I have been very closely following the various viewpoints in
the scientific journals and reports coming out in the media
regarding the deaths allegedly reported following
introduction of pentavalent vaccine in the states of Kerala
and Tamil Nadu, since December 2011.
Currently, pentavalent vaccines are
manufactured worldwide by 8 different manufacturers. In
addition, five of these vaccines are prequalified by WHO
[1]. The prequalification happens only after release of the
vaccine by independent international laboratories.
Controversies surrounding the vaccine
from Bhutan, and Sri Lanka, are often cited. The pentavalent
vaccine was suspended in Bhutan on 23 October 2009, after
reports of deaths. However, the investigation by MOH and WHO
concluded that the deaths were coincidental. The vaccine was
reintroduced in the country in June 2011 and is used as of
now without any adverse reports [2]. Similarly, in Sri
Lanka, use was suspended due to reports of a few deaths. The
MOH and WHO found no evidence of a causal relationship. In
fact, similar deaths temporally associated with other
vaccines continued to be reported even after pentavalent
vaccination was temporarily suspended. The vaccine was
reintroduced in February 2010 and continues to be used [3].
Vaccines are normally scheduled early in
life, when infections and other illnesses are common. It is
therefore possible for many Serious Adverse Events Following
Immunization (AEFI), including deaths, to be falsely
attributed to vaccine through chance association.
The decision to continue inclusion of Hib
vaccines in Universal Immunization Programme as liquid
Pentavalent vaccine in Kerala and Tamil Nadu and later in
six additional states was taken during the 8
th
meeting of the Mission steering Group of the National Rural
Health Mission (NRHM) chaired by the Union Health Minister
of Health and Family Welfare. This meeting was attended by
Principal Secretaries (Health) of various states, Public
Health Professionals, Physicians, Surgeons and senior
officials from various Ministries including Ministers of
HRD, Rural Development and Women and Child Development. [4]
The Indian Academy of Pediatrics
Committee on Immunization (IAPCoI) under my chairmanship
first recommended the use of DTPw-HB-Hib pentavalent vaccine
for its members in the year 2001 and requested the
Government of India (GoI) to include the same in the
National Immunization Program. Since then, several thousand
Pediatricians and other practitioners all over the country
have been using this combination vaccine manufactured by
Glaxo Smithkline, Sanofi Aventis and now by indigenous
vaccine manufacturers.
The GoI AEFI investigation committee and
the Kerala & TN AEFI investigation committees have ruled out
any causal relationship of pentavalent vaccine
administration with the deaths reported, establishing causes
like other co-morbid conditions in the vaccinees.
The vaccine has been demonstrated to be
efficacious and effective in numerous studies and is widely
supported by global and Indian health communities.
We should welcome this positive step
taken by the Ministry of Health by including the pentavalent
vaccine in the Universal Immunization Programme (UIP) in
India. Based on the available data, I reiterate that the
pentavalent combination vaccines (DTPw-HB-Hib) are very safe
and there should not be cause for concern. Moreover, each
batch of these vaccines is released by the National Control
Laboratory, CDL, Kasauli (H.P.) before it comes to market.
As of October 2012 data, 114 countries in
the world have introduced pentavalent vaccine in their
national immunization programs [5].
References
1. WHO prequalified vaccines. Available
from:
URL:http://www.who.int/immunization_standards/vaccine_quality/PQ_vaccine_list_en/en/
Accessed on 21 January, 2013.
2. Pentavalent Vaccine to be reintroduced
in June. Bhutan Observer. Available from:
http://www.bhutanobserver.bt/pentavalent-vaccine-to-be-re-introduced-in-june.
Accessed on 21 January, 2013.
3. GACVS statement on Pentavalent vaccine
use in Asia. Available from: URL:
http://www.who.int/vaccine_safety/pentavalent3.pdf. Accessed
on 10 September 2013.
4. Press Information Bureau. Govt. of
India, Ministry of Health and family Welfare. 17-April,
2012.
5. WHO vaccine-preventable diseases: monitoring system
2012 global summary Available from: URL:
http://apps.who.int/immunization_monitoring/en/globalsummary/ScheduleResult.cfm.
Accessed on 21 January, 2013.