As the Covid-19 vaccines were being rolled out across the globe, IMSN members were all concerned about the safety issues relating to the operation and the process of vaccination including transport, storage, preparation, administration, and patient monitoring. In February 2021, the IMSN Executive Committee formed the IMSN Covid-19 Vaccine Safety Interest Group, an international interest group to address these potential issues and stimulate global implementation of safer Covid-19 immunization practices.
The two primary objectives of the IMSN Covid-19 Vaccine Safety Interest Group were:
- To address Covid-19 vaccine safety issues by sharing the experience and learning from member countries on issues being encountered during the vaccine rollout.
- To make appropriate recommendations for global implementation of safe Covid-19 immunization practices.
In a series of CVSIG meetings in mid-2021, as vaccination campaigns rolled out, IMSN members shared firsthand experience with a variety of risks, near-misses, errors, and adverse events following immunization with COVID-19 vaccines on the basis of aggregated analysis by CVSIG members. These included issues with:
- screening (e.g., wrong age, patients with contraindicated conditions),
- storage (e.g., inappropriate storage temperature, confusion and mis-selection resulting from storage near other vaccines or monoclonal antibodies),
- preparation (e.g., serial errors for vaccines needing a two-step reconstitution process, diluent errors including incorrect diluent volume or no dilution, dosing errors including wrong dose, no dose, expired dose),
- administration (e.g., shoulder injury related to vaccine administration, wrong time interval for second dose or third dose, syringe and/or needle malfunction or misuse leading to underdose, wrong vaccine, wrong drug, wrong route of administration, accidental exposure),
- and monitoring (e.g., missed second or third doses).
IMSN members also provided a pharmacovigilance overview of adverse events following immunization reported with COVID-19 vaccines. In addition, the approach to errors has evolved over the course of COVID-19 vaccination campaigns (for example, intervals between doses, authorized ages, authorized doses, and recommended vaccines).
IMSN CVSIG Recommendations for Global Implementation
of Safe COVID-19 Immunization Practices - January 2022
These safety recommendations were developed based on the collective experience and learning from IMSN member countries and should be considered for implementation in global COVID-19 immunization efforts. For a complete copy of the IMSN CVSIG Recommendations for Global Implementation of Safe COVID-19 Immunization Practices, click here.
Updated February 16, 2022