 73 percent of recent COVID-19 cases in the U.S.The Pfizer and Moderna mRNA vaccines remain effective against omicron but are much less effective than with earlier variants. Evidence shows 2 doses of the mRNA vaccines are 30–40 percent effective against a symptomatic omicron infection. The 2‑dose regimen plus a booster is roughly 70 percent effective.

Fortunately, two new antivirals have been submitted to the Food and Drug Administration for emergency use authorization. Antivirals are to viral infections what antibiotics are to bacterial infections. They effectively poison the pathogen and prevent it from replicating and surviving.

Merck submitted molnupiravir to the FDA to consider for emergency authorization on October 11, 2021—71 days ago. Randomized controlled trials show the drug prevents 30 percent of symptomatic cases from progressing to severe disease. No patient receiving molnupiravir died of COVID-19. The U.K. Medicine and Healthcare Products Regulatory Agency approved its use in Britain on November 4. On November 30 an FDA advisory committee recommended its approval but the FDA has yet to act on the recommendation.

Pfizer submitted its antiviral drug Paxlovid to the FDA for emergency use authorization on November 16 after controlled trials found it to be 89 percent effective in preventing hospitalization. There were no deaths reported in any patient receiving Paxlovid.

Both drugs were so effective that trials were interrupted because it was unethical to deny the drug to the trials’ placebo arms.

The FDA has not yet scheduled a meeting of its advisory committee to discuss Paxlovid.

Days Since Merck Submitted EUA Request to FDA: 71

Days Since Advisory Panel Recommended EUA of Merck Antiviral: 20

Days Since Pfizer Submitted EUA Request to FDA: 34

U.S. COVID-19 Deaths Since October 11, 2021: 84, 156

U.S. COVID-19 Deaths Reported on December 19, 2021: 206

(Source: Worldometer)

Each day that the FDA holds American patients hostage, delaying a decision on allowing them to try these antiviral drugs, potentially 89 percent of COVID infections could be prevented from going to the hospital.

I will update these numbers regularly.

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