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Thursday, December 23, 2021

Paxlovid / Molnupiravir /Boosters

 Not medical advice for research only 

FDA authorizes first pill developed specifically to treat COVID-19


If you take Paxlovid, you might get symptoms again,” Walensky told CBS News on Tuesday. We haven’t yet seen anybody who has returned with symptoms needing to go to the hospital. So, generally, a milder course.”


May 24, 2022 


Rebound After Paxlovid Treatment Summary The Centers for Disease Control and Prevention (CDC) is issuing this Health Alert Network (HAN) Health Advisory to update healthcare providers, public health departments, and the public on the potential for recurrence of COVID-19 or “COVID-19 rebound.” Paxlovid continues to be recommended for early stage treatment of mild to moderate COVID-19 among persons at high risk for progression to severe disease. Paxlovid treatment helps prevent hospitalization and death due to COVID-19. COVID-19 rebound has been reported to occur between 2 and 8 days after initial recovery and is characterized by a recurrence of COVID-19 symptoms or a new positive viral test after having tested negative. A brief return of symptoms may be part of the natural history of SARS-CoV-2 (the virus that causes COVID-19) infection in some persons, independent of treatment with Paxlovid and regardless of vaccination status. Limited information currently available from case reports suggests that persons treated with Paxlovid who experience COVID-19 rebound have had mild illness; there are no reports of severe disease. There is currently no evidence that additional treatment is needed with Paxlovid or other anti-SARS-CoV-2 therapies in cases where COVID-19 rebound is suspected. 

Or just take IVM and get rid of COVID once and for all! (My words not the CDC) 

December 23, 2021 PAXLOVID and Molnupiravir: Avoid Steve Kirsch My opinion on these drugs is pretty simple: avoid.
How good is the FDA at EUA approval for COVID drugs? Well, so far, to be honest, pretty shitty.

The first three Covid drugs approved under EUA were Remdesivir, Baricitinib, and Tofacitinib. All were EUA approved for inpatient use (in hospital) only, demonstrate dismal effectiveness and are replete with black box warnings and side effects such as organ failure, blood clots, serious infections and malignancy.


PAXLOVID

PAXLOVID was recently approved by the FDA without any external meetings or disclosure. There was no opportunity for public input. Essentially all done behind closed doors.

Dr. Ryan Cole on the drug’s mechanism of action after infection explains, the Covid virus enters the cell and commandeers the cell forcing it to produce proteins. Protease enzymes must be present for the virus to successfully complete the cycle before taking the cell over. PAXLOVID or any drug classified as a ‘Protease Inhibitor’ will inhibit or decrease the Protease enzyme interfering with the virus. Ivermectin is the most successful and proven protease inhibitor in production. Just as with Paxlovid, ivermectin decreases the protease enzyme but...the benefits of ivermectin in Covid treatment are obvious and not present in paxlovid. Additional actions of ivermectin include anti-coagulant action and anti-inflammatory actions, both observed in Covid infections.

PAXLOVID requires combination with an HIV/AIDS drug, Ritonavir, preventing the breakdown of the PAXLOVID so it may inhibit or decrease the enzyme interrupting the viral life cycle. Dr. Cole reports Ritonavir also has its own black box warning and side effects include life-threatening liver, pancreas and heart issues.

According to Pfizer’s press release, PAXLOVID reduces hospitalization/death by 89%. So in the treatment group we had 5 of 697 hospitalized with no deaths compared to 44/682 hospitalized with 9 subsequent deaths.

How does that compare with the Fareed and Tyson protocol? Well, Fareed and Tyson had 10 times as many patients taking the drug combo and yet they had fewer hospitalizations (4) and the same number of deaths (0).

So you’re way better off with the Fareed and Tyson protocol.

Molnupiravir

First, the efficacy when it works is poor, only 50%. There were two groups in the randomized trials and in the second group, the people who got the drug ended up worse. And then there is the problem of causing cancer.

