“Pfizer Pill Becomes 1st US-Authorized Home COVID Treatment”

The pill

“The drug, Paxlovid, is a faster, cheaper way to treat early COVID-19 infections, though initial supplies will be extremely limited. All of the previously authorized drugs against the disease require an IV or an injection.

An antiviral pill from Merck also is expected to soon win authorization. But Pfizer’s drug is all but certain to be the preferred option because of its mild side effects and superior effectiveness, including a nearly 90% reduction in hospitalizations and deaths among patients most likely to get severe disease.

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

The Food and Drug Administration authorized Pfizer’s drug for adults and children ages 12 and older with a positive COVID-19 test and early symptoms who face the highest risks of hospitalization. That includes older people and those with conditions like obesity and heart disease. Children eligible for the drug must weigh at least 88 pounds (40 kilograms).

The pills from both Pfizer and Merck are expected to be effective against omicron because they don’t target the spike protein where most of the variant’s worrisome mutations reside.” Newsmax

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“Scientists at the Walter Reed Army Institute of Research expect to announce they have developed a vaccine effective against COVID-19 and all its variants — including omicron and previous SARS-origin viruses, Defense One reported.

The remarkable achievement comes after nearly two years of work on the virus, the news outlet reported.

The Army lab received its first DNA sequencing of the COVID-19 virus in early 2020, and very early on, Walter Reed’s infectious diseases branch decided to focus on making a vaccine that would work against not just the existing strain but all of its potential variants, Defense One reported.

Walter Reed’s SpFN vaccine — Spike Ferritin Nanoparticle —   completed animal trials earlier this year with positive results, the news outlet reported.

Phase 1 of human trials tested the vaccine against omicron and the other variants and wrapped up this month with positive results that are undergoing final review, Dr. Kayvon Modjarrad, director of Walter Reed’s infectious diseases branch, told Defense One.

The new vaccine will still need to undergo phase 2 and phase 3 trials.” Newsmax

Comment: More good news all around. pl

https://www.newsmax.com/finance/streettalk/virus-outbreak-treatments/2021/12/22/id/1049649/

https://www.newsmax.com/us/army-covid-variants-vaccine/2021/12/22/id/1049648/

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8 Responses to “Pfizer Pill Becomes 1st US-Authorized Home COVID Treatment”

  1. zmajcek says:

    Omicron variant could end up being the best vaccine. It is free, distribution is quick and side effects relatively mild.

    As of Friday, out of 25 000 UK omicron cases there are about 85 hospitalizations.

    https://www.cnbc.com/2021/12/19/omicron-coronavirus-cases-surge-in-uk-scientists-see-bigger-wave.html

    “The government’s Scientific Advisory Group for Emergencies (SAGE) said it was almost certain” that hundreds of thousands of people were being infected with the variant every day and were not being picked up in the figures.”

    • Datil D says:

      That’s good news. Apparently it’s true that a virus mutates to more transmissible and less severe variants rather than have a dead host. Natural immunity being the best and as Larry pointed out on this blog, if the vaccine works it’s only transiently, with possible side effects. I don’t see why a healthy person would want to be injected with 40 million RNA particles that make a toxic spike protein.

  2. Fred says:

    “The new vaccine will still need to undergo phase 2 and phase 3 trials.””

    “The vaccine’s human trials took longer than expected, he said, because the lab needed to test the vaccine on subjects who had neither been vaccinated nor previously infected with COVID.”

    This is good news all around, yet I do not believe the mRNA vaccine makers placed that limitation on themselves. There’s no plan for emergency use authorization or notice of who might make these?

  3. akaPatience says:

    This very well may be excellent news about the Pfizer pill, but because of Covid policy so far (secrecy and censorship of data), it’ll be interesting to follow as more clinical info becomes available. The Merck drug turned out to be significantly less effective in trials than proclaimed at first, after all. I hope the medical establishment will at last end it’s proscription of the use of ivermectin and hydroxychloroquine as treatments, and allow doctors to prescribe them without court orders – plus allow pharmacies to freely sell them again – all without risk of jeopardizing licensing and professional standing. But it’s likely a vain hope. I concede I’m cynical and could end up being totally wrong, but I suspect those formally-over-the-counter, inexpensive drugs won’t become readily available again until the Covid scare has played out, if even then.

