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The East African : Jan 26th 2015
The EastAfrican OUTLOOK JANUARY 24-30,2015 er as policy on malaria vaccine expected 3.2 billion FACTSHEET ON THE WORLD MALARIA REPORT 2014 90pc Of the estimated 627,000 global malaria deaths occurred in Africa in 2012. Estimated number of people at risk of malaria, of whom 1.2 billion are at high risk. In high-risk areas, more than one malaria case occurs per 1,000 population. Cummins, this posed “a potential conflict of interest.” While Ms Cooper confirmed that the authors of the RTS,S studies include scientists from GSK as well as from other or- ganisations, she, however, ruled out any possibility of conflict of interest. “Scientific papers are peer reviewed by independent reviewers; besides, the authors and con- ding to sub-SaAfrica ues to he brunt global n of a. : File mainly little children and pregnant women. It is better to conduct the trials on children rather than on the women to guard against ethical issues, which would be greater as this would put unborn babies at potential risk,” said Dr Kiarie. But according to Hans Herren, the head of the US-based Millennium Institute, who once headed the Nairobi-based International Centre of Insect Physiology and Ecology (Icipe), a more integrated approach to control malaria is the best option. “Why wait for a vaccine when we know what to do today? A more integrated approach would put the local people in charge and thereby create jobs and assure long term sustainability and success. Besides, it is very affordable,” said Dr Herren. Another area of controversy are claims that the trials were sponsored by the vaccine manufacturer GlaxoSmithKline Biologicals, and that its employees made up a large proportion of the co-authors that gave the RTS,S/AS01 vaccine a clean bill of health. According to Dr Ho and Prof ference presenters are required to disclose to the publication or conference any financial interest that may pose a conflict of interest,” said Dr Cooper. For example, Dr Joe Cohen, who co-invented RTS,S/AS01 serves as the vice president of R&D, Vaccines for Emerging Diseases and HIV at 80pc 30pc Source: WHO the writing of the scientific article Long-term Safety and Efficacy of the RTS.S/AS02A Malaria Vaccine in Mozambican Children published in the Journal of Infectious Diseases. The article concluded that “immunisation with RTS,S/AS02A reduced the burden of malaria by approximately one-quarter” and that the results “strengthened the rationale for advancing towards phase III trials, aiming to register RTS,S/AS.” It was also established that Wil- liam Ripley Ballou — who had coauthored a similar scientific assessment report on the vaccine in the New England Journal of Medicine, was an employee of GlaxoSmithKline Biologicals and held shares in the parent company. According to WHO, sub-Saharan Portion of the estimated 207 million malaria cases worldwide that were recorded in sub-saharan Africa in 2012 GSK Biologicals, and was one of the co-authors of two scientific reports on the phase II trials. His report was published in the Lancet in 2001 and 2004. And together with other scientists, Dr Cohen had concluded in 2001 that the RTS,S/AS02 is “safe” and is “the first vaccine to show significant protection against natural Plasmodium falciparum infection.” Further, in a 2004 assessment, he described the vaccine as “safe, well tolerated, and immunogenic,” and that it was “an effective vaccine against malaria is feasible.” Dr Cohen also participated in Africa continues to bear the brunt of the global burden of malaria. In 2012, 80 per cent of the estimated 207 million malaria cases worldwide were in Africa. In the same year, 90 per cent of the estimated 627,000 global malaria deaths occurred on the continent. The past decade however, has witnessed unprecedented progress in malaria prevention and control on the continent. Between 2000 and 2012, malaria mortality rates among children under-five declined by 54 per cent. During the same period, malaria death rates decreased by 49 per cent in the population at large. To fight malaria, many ap- proaches have been used across the continent including the use of insecticide-treated nets, sterilising mosquito larvae, and the use of artemisinin-based combination therapies. s, involving thousands of voluntee≥s and the publicns on ethics roponents of h Organisation ork (who have als) — failed to or interviews while the Bill ined to answer — that on e, said that the on in the ma- vaccine is a of thousands costs pharor more to for a vaccine candidate in a process that can take up to 12 years with some 50,000 to 100,000 people participating as volunteers. Usually, vaccine trials involve an independent group of researchers who scrutinise the protocol (the method or guidelines used in the trials) to determine whether it corresponds with standard practices including respect for trial subjects, scientific validity, social value and ethical principles. A data