The U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) cooperated to issue Emergency Use Authorizations (EUA) and roll out new, bivalent Pfizer and Moderna COVID-19 vaccines this week, without any human trials, which is unprecedented.
There is international coordination regarding bivalent boosters, and a major effort will be undertaken to get them into arms, despite historically low levels of severe COVID-19. Why?
These vaccines continue to enjoy extraordinary protection from liability, while the recipient has no access to the legal system in the case of injury.
There is no evidence the new vaccines are safe, while there is limited evidence that they may be more harmful than earlier COVID-19 vaccines. However, in the absence of human testing, there is no way to truly predict their safety. Safety data are being concealed by federal health agencies. Messaging by them is misleading.
There is no evidence the new bivalent vaccines will be more effective than the older vaccines, and existing evidence suggests that any efficacy they provide will persist no longer than one to several months.