Focus on management of adverse events in COVID-19 vaccination

 

New Delhi: The operation guidelines prepared by the Central Government for the COVID-19 vaccination programme currently underway, provides a detailed roadmap to ensure a robust surveillance system to monitor adverse events post-immunization and better understand the safety profile of the vaccines.

 

The recommended measures take into account the need to rapidly detect and promptly respond to adverse reactions since otherwise, it can undermine confidence in the vaccine and immunization programme as a whole. Programme managers have been advised to be extra careful since the process involved vaccination of a large population within a short period.

 

It was emphasised that immunization errors that might lead to adverse events must be prevented at all costs through regular and intensive monitoring and supervision, and strict adherence to proper vaccine / diluent handling procedures and injection practices. It was stressed that all deaths and hospitalizations should be reported and investigated immediately.

 

An adverse event following immunization is defined as any untoward medical occurrence which follows vaccination including those that do not necessarily have a causal relationship with the usage of the vaccine. It may be any unfavourable or unintended disease, symptom, sign or abnormal laboratory finding. The reported events can either be true adverse events as a result of the vaccine or immunization process, or coincidental events that are not due to the vaccine or immunization process but are temporally associated with immunization.

 

The guideline particularly highlighted the possibilities of errors in the handling of the vaccines. It urges that special attention be given to ensure that the vaccines/diluents are stored separately and that there should be screening for contraindications of the vaccine.

 

All fixed session sites should have emergency kits to handle adverse events, with the vaccinators properly trained to suspect signs and symptoms and take immediate remedial measures. In the case of outreach session sites, they should be linked to an identified adverse event management centre to provide immediate treatment for serious cases. Adequate transportation should be available to transfer serious cases to the nearest identified adverse event management centre or health facility. The vaccinators at the session sites must be aware of all relevant contact numbers like ambulance services.

 

It also urged that States and UTs should identify at least one adverse event management centre in each block. Further, it was specified that State and district authorities should proactively reach out to all health care service providers such as medical colleges, hospitals (public, autonomous and private) and individual practitioners and sensitize them to report any adverse event.