Response to Cunliffe et al Should India launch a national immunisation programme against rotavirus?

http://www.bmj.com/content/345/bmj.e7832?tab=responses

Jacob Puliyel, Joseph L Mathew

We thank Cunliffe and his co-authors from PATH and the Bill and Melinda Gates Foundation (B&MGF) for their response to our article. We note however, that they employ a straw-man fallacy to support rotavirus vaccine introduction globally.

Evidence from the Cochrane meta-analysis has demonstrated that rotavirus vaccine does not to reduce childhood mortality. (1) This makes it difficult to defend the promotion of this expensive vaccine in developing countries – being pushed as a ‘key step’ to lowering childhood mortality. (2)

Cunliffe et al argue that diversity of rotavirus strains may not be responsible for the lower efficacy of the vaccine in developing countries. We agree they could be right. Gladstone and colleagues, who we have quoted in our paper, have shown that even after episodes of natural infection in India, there is no decrease in risk of subsequent, homotypic rotavirus infection. (3) It indicates that protection is unlikely in India, even if a new vaccine were introduced that matched the genotype of the local strains.

The present day poor understanding of the reasons for this lack of efficacy does not detract from the fact that the vaccine is less effective in developing countries. It cannot logically be argued that because we do not understand the lack of efficacy, we must promote the vaccine as if it were efficacious. It is tragic that international organizations like the WHO and the B&MGF continue to promote this vaccine to poor countries in the face of all this evidence.

What is the way forward? The available (lack of) evidence to support rotavirus vaccination in India argues for supporting and encouraging the conduct of well-designed research studies to determine (i) whether rotavirus vaccination is a priority, and (ii) if so, what the appropriate vaccine composition should be. Action(s) in this direction would be more suitable than finding props through post hoc analysis, to support the argument that “one hat fits all”. Since, developed countries work out their vaccine and vaccination needs through meticulous locally relevant research, despite having a lower disease burden; it is only justified that a similar scientific process should be encouraged in developing countries and other resource-limited settings as well.

Reference
1. Soares-Weiser K, Maclehose H, Bergman H, Ben-Aharon I, Nagpal S, Goldberg E, et al. Vaccines for preventing rotavirus diarrhoea: vaccines in use. Cochrane Database Syst Rev 2012;2:CD008521

2. GAVI Alliance. Rotavirus vaccine support. www.gavialliance.org/support/nvs/rotavirus/

3. Gladstone BP, Ramani S, Mukhopadhya I, Muliyil J, Sarkar R, Rehman AM, et al. Protective effect of natural rotavirus infection in an Indian birth cohort. N Engl J Med 2011;365:337-46.