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Shantha Biotechnics, a Hyderabad-based French-Indian vaccine company, has recently launched an oral cholera vaccine with the trade name Shanchol. The scientists associated with this vaccine claim it to be cheap and offering high protection (70%) over two years. They are currently lobbying inside the World Health Organization (WHO) and UNICEF to promote the vaccine for global use against cholera. However, they have concealed vital information on the vaccine’s composition and protective efficacy. The company claims to have received enquiries from Bangladesh where it wants to market the vaccine .
Concealing vaccine’s vital information:
Information concerning the vaccine is available from the Internet-based documents as the vaccine was tested on several thousand slum-dwellers of Kolkata (India) in 2006. The vaccine’s prime mover is a group of scientists based in South Korea and Sweden (John Clemens of the International Vaccine Institute, South Korea and Jan Holmgren, Gothenburg University, Sweden). They had been working on this vaccine for several years in Vietnam. The Vietnamese drug agency is not recognized internationally. They decided to exploit the Indian drug agency as it is globally accepted. Hence they moved their operations to Kolkata (India) with a view to capture the global cholera vaccine market.
The vaccine contains large amount of two groups of killed cholera bacteria (Vibrio cholerae O1 and O139). It is administered orally in two doses separated by a two week interval. The vaccine requires cold chain as it is to be stored at 4-8 oC. It contains the toxic mercury containing compound thiomersal as preservative. Both the vaccine producer (Shantha Biotechnics) and its scientists (John Clemens and Jan Holmgren) have concealed this information from the Indian public. One does not know how much toxic mercury one has to swallow per dose of the vaccine. Because of toxic effects, the use of thiomersal in vaccines has been banned in many countries including several states of USA. WHO’s Expert Committee on Biological Standardization does not recommend the use of thiomersal in cholera vaccines. Shantha Biotechnics owes the Indian public an explanation for concealing information. It is not the first time that Shantha’s scientists (John Clemens and JanHolmgren) have done so. They have done it previously in Vietnam and in Bangladesh. They are habituated to concealing information on their vaccine’s mercury content in scientific journals [The Lancet (1986, 2:124-7); Vaccine (2006, 24: 4297-303)]. This is to deceive readers by pretending that the vaccine is mercury free.
The vaccine trial is ethically questionable as no scientific tests were performed to determine pregnancy of women trial participants.
Cholera, whether in Zimbabwe or in India, is presently caused by strains belong to one type of cholera bacteria (Vibrio cholerae O1, El Tor). Yet the vaccine contains lesser amount of El Tor strains compared to the strains of the other type (the classical biotype). This raises questions about the suitability of this vaccine to control El Tor cholera effectively. The vaccine’s protective efficacy against cholera caused by the other bacterium (Vibrio cholerae O139) did not become evident from the trial. Vaccine’s poor performance after one year:
As reported in the Times of India (11 April 2009), the vaccine provided 70% protection over two years. But what was the protection rate after one year? The company and its scientists have concealed this information from the Indian public. The vaccine’s efficacy against cholera was very poor during the first year of follow-up as it registered only 40-45% protection. If the vaccine protected only 40-45% of the trial participants during the first year, how was it scientifically possible that its protective efficacy increased up to 70% in the second year? The authenticity of the information coming out of the trial is questionable. As the vaccine demonstrated poor efficacy soon after its administration, it cannot be regarded as an effective vaccine to control cholera.
Not a suitable vaccine to control cholera outbreaks:
Since it is a two-dose vaccine, administered with an interval of 14 days, protective efficacy starts 3 weeks after the first dose, making the vaccine of little use once a cholera outbreak has started. That is the reason that Dukoral, the currently available two-dose oral cholera vaccine produced in Sweden, was not used in controlling the ongoing cholera epidemic in Zimbabwe. Besides, the Indian vaccine requires cold chain that is difficult to maintain in several tropical and subtropical countries where cholera is prevalent.
Concealing information on the earlier cholera vaccine trial:
Shantha scientists have concealed information of the earlier trial of a cholera vaccine that was tested in Kolkata in 1975. According to WHO, it was a single dose injectable vaccine adsorbed with aluminium phosphate. It had offered much better protection, in all age groups and in children under 4, during the first year of follow up than the two-dose oral vaccine recently tried in Kolkata. Besides the injectable vaccine was much cheaper to produce as the present oral cholera vaccine contains 44 times more cholera bacteria than the former one.
Is the vaccine cheap?
A few years ago WHO’s Director-General Dr. Hiroshi Nakajima had mentioned that the price of a vaccine should not be above one dollar per dose, other wise it would be out of reach for much of the world. But as reported widely in the Indian press (the Business Daily from the Hindu group of publications, 27 April, 2009), the two-dose Indian oral cholera vaccine will be sold by the vaccine producer (Shantha Biotechnics) at the cost of the Indian Rupees 600 (12 US Dollars). It is absurd that a vaccine that costs 12 US Dollars in India should be regarded as cheap.
