Overcoming the Complexity of Vaccine Development for Global Health

Trevor Mundel, MD, PhD
President, Global Health Program
Bill and Melinda Gates Foundation

Worldwide, immunization coverage has never been higher and vaccines are saving more lives than ever.  Yet every 20 seconds a child still dies from a disease that could be prevented by a vaccine.

Overwhelmingly, the burden of infectious diseases continues to fall on poor countries, in part because the technology hurdles associated with producing vaccines for developing countries are much higher than in wealthy countries.

Not only must vaccines for the developing world be safe and effective.  They must also be affordable, and possess other attributes essential for low-infrastructure settings, including single-dose efficacy, thermostability, ease of administration, prolonged shelf life, and low-volume packaging.

Often, innovations in these areas occur incrementally.  The new ROTAVAC rotavirus vaccine, which recently concluded successful Phase III clinical trials in India, is expected to have enormous life-saving potential—preventing up to 100,000 child deaths a year from the predominant strain of rotavirus.  Scientists are now working on a second-generation rotavirus vaccine with enhanced thermostability and greater ease of administration.

Building on the success of a three-in-one vaccine for diphtheria, whooping cough, and tetanus, a five-in-one vaccine added protection against two other deadly diseases, hepatitis B and Haemophilus influenzae type B (which causes meningitis and pneumonia).

A six-in-one vaccine, which also immunizes against polio, is available in some markets.  And researchers have now set their sights on an eight-in-one vaccine that would add protection against pneumococcal disease and rotavirus.

Innovative partnerships with vaccine manufacturers are also critical in getting life-saving vaccines to children in developing countries.  A nearly two-thirds drop in the cost of the five-in-one vaccine, for example, has led to an 18-fold increase in the number of children reached.

Research breakthroughs, such as high-throughput DNA sequencing technologies and advances in structural biology, also have the potential to help scientists accelerate the development of effective prevention and treatment measures for global health.

The biopharmaceutical company Atreca is working on a platform to identify the antibodies produced in humans during immune responses, which can be useful in creating new vaccines, drugs, and diagnostics to tackle infectious diseases like tuberculosis, HIV, and malaria.  And advances producing human antibodies in mice (known as transgenic platforms) hold promise for accelerating vaccine development by informing the design of vaccines for humans.

Other areas of promise include enabling technologies that decrease production costs of vaccines and other biopharmaceutical products, and computer simulations that help increase mammalian cell culture-based production.

With more of the right investments, we have the potential within a generation to create a more equitable world where all people have the opportunity to build a healthy and productive life.