A lab technician prepares blood samples from volunteers in the malaria vaccine trials at Bagamoyo in Tanzania; and below, a sample is taken from an infant
trials, the vaccine had gone through proper testing and it is safe. Up to this point, just in case new information comes out and RTS,S is deemed to be unsafe, the trials will be stopped, but so far nothing alarm- ing has been spotted.” GSK’s spokesperson, Didier Lapierre,
who is also the vice president in charge of Malaria Clinical Development at GSK, refutes the allegations of unethi- cal practice by the pharmaceutical giant and echoes Dr Njuguna’s sentiments. “GSK-sponsored clinical trials, includ-
ing those for RTS,S, are conducted to the same ethical standards irrespective of where they take place in the world,” Lapierre says. “Te RTS,S studies are conducted accord- ing to the highest international standards for safety, ethics, and clinical practices. “Te trials are reviewed by national reg-
malaria vaccines on infants raise serious concerns over the safety of multiple vaccinations of the very young.”
“Clinical trials of
ulatory authorities, national and interna- tional ethical bodies, and local institutional and ethical review boards. In addition, an independent data monitoring committee (IDMC) oversees the trials, supported by local safety monitors (LSM) at each of the research centres. Te main objectives of the IDMC and the LSM are to oversee the safety data and data collection processes.”
Cummins speaks New African managed to trace Cummins and asked him if it was ethical to involve infants in the RTS,S vaccine trials? “By participating in the vaccine trials,
the children may have been denied effec- tive protection from insecticidal bed nets and treatment with effective drugs that are proven to reduce the impact of malaria. Te ethics of the trials on children bears careful review,” Cummins said. On whether he stands by what he and
“All our trials have been properly moni-
tored. Everything is documented for peer review by independent groups,” Njuguna said. “We have an Independent Data Moni- toring and Safety Board which reviews all data and advices accordingly.” According to Njuguna: “As far as we
know and from all the trials we have con- ducted so far, there are no untoward side effects. Even before we began Phase 2 of the
Dr Ho wrote two years ago and if there has been any change since ISIS published their report, Cummins said: “Tere does not appear to have been major efforts to improve those important considerations. “Tere have been several scientific re-
ports on the results of RTS,S clinical trials and most of those were authored by indi- viduals who were employed by the vaccine manufacturer and many of those owned
stock in the company. It is inescapable that the studies cannot be presumed to be free of conflict of interest. Tere should have been conflict-of-interest-free adjudica- tors of the experiments.” Defending the RTS,S trials, Dr Ally
Olotu, a research clinician involved in the trials, who has also published extensively in international scientific journals on the trial findings, says that the vaccine passed all the rigorous procedures required before testing was allowed. “Tere are mechanisms and protocols
all dealing with safety to ensure that the highest safety standards of participants in any clinical trials are maintained. So far no safety concerns have been raised. It is pretty much clear that up until now the RTS,S vaccine is safe,” Olotu said. Te RTS,S latest findings were pub-
lished in the July 2011 edition of the Journal for Infectious Diseases which was authored by Dr Njuguna, Dr Olotu and the RTS,S co-inventor, Dr Cohen, among others. Prof Cummins describes the report as “perplex- ing”, particularly the paragraph that notes: “Vaccination with RTS,S/AS01E reduces exposure to blood-stage parasites and, thus, reduces antimerozoite antigen antibody concentrations.” According to Cummins: “Te vaccination of children in Africa leads to effects that are difficult to interpret.”
Phase 3 Should the Phase 3 trials progress as ex- pected, RTS,S will be submitted for regula- tory review in 2012. Te results of the over- two-decades’ research will be submitted to the European Medicines Agency (EMEA) for assessment. After this, RTS,S will be open to review by the WHO and national drug regulatory agencies in Africa. WHO has already indicated that a policy recom- mendation for RTS,S is possible by 2015. Tis does not surprise Cummins who says “WHO prequalification may be accelerated following extensive efforts by GSK.” Andrew Witty, GSK’s CEO, promises a
fair price for the vaccines. “We have com- mitted to price RTS,S responsibly and will seek to ensure that the price will not be a barrier to access. We will set a price which covers our costs and generates a small re- turn of around 5% which will be reinvested in the development of the next generation malaria vaccines or for other products for diseases of the developing world.”
New African | October 2011 | 25
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