Bottom line

Avoid these drugs.

Early treatments using repurposed drugs have a track record that is safer and more effective than either of two drugs that the FDA likes.

But thanks to the NIH, you’ll never hear about early treatment protocols unless you live in Florida.


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December 23, 2021 FDA Authorizes Merck’s COVID-19 Pill Weeks After US Makes $2.2 Billion Purchase by Jack Phillips 

 The Food and Drug Administration (FDA) on Thursday morning issued an emergency use authorization for Merck’s antiviral pill for COVID-19, more than 12 hours after giving the green light for a similar, oral drug made by Pfizer.

Merck’s drug, named molnupiravir, was developed with Ridgeback Biotherapeutics, and it was shown to reduce hospitalizations and deaths from 9.7 percent to 6.8 percent in clinical trials of high-risk individuals, according to the federal drug regulator.

The medication is designed to treat adults who are at a high risk of becoming severely ill from COVID-19, the illness caused by the CCP (Chinese Communist Party) virus. The oral drug can also be used in the treatment of mild-to-moderate COVID-19 cases in adults and for whom alternative COVID-19 treatments are not accessible or aren’t clinically appropriate, the agency said.

“As new variants of the virus continue to emerge, it is crucial to expand the country’s arsenal of COVID-19 therapies using emergency use authorization,” Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in a statement.

And Thursday’s emergency use authorization “provides an additional treatment option against the COVID-19 virus in the form of a pill that can be taken orally,” Cavazzoni continued in her statement.

On Nov. 30, the FDA’s advisory panel narrowly voted 13–10 to recommend the drug amid concerns about its effectiveness and safety. The drug cannot be authorized for use in patients under the age of 18 because molnupiravir might impact bone and cartilage growth, according to the FDA.

Possible side effects of the pill include diarrhea, nausea, and dizziness, the FDA said. The agency’s advisory committee last month referenced concerns about whether the drug presents a potential risk to pregnant women and their unborn children.

Authorities said that an advantage of Pfizer’s and Merck’s oral drugs is that they can be taken at home and do not require an injection or IV at a medical clinic or hospital.

The U.S. federal government previously agreed to purchase 3.1 million courses of the Merck antiviral drug for about $2.2 billion. Jeff Zients, the White House’s COVID-19 response coordinator, told reporters Wednesday that if molnupiravir is authorized, most of those treatment regimens could be distributed to states and municipalities by the end of next month.

As for Pfizer’s drug, Paxlovid, the United States purchased 10 million courses several weeks ago in a deal worth more than $5 billion, according to a Department of Health and Human Services news release.

The drug, which was authorized by the FDA for emergency use, is taken twice per day for five days in combination with a second medicine called ritonavir, classified as a generic antiviral drug. It is aimed at COVID-19 patients with “mild-to-moderate” symptoms to prevent them from becoming so sick that they need to be hospitalized, FDA officials and Pfizer have said.

Before the FDA decisions this week, the only COVID-19 antiviral treatment that had been granted emergency authorization by the FDA is remdesivir, a drug that’s being sold under the brand name Veklury.

In recent months, some severely sick COVID-19 patients and their family members have said that the cheaply produced anti-parasitic drug ivermectin produced positive results. An elderly patient in Illinois recovered following a court order that allowed him to use the medication, which the FDA hasn’t cleared for use for COVID-19, the man’s attorney said on Dec. 1.

Merck has not responded to a request for comment.


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December 24, 2021 - UK Agency: Pfizer Booster's Ability to Prevent Symptomatic COVID Wanes within weeks 

Data shows 3rd shot 70% effective in preventing illness after 2 weeks but only 45% after 10 weeks; Moderna seems to offer more durable protection, staying at 70% after 10 weeks

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December 29, 2021 by David Axe  - Dreams of a New COVID Pill Panacea Have Been Dashed

NOT OVER YET

Two newly approved antiviral drugs will be important weapons against COVID, but experts fear they will not solve all of our problems.

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