Pfizer pill becomes 1st US-authorized home COVID treatment

T. Belman. Probably the promotion of Ivermectin and Hydroxychloroquine was prohibited, in order to give Pfizer the opportunity to come out with a competing and more costly product.

Dr Zelenko is now promoting his own product. HERE

The U.S. has authorized the first pill against COVID-19, a Pfizer drug that Americans can take at home to reduce the risk of hospitalization and death.  Pfizer pill becomes 1st US-authorized home COVID treatment

By MATTHEW PERRONEAP Health Writer, The Associated Press

WASHINGTON (AP) — U.S. health regulators on Wednesday authorized the first pill against COVID-19, a Pfizer drug that Americans will be able to take at home to head off the worst effects of the virus.

The long-awaited milestone comes as U.S. cases, hospitalizations and deaths are all rising and health officials warn of a tsunami of new infections from the omicron variant that could overwhelm hospitals.

The drug, Paxlovid, is a faster 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, though the drug is not recommended for patients with severe kidney or liver problems. 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.

Pfizer currently has 180,000 treatment courses available worldwide, with roughly 60,000 to 70,000 allocated to the U.S. The company said it expects to have 250,000 available in the U.S. by the end of January.

Federal health officials are expected to ration early shipments to the hardest hit parts of the country. Pfizer said the small supply is due to the manufacturing time — currently about nine months. The company says it can halve production time next year.

The U.S. government has agreed to purchase enough Paxlovid to treat 10 million people, and it will be provided free to patients. Pfizer says it’s on track to produce 80 million courses globally next year, under contracts with the U.K., Australia and other nations.

President Joe Biden said the pill marks a “significant step forward in our path out of the pandemic” and said his administration will work with states to ensure equitable distribution.

Health experts agree that vaccination remains the best way to protect against COVID-19. But with roughly 40 million American adults still unvaccinated, effective drugs will be critical to blunting the current and future waves of infection.

The U.S. is now reporting more than 140,000 new infections daily and federal officials warn that the omicron variant could send case counts soaring. Omicron has already whipped across the country to become the dominant strain, federal officials confirmed earlier this week.

Against that backdrop, experts warn that Paxlovid’s initial impact could be limited.

For more than a year, biotech-engineered antibody drugs have been the go-to treatments for COVID-19. But they are expensive, hard to produce and require an injection or infusion, typically given at a hospital or clinic. Also, laboratory testing suggests the two leading antibody drugs used in the U.S. aren’t effective against omicron.

Pfizer’s pill comes with its own challenges.

Patients will need a positive COVID-19 test to get a prescription. And Paxlovid has only proven effective if given within five days of symptoms appearing. With testing supplies stretched, experts worry it may be unrealistic for patients to self-diagnose, get tested, see a physician and pick up a prescription within that narrow window.

“If you go outside that window of time I fully expect the effectiveness of this drug is going to fall,” said Andrew Pekosz, a Johns Hopkins University virologist.

The FDA based its decision on company results from a 2,250-patient trial that showed the pill cut hospitalizations and deaths by 89% when given to people with mild-to-moderate COVID-19 within three days of symptoms. Less than 1% of patients taking the drug were hospitalized and none died at the end of the 30-day study period, compared with 6.5% of patients hospitalized in the group getting a dummy pill, which included nine deaths.

Pfizer’s drug is part of a decades-old family of antiviral drugs known as protease inhibitors, which revolutionized the treatment of HIV and hepatitis C. The drugs block a key enzyme which viruses need to multiply in the human body.

The U.S. will pay about $500 for each course of Pfizer’s treatment, which consists of three pills taken twice a day for five days. Two of the pills are Paxlovid and the third is a different antiviral that helps boost levels of the main drug in the body.

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Associated Press writer Tom Murphy contributed to this report.

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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.

 

December 23, 2021 | 20 Comments »

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20 Comments / 20 Comments

  1. You are entitled to your views and opinions as the first amendment covers you. More than that I have not much interest in views. Do be happy as I wish you no ill will.

  2. @Bear
    Ridicule should be reserved for those who have no argument to make or no aptitude to make it. I trust you can support your view better than the void you fill with your chuckles and derision.

    Hence please do inform us all how you explain that the dereliction of duty performed by the very organizations, agencies and doctors, both in the US and around the world, who should have been promoting and prescribing some collection of these generic medications known to be safe and proven to be effective to stop this pandemic. Furthermore, perhaps you can expand further on how these officials and physicians stood by mindlessly obedient to the official mantra of do not treat the ill as if they were beyond the merit of medication. They were not and they still are not. Why is Israel able to test out the experimental treatment you shared yesterday, but not widely prescribe IVM which has been associated with fewer deaths in 40yrs than will die from an ibuprofen-class(NSAIDs) drug in the course of a week.

