After 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 for non-serious events and involved local and systemic symptoms; transient local and systemic reactions were also frequently reported in v-safe. Reports of anaphylaxis have been observed after administration of both vaccines. 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. Cases of anaphylaxis after receipt of both authorized vaccines have been observed, though rarely; anaphylaxis rates are comparable with those reported after receipt of other vaccines. No unexpected patterns of reactions or other safety concerns have been identified during early monitoring. CDC and FFDA will continue to monitor the safety of COVID-19 vaccines to inform vaccination policy and to maintain public confidence.
Stay the course, stay well, wear a mask, get vaccinated, and stay tuned!