  4. Dorothy108 says:

    The new Pfizer pill contains the protease inhibitor, Ritionavir which has been used to treat HIV infection. Instead of optimism, I fear a rise in liver illness.

    “The drug consists of a combination of a SARS-CoV-2 (the virus that causes COVID-19) nsp5 inhibitor called PF-07321332 (see Figure 2, below) and an inhibitor of Cytochrome P450 3A4 (a human protein that often breaks down drugs) called Ritonavir, which has been used with other protease inhibitors in the past…”

    https://sites.dartmouth.edu/dujs/2021/12/08/pfizers-new-covid-19-drug-paxlovid/

    “Ritonavir is an antiretroviral protease inhibitor that is widely used in combination with other protease inhibitors in the therapy and prevention of human immunodeficiency virus (HIV) infection and the acquired immunodeficiency syndrome (AIDS). Ritonavir can cause transient and usually asymptomatic elevations in serum aminotransferase levels and, rarely, can lead to clinically apparent acute liver injury.”

    https://pubchem.ncbi.nlm.nih.gov/compound/ritonavir

  5. TTG says:

    That Walter Reed vaccine seems to be a modular, multi-mission vaccine to be used against multiple SARS and COVID virii. It it works as advertised, it’ll be a hell of a thing, definitely good news.

  6. Matt says:

    what gets my goat about this Pfizer pill is that it tries to deal with covid in exactly the same way as ivermectin but using a new molecule that can be patented and sold at mark up prices,
    I remember this comprehensive walk through of the pharmacology involved,

    https://www.youtube.com/watch?v=ufy2AweXRkc

    why wait 18 months to design a new rifle when you had warehouses full of perfectly servicable rifles sitting there waiting to be put into use?

  7. Jim says:

    Lolypops for breakfast and VE=ZERO

    Leading medical journals and scientists and MDs and researchers are spreading insanity; I believe, is correct terminology.

    How does one square the following —- in same pre-print? —-
    1] Vaccine Effectiveness = ZERO for Omicron; and calling for
    2] “In light of the exponential rise in Omicron cases, these findings highlight the need for massive rollout of vaccinations and booster vaccinations” ??

    Published Dec. 23, 2021, titled “Vaccine effectiveness against SARS-CoV-2 infection with the Omicron or Delta variants following a two-dose or booster BNT162b2 or mRNA-1273 vaccination series: A Danish cohort study”

    https://www.medrxiv.org/content/10.1101/2021.12.20.21267966v3.full.pdf

    This is how authors explained VE = less than zero:

    “The negative estimates in the final period arguably suggest different behaviour and/or exposure patterns in the vaccinated and unvaccinated cohorts causing underestimation of the VE. >>>>>>>>This was likely the result of Omicron spreading rapidly initially through single (super-spreading) events causing many infections among young, vaccinated individuals.”<<<<<<<<<<<days after fully vaxxed#casesVEconfidence interval>I had a lolypop for breakfast, I was good the first 25 minutes, but after that I was hungry.<< That is what this is saying. Does a meal carry you to the next meal? If not, that is Meal Failure. Here we have Science Failure pretending to measure Vaccine Failure.

    "Although estimated with less precision, VE against Omicron after primary mRNA-1273 vaccination similarly indicated a rapid decline in protection."

    This study aimed to compare "the rate of infections in unvaccinated and vaccinated individuals with a two-dose BNT162b2 or mRNA-1273 vaccination series."

    The results are Vaccine Failure.

    The conclusion is "Omicron decreases quickly over time with booster vaccination offering a significant increase in protection. In light of the exponential rise in Omicron cases, these findings highlight the need for massive rollout of vaccinations and booster vaccinations"

    https://www.medrxiv.org/content/10.1101/2021.12.20.21267966v3.full.pdf

    -30-

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