    If there is no conspiracy, do explain these matters clearly. Hint: these people, the medical administrators and physicians, do not use the Q&A from Mayo Clinic, John Hopkins or other institutions, which are only used to manipulate the public towards the goals of public health. Instead, they bring the receipts, the source papers I shared with you yesterday, and argue right or wrong based on clinical data, and pursue such matters as warrant review with further actual clinical trials for support.

    Feel free to consult the research here for input on your argument, you might find it revealing:
    https://ahrp.org/covid-conspiracy-laid-bare-by-dr-anthony-faucis-email-correspondence/

    https://roundingtheearth.substack.com/p/the-chloroquine-wars-part-xiv

    https://roundingtheearth.substack.com/p/the-chloroquine-wars-part-xv

  3. @peloni

    What you have stated is not incompatible with the idea that banning of cheap and effective cures served the needs of Big Pharma

    by giving them the opportunity to come out with a competing and more costly product.

    No one was saying that giving Pfizer some breathing room to create their own “cure” was the ONLY reason for the virus debacle..

  4. @Ted
    @Reader

    Forgive me if I am misunderstanding your statements here, but IVM and HCQ and every other effective treatment were prohibited to establish a plague and sell a vaccine which failed, and is now to be backstopped by this latest experimental gambit. The purpose was simply to gain the capture of the nations of the world in a self-generated and medically sponsored tyranny that is now in place at various stages among the world’s nations and its expanding authority continues to corrupt nations states and capture their independence into a single enterprise, based on the prohibition of every single reasonable and safe treatment that does not lend itself towards this goal. IMHO of course.

  5. @Ted Belman

    Probably the promotion of Ivermectin and Hydroxychloroquine was prohibited was to give Pfizer the opportunity to come out with a competing and more costly product.

    Have no doubt about it!

    How ethical is that? (A rhetorical question.)

  6. @Bear

    The studies have since been retracted, or pulled back

    .

    Not true. We do this every few months. You share a statement from some medical elite university or organization and I show you they lied and you show me another and I show you they lied too. So lets follow thru. Go to this page:
    https://hcqmeta.com/
    Right under the blue box at the top, there are a list of the 33 trials for early treatment. Click on one of them. About 5 lines from the top will be a hyperlink named ‘Source’. Click on that. It will take you to the source paper. If it is pulled back it will state the paper is not available for whatever reason they give. I’ll do one
    Here is the source page
    https://www.sciencedirect.com/science/article/pii/S1567576921002721
    and it is not pulled back.

    Lets do another, here is the source page:
    https://www.medrxiv.org/content/10.1101/2020.09.09.20184143v1
    and it is not pulled back.

    There are 33 of them, so I will let you play with them. I arbitrarily picked these two based on the patient size.

    I understand why you would believe that you could trust these organizations, pillars of the medical community that they represent. Yet, we keep finding that they are holding certain statements as fact, while we can prove they are false statements with but a couple of very short clicks, a living euphemism for lies. So, you can share another page and we can keep going. Til then, we now have John-Hopkins, Yale, Harvard and now Mayo Clinic. There are likely others we have played with, but these are the ones who stick in my mental craw. So, have fun with the links and let me know if you find any are pulled back. Likely enough there might be one or two or some number. It isn’t 33 out of 33, and if you do play with it you will see that it is a damn bit closer to 0 than not.

    FYI, Dr. McCullough, Dr. Fareed, Dr. Tyson, Dr. Zelenko among others are using these drugs routinely. If there was no proof they worked or that they caused harm, you would find these doctors in jail. Also their patients would be dying due to the snake oil prescribed treatments. Neither of these facts are taking place.

  7. Hydroxychloroquine Does It Treat COVID-19? (this sums up what I read overall)

    The evidence is mixed. There’s interest in hydroxychloroquine as a COVID-19 treatment because early studies in the lab showed promise. They found that the drug had some antiviral effect on the cells infected with SARS-CoV-2. That’s the virus that causes COVID-19. So far, there’s no strong evidence that it does the same thing in people. The studies have since been retracted, or pulled back.

    Side Effects

    You might not have any problems if you take hydroxychloroquine. But like any drug, it could cause unwanted symptoms. Some are mild and might get better with time.

    The most common side effects are:

    Nausea
    Throwing up
    Diarrhea
    Belly pain

    You could get low blood sugar if your diabetes isn’t under control. It might help if you take hydroxychloroquine with food.

    https://www.webmd.com/lung/hydroxychloroquine#1

  8. @Morry Rotenberg
    You are quite correct. The required use of Ritonavir with Paxlovid is quite worrisome. Ritonavir has a black box warning and has serious side effects including life-threatening liver disease, pancreas disease and heart issues. Among the potential harms from this drug include diabetes and liver failure. A patient should be screened prior to this drug being prescribed. There is no reason beyond profit why this combination would be chosen over a well established safety and efficacy described for IVM. This is sinister.

