Thursday, March 23, 2017

New low-cost, heat-stable rotavirus vaccine found to be highly effective in Niger

A 3 dose regimen of BRP-PV, an oral rotavirus vaccine produced by the Serum Institute of India, was recently tested in Niger for efficacy and safety. BRP-PV is heat-stable — unlike other oral rotavirus vaccines that are currently in use, it can be stored at room temperature and survive temperatures much higher, making it far easier to transport than vaccines that have strict refrigeration requirements. It is also produced at an equal or lower price than the other two rotavirus vaccines currently supported by WHO and Gavi, Rotateq (Merck) and Rotarix (GlaxoSmithKline).

In a phase 3 trial reported in the New England Journal of Medicine today,  BRP-PV had an efficacy of 69.1%, superior to other rotavirus vaccines tested in other African countries — Rotateq (39.9% efficacy), Rotarix (61%) and Rotavac (55%). It lowered the the number of deaths due to rotavirus gastroenteritis by 4.3 deaths per 100 infant-years.

They did not find any safety concerns or adverse events associated with the vaccine group compared to control, although they did note that the study lacked the power to detect any possible change in incidence of intussusception (a fatal intestinal collapse)

This is very exciting news indeed. Introducing BRP-PV to the list of vaccines for rotavirus could make it easier to produce and distribute the vaccine cheaply in regions with a high burden of rotavirus. As diarrhea caused by rotavirus (and other viruses) is a leading cause of death in children around the world, getting this vaccine approved and out into the world is of utmost importance.

Sources:
Isanaka S et al. Efficacy of a Low-Cost, Heat-Stable Oral Rotavirus Vaccine in Niger. N Engl J Med 2017; 376:1121-1130. http://www.nejm.org/doi/full/10.1056/NEJMoa1609462#t=articleResults

Bhandari N. Efficacy of ROTAVAC® Monovalent 116E Vaccine (BBIL). Centre for Health Research and Development Society for Applied Studies: 13. http://www.sabin.org/sites/sabin.org/files/2.1%20Nita%20Bhandari.pdf


-Richa Wadekar

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