Strategies for Surveillance of Adverse Events to Immunization Against COVID-19: Cuban Experience

Abstract

Under the conditions of the health crisis generated by COVID-19, the Cuban surveillance system for events supposedly attributed to vaccination or immunization needed to be adjusted to detect and respond to events generated using new vaccines, and to adverse events of special interest. A strategy was designed to adjust the operation of the surveillance system for adverse events, which entailed a health intervention with the Cuban vaccine candidates, and consisted of: selection process, evaluation and certification of new vaccine sites with special interest in the post-vaccination observation to guarantee adequate supervision of adverse events and events of special interest, by medical personnel trained in management and care, who will have a minimum of emergency medications. The systematic monitoring of surveillance was carried out in parallel to the health intervention with the different vaccine candidates and in population groups, with periodic evaluations and sending of safety reports. Surveillance monitoring demonstrated the flexibility and usefulness of the system. The safety of Cuban vaccines is demonstrated for subsequent health registration. The designed strategy allowed the operation of the ESAVI surveillance system to be adjusted to the conditions of the health crisis generated by COVID-19. Evidence was generated that demonstrates the safety of Cuban vaccines for subsequent health registration.