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Rapid Rollout of New COVID Boosters With No Human Trials — ‘A Tale of Recklessness’

The 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.

The desired composition of the vaccine had only been formally determined by the FDA after its advisory committee met on June 24.

The vaccines contain a mix of the old, original Wuhan strain vaccine mRNA (now also referred to as the ancestral vaccine) and a new Omicron BA.4/5 mRNA coding for the Omicron spike protein.

The total amount of mRNA for the Pfizer and Moderna booster vaccines is the same as before: 30 mcg for Pfizer and 50 mcg for Moderna.