Feature Kenya
Prof Cummins adds: “We have criticised
this vaccine based on the unacceptably high adverse impacts on infants and children during previous clinical trials and the low effectiveness of the vaccine.” Te two scientists criticised GSK, the
seven participating governments in Africa, and the Bill and Melinda Gates Founda- tion. “Misguided governments and mega- foundations such as the Bill and Melinda Gates Foundation,” Ho and Cummins say, “are complicit in the promotion of these and other even more aggressive vaccines in the pipeline that are of dubious benefit to the countries whose infants are being recruited for clinical trials.” In a report published in 2009, Cummins
and Ho commented: “Te RTS,S vaccine is the [nearest] to clinical use. It gave satis- factory but short-lived protection of adults who had never been exposed to malaria. An efficacy of more than 70 per cent was reported in 250 male Gambian adults dur- ing the first two months of follow-up, but falling to zero per cent in the last 6 weeks. “Tis vaccine has since been tried on
children and infants. Studies with infants and children are considered important be- cause they are the most sensitive group for malaria infection.” Te two scholars still assert that RTS,S has adverse effects even though it has been passed as “safe, well tol- erated, and immunogenic in young infants”. GSK defends itself by saying “to stimu-
late an immune response to the malaria parasite, the RTS,S antigen fuses a criti- cal circumsporozoite protein – the surface protein that helps the parasite to invade human liver cells – with a protein found in GSK Biologicals hepatitis B vaccine. Te addition of GSK’s proprietary Adju- vant Systems (AS) strengthens the immune response even further.” But other authorities have criticised the
vaccine. Tey say the recent trials of malaria vaccines on infants in Africa raise serious concerns over safety, especially as vaccines are administered in large numbers to the young and very young, whose brains may not yet be properly formed. From 1990 to the end of 2002, accord-
ing to critics, the Vaccine Adverse Events Reporting System (VAERS), set up by the US Centers for Disease Control and Preven- tion, and the US Food and Drug Admin- istration, received reports of 9,520 serious adverse events in children under one year
24 | October 2011 | New African
of age after one dose of hepatitis B vaccine, either alone or with other vaccines; among these were 627 deaths. In the same period, there were 38,600 serious adverse events and 753 deaths over all ages for the hepatitis B vaccine. Clearly, deaths among infants less than one year old after hepatitis B vaccina- tion were much higher than those in adults and older children. It is alleged that in the malaria vaccine
trials, serious adverse events of 10 to 20 per cent or more and even deaths in both trial and control groups are routinely dismissed as “unrelated to vaccination”, and hence did not even enter into the VAERS statistics. Dr Patricia Njuguna, the RTS,S princi-
pal investigator at KEMRI Kilifi, however, reckons that all laid-down guidelines have been followed to the letter and no adverse effects have been recorded in Kenya.
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