A Swedish oral cholera vaccine, an earlier version of Dukoral, was field tested by the International Centre for Diarrhoeal Disease, Bangladesh (ICDDR,B) in 1985 in a trial involving 90,000 poor women and children of Bangladesh. Protests against this trial concerning its ethical validity and the vaccine’s high cost were launched in Bangladesh and in Sweden. At that time both the ICDDR,B’s director and Jan Holmgren , the Swedish scientist behind the vaccine, had claimed the vaccine to be cheap. They lied on the vaccine’s cost to deceive the public by stating that the production cost of the vaccine would be US Dollars 1.5 – 2.0 per dose (Dhaka Courier, August 29, 1966; Upsala Nya Tidning, Sweden, April 23, 1987). Now Dukoral, the two-dose oral cholera vaccine of short-term protective efficacy produced in Sweden, is sold in Europe at an exorbitant price of approximately 60 US Dollars.
Promoting the oral cholera vaccine for profit:
Cholera vaccination has a long history spanning over one hundred years. To protect people against cholera, vaccination with the injection of killed whole bacteria was introduced towards the end of the 19th century. The vaccine is cheap and moderately effective. It was used in India in the 1930s as a cholera prevention measure and a substantial decline in the number of cholera cases was achieved.
Injectable cholera vaccine was in use until the 1970s when a group of scientists influenced WHO to abandon the cheap and effective injectable cholera vaccine using false and fabricated negative campaign concerning its efficacy and side-effects. Further, they used WHO to sponsor a highly expensive oral cholera vaccine of short term protective efficacy (now sold as Dukoral) produced by a private vaccine company. In depth survey of several cholera vaccine trials performed by Britain’s eminent Cochrane group has rebutted various negative allegations against injectable vaccines. Protection rendered by injectable vaccines in cholera endemic areas can persist up to 2 years following a single dose and for 3-4 years withan annual booster. For children under 5, the group most vulnerable to cholera, scientists in India and Indonesia had shown in the 1970s that injectable cholera vaccines adsorbed with adjuvants offered very good protection during a period of 12-18 months. All these led the Cochrane group of Britain to question the rationale to abandon injectable cholera vaccine thereby depriving “humanity… of safe and relatively effective vaccines”.
Injectable cholera vaccines, which are much cheaper to produce than the oral cholera vaccines such as Dukoral and Shanchol, stand in the way of those who want to make money out of human misery.
Sanitation and diarrhoea control:
Cholera was prevalent in Europe and America in the nineteenth century and took a toll of human lives. The disease was eradicated in industrialized nations more than a century ago through effective sanitation and public health measures. Diarrhoea can be caused by a number of bacteria other than Vibrio cholerae. Non-cholera diarrhoeas are very frequent. Instead of developing strategy to combat only cholera, a comprehensive diarrhoeal disease control programme should be launched. Good sanitary measures are keys to this programme to which Shantha’s scientists (John Clemens and Jan Holmgren) pay only lip service.
Suggested further readings:
1. The Times of India, Oral Cholera vaccine may soon be used in India, 11 April 2009
2. Business Daily from The Hindu group of publications, Oral cholera vaccine Shanchol from Shantha for India, 27 April 2009. 3. Randomized Controlled Trial of Killed Oral Cholera Vaccine in Kolkata
http://www.clinicaltrial.gov/ct2/show/NCT00289224 ;
www.plosone.org/article/fetchSingleRepresentation.action?uri=info:doi/10.1371/journal.pone.0002323.s001 –
4. WHO Expert Committee on Biological Standardization, 52nd Report, page 137.
5. Graves P, Deeks J, Demicheli, V, Pratt M, Jefferson T. Vaccines for preventing cholera. Cochrane Database Syst Rev 2000; 4: CD000974.
6. Arnold D. Cholera and colonialism in British India. Past and Present 1986;
113: 118-51.
7. Preston NW. Prevention of cholera. Lancet 2004; 363:898.
8. Kabir S. Cholera vaccines. Lancet Infect Dis. 2007; 7:176-8.
9. Finkelstein RA. Why do we not have a suitable vaccine against cholera?
Advances in Experimental and Medical Biology 1995; 371B:1633-40
10. Pal SC, Deb BC, Sen Gupta PG, De SP, Sircar BK, Sen D, et al.
A controlled field trial of an aluminium phosphate-adsorbed cholera vaccine in
Calcutta. Bull World Health Organ 1980; 58(5):741-5. |
