COVID 19 activities related to vaccine safety
In pre COVID-19 phase, the focus has been in strengthening AEFI surveillance for routine immunization. Since October 2020, the AEFI Secretariat worked on ensuring that AEFI surveillance was modified to capture AEFIs reported following use of novel vaccines in adults. Steps taken to strengthen AEFI reporting mechanism in the country are:
- Enabling Integration of CoWIN and SAFEVAC software to provide online platform for vaccinators/health worker and DIO to report AEFIs (including minor AEFI cases) occurring following COVID-19 vaccinations.
- Necessary guidance issued to states/UTs to strengthen AEFI surveillance for COVID-19 vaccinations such as inclusion of medical specialists, neurologists, cardiologists, obstetrician-gynaecologists, etc. in state and district AEFI committees, collaborating with state medical colleges to function as state AEFI technical collaborating centre, cascade trainings of health work force (including state and DIOs and medical officers) on AEFI surveillance, hiring of state AEFI consultants, expansion of reporting network to include private health care facilities and large hospitals for sensitizing and reporting AEFIs, etc. Guidance issued to states/UT for death investigations – conduct of post mortems by multidisciplinary panel in medical colleges/district hospitals, videography of post mortem, RTPCR test etc.
- Rapid review of reported serious/severe AEFI cases was done to understand trends/possible safety issues following use of COVID-19 vaccines. Advisory issued for Thrombosis with Thrombocytopenia Syndrome (TTS) was shared with states. Read more
- Timelines for submission of reporting, investigation, causality assessment forms were reduced to enable quick assessment of causality by trained medical experts. Causality assessments of serious/severe AEFI cases are expedited through frequent meetings of national AEFI committee and causality assessment sub-committees. Approved causality assessment results of 1099 cases are uploaded on MoHFW website for general public. Read more
- Signals are previously unknown reported adverse events suspected to be caused due to a particular vaccine requiring in-depth assessment to see if these could actually be causally due to the vaccine. Framework for systematic processes to identify, assess and manage such signals is being developed and will be implemented soon. This will be a collaborative effort with support of Central Drugs Standards Control Organization (CDSCO) and Pharmacovigilance Programme of India (PvPI) which has the expertise of implementing the same for drugs.
- Active vaccine safety surveillance system in the form of sentinel surveillance for Adverse Events of Special Interest following COVID-19 vaccination is being implemented to complement the passive AEFI surveillance system. A network of 18 sentinel sites in medical colleges across India is being used to collect information on select events. ITSU is supporting other partners and research organizations to conduct active AEFI surveillance studies related to COVID-19 vaccinations such as Cohort Event Monitoring/sentinel surveillance studies.
- Sharing of information with national drug regulators and international organizations such as WHO and Global Advisory Committee on Vaccine Safety (GACVS), etc.
- Supporting MoHFW to respond to media queries, parliamentary questions, legal notices, etc.