Who says Merck and GlaskoSmithKline don’t care? They just funded a major rotavirus vaccine trial in Malawi and South Africa to determine if two or three doses of their vaccine are more effective at preventing rotavirus infections than a placebo is. Clinical trials of this scale can’t be done in the US because, being an industrilaized nation, hardly anyone gets the gastro associated with rotavirus. But with hundreds of millions of dollars from health agencies on the line, it would be silly not to use Africans as their guinea pigs- you can only run so many trials on the military, after all.
First the transparency: “Dr. Madhi reports receiving lecture fees from GlaxoSmithKline and consulting fees from Merck; Dr. Cunliffe, receiving lecture fees and grant support from Sanofi Pasteur and GlaxoSmithKline; Dr. Gillard, owning shares in GlaxoSmithKline; and Dr. Han, owning shares in GlaxoSmithKline.”
Next, their results: “This study shows that a live, oral rotavirus vaccine significantly reduces the episodes of severe rotavirus gastroenteritis in African children during the first year of life.” Well, almost. NEJM generously supplied the full text of the article and its appendix, which allows us to discover that there were no significant differences between those children hospitalized who had been given either amount of vaccine and those given a placebo, and there were no significant differences in adverse events such as gastroenteritis (emphasis added), pneumonia, bronchopneumonia, a slightly higher rate of sepsis in the vaccinated group and, of course, vaccine-related adverse events. But there were less incidences of the babies’ bowels glueing themselves together in this trial than with the previous rotavirus vaccine, so the authors thought that was a plus.
Oh, and the death thing. There were no significant differences betweent the vaccinated group and the placebo group in the number of infants who died during the trial.
Almost forgot- there wasn’t a signifcant difference between giving the babies two and three doses.
A wonderfully enlighted passage of the paper points to why this trial wasn’t as successful as previous trials of the rotavirus vaccine around the world: “Several mechanisms have been proposed to explain why live oral rotavirus vaccines may not be as efficacious in populations of infants from low-income countries. Possible reasons include host characteristics, such as poor nutritional status and enteric coinfections; levels of antirotavirus antibodies in breast milk; and interference by maternal antibody or by coadministration of the oral poliovirus vaccine, which may reduce rotavirus antibody levels…”
Shabir A. Madhi, M.D., Nigel A. Cunliffe, M.B., Ch.B., Ph.D., Duncan Steele, Ph.D., Desirée Witte, M.D., Mari Kirsten, M.D., Cheryl Louw, M.D., Bagrey Ngwira, M.D., John C. Victor, Ph.D., M.P.H., Paul H. Gillard, M.D., Brigitte B. Cheuvart, Ph.D., Htay H. Han, M.B., B.S., and Kathleen M. Neuzil, M.D., M.P.H. (2010). “Effect of Human Rotavirus Vaccine on Severe Diarrhea in African Infants.” New England Journal of Medicine 362(4): pages 289-298.