safety monitoring body is mandated to constantly check for any adverse effects. The body meets regularly and is given occasional results to determine whether the vaccine group and the group treated using placebo (or the simulated ineffectual treatment) are safe. The group then decides whether the trials should continue. “Although the ongoing malaria trials have been scrutinised carefully, the thing with vaccine trials is that you do not know how the results will turn out,” said James Kiarie, a senior lecturer at the University of Nairobi’s obstetrics and gynaecology department. Dr Kiarie, however, said the RTS,S trials were made unnecessarily expensive partly because Path, the implementing agency, appointed Washington University in the US to carry them out. “Had the vaccines been made in India or South Africa, then half the cash spent on the trials would have been saved,” said Dr Kiarie. “You can do similar trials with half the amount of cash invested in the ongoing malaria trials.” Although the bulk of the cash came from the US-based Bill & Melinda Gates Foundation and the USAid, it is not clear whether this will eventually translate into higher prices of the vaccine should it get a policy nod from the WHO. - By John Mbaria A child lies on a bed under a mosquito net. The use of insecticide-treated nets is one of several methods used in sub-Saharan Africa to fight malaria. Pic: File Global reductions in malaria incidences between 2000 and 2013, due to an expansion of interventions; the reduction in Africa was 34 per cent. There are claims that the use of 16,000 infants in Africa in the trials for the malaria vaccine was unethical. What is your take? In sub-Saharan Africa, the majority of malaria deaths occur in children under the age of five. We, therefore, are developing this vaccine for the population most in need — and we needed to know if it is safe and effective in that population. The clinical trials were care- fully conducted, starting with adults and gradually moving down to the younger groups it is designed to protect. Before starting clinical trials in African children, the RTS,S malaria vaccine candidate was evaluated in adult volunteers in the US, Belgium and The Gambia. Besides, the clinical trials were designed to adhere to strict international and national safety and ethical guidelines. How did GSK and its partners ensure that the safety of the subjects and ethics concerns were adequately met during the trials? Safety was carefully monitored by the investigators and closely reviewed by an independent data monitoring committee, GSK and Path’s Malaria Vaccine Initiative, as well as regulatory authorities and ethics review committees. But there are reports that some infants developed Serious Adverse Events during the clinical trials? Any SAEs reported were not caused by the vaccine under trial. Side effects that we encountered included mainly common reactions such as pain or swelling at the site of injection and fever — these cannot be regarded as serious side effects. Besides, after more than 18 months of follow-up after vaccination, there was no difference of the SAEs reported between those receiving RTS,S and those receiving a comparator vaccine. Critics say that the trials have shown that with a low efficacy of 29 Q &A WI T H R AC H E L C O O P E R GSK’s global external communications manager spoke with JOHN MBARIA about the controversies surrounding RTS,S/AS01 If approved, we shall ensure that the vaccine is available to those who need it most.” Rachel Cooper, GSK between 33 per cent and 55 per cent, the vaccine may not be an effective solution to malaria in subSaharan Africa and other countries within the tropics. Why did GSK rush to take it for approval despite the low efficacy levels? GSK, along with its partners, has been developing RTS,S for 30 years. The latest results from the Phase III trials demonstrated that RTS,S was effective in treating almost half the number of malaria cases in young children aged five to 17 months at first vaccination, and that it cut the number of malaria cases in infants aged six to 12 weeks by about a quarter at first vaccination. Given the huge human and economic cost of malaria in Africa, we believe that RTS,S could make a big difference to public health on the continent. The sheer number of children affected by malaria means that the number of cases that the vaccine can help prevent is impressive; and when used alongside established interventions such as bed nets, it could have a significant public health impact in Africa. When does GSK plan to market the vaccine and how much will be sold in Africa? RTS,S has been developed in Africa and is intended for use among children in Africa. If the vaccine is approved and recommended for use, we have committed to making it available on a not-for-profit basis. We shall work with other organisations to ensure that the vaccine is made available to those who need it most.
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