Rapid Rollout of New COVID Boosters With No Human Trials

The fastest rollout of a new vaccine in world history occurred the only way it could possibly occur — by bending the rules, creating a new regulatory playbook and failing to obtain any human data for the new vaccines.  

he FDA on Aug. 31 issued EUA for new Pfizer and Moderna mRNA booster vaccines for COVID-19.

One day later, the CDC and its director, Dr. Rochelle Walensky, approved the immediate rollout of the new vaccines, which will be administered in the U.S. beginning this week.

Surprisingly, more than a month before either agency had given its okay to the entirely new formulation, the federal government ordered 105 million doses from Pfizer and 66 million doses from Moderna.