New pharmaceutical nightmare ahead

New pharmaceutical nightmare ahead. By Toby Rogers.

Pfizer and Moderna have a problem — their mRNA Covid-19 shots do not stop infection, transmission, hospitalization, nor death from the SARS-CoV-2 virus. Everyone knows this. Over half a billion doses of this product have been injected into Americans in the past 17 months and these shots have made no discernible impact on the course of the pandemic. Far more Americans have died of coronavirus since the introduction of the shots than before they were introduced.

Pfizer and Moderna are making about $50 billion a year on these shots and they want that to continue. So they need to reformulate the shots. Maybe target a new variant, maybe change some of the ingredients — who knows, these shots don’t work so it’s not clear what it will take to get them to work. …

There is a decent chance that any reformulated shot might fail a new clinical trial and the public is deeply skeptical of these shots so the scrutiny would be intense.

So Pfizer and Moderna have figured out a way to use regulatory capture to get their reformulated Covid-19 shots approved WITHOUT further clinical trials. Their scheme is called the “Future Framework” and it will be voted on by the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on June 28.

Like the flu vaccines:

Viruses vary by region. At any given time, the influenza strain circulating in England is different than it is in Thailand, the U.S., or South Africa. However, pharmaceutical companies prefer to create one-size-fits-all vaccines in order to decrease manufacturing costs and thereby increase profits. …

There is one flu shot for all countries in the northern hemisphere and one flu shot for all countries in the southern hemisphere, that’s it. …

Over the last thirty years, the federal government has paid out more compensation for adverse events in connection with the flu shot than any other vaccine — so we know that the shot comes with a high rate of harms. Given that the flu shot does not stop the overwhelming majority of flu cases, the harms likely outweigh any benefits.

In a sane world, the WHO, FDA, and CDC would admit that they made a strategic mistake and then change course to find better ways to support the human immune system. But we don’t live in a sane world. Instead, the FDA is proposing to take the failed flu strain selection process and apply it to future Covid-19 shots. …

Anti-virals and early treatment are the way to go, not vaccines that are always going to be highly problematic:

Viruses that evolve rapidly are bad candidates for a vaccine. There is no vaccine for the common cold nor HIV because these viruses evolve too quickly. The SARS-CoV-2 virus is a bad candidate for a vaccine which is why all previous attempts to develop a vaccine against coronaviruses have failed (they never made it out of animal trials because the animals died during challenge trials or were injured by the vaccine).

What are some of the bad things that can happen when you vaccinate against a rapidly evolving virus? Original antigenic sin, antibody dependent enhancement, and the possibility of accelerating the evolution of the virus in ways that make it more virulent (and even more resistant to vaccination). …

SARS-CoV-2 evolves twice to ten times as fast as the flu virus and these mutations “substantially” reduce vaccine effectiveness.

The only way out of the pandemic is to withdraw these vaccines from the market and pivot to therapeutics. Instead, the FDA is proposing to just hide the data from the American people. ….

Future failure, Pfizer profits:

The purpose of the “Future Framework” is to rig the Covid-19 vaccine regulatory process in perpetuity in favor of the pharmaceutical industry. If this “Future Framework” is approved all future Covid-19 shots, regardless of the formulation, will automatically be deemed “safe and effective” without additional clinical trials because they are considered “biologically similar” to existing shots.

This is literally the worst idea in the history of public health.

hat-tip Scott of the Pacific