How it began
Outbreaks of meningococcal disease began in Cuba in 1976 and grew into an epidemic. By 1980 incidence reached 5.9 cases per 100,000 people, about 80 percent of them caused by serogroup B, and health authorities declared the disease the main public health problem of the country. Cuban scientists at the National Center for Meningococcal Vaccine Development in Havana, the forerunner of the Finlay Vaccine Institute, developed a vaccine against serogroups B and C between 1980 and 1986. It was field tested from 1987 to 1989.
Before it existed
At the time, no vaccine had proven efficacy against serogroup B of Neisseria meningitidis, and no candidate looked likely to succeed in the short term. In Cuba several provinces reported more than 120 cases per 100,000 children under one year old, almost all from serogroup B. By 1984 overall incidence had risen to 14.4 per 100,000 people.
How it works
The vaccine is built on outer membrane vesicles, also called proteoliposomes, taken from the bacterium. These vesicles are the basic structure that makes the vaccine able to raise a protective immune response. According to a review in MEDICC Review, this was the first time vesicle technology was used in vaccine production.
How it spread
In 1989 and 1990, 2.4 million children in the state of São Paulo, Brazil, received two doses. Other countries and regions later adopted the vaccine. More than 60 million doses have been given in Latin America. The United States approved its first serogroup B meningococcal vaccine in 2014.
What changed first
A randomized, double-blind, placebo-controlled trial from 1987 to 1989 covered 106,251 young people aged 10 to 16 in seven provinces and estimated efficacy at 83 percent. The vaccine was used in a mass campaign and joined the National Immunization Program in 1991. Annual incidence fell to 1 per 100,000 or less in 1993. In 1989 the World Intellectual Property Organization gave its gold medal to the main authors of the patent.
Where it stands today
Incidence in Cuba has stayed below 0.1 per 100,000 people since 2008, and the cumulative effect on serogroup B disease is estimated at 95 percent. The disease is no longer a public health problem in the country. The review describes the vaccine as the most widely applied against serogroup B disease and notes continued interest in its vesicle technology for other vaccines and adjuvants.