Couldn’t resist! I literally LOL’d when they mentioned Moderna; a company that will profit from the new vaccines! 🤦🏼♀️
Previously:
Tag: clinical trials
Natural immunity wins
Elon Musk Says Neuralink Is The Only Way To Survive And Compete With AI
Elon Musk, the genius behind SpaceX and Tesla Inc., has declared that humanity must embrace the merging of man and machine if we hope to survive in a world dominated by artificial intelligence (AI).
Elon Musk Says Neuralink Is The Only Way To Survive And Compete With AI
From FDA to MHRA: are drug regulators for hire?
Patients and doctors expect drug regulators to provide an unbiased, rigorous assessment of investigational medicines before they hit the market. But do they have sufficient independence from the companies they are meant to regulate? Maryanne Demasi investigates
From FDA to MHRA: are drug regulators for hire?
Why India did not allow Pfizer’s Covid-19 vaccine
Why India did not allow Pfizer’s Covid-19 vaccine
In Latin America pharmaceutical bullying went a notch higher. In addition to legal indemnity, Pfizer demanded protection against their own negligence and mistakes. Argentina amended its vaccine law, three times, yet Pfizer was not happy. Pfizer wanted Argentina’s bank reserves and military bases as “guarantees”.
In the era of neo-colonialism, Pharma industry was the new East India Company.
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Despite such pressure, India did not succumb. Eventually, Pfizer withdrew its application in 2021 We continued our vaccine programme with drugs that complied with our legal requirements.
Alzheimer’s latest drug and science journalism’s memory problem
In July, the medical community was rocked by a disappointing reminder of science’s weakest link: the humans doing the work. The journal Science had shared that its six-month investigation supported the findings of whistleblower Matthew Schrag, who first noted altered images in a high-impact paper on Alzheimer’s, published in Nature in 2006. That paper is still flagged on Nature as under review, but the damage has already been done. Alzheimer’s drugs for the last decade and a half have been developed around claims without as much evidence as initially believed—which might also explain why they haven’t been working, leading people to pour false hope into useless and often expensive treatment plans for declining loved ones.
Alzheimer’s latest drug and science journalism’s memory problem
‘There’s no way that patients are going to be able to afford that.’ Why aren’t new drugs that can help you lose weight more widely used?
A pair of new drugs offer something many Americans desperately want: a way to lose weight.
‘There’s no way that patients are going to be able to afford that.’ Why aren’t new drugs that can help you lose weight more widely used?
“Ten years ago, policymakers would come out and say, ‘Fat people need to eat less and move more.’” – majority of people still feel this way, unfortunately. Most of them don’t know how hard it is to lose weight or if they have, they don’t understand that one weight loss plan may not work for another. Same way it is with medical treatments. One size fits all doesn’t fit all!
New COVID Booster Approved From Final Study of Mice, Not Humans, But Using Only Animal Data Is a Needless Gamble
VERIFY: New COVID booster approved from final study of mice, not humans
According to documents on the CDC website, human tests of Moderna’s version of the new booster are still “ongoing.” Right now, there is only final evidence from “8-10 mice” per group.”
The FDA’s website shows for Pfizer the agency also relayed on the final study evidence from “8 mice.” But human trials are also ongoing. So far, the new boosters “showed a similar local reaction and systemic event profile.” That means side effects appear to be about the same including “mild to moderate injection site pain, fatigue, and muscle pain.”
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“To advance the Omicron BA.4/BA.5 bivalent vaccine as rapidly as possible, regulators, including the FDA, WHO and EMA, have advised that our submissions be based on safety and immunogenicity data generated in adults with an Omicron BA.1 bivalent vaccine and supported by BA.4/BA.5 bivalent pre-clinical data and BA.4/BA.5 bivalent quality and manufacturing data. These packages follow a similar model to that provided to public health officials who evaluate seasonal flu vaccines each year. Moving forward, this approach may help address the pressing need for vaccines that provide a high level of protection against current and emerging variants of concern so that we can remain vigilant against this evolving virus. The FDA has authorized our Omicron BA.4/BA.5 bivalent vaccine based on clinical data generated in adults with an Omicron BA.1 bivalent vaccine, pre-clinical data with a BA.4/BA.5 bivalent vaccine and BA.4/BA.5 bivalent quality and manufacturing data. Pre-clinical data showed a booster dose of Pfizer and BioNTech’s Omicron BA.4/BA.5- bivalent vaccine generated a strong neutralizing antibody response against Omicron BA.1, BA.2 and BA.4/BA.5 variants, as well as the original wild-type strain. A clinical study investigating the safety, tolerability and immunogenicity of the Omicron BA.4/BA.5 bivalent vaccine in individuals 12 years of age and older is ongoing. Data will be shared with regulators when available. We are facing a virus with an exceptionally high mutation rate, which the nimble mRNA platform is well situated to address. Only the mRNA sequence requires updating to match emerging strains, and utilizing a bivalent vaccine aims to provide broader coverage against known and future COVID-19 variants of concern.”
Related:
Read More »Pfizer’s anti-COVID pill Paxlovid shows no benefit for younger adults
Pfizer’s anti-COVID pill Paxlovid shows no benefit for younger adults
The report’s authors found that Pfizer’s antiviral medication Paxlovid offered little to no benefit for younger adults. However, it did reduce the risk of hospitalization for high-risk seniors. Notably, supplementary material from the original study of Paxlovid in high-risk non-hospitalized adults with COVID-19 during the Delta wave had demonstrated benefits in those younger than 65, albeit the difference compared to the placebo was much less than in those 65 and older.
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Among those over 65, there was a 73 percent decrease in the hospitalization rate and a 79 percent reduction in the risk of death. However, patients between the ages of 40 and 65 saw no benefit in taking the antiviral medication in either category, regardless of previous immunity status.
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Another critical study from Hong Kong published in Lancet Infectious Diseases on the same day as the Israeli study but which went unmentioned in the press offered further evidence of Paxlovid’s limited therapeutic role. The authors reviewed their clinical experience with Paxlovid and Lagevrio, Merck’s antiviral pill, Molnupiravir, in hospitalized patients. They compared them to hospitalized patients who did not receive those medications during the horrific wave of infections that slammed into the semi-autonomous region in February and March.
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The mortality risk reduction for Lagevrio was 52 percent, and for Paxlovid it was 66 percent. Those receiving antivirals had a lower risk of their disease progressing, but the drugs did not significantly impact their need for mechanical ventilation or ICU admission. The patients in the study averaged in age from mid-70s to early 80s.
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Given the results of these studies, it bears mentioning that the Centers for Disease Control and Prevention (CDC) has recently estimated that approximately 95 percent of Americans aged 16 and older have some level of immunity against COVID-19.
Ms. Cat’s Chronicles 
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