There is an established system for reporting of adverse events following immunization (AEFI) applicable for vaccines in universal immunization programme in India. Is there a similar surveillance system for reporting adverse events of COVID-19 vaccines ? Is the VigiFlow system (https://www.who-umc.org/global-pharmacovigilance/vigiflow/about-vigiflow/) recording COVID-19 vaccine adverse events in India ?
Hi! Yes, I've found a lot of information about blood clotting raise after vaccine. some died especially allergic
The prcedures used after the infrastructure come concers about how well adverse events following immunization are being tracked ,reported,recorded and investigated by the the Goverment,experts told Indiaspend.
Rference:www.bloombergquint.com.
They can report to any ADR monitoring centre, those centre are working with IPC in collaboration with AEFI
The system for reporting AEFI for COVID-19 vaccination in India has been described in the Operational Guidelines for COVID-19 Vaccination released in December 2020 (https://www.mohfw.gov.in/pdf/COVID19VaccineOG111Chapter16.pdf). As per the guidelines, the reporting of AEFI has been integrated with the CoWIN platform (linked with SafeVac). Whether this information is further integrated onto the VigiFlow platform or any other international database is unclear from the publicly available information. For a precise answer on Vigiflow for COVID-19 related AEFI, an RTI can be filed with the Ministry of Health and Family Welfare (MoHFW). The guidelines for India's use of VigiFlow are available here - https://www.who-umc.org/media/1075/india.pdf.
The reporting and monitoring of AEFI for COVID relies on the systems put in place for the Universal Immunisation Programme related AEFI for which the Operational Guidelines were released in 2015 (https://nhm.gov.in/New_Updates_2018/NHM_Components/Immunization/Guildelines_for_immunization/AEFI_Surveillance_and_Response_Operational_Guidelines_2015.pdf). This is monitored at the national level through the AEFI Secretariat at the Immunisation Technical Support Unit (ITSU). For more information, see here - https://itsu.org.in/aefi/. This website has a host of resources and guidelines on AEFI related systems and processes.
As per the MoHFW website and the COVID Vaccination Operational Guidelines, beyond the 30 minute observation period immediately following the vaccine, the onus of recognising and reporting AEFI is largely on the recipients themselves. This is clear from the FAQs provided on the website - https://www.mohfw.gov.in/covid_vaccination/vaccination/common-side-effects-aefi.html
In continuation please check SOP of AEFI and IPC, as IPC has 300+ ADR monitoring centre under PvPI programme
- Badges
- Science topic
- Similar topics
- Geoscience
- Asia
- India