Context:
- The Union Health Ministry is to study a reported rise in “adverse events” following vaccinations in 2017 as compared to the two previous years.
- Between April and December last year, reports from across States recorded that 1,139 children had died following immunisation. By comparison, there were 176 and 111 such deaths during the same period in 2016 and 2015. The statistics have been compiled by a Health Ministry database.
- Sources, however, stressed that along with children who may have died due to adverse reaction to a vaccine or improper administration or due to inherent defects in the vaccine itself, the numbers include children who were already seriously ill or had congenital diseases but had died during a specified period after vaccination.
- A Health Ministry official told that the 2017 numbers — termed deaths due to Adverse Events Following Immunisation (AEFI) — appeared “marginally higher” than the previous years, but the process of investigation was still on.
- India’s Universal Immunisation Programme has vaccines for 12 diseases. Vaccination coverage is about 65%, and the government aims to ensure 90% coverage by the end of the year.
Adverse events following immunization (AEFI)
As vaccine-preventable infectious diseases continue to decline, people have become increasingly concerned about the risks associated with vaccines. Furthermore, technological advances and continuously increased knowledge about vaccines have led to investigations focused on the safety of existing vaccines which have sometimes created a climate of concern.
Adverse event following immunization is any untoward medical occurrence which follows immunization and which does not necessarily have a causal relationship with the usage of the vaccine. If not rapidly and effectively dealt with, can undermine confidence in a vaccine and ultimately have dramatic consequences for immunization coverage and disease incidence.
Alternatively, vaccine-associated adverse events may affect healthy individuals and should be promptly identified to allow additional research and appropriate action to take place. In order to respond promptly, efficiently, and with scientific rigour to vaccine safety issues, WHO has established a Global Advisory Committee on Vaccine Safety.
Key points
- There is no such thing as a “perfect” vaccine which protects everyone who receives it AND is entirely safe for everyone.
- Effective vaccines (i.e. vaccines inducing protective immunity) may produce some undesirable side effects which are mostly mild and clear up quickly.
- The majority of events thought to be related to the administration of a vaccine are actually not due to the vaccine itself – many are simply coincidental events, others (particularly in developing countries) are due to human, or programme, error.
- It is not possible to predict every individual who might have a mild or serious reaction to a vaccine, although there are a few contraindications to some vaccines. By following contraindications the risk of serious adverse effects can be minimized.
An AEFI will be considered serious, if it:
- results in death,
- is life-threatening,
- requires in-patient hospitalization or prolongation of existing hospitalization,
- results in persistent or significant disability/incapacity,
- is a congenital anomaly/birth defect, or
- requires intervention to prevent permanent impairment or damage.