After the administration of 13.8 million doses of Pfizer-BioNTech and Moderna COVID-19 vaccines to the U.S. population during the first month of the vaccination program, the post-authorization safety profiles for both vaccines are reassuring. Most (90.9%) VAERS reports were more non-serious events and involved local and systemic symptoms; transient local and systemic reactions were also frequently reported in v-safe. The occurrence of anaphylaxis after receipt of COVID-19 vaccines during the analytic period, 4.5 cases per million doses administered, is within the range reported after receipt of inactivated influenza vaccine (1.4 per million), pneumococcal polysaccharide vaccine (2.5 per million), and live attenuated herpes zoster vaccine (9.6 per million).

Mass vaccination with highly effective vaccines is critical to controlling the COVID-19 pandemic. Because of the speed of COVID-19 vaccine development and deployment, there have been concerns among the public about the safety of these new vaccines. In response to these concerns, the U.S. government has implemented the most comprehensive vaccine safety monitoring program in its history. No unexpected patterns of reactions or other safety concerns have been identified during early monitoring. CDC and FDA will continue to monitor the safety of COVID-19 vaccines to inform vaccination policy and to maintain public confidence.

Stay the course, stay well, mask up, get vaccinated and stay tuned!