ACCESS Consortium (Vaccine Approval) -- No Safety Data? No Problem!

[Giraffe]

No Safety Data? No Problem!

On March 4 and 5, Canada, the UK, Australia, Switzerland and Singapore released identical guidelines for fast-tracking release onto the market of vaccines for the new variants. The countries issued the recommendations under the banner of the ‘ACCESS Consortium.’ ACCESS is an acronym based on the first letters of the five countries’ names.

A few days earlier, on February 22, the US Food and Drug Administration (FDA) released a similar set of recommendations. They allow Emergency Use Authorizations (EUAs) for “investigational” vaccines for new variants, letting them be used on the general public without first showing evidence of safety or effectiveness.

The recommendations all state that companies don’t need to conduct new clinical trials before putting the new-variant vaccines onto the market and potentially into millions of people’s arms. Requiring new trials, the ACCESS document asserts, would cause “considerable delay” and “bears the risk that the virus is evolving even further, potentially making a new vaccine version outdated at the time of approval again.”

Instead, the safety record of the currently used Covid vaccines can be used to judge the safety of the new ones, the countries’ regulatory agencies declare.

 

[tankasnowgod]

No Safety Data? No Problem!

Well, with no trials whatsoever, drug companies wouldn't have to bother with conducting fraud during said trials, and then having their regulatory agency cronies cover up said fraud, so oddly, it would be a more honest system.

Would it really change who in the "general public" would take these vaccines?

 

[tankasnowgod]

One other thought......

The article said that "producing antibodies" would be a good enough surrogate to show that any variant vaccines work.

Don't germs that cause disease cause antibodies to be produced in the first place?

Am I reading this wrong, or is this sheer clown world insanity? Wouldn't this be the same as saying bleeding is enough evidence to prove protection from being cut by a knife?

 

[Tim Lundeen]

The problem with antibodies is that effective protection from COVID requires activated T cell immunity. People who don't develop this end up very sick or dead, despite developing very high levels of antibodies.

Adaptive immunity to SARS-CoV-2 and COVID-19 - PubMed

The adaptive immune system is important for control of most viral infections. The three fundamental components of the adaptive immune system are B cells (the source of antibodies), CD4⁺ T cells, and CD8⁺ T cells. The armamentarium of B cells, CD4⁺ T cells, and CD8 …

pubmed.ncbi.nlm.nih.gov