Tuesday, March 9, 2021

No Safety Data? No Problem!


vaccines safety pharmaceuticals business accountability haste pandemic

On March 4 and 5, Canada, the UK, Australia, Switzerland and Singapore released identical guidelines for fast-tracking release 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 direct 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delay” and “bears the risk that the virus is evolving even further, potentially making a new vaccine version outdated at the time of approval again.”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.

And they claim that the currently used vaccines are safe and effective: “[T]here is considerable safety experience accumulating as the pandemic progresses and vaccines are rolled out, and [in any case] efficacy has been established for the initial vaccine candidate [i.e., the original Covid vaccines] via large clinical Phase 3 studies,” the ACCESS document states, for example.

This is despite the fact that many observers have documented significant safety problems associated with the Covid vaccines, including high death rates.  (more...)

No Safety Data? No Problem!

Mar 9 afternoon - No_Safety_Data_No_Problem from Rosemary Frei on Vimeo.

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