Wednesday, April 25, 2012

Why the Pentavalent Vaccine Should Not Be Allowed.


Introducing pentavalent vaccine in EPI in India: issues involved
- Discussion in Indian Journal for Medical Research

The correspondents say we have made this allegation a 'second time' in Indian Pediatrics (IP) (3). Actually the 'allegation in Indian Pediatrics (IP)' was sent first, soon after the NTAGI report was published in November 2009, well before the December 14, 2009 meeting with the Health Secretary. Pertinently, NTAGI authors did not respond to that letter, in spite of repeated reminders from the Editor. In the end, our letter was published in IP in June 2010 without a NTAGI response. The authors (JJ & JM) say they have refuted our IP letter in writing and in spite of that, we have made the allegation a 'third time' in this editorialpublished in the IJMR in July 2010. We must point out respectfully that the reference they give of 'refuting in writing' (Reference 11 in their letter) is an article that has not been published (even as we write this reply in August 2010). Perhaps it was written after our IP letter appeared on June 17, 2010 (3). Admittedly we do not have any powers of clairvoyance. We could have known in December 2009 (when we were asked to write the Editorial) what the authors will write 6 months later in June 2010. It seems evident that all this mock indignation is aimed at altering this record of events retrospectively, to shore up the reputation of the NTAGI.

2. We concluded the editorial asking for caution based on 3 reasons:
(i) Proven low incidence of invasive disease (in Asia).
(ii) Absence of benefit from Hib vaccination demonstrated in probe studies and probe-like studies from Asia.
(iii) Evidence of strain replacement in the West.
Each of the three conditions above would independently be sufficient and compelling reason not to introduce this vaccine.

3. We quoted evidence of low incidence of invasive Hib disease in Asia. The incidence was considered to be low even in the 1990s. We presented pre-vaccination data available in publications prior to 1998, from Apache Reservation, of invasive disease of 500-1000 per 100,000 children under-2 and contrasted this with Asian data of invasive disease of 3 to 9 per 100,000. The methodology used to arrive at these figures is not very clear and so we also provided references of systematic studies done in India from 2000 to 2010 to prove our point. The correspondents use the figures of 'pneumonia from any cause' and 'meningitis from any cause' from the Vellore limb of the ICMR multicenter study and add-on assumptions about what percentage of these pneumonia and meningitis are 'Hib related' and arrive at a figure that matches that of the Appache Reservation. As the assumptions are made by the correspondents, and these were not stated in the Editorial, we will not expend the space allotted for the defense of our editorial to argue those assumptions here.

To get back to Primo Levi: Hib vaccine does not reduce the torment of disease and Pentavalent vaccine is associated with 'sudden deaths': Not writing 'a counsel for caution', would be siding with the tormentor.

Zubair Lone & Jacob Puliyel *
St Stephens Hospital
Delhi 110 054, India
* For correspondence: puliyel@gmail.com
References
(1.) Lone Z, Puliyel JP. Introducing pentavalent vaccine in the EPI in India: A counsel for caution. Indian J Med Res 2010; 132 : 1-3.
(2.) Subcommittee on introduction of Hib vaccine in the universal immunization programme, National Technical Advisory Group on Immunization, India, Kant L. NTAGI Subcommittee Recommendations on Haemophilus influenzae Type b (Hib) Vaccine Introduction in India. Indian Pediatr 2009; 46 : 945-54.
(3.) Dutta P, Puliyel JM. NTAGI recommendations overlooked crucial ICMR data. Indian Pediatr 2010; 47 : 542-3.
(4.) Puliyel JM, Mathew JL, Priya R. Incomplete reporting of research in press releases: Et tu, WHO? Indian J Med Res 2010; 131 : 588-9.
(5.) Puliyel J. GAVI and WHO; Demanding accountability. BMJ 2010; 10.1136/bmj.c4081.
(6.) http://www.bmj.com/cgi/eletters/340/apr20_2/c2004 accepted for the print version). Saxena KB, Banerji D, Qadeer I, Kurian NJ, Priya R, Shiva M, et al. Antivaccine Lobby" replies to the BMJ. BMJ2010; 341c4001 p. 218.
(7.) Mittal SK. Sudden Deaths' after pentavalent vaccination: Is the vaccine really safe?http://www.bmj.com/cgi/eletters/340/jun29_4/c3508
(8.) Simha V. More than a pin prick. Tehelka Magazine 2010; 7 : June 19, 2010. Available at:http://www.tehelka.com/story_main45.asp?filename=Ne190610coverstory.asp, accessed August 3, 2010.
(9.) Kaur R. Officials push five-in-one vaccine Down to Earth. July 31, 2010. Available at:http://downtoearth.org.in/node/1519, on August 3, 2010.
(10.) Indian Council of Medical Research: Core Committee on Vaccine. Minutes of the meeting of the core committee on vaccine. Available at: http://www.icmr.nic.in/minutes/Minutes Core Committee on% 20Vaccines.pdf, accessed on August 4, 2010.
(11.) Karat B. Need to exercise caution in introduction of new vaccines in the country. Today in Parliament 2/8/10. Available at: http://164.100.47.5/newsynopsis1/Englishsessionno/220/Synopsis English Dated 02.08.2010.pdf, accessed August 3, 2010.
COPYRIGHT 2010 Indian Council of Medical Research
COPYRIGHT 2010 Gale, Cengage Learning

Dr Jacob Puliyel, MD

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