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Science disclosed formula of the first synthetic
vaccine
José Angel Acosta
Havana, July 29, 2004 - Large-scale synthesis,
pharmaceutical development and clinical trials of the first worldwide
synthetic vaccine have been published six days ago by Science Magazine
( Science,
July 23, 2004, 305: 522-525 and an editorial
comment ). At the same time, this result was described as a
sweet victory for Cuban science by a well known reporter from this
prestigious scientific publication (Science, July 23, 2004 , 305:
460). This new vaccine is composed of a synthetic capsular polysaccharide
antigen of Haemophilus influezae type b (Hib). The vaccine
(QuimiHib) was obtained as result of a joint effort between the
University of Havana , the University of Ottawa , the Finlay Institute,
the Tropical Medicine Institute, the National Center for Bioreagents,
and the Center for Genetic Engineering and Biotec hnology (CIGB).
In clinical trials phase II, 99.7% of the test infants reached
antibody titres above those considered appropriate for long-lived
protection against Hib. The success of the QuimiHib vaccine demonstrates
that access to synthetic complex carbohydrate-based vaccines is
feasible and provides a basis for further development of similar
approaches for other human pathogens.
Last year, the CIGB received final approval from the Cuban regulatory
authority for the vaccine against Hib, which is manufactured in
a cGMP plant in accordance to the highest regulatory standards.
The Cuban pharmaceutical company Heber Biotec S. A. owns the worldwide
exclusive rights for the commercialization of this novel vaccine.
A non-disclosed licence agreement was signed last year between
Heber Biotec S. A., the University of Havana and the University
of Ottawa for the commercial exploitation of this scientific result.
About Haemophilus influezae type b (Hib)
According to the World Health Organization, H.
influenzae type b (Hib) is estimated to cause at least 3 million
cases of serious disease and 400 000-700 000 deaths each
year in young children. Rarely occurring in infants under 3 months,
and after the age of 6 years, the disease burden is highest at
4-18 months
of age. In both developed and developing countries Hib is the dominant
cause of non-epidemic bacterial meningitis in this age group, and
is frequently associated with severe neurological sequel despite
prompt and adequate antibiotic treatment. In economically developed
countries meningitis accounts for the majority of invasive Hib
disease, whereas in developing countries acute respiratory infection,
particularly the estimated 2-3 million cases of Hib pneumonia occurring
each year, represents an even heavier disease burden. Other important,
but less frequent, manifestations of Hib disease include epiglottises,
osteomyelitis, septic arthritis, and septicemia.
About the CIGB
The CIGB has more than 18 years experience in
the research and production of several biopharmaceutical molecules
such as interferons, hepatitis B vaccine, streptokinase, epidermal
growth factor, and other products, which are already producing
a positive impact on public health in Cuba and a positive cash
flow from sales to more than 50 countries. The Hib vaccine is part
of the partnership opportunities offered by the CIGB for the registration
and commercialization of innovative pharmaceutical products in
developed countries. This product has been included within the
CIGB's negotiation portfolio focused on the industrialized countries;
it is able in the web sitehttp://gndp.cigb.edu.cu/ ,
to facilitate the access to the medical community, companies and
research institutions to the most up to date R&D results.
For information: http://gndp.cigb.edu.cu/ or http://www.cigb.edu.cu/
Contact: ernesto.lopez@cigb.edu.cu
Phone: (53-7) 271 2397. |
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