What's the issue? Access to Affordable Haemophilus influenzae type B (HiB) Vaccines[i]

Haemophilus influenzae type B, or Hib, is a bacterium estimated to be responsible for some three million serious illnesses and over 350,000 deaths per year, chiefly through meningitis and pneumonia. Almost all victims are children under the age of five, with those between four and 18 months of age especially vulnerable.

Hib meningitis is a more serious problem in developing countries, with mortality rates several times higher than seen in developed countries; it leaves 15 to 35% of survivors with permanent disabilities such as mental retardation or deafness.

However, Hib is preventable — highly effective vaccines have been available since the early 1990’s. Yet hundreds of thousands of children die year after year from Hib disease. One major reason is that the Hib vaccine is significantly more expensive than other childhood vaccines; for a low and middle income country the Hib vaccine costs roughly seven times the cost of vaccines against measles, polio, tuberculosis, diphtheria, tetanus, and pertussis combined (about $7 USD versus $1 USD).

 

Cuban Research, Development and Distribution of Vaccines and Biologicals – Capturing the Entire Supply Chain 

In Cuba, national research and policy organizations have joined forces to implement an integrated strategy governing vaccines from the development stage to the distribution stage. This strategy brings together institutions involved in every life stage of a vaccine (including government ministries, clinical research organizations, support institutions and manufacturing facilities)[ii].

Cuba has invested heavily in training programs and facilities to support integrated research and production systems for biotechnology. In particular, the Center for Genetic Engineering and Biotechnology (CIGB) is a leading Cuban institution dedicated to research, development, production and commercialization of vaccines and biologicals (i.e. antibiotics.). It has over 15 years of experience in clinical research for vaccine development and enjoys a close relationship with the Cuban health system. The Center currently exports 12 products to over 44 countries[iii].

As a result of its integrated vaccine strategy, Cuba has overcome many of the barriers to vaccine research and distribution in middle and low income countries. Thanks to the development of capacities and facilities to internalize the entire supply chain of vaccines, Cuba has been able to develop various vaccines and antibiotics at low cost while ensuring distribution of these life-saving advances throughout the country.

Research to Practice: Development and Distribution of the HiB Vaccine in Cuba

In 1999, the first commercial vaccine containing a synthetic carbohydrate antigen was developed in Cuba against Hib. This vaccine, Quimi-Hib® (Heber Biotech), exhibits several advantages over naturally-derived vaccines, such as:

·        Lower production costs compared with conventional vaccines

·        Controlled production of a homogeneous, single compound

·        Minimal batch-to-batch variability during the manufacturing process

·        Higher quality control standards compared with naturally-derived agents[iv]                

In clinical trials, also conducted in Cuba, researchers found that the HiB vaccine provides protection to nearly 100 percent of immunized infants after primary vaccination and a second booster dose. Additionally, clinical trials showed the vaccine to be very safe[v].This lower-cost alternative provides access to the Hib vaccine for those who otherwise would not have been able to afford it.

In 2004, Quimi-Hib® became part of Cuba’s national vaccination program.

Today, Quimi-Hib is being produced in Cuba in a new modern plant at CIGB that has been outfitted with state-of-the-art technology. The plant was designed to produce enough doses to immunize all children in Cuba with the capacity to eventually produce doses for export to other countries.

What’s Next? Overcoming barriers to vaccine development  

The CIGB has also participated in technology transfers, sharing knowledge and scientific protocols with Brazil, China, Vietnam and Iran. Investigators continue to research and develop vaccines and antibiotics to fight various diseases such as Hepatitis A, B and C, Dengue, Malaria, Chagas and Cholera[iii].

However, Cuba (along with many other countries around the world) still faces many barriers to vaccine development and distribution including:

1. High (and increasing) development costs
2. Long development timeframes
3. Patent periods
4. Restrictive regulatory environments
5. Insufficient industrial capacity

Continued biological and health delivery research will help to address some of these barriers and ensure the distribution of important vaccines and biologicals around the globe.

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References:

[i] Information from the World Health Organization Website: http://www.who.int/mediacentre/factsheets/fs294/en/

[ii] Akira Homma, José Luis di Fabio1 y Ciro de Quadros. Los laboratorios públicos productores de vacunas: el nuevo paradigma. Rev Panam Salud Publica/Pan Am J Public Health 4(4), 1998

[iii] Centro de Ingenieria Genetica y Biotecnologia (Center for Genetic Engineering and Biotechnology):

http://www.cigb.edu.cu/ (Spanish)

http://www.cigb.edu.cu/index.php?lang=english (English)

[iv] Astronomo, RD & DR Burton. 2010. Carbohydrate vaccines: developing sweet solutions to sticky situations? Nature Reviews Drug Discovery 9, 308-324.

[v] Verez-Bencomo, V. et al. A synthetic conjugate polysaccharide vaccine against Haemophilus influenzae type b. Science 305, 522–525 (2004).