In this issue:

 

 

 

 

 

 

Welcome to the first installment of Vaccines for the Future, featuring updates from PATH’s vaccine development program. In the year and a half since PATH launched this effort, we have established a solid foundation for the development of new, appropriate vaccines for children in the developing world. Our goal is to accelerate the development of life-saving vaccines for pneumococcal and diarrheal disease, which kill over a million children each year in the developing world.

 

We look forward to bringing you information about our projects and progress in the vaccine development program at PATH.

 

Sincerely,

 

John W. Boslego, MD

Director, Vaccine Development Program

PATH

 

 

 

 

 

Developing new vaccines against diarrheal disease

This month, PATH is launching a new project to protect infants and children in low-resource countries by advancing development of safe, affordable, and effective new vaccines targeted against two of the most important bacteria that cause diarrheal disease. We will collaborate with a number of private- and public-sector partners to advance the development of promising vaccines against the leading bacterial causes of diarrheal disease: Shigella and enterotoxigenic Escherichia coli (ETEC). During the month of October, we will issue a Request for Proposals for vaccine discovery and development projects and research activities in support of vaccine development.

 

We are pleased to welcome Dr. Richard Walker as the director of this project, the Enteric Vaccine Initiative. Dr. Walker has over 25 years experience in vaccine development at the Naval Medical Research Institute—where he directed the enteric diseases program, the Armed Forces Radiobiology Research Institute, and Antex Biologics, Inc. For the past seven years, he has served as Director, Division of Bacterial, Parasitic, and Allergenic Products at the US Food and Drug Administration.

 

 

 

 

 

Ramping up against rotavirus 

PATH is working to advance development of two new rotavirus vaccines. In collaboration with the US National Institutes of Health and Dr. Al Kapikian, PATH is providing a “shared technology platform” to seven manufacturers developing a human bovine reassortant vaccine. Manufacturers can access a host of technologies, training, and common technical support that will help to maximize the production capacity and global availability of rotavirus vaccine. In addition, we are directly partnering with two manufacturers—Shantha Biotech in India and the Wuhan Institute of Biological Products in China—to provide financial support and developmental assistance to accelerate development and clinical trials of the human bovine reassortant vaccine.

 

For the past five years, PATH has been part of a collaborative effort with Bharat Biotech International (BBIL), the government of India, and leading experts in the rotavirus field to develop the 116E vaccine. PATH is working with BBIL and an expert consultative group on the Phase 1/2 clinical trials of the 116E vaccine now underway. 

 

In addition to these efforts to develop new vaccines, the PATH Rotavirus Vaccine Program is working with the GAVI Alliance, the World Health Organization, and the US Centers for Disease Control to help countries access and afford the currently licensed vaccines.

 

 

 

 

 

Expanding protection against pneumonia

PATH is pursuing a number of approaches to develop pneumococcal vaccines that will be effective and affordable in the countries that most urgently need them. We partner with scientists and manufacturers from initial discovery through clinical trials to shorten the development timeline. Currently, PATH is working with Intercell AG, an Austrian biotechnology firm, on preclinical development of their common protein vaccine, and Children’s Hospital Boston on an inactivated whole cell vaccine approach. We recently issued a Request for Proposals to support development of additional vaccine candidates and other research efforts to advance the pneumococcal field, and we anticipate beginning additional partnerships by the end of this year.

 

 

 

 

 

Assessing influenza vaccine needs

In response to widespread concern that the highly pathogenic avian influenza strain could evolve into one readily transmitted among humans, PATH is conducting an analysis of influenza vaccine supply and demand as well as a technical evaluation of influenza vaccine technologies. The analysis, conducted in conjunction with Oliver Wyman, Inc., highlights vaccine supply gaps and identifies promising new approaches for development of new influenza vaccines. Because most currently available influenza vaccines are egg-based, if the avian flu becomes a pandemic strain, decimated poultry flocks could make vaccine supplies even more constrained—underscoring the need for innovative vaccine technologies.

 

 

 

 

 

 

 

 

PATH’s vaccine development program is working to accelerate development of innovative, safe, effective, and affordable vaccines for the diseases that are the leading causes of childhood deaths in the developing world: pneumococcal disease, diarrheal disease, and influenza. PATH is also partnering on vaccine development through its Malaria Vaccine Initiative and the Meningitis Vaccine Program. The work of the vaccine development program is currently supported by grants from the Bill & Melinda Gates Foundation.