LETTER TO EDITOR
Year : 2017 | Volume
: 61 | Issue : 2 | Page : 146--147
Adverse events following immunization: A challenge in India
Anju R Marak1, Dhriti Kumar Brahma2, Joonmoni Lahon3,
1 Senior Medical and Health Office and In-Charge of Maternal and Child Health, Senior Medical & Health Officer, Ri-Bhoi District, Nongpoh, Meghalaya, India
2 Associate Professor, Department of Pharmacology, Northeastern Indira Gandhi Regional Institute of Health and Medical Sciences, Shillong, Meghalaya, India
3 Senior Resident Doctor, Department of Pharmacology, Northeastern Indira Gandhi Regional Institute of Health and Medical Sciences, Shillong, Meghalaya, India
Dhriti Kumar Brahma
Department of Pharmacology, Northeastern Indira Gandhi Regional Institute of Health and Medical Sciences, Shillong, Meghalaya
|How to cite this article:|
Marak AR, Brahma DK, Lahon J. Adverse events following immunization: A challenge in India.Indian J Public Health 2017;61:146-147
|How to cite this URL:|
Marak AR, Brahma DK, Lahon J. Adverse events following immunization: A challenge in India. Indian J Public Health [serial online] 2017 [cited 2022 Oct 4 ];61:146-147
Available from: https://www.ijph.in/text.asp?2017/61/2/146/207404
This is in reference to the article entitled, “Challenges in New Vaccine Introduction in a National Program in India” published in the “India Journal of Public Health, November 10, 2016, IP: 184.108.40.206.” The author has rightly pointed out multiple challenges involving administrative, logistic, and operational issues when introducing a new vaccine into the public health system. We are of the opinion that challenges also do exist even after the introduction of a vaccine in public health system. As vaccines are given prophylactically to healthy individuals, often young children and successfully controlled vaccine-preventable infectious diseases so far, the expectations of general public to the vaccine safety are usually very high in spite of the reality that modern vaccines have become increasingly more effective, safe, and of high quality. Adverse events following immunization (AEFI) reporting is one of the tools of monitoring vaccine safety.
The WHO has defined AEFI as any untoward medical occurrence which follows immunization and which does not necessarily have a causal relationship with the usage of the vaccine. The adverse event may be any unfavorable or unintended sign, abnormal laboratory finding, symptom, or disease. AEFI may range from mild side effects to life-threatening events, may be caused by the vaccine itself, or may be immunization error related, anxiety-related, and coincidental.
Vaccine pharmacovigilance is an important tool for continuous monitoring of the safety of marketed vaccines and detection of vaccine safety signals. One must understand that premarketing vaccine trials are controlled trials conducted in a limited number of populations for a limited time and usually cannot detect rare reactions or delayed onset types of reactions. Reporting of AEFI, especially in the 1st year or so following introduction of a new vaccine, and other vaccine-related or immunization-related issues by health-care professionals is considered to be a moral responsibility.
The majority of 2.7 crore children eligible for vaccination in our country under Universal Immunization Programme (UIP) receives immunization through public health facilities. Approximately 10%–20% of total immunization is provided through private sector and by pediatricians. Moreover, the vaccines which are not part of the UIP are provided only by the private sectors.
As per the National AEFI Surveillance and Response Operational Guidelines, 2010, nonserious AEFI should be reported “routinely” on a monthly basis and the serious AEFI should be reported immediately by auxiliary nurse midwife up to the national level (coordinated by the district) through monthly progress reports using existing immunization monthly progress reports/forms and also to be included in the monthly reports. However, it is a fact that the reporting from private sector is very limited till today. The scenario has not improved in spite of the concerns raised by the Indian Academy of Pediatrics over the paucity AEFI reporting and publishing a position paper in 2013.
Increased reporting helps in generating more data on AEFI in our country to identify new safety concerns, if any, for making an immunization program successful by preserving public confidence in immunization.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
|1||Sur D. Challenges in new vaccine introduction in a national program in India. Indian J Public Health 2016;60:171-5.|
|2||WHO. Causality Assessment of an Adverse Event Following Immunization (AEFI): User Manual for the Revised WHO Classification. Geneva: World Health Organization; 2013. Available from: http://www.who.int/vaccine_safety/publications/aevi_manual.pdf. [Last accessed on 2016 Mar 27].|
|3||World Health Organization. Surveillance of Adverse Events Following Immunization: Field Guide for Managers of Immunization Programmes. Geneva: World Health Organization; 1997. Available from: http://www.measlesrubellainitiative.org/wp-content/uploads/2013/06/Surveillance-for-AEFI-Field-Guide.pdf. [Last accessed on 2016 Mar 25].|
|4||World Health Organization. Surveillance of Adverse Events Following Immunization: Field Guide for Managers of Immunization Programmes. Geneva: World Health Organization; 1997.|
|5||Government of India. Multi Year Strategic Plan (MYP) for UIP of India 2005-10. New Delhi: Ministry of Health and Family Welfare, Government of India; 2010.|