Focus on management of adverse events in COVID-19 vaccination
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 immunizationand 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 / diluenthandling procedures and injection practices.
It was stressed that all deaths and hospitalizationsshould be reported and
investigated immediately.
An adverse event
following immunization is defined as any untoward medical occurrence which
followsvaccination 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 laboratoryfinding. The reported
events can either be true adverse eventsas a result of the vaccine
orimmunization process, or coincidental events that are not due to the vaccine
or immunization process butare 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 suspectsigns 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 provideimmediate treatment for
serious cases.Adequate transportation should be available to transfer serious cases
tothe nearest identified adverse event management centre or health facility.
The vaccinators at the session sites mustbe 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 careservice providers such as medical colleges, hospitals (public, autonomous and private) and individualpractitioners and sensitize them to report any adverse event.
INA NEWS(Initiate News Agency)