TWN Info Service on Health Issues (December 06/06)

12 December 2006

Cuba: Vaccines to battle diseases and Big Pharma

Cuba is on its way to become a major world player in vaccine production. Half of the research projects deal with vaccines which are unprofitable to the giant pharmaceutical companies but are important for diseases which afflict the people of poor nations. The article below highlights the efforts being made and the beneficial outcomes to developing countries.

It is reproduced with the permission of South-North Development Monitor (SUNS) # 6155, 5 December 2006.

With best wishes
Evelyne Hong
TWN

Cuba: Conquering vaccines - and their markets

By Patricia Grogg, IPS, Havana, 1 December 2006

Deliberately putting human health before economic considerations, according to local experts, Cuba has launched full-tilt into the vaccine industry to compete on the international market with its products, some of which are unique.

Cuban scientists are devoting themselves to investigating therapeutic products against cancer, malaria and cholera, diseases that ravage the people of poor nations.

However, the first destination of every new pharmaceutical is the Cuban market and the national hospital network. Medical sources indicated that eight of the 13 vaccines included in the national immunisation programme are produced locally.

"Half of our research projects deal with vaccines, which are financially unattractive to the big pharmaceutical companies," Carlos Borroto, deputy director of the Genetic Engineering and Biotechnology Research Centre (CIGB), told IPS.

In the early 1980s, the Fidel Castro administration made biotechnology a priority area for the country's social and economic development. The financial support granted to the sector was maintained even during the crisis of the 1990s, triggered by the break-up of the Soviet Union, Cuba's main trading partner.

Spokespersons for the Pan American Health Organisation (PAHO) reported that Cuba, together with Mexico and Brazil, are among the countries which made significant investments in installations and capacity-building for producing vaccines and other medicines between 1980 and 2000.

Cuba devotes 1.7% of its gross domestic product (GDP) to science and technological innovation, a proportion that is higher than that of Latin America as a whole, which invests an average of 0.7% of GDP, according to the Ministry of Science, Technology and the Environment.

This Caribbean island nation possesses 222 scientific research centres, employing 31,000 people, although only the six main institutes conduct the complete cycle: research, production and marketing.

The "West Havana Scientific Pole" is made up of the CIGB, the Finlay Institute for Serum and Vaccines, the Centre of Molecular Immunology, the National Centre for Scientific Research and the National Bio-preparations Centre.

Instead of competing with each other, as might be supposed, the Pole institutions work on the basis of cooperation, and each project usually involves more than one unit.

"Nearly all the products are a result of integration, which is something that gives us an advantage over other countries," CIGB's director of Regulatory Affairs and Clinical Trials, Pedro Lopez-Saura, told IPS.

CIGB was the first institute to link up with a marketing company, Hebert Biotec, founded in 1991, which was seen as a milestone in its development. At present, each of the units is associated with a company that handles export sales, although they are all financed by the state.

CIGB, the leading institute in Cuban scientific development, has just celebrated the 20th anniversary of its foundation. Its laboratories were responsible for producing an effective vaccine against hepatitis B, a liver disease that causes 520,000 deaths a year worldwide, according to the World Health Organisation (WHO).

Heberbiovac HB, the first vaccine obtained in Cuba using molecular biology techniques, is now exported to some 20 countries, and has contributed to a considerable reduction in the incidence of the disease among Cuba's 11.2 million people.

Hepatitis B cases have fallen from over 2,000 a year before vaccination began in 1992, to less than 50 a year at present. Medical sources reported that the decline is continuing, and that the disease is likely to be eliminated.

But in Latin America, the most widely-used Cuban vaccine is VAMENGOC-BC, the only vaccine in the world against meningitis caused by serotype B bacteria, which is the predominant strain in the region.

The Finlay Institute is currently developing a vaccine against cholera bacteria, based on a Cuban attenuated strain (Tor 638) which has been genetically engineered in a novel way.

The strain has been modified so that it is still capable of generating a protective immune response, but not of causing the disease itself. The new product is administered orally in a single dose, and is now at the clinical trial stage in healthy volunteers, for safety evaluation.

Two other cholera vaccines are being developed in the Finlay Institute. One is based on inactivated strains, and the other on sub-fractions of the cholera bacterium, applying innovative molecular biology techniques. The second project is in the research and process development phase.

Other Cuban biotechnology research projects include producing vaccines against the viruses that cause hepatitis A, dengue and AIDS, the parasites causing malaria, and leptospirosis bacteria.

Exchange agreements with various countries channel the transfer of technology for producing vaccines like Heberbiovac HB and VAMENGOC-BC, thus avoiding the high prices charged by transnational laboratories.

For example, cooperation with Brazil will enable Cuba to export meningitis vaccine for mass immunisation in Africa "at competitive prices," Marcel Biato, minister counsellor of the Brazilian embassy in Havana, told IPS.

One of the latest trends in the vaccine industry, in Cuba and worldwide, is formulating combined products for immunisation. Here, the active principles of two or more vaccines already available on the market are mixed into one preparation, so that fewer injections are needed for prevention of multiple diseases.

The Finlay Institute and CIGB took up the challenge and achieved a combined vaccine against diphtheria, tetanus, whooping cough and hepatitis B, which has been introduced with good results in the National Vaccination Programme.

Since September, Cuban children have been receiving pentavalent vaccine, which protects against the four diseases named above, plus a type of bacterial meningitis caused by Haemophilus influenzae type B.

According to experts, this is the second vaccine of its kind in the world after one developed in France, and its safety has been demonstrated in trials involving 500 infants aged between six and 10 weeks.

Meanwhile, the Molecular Immunology Centre is working on eight projects to produce therapeutic agents against different types of cancer. Three of the projects are undergoing phase III clinical trials.

Phase III trials are carried out after establishing that a product has a reasonable probability of effectiveness, and the aim is to glean additional information about its effectiveness for specific indications, and more detailed knowledge of the adverse reactions associated with its use.