FDA issues first COVID-19 vaccine emergency use authorizations
On December 11, 2020, FDA issued an EUA for the Pfizer-BioNTech vaccine (ages 16+), the first COVID-19 vaccine authorized in the U.S.; on December 18 it issued an EUA for the Moderna vaccine (ages 18+). FDA reported 95% efficacy for Pfizer and 94.1% for Moderna in their pivotal trials, following public advisory committee review. FDA stated in both releases that data were not yet available on duration of protection or on whether the vaccines prevent person-to-person transmission.
Primary quotes
“At this time, data are not available to make a determination about how long the vaccine will provide protection, nor is there evidence that the vaccine prevents transmission of SARS-CoV-2 from person to person.”
FDA, Pfizer EUA announcement
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- •Moderna EUA press release cited via Wayback; original fda.gov URL now 404s
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Related contentions
Partially resolved procedurally, unresolved substantively. Courts settled who held legal authority (OSHA stayed, CMS upheld) and Congress ended the military mandate, but no court or official body has adjudicated the underlying disputes over natural-immunity exemptions, transmission benefit post-Delta, or whether the uptake gains justified the coercive costs — interpretation of those trade-offs remains contested.