No Covid Safety Data? No Problem!
US, UK, Canada, Australia, Switzerland and Singapore Will Let New-Variant Vaccines Onto the Market Without Safety or Efficacy Testing
By Rosemary Frei, MSc
March 9, 2021
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delay” and “bears the risk that the virus is evolving even further, potentially making a new vaccine version outdated at the time of approval again.”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………………