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What was the average follow up time for people who enrolled in the main clinical trial used by the FDA to approve Pfizer's Covid-19 vaccine?

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In approving Pfizer's Covid-19 vaccine, the FDA mainly relied on a large randomized controlled trial (RCT) that enrolled more than 40,000 subjects for an average of 3.3 months after their second dose. Pfizer removed all subjects from the RCT by 6 months in defiance of a global association of 24 healthcare regulatory agencies (including the FDA) which recommended that the RCT have "a follow-up of at least one year or more from completion of assigned doses." The purpose of this guidance was to measure "longer-term safety," "potential risks of vaccine-induced enhanced disease," and "whether protection against Covid-19 disease wanes over time." Buried 23 pages into its approval summary for the vaccine, the FDA revealed that deaths were more common among subjects who received the vaccine than those who did not.

DocumentationPfizer RCTRegulatory GuidanceWaning Vaccine Efficacy




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