Madhava Setty

The U.S. Food and Drug Administration appears set to circumvent its own regulatory process in order to authorize Pfizer’s new bivalent COVID-19 vaccine that targets the Omicron BA.4 and BA.5 subvariants — without requiring clinical trials on humans.

… Yes, it’s an unprecedented move by the FDA, but Dr. Ofer Levy, professor of pediatrics at Harvard and advisor to the FDA argues that the country has had enough experience with the vaccines at this point to be con dent the shots are safe and that there’s not enough time to wait for data from human studies.

… Can we dispense with the pretense any of this is about health?

… No sane person vaccinates the entire country with an experimental vaccine without trials …