Professor Kalil described how Brazil has become an international reference in immunization. The national immunization program, PNI, founded in 1973, eradicated smallpox locally, and controlled polio and measles. It has brought neonatal and accidental tetanus numbers down, as well as TB, diphtheria, pertussis, hepatitis B, influenza and pneumococcal disease. Additionally, 77% of biologics are produced in Brazil, and Brazil has about 300 million vaccinations per year. Bhutantan is a public institution of the state government of Sao Paolo, and was established in 1901 to make serum against bubonic plague and snakebites. Currently their work focuses on producing vaccines, antivenoms, and antitoxins. The private market in Brazil is very small. Butantan has 56% of market share of antivenom/antitoxin production in Brazil, as of 2010.
They coordinate with various institutions for development and production of vaccines for different pathogens and diseases: NIH-PATH (rotavirus), NIH-DVI (dengue), Sabin (Necator, Schistosoma), PATH Children’s Hospital Harvard (Pneumococcus), IDRI (visceral leishmaniasis), etc. Some examples of recent innovations include:
â¢ Pertussis(low) vaccine – through new vaccine production techniques, they have reduced the LPS content, and are starting Phase I clinical studies this year.
â¢ BpMPLA (Monophosphoryl lipid A) – an adjuvant under production. Clinical trials are underway using this agent for pandemic influenza H1N1 and others are planned.
â¢ OncoBCG – a neonatal vaccine for bladder cancer. Recombinant BCG-pertussis . express the S1 subunit of pertussis toxin. There is data showing protection in a mouse model.
â¢ Silica SBA-15 – This is an immunogenic complex formed by vaccine antigens encapsulated by nanostructured mesoporous silica, with hexagonal porous uniformity, size 3.1-6.5nm. It features thermal and hydrothermal stability, and exhibits potential applications for selective adsorption and catalysis.
â¢ Pentavalent rotavirus vaccine – While Brazil is already using the vaccine from GSK, they are working with the NIH to focus on G1-G4, G9 serotypes which are important in Brazil. They produce the vaccine in Vero cells. Phase I results show safety and immunogenicity.
â¢ Dengue vaccine – There is a collaboration with the NIH, DVI (Steve Whitehead) and BNDES/ FAPESP. For this vaccine, the attenuated backbone is the dengue virus itself, which may be more effective in vaccinations. Phase II trials should begin in 2012 or 2013, and it also uses Vero cell technology.
While they are primarily focused on the Brazilian market, there are many potential applications for uses outside of the country.
Check back here in a couple of days for the full presentation. Excellent presentation Pro Kalil!