SOP for immunisation emergencies issued by The Union Ministry of Health and Family Welfare

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).

Background:

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”.

Leave a Reply