Vaccine Safety Surveillance for Covid-19 Vaccinations

Vaccines are administered to healthy individuals to protect against vaccine preventable diseases. Vaccines are licensed for public use after they undergo rigorous regulatory process involving pre-clinical assessment and clinical trials not only to establish immunogenicity and effectiveness but also the safety of the vaccine. However, no vaccine is entirely without risk, and adverse events may occasionally occur following vaccination. India already had an established system of vaccine safety surveillance for both UIP and non-UIP vaccines. Regular Adverse Events Following Immunization (AEFI) Surveillance Programme structures and guidelines were suitably modified and strengthened to mount AEFI Surveillance for Covid-19 vaccination drive. The advisories regarding the modifications and implementation of the revised guidelines were issued to the states. Simultaneously, large-scale capacity building efforts were undertaken to train the health managers and health care workers to recognize, manage, report and investigate the AEFIs. An entire module was created within the existing SAFE-VAC (electronic reporting system for serious and severe AEFIs) to capture minor AEFIs and enabling the reporting by vaccinators directly into Co-Win. For transparency and public trust in the Covid-19 vaccines, media was briefed on daily basis on occurrence of AEFIs and press releases were given time to time about such happenings. Causality assessments of AEFIs were expedited and reports put up on website of MoHFW. Special emphasis was given to pregnant women being administered Covid-19 vaccines. No substantial risk of the vaccines could be established in pregnant women. Under the Covid-19 vaccination program, signal review system was strengthened to pick up any safety signal concerning Covid-19 vaccination. In addition to the existing passive AEFI Surveillance Programme, a separate study to monitor Adverse Events of Special Interest (AESI) following Covid-19 vaccines was initiated to carry out active surveillance through sentinel sites.