Tuesday, September 12, 2023

FDA has Gone Rogue

 "There's a new vaccine that's coming around the corner, a new mRNA COVID-19 vaccine, and there's essentially no evidence for it," Ladapo said during the news conference, according to local news outlets.

Once again- VIRUS NEUTRALIZATION IS NOT A PROVEN CORRELATE OF PROTECTION. Back in the day, before 2020, if a vaccine company were so bold as to assert that a mouse virus neutralization assay predicted vaccine protection in humans without having proven that the assay actually predicted whether or not the vaccine would protect humans, they would be sued and blocked from making such false unsupported claims.

The benefit-risk profile of previously authorized and approved mRNA COVID-19 vaccines is well understood as these vaccines have been administered to hundreds of millions of people in the United States.

What we need is a proper explanation for perceived COVID-19 vaccine negative effectiveness, by the vaccine manufacturers or drug regulators.

On COVID-19 vaccine case-counting window biases overstating vaccine effectiveness.

Doshi P, Fung K. How the case counting window affected vaccine efficacy calculations in randomized trials of COVID-19 vaccines.

Kaiser Fung MPhil, MBA, Mark Jones PhD, Peter Doshi PhD. In late 2020, messenger RNA covid-19 vaccines gained emergency authorisation on the back of clinical trials reporting vaccine efficacy of around 95%,1,2 kicking off mass vaccination campaigns around the world.

https://rwmalonemd.substack.com/p/fda-has-gone-rogue?utm_source=post-email-title&publication_id=583200&post_id=136958530&utm_campaign=email-post-title&isFreemail=true&r=1mr4m3&utm_medium=email

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