Skip to main content

Is the FDA “doubling down” on a failed strategy?

 The FDA convened its Vaccines and Related Biological Products Advisory Committee (VRBPAC) to discuss the future of covid vaccines. The panel voted 21 to 0 in favor of moving towards a more simplified vaccine schedule - an annual shot which would be updated as new variants emerge - much like the annual flu shot

Still no correlate of protection

  • Three years into the pandemic, the FDA has still not established a "correlate of protection" for the vaccines
  • The idea is, the more antibodies produced, the better you are protected
  • But neutralizing antibodies do not predict the degree to which someone is protected from infection... and the FDA knows it
  • We are at risk of doubling down on a failed strategy
  • Ofer Levy, VRBPAC member and Professor of Pediatrics at Boston Children's Hospital, voiced his concern that we may be using poor man's immune correlates of protection here
  • Peter Marks, FDA's top vaccine official, agreed that there is not a clear, perfect immune correlate
  • Fast forward to this latest meeting, and it becomes clear that we're all still in the dark
  • Doctors are refusing to give any more COVID shots until there are better studies

No Update on Subclinical Myocarditis

  • Pfizer is obligated to conduct a study involving people aged 16 to 30 to look at rates of subclinical myocarditis (i.e. underlying damage to the heart muscle without causing symptoms).
  • The final report was due 31 December 2022, but that deadline lapsed, and the FDA said nothing.
  • Jessica Adams, an expert in drug regulatory affairs, pointed out that the FDA had quietly changed the due date for the study to 30 June 2023.

FDA still working from home

  • Since all federal employees have been mandated to take the COVID-19 vaccine to "protect themselves and those around them," why aren't they conducting face-to-face meetings?
  • "FDA leaders are in a bubble. How much longer will the FDA (18,000-employees) continue to work remotely?" asked Marty Makary, surgeon and public policy researcher at Johns Hopkins University.

https://rwmalonemd.substack.com/p/is-the-fda-doubling-down-on-a-failed?utm_source=post-email-title&publication_id=583200&post_id=100007151&isFreemail=true&utm_medium=email

Comments

Post a Comment

Popular posts from this blog

Fauci Files Reveal Pfizer Helped Biden Rig 2020 Election

 Pfizer secretly colluded with Joe Biden's team to help him rig the 2020 election against Trump, according to new Fauci documents. In his new book, "On Call," Fauci admits that Albert Bourla, the CEO of Pfizer, called him the night after Biden was declared the winner of the election, to inform him of Pfizer's "Game-changing results" from the rigged mRNA trial. "On November 7, after the absentee ballots were counted, Joe Biden was declared the winner of the presidential election. It was the very next night that Albert Bourla, Pfizer's CEO, called me away from my neighbors' fire pit to inform me about the game-changing results from the Pfizer mRNA vaccine trial. I finally thought we had truly turned a corner in defeating this terrible disease." Today reports: In another interesting tidbit, Fauci discusses Trump's FDA Commissioner Stephen Hahn declaring that he would not go along with the Trump Administration's plan to roll out the vac...
Post a Comment
Read more

Republicans Withdraw $1 Billion From BlackRock Due To Its ESG Policies

  Multiple U.S. states governed by Republicans are withdrawing state funds from BlackRock's management, as they disapprove of the ESG investment policies of the world's top asset manager, the Financial Times reports. In recent weeks, Louisiana, South Carolina, Utah, and Arkansas have announced they would divest funds from... For months now, Republican states have said they would not do business anymore with asset managers who have ESG-aligned investment policies, which, the states say, show that those financial firms are boycotting the oil and gas industry. Texas is leading the campaign against this movement The Lone Star State published a list of financial firms that could be banned from doing business with Texas, its state pension funds, and local governments. https://oilprice.com/Latest-Energy-News/World-News/Republicans-Withdraw-1-Billion-From-BlackRock-Due-To-Its-ESG-Policies.html
Post a Comment
Read more

EU Ambassador & Munich Security Conference Chair Headline Chinese Communist Party Influence Event.

  The Vice Chairman of the Munich Security Conference and a former Ambassador of the European Union to the U.S. headlined an event sponsored by a leading Chinese Communist Party influence group The China-United States Exchange Foundation (CUSEF) CUSEF has been identified by the US government as part of China’s “United Front” which works “to co-opt and neutralize sources of potential opposition to the policies and authority of its ruling Communist Party.” O’Sullivan Director General of the Institute of International and European Affairs Has held a variety of influential positions within the European Union including Chief Operating Officer of the European External Action Service (EEAS) Ruge also has ties to the EU’s military infrastructure Vice Chairman of the Munich Security Conference https://thenationalpulse.com/2022/10/20/eu-amb-and-munich-chair-headline-cusef-webinar/
Post a Comment
Read more