  9. The “breakthrough” drug is actually a combination of drugs. The paxlovid which is the new “miracle” drug must be given with a drug named Retonavir used to treat HIV. There is currently no information about drug interactions with paxlovid but retonavir has literally dozens of adverse interactions with commonly used meds. Unless the doctor is scrupulous in checking for drug interactions before prescribing paxlovid/retonavir many people will be harmed worse than if they did nothing. At present the monoclonal antibody sotrovimab is the one safe and effective treatment for omicron when given in the first few days of illness in at risk patients.

  10. Here is a list of existing treatment drugs and their research results:
    https://c19early.com/

    There are links to all their associated drug studies, the odds ratio comparing their various benefits between these drugs, their effects on mortality rates, their results with early treatments. It is a very useful site to peruse and share with family, friends and some physicians who still think the only treatment possible it an injectable gene therapy.

  11. @Bear

    Hydroxychloroquine I have read might have seem anecdotally promising early in the pandemic, I read that upon further study it is not.

    This is simply not true, forgive me, but it is just dishonest to suggest this.

    There are over 303 trials, now, including work from 4,815 scientists, and the participation of 415,929 patients.

    There are 47 randomized control trials that have looked at HCQ with Covid at various treatment stages with 20% improvement.

    33 trials looked specifically at early treatment with a 64% improvement and all but one found some improvement and all but 3 found marked improvement.

    8 trials looked at its use as prophylaxis, and all but one proved to be successful in providing improved odds against established disease and the one that wasn’t was barely not successful.

    Here is a list of all the research that has been performed on HCQ
    https://hcqmeta.com/

    Whatever you may judge of HCQ’s use on Covid, its depth of trial work is substantially more significant and more broadly proven than the this new treatment. To compare to the 303 studies of HCQ, how many studies do we have with this current Pharma boondangle? With how many days of safety data?

    If you care to understand what did happen to HCQ, read this:
    https://roundingtheearth.substack.com/p/the-chloroquine-wars-part-xiv
    or this
    https://roundingtheearth.substack.com/p/the-chloroquine-wars-part-xv
    or this
    https://ahrp.org/covid-conspiracy-laid-bare-by-dr-anthony-faucis-email-correspondence/

  12. @Bear

    Hydroxychloroquine I have read might have seem anecdotally promising early in the pandemic, I read that upon further study it is not.

    This is simply not true, forgive me, but it is just dishonest to suggest this.

    There are over 303 trials, now, including work from 4,815 scientists, and the participation of 415,929 patients.

    There are 47 randomized control trials that have looked at HCQ with Covid at various treatment stages with 20% improvement.

    33 trials looked specifically at early treatment with a 64% improvement and all but one found some improvement and all but 3 found marked improvement.

    8 trials looked at its use as prophylaxis, and all but one proved to be successful in providing improved odds against established disease and the one that wasn’t was barely not successful.

    Here is a list of all the research that has been performed on HCQ
    https://hcqmeta.com/

    Whatever you may judge of HCQ’s use on Covid, its depth of trial work is substantially more significant and more broadly proven than the this new treatment. To compare to the 303 studies of HCQ, how many studies do we have with this current Pharma boondangle? With how many days of safety data?

    If you care to understand what did happen to HCQ, read this:
    https://roundingtheearth.substack.com/p/the-chloroquine-wars-part-xiv
    or this
    https://roundingtheearth.substack.com/p/the-chloroquine-wars-part-xv
    or this
    https://ahrp.org/covid-conspiracy-laid-bare-by-dr-anthony-faucis-email-correspondence/

  13. the contest let’s name the pill take the survey
    poxlivid
    pfizermectin
    chicomclonal
    zelenx
    zstackless
    hidedroxy
    any other suggestions ?

  14. I was asked by Dr H. Risch and others over a year ago to approach Israel to sell them on Hydroxycloroquine.. Try as I might I could not get in the door. Nobody was interested in listening to what Risch had to say. Many raised the issue that it didn’t work and cited a test but that test was done at the wrong time, namely when the patient had been hospitalized..

    i tried to tell them that what matters is early treatment and the addition of Zinc and all in the right doses. Nobody cared to listed. That was my experience.

  15. @Ted, I know you now also have an MD degree (just teasing). I know you used to practice law not medicine in your past.

    While I have read promising things about Ivermectin (from actual medical people). Hydroxychloroquine I have read might have seem anecdotally promising early in the pandemic, I read that upon further study it is not.

    So if Pfzier has come up with a viral pill against Covid that works, that is a good thing in my personal view. It would seem various treatment options should be a good thing and not disparaged.

  16. The Pfizer CEO said there is a BIOLOGICAL PILL that is a MICROCHIP that you swallow and that effectively will FORCE people to comply…it sends a signal to your health care providers and insurance companies and tells them exactly what you are taking! If you’re not taking what you’re supposed to be taking – you will be cut off.