FDA Analysis Of Moderna COVID-19 Vaccine Finds It Effective And Safe
December 16, 2020
The Food and Drug Administration released a detailed analysis Tuesday morning of the COVID-19 vaccine from drugmaker Moderna that supports the authorization of the company's vaccine for emergency use.
The FDA's briefing document along with one from Moderna were posted two days before a group of experts will convene to advise the agency on whether to grant the vaccine emergency authorization for use, or EUA, during the pandemic.
The agency's analysis finds the vaccine has a "favorable safety profile" and that there are "no specific safety concerns identified that would preclude issuance of an EUA." Serious reactions were rare. Side effects are common, however, with a majority of study volunteers experiencing pain at the site of injection, fatigue and headaches.