NEW VACCINE TECHNOLOGIES: PROMISING ADVANCES MAY SAVE MORE LIVES

In the past 20 years, immunization has prevented nearly 20 million deaths from vaccine-preventable infections. Despite this success, poorer countries often lack access to newer and more expensive vaccines, and vaccines are not yet available for many illnesses. PATH is working to narrow the immunization gap between developed countries and developing countries by increasing the availability of existing vaccines, reducing the lag time for adoption of recently-licensed vaccines, developing technology in support of vaccines and immunization (e.g. vaccine vial monitor, Uniject, vaccine stabilization platforms) and working with partners to develop new vaccines. Vaccine development is expensive and manufacturers often focus on products for wealthy countries. To remedy this, PATH partners with industry, researchers, and governments worldwide to develop vaccines that meet the unique needs of low-resource countries. PATH is developing new vaccines for malaria, meningitis, and influenza, as well as common illnesses like diarrhea and pneumonia—two leading causes of death for children under five. Current disease targets for new vaccine development are: P. falciparum, N. meningitides Group A, influenza (seasonal and pandemic), rotavirus, enterotoxigenic E. coli, Shigella species, and the pneumococcus. New technologies offer new hope for safe, effective, affordable, and accessible vaccines to better fight these illnesses. From novel vaccine approaches to new delivery methods and improved additives, PATH is accelerating a wide spectrum of technological innovations to help the people who need vaccines most urgently

Efficacy of a monovalent human-bovine (116E) rotavirus vaccine in Indian children in the second year of life

Rotavirus gastroenteritis is one of the leading causes of diarrhea in Indian children less than 2 years of age. The 116E rotavirus strain was developed as part of the Indo-US Vaccine Action Program and has undergone efficacy trials. This paper reports the efficacy and additional safety data in children up to 2 years of age. In a double-blind placebo controlled multicenter trial, 6799 infants aged 6-7 weeks were randomized to receive three doses of an oral human-bovine natural reassortant vaccine (116E) or placebo at ages 6, 10, and 14 weeks. The primary outcome was severe (≥11 on the Vesikari scale) rotavirus gastroenteritis. Efficacy outcomes and adverse events were ascertained through active surveillance. We randomly assigned 4532 and 2267 subjects to receive vaccine and placebo, respectively, with over 96% subjects receiving all three doses of the vaccine or placebo. The per protocol analyses included 4354 subjects in the vaccine and 2187 subjects in the placebo group. The overall incidence of severe RVGE per 100 person years was 1.3 in the vaccine group and 2.9 in the placebo recipients. Vaccine efficacy against severe rotavirus gastroenteritis in children up to 2 years of age was 55.1% (95% CI 39.9 to 66.4; p<0.0001); vaccine efficacy in the second year of life of 48.9% (95% CI 17.4 to 68.4; p=0.0056) was only marginally less than in the first year of life [56.3% (95% CI 36.7 to 69.9; p<0.0001)]. The number of infants needed to be immunized to prevent one episode of severe RVGE in the first 2 years of life was 40 (95% CI 28.0 to 63.0) and for RVGE of any severity, it was 21 (95% CI 16.0 to 32.0). Serious adverse events were observed at the same rates in the two groups. None of the eight intussusception events occurred within 30 days of a vaccine dose and all were reported only after the third dose. The sustained efficacy of the 116E in the second year of life is reassuring

Team science and the creation of a novel rotavirus vaccine in India: a new framework for vaccine development

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