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.
The agency’s analysis also affirms the effectiveness of the vaccine. It is 94% overall, assessed at least two weeks after the second dose of vaccine, in the final analysis. An interim analysis put it at 95%. The vaccine shots are given 28 days apart.
The vaccine is less effective in older people, the FDA analysis finds. For people ages 18 to less than 65, the effectiveness is 96%, compared with 86% for people 65 and older.
Pfizer’s website claims their vaccine:
“Efficacy was consistent across age, gender, race and ethnicity demographics; observed efficacy in adults over 65 years of age was over 94%”