The Union Ministry of Health and Family Welfare (Immunisation Division) has issued a Standard Operating Procedure for the Ministry of Home Affairs in case of Adverse Events Following Immunisation (AEFI).
Emergencyy Use Authorisation or Accelerated Approval has been granted by the National Regulator for two vaccines (Covishield and Covaxin) which have established safety & immunogenicity against covid 19.
Standard Operating Procedure:
The SOP is meant to help the investigator ensure appropriate handling of the vaccine, victim assistance as well as timely and effective law enforcement.
- In case of an AEFI, the officer must ensure proper handling of the vaccine and diluent as evidence, and make sure the samples are preserved maintaining proper cold chain.
- The police officer must also ensure that the AEFI victims, and any witnesses, are provided assistance and appropriate protection, care and attention.
- The SOP also provides for investigation/interrogation of the vaccinator, if needed.
- This will help in monitoring immunisation safety, correcting unsafe immunisation practices, reducing negative impact of the event on health and contributing to the quality of immunisation.
- Documentation and completed requisition form for transportation of AEFI samples to a laboratory must have same official stamp.
- The seal will ensure the samples and details sent to the lab are not tampered with during transportation.
- While probing serious AEFI, which has resulted in death, the police must “always keep the perspective that the event might be coincidental and/or reaction to the vaccine and it may not be criminal negligence of the vaccinator and/or other workers, for which causality assessment report by an expert is needed”.