to accelerate global use of new generation cholera vaccines gained
significant momentum with the licensure of a new oral cholera vaccine,
Shanchol, from Shantha Biotechnics in India in 2009.
Approximately 200,000 cases of cholera cases per year are notified to
the World Health Organization (WHO) in 2007 from 52 countries. This
represents an increase of 46 percent in the mean number of cases
reported during 2002–05 period. In India alone, the overall
incidence of cholera is estimated as 1.9 cases per 1,000 but can be as
high as nine per 1,000 among children. There are many outbreaks but
cholera as a disease is largely unreported.
India used to administer an injectable vaccine in the 1970s when
cholera was a notifiable disease. However, in 1973, its use was
scrapped, as it was only 30 percent effective and provided immunity
only for eight months.
The only WHO-pre-qualified oral cholera vaccine to date is the double
dose Swedish vaccine called Dukoral, which is priced at $60 and needs
to be co-administered with a relatively high volume of buffer solution.
After 38 years, Indian population gets an affordable and efficacious
cholera vaccine in the form of Shanchol. The bivalent oral vaccine is
produced by the Indian vaccine giant, Shantha Biotechnics, which is now
part of the Sanofi-Aventis group after its vaccines division Sanofi
Pasteur, the world's largest vaccine-maker, bought Shantha
from Merieux for $550 million, valuing the company at a stunning Rs
3,740 crore (about $809 million), more than 16 times its turnover.
Shanchol consists of killed whole cells from a mix of pathogenic
strains of Vibrio cholerae (O1and O139) and is given in two doses, each
dose in six weeks gap. The vaccine currently priced at $1.85
is licensed for use in adults and children above one year
old. The product is very innovative as it incorporates all the
important genes required to make it very selective and more effective
without harming the intestines in any way. It is designed to prevent
even severe infections caused by various mutants of the cholera virus.
The vaccine was approved in India last year based on the results of
phase II trial on 70,000 human subjects (aged one year and over)
conducted in Kolkata by the National Institute of Cholera and Enteric
Diseases (NICED). The Kolkata trials found the oral cholera vaccine to
provide over 67 percent protection and no decline in protection over
two years. Shantha Biotech has spent $1.5 million to set up facilities
for Shanchol production.
The bivalent inactivated-whole-cell oral cholera vaccine has been
developed in collaboration with the International Vaccine Institute
(IVI), Seoul, South Korea. IVI scientists developed this vaccine, with
funding from the Bill & Melinda Gates Foundation, by
significantly modifying a vaccine used and produced only in Vietnam by
VA Biotech, so that it meets international GMP standards and WHO
Following field trials in India and Vietnam showing the new vaccine to
be safe and immunogenic in both adults and children, IVI scientists
transferred the technology for the vaccine to Shantha Biotechics.
“Shanchol is the first new vaccine to be developed and
licensed with funding from the Gates Foundation, also the first
licensed vaccine developed by the IVI” says Varaprasad Reddy,
Managing Director, Shantha Biotechnics, Hyderabad, India.
The IVI aims to make this vaccine available for use in public health
programs in India and other cholera-affected countries in Asia and
Africa to control endemic cholera, also to help control large scale
Shantha has applied to WHO for pre-qualification of Shanchol, to allow
its purchase by United Nations agencies, including UNICEF, and to
facilitate its use in other countries. The company is currently
producing 1.5 million doses of the vaccine but Reddy has plans to scale
it up to 10 million doses in the next
Among other developments, the company is progressing with its plans to
start the first human clinical trial of rotavirus vaccine. It is also
about to start the phase I trial for the typhoid polysaccharide in the
next few months. The company is also in the process of developing a
As the first Indian company to launch an r-DNA hepatitis B vaccine,
Shanvac B, in 1997, Shantha heralded a new beginning for biotechnology
and affordable healthcare in India. The Indian company continues to
push boundaries and transcend limitations, bolstered by its
research-driven scientific ethos. Shantha spends 24 percent of its
revenue for R&D each year.