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correspondence

Indian Pediatr 2009;46: 733-734

Typhoid Vaccine(s) – To Give or Not to Give


Ajay Kalra and *Vipin M Vashishtha,

SN Medical College, Agra; and
*Mangla Hospital, Bijnor; UP, India.
Email: [email protected] 
 


The two articles on typhoid vaccination(1,2) published in the February 2009 issue of Indian Pediatrics raise some pertinent questions.

The author of the first article(1) does not consider the burden of typhoid in India high enough to merit this being included in the national immunization program or, for that matter, even important for individual immunization. On the other hand, the very study that has been quoted(3) not only makes out that India is a country with a high incidence of typhoid disease but also makes a case for conjugate vaccine to enable this to be given to children below 5 years.

The author has based his assessment of disease burden entirely on culture positive cases. However, majority of cases in India are diagnosed and treated without opting for blood culture and sensitivity report which is not routinely available at all places. There are many reports emanating from different parts that incidence of typhoid is even going up even in children around two years of age(4,5). The author also challenges the Cochrane review in this regard, which is considered to be a robust evidence pertaining to any clinical entity, interventions and therapy. They are not based on "assumption by extrapolation". The conclusion reached by the author that typhoid is not a major public health problem in India, therefore, needs clarification. It may not have high mortality burden but definitely has high morbidity. Further, the author states that the two dose typhoid vaccine was abandoned from the national immunization schedule because of "lack of robust evidence". However, the reasons for withdrawing this vaccine were the "reports of severe drug reaction including the reports of septic shock like picture and sudden deaths following these vaccines"(6).

In response to the second article(2), we have several queries. Which evidence on vaccines should be considered as acceptable and which one as non acceptable? What are the minimum standards laid down for accepting studies on vaccines as authentic in terms of the place of study, the authors, the number of cases undertaken in the study, the number and type of publications, the manufacturers etc? What is the status of data from our own country? Do we have ICMR data or any other data which we would be willing to accept? On this count of lack of indigenous data, even licensure of many new vaccines such as Rotavirus, JE SA-14-14-2 etc can also be challenged.

What is the procedure of licensing a vaccine for use in our country? Does not the national licensing/regulatory authority satisfy itself on all accounts before granting permission for its use? What is the liability/accountability of the regulatory authority if vaccines supposedly not meeting the standards are licensed? What is the liability of medical practitioners in case they decide to give or not to give the vaccine on the basis of conflicting opinions? What is the liability of academic forums from where these vaccines are launched to give them a degree of credibility?

The IAP needs to address these questions and lay down guidelines in respect to all vaccines as a matter of ethical importance.

References

1. Mathew JL. Conjugate typhoid vaccine(s) in the Indian context. Indian Pediatr 2009; 46: 182-184.

2. Shah NK. Indian conjugate Vi typhoid vaccine: Do we have enough evidence? Indian Pediatr 2009; 46: 181-182.

3. Ochiai RL, Acosta CJ, Danovaro – Holiday MC, Baiqing D, Bhattacharya SK, Agtini MD, et al. A study of typhoid fever in five Asian countries: disease burden and implications for controls. Bull WHO 2008; 86: 260 - 268.

4. Sinha A, Sazawal S, Kumar R, Sood S, Reddaiah VP, Singh B, et al. Typhoid fever in children aged less than 5 years. Lancet 1999; 354: 734-737.

5. Saha MR, Dutta P, Palit A, Dutta D, Bhattacharya MK, Mitra U, et al. A note on incidence of typhoid fever in diverse age groups in Kolkata, India. Japanese Journ Infect Dis 2003; 56: 121 – 122.

6. Shah NK. Typhoid vaccines revisited. In: Ganguly N, Kundu R, Ghosh TK, editors. Common MDR infections in children. New Delhi: CBS Publishers; 2005. p. 36-47.
 

 

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