Global Health Challenges Spur Vaccine Development - Pharmaceutical Technology

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Global Health Challenges Spur Vaccine Development
Manufacturers fund research and reduce prices to tackle diseases.

Pharmaceutical Technology
Volume 35, Issue 10, pp. 28-36

Increased investment

Despite lingering safety issues, vaccine research and new product development is expanding, generating optimism for new discoveries that will guard against AIDS, cancer, and multiple infectious diseases. Led by the Bill & Melinda Gates Foundation, which has committed more than $10 billion to support vaccine innovation, donor nations are boosting support for global vaccine R&D. Researchers anticipate that a dozen new vaccines may be rolled out in the next decade against diseases such as typhoid, malaria, and dengue fever. Gates has signed up the world-famous Barcelona soccer team to promote polio eradication, despite fears of some health authorities that complete elimination of the disease is too difficult and costly.

The journal Health Affairs discussed strategies for achieving Gates' "Decade of Vaccines" in a special June 2011 issue that explores new vaccines in the pipeline along with new models for financing and paying for vaccine development and delivery. The promise is that investing more in immunization science and expanding vaccine distribution globally will reduce healthcare costs, promote economic activity, and save the lives of more than 6 million children through 2020.

Pharmaceutical manufacturers now regard vaccines as a potential source of steady revenue, if not blockbuster profits. The world market for preventive vaccines exceeded $20 billion in 2009 and grew to nearly $30 billion in 2010. Projections call for 10% annual growth during the next five years due to new product introductions and broader use. Expanded global production of seasonal flu vaccine is setting the pace: by 2015, WHO predicts that some 37 vaccine makers will be able to produce 1.7 billion doses of influenza vaccine, enough to handle any pandemic. Merck, GlaxoSmithKline (GSK), Sanofi Pasteur, Pfizer, and Novartis dominate the market and continue to invest in the field.

A main target of vaccine research is the development of new treatments for third-world diseases. A new meningitis A vaccine has been distributed to more than 19 million people in West Africa, providing a model for collaboration to produce and distribute a vaccine that costs less than 50 cents. Sanofi Pasteur is testing the first vaccine for dengue fever, which sickens some 2 million children a year, primarily in Latin America and Asia. Researchers have begun early clinical trials for a new vaccine for tuberculosis, with initial results expected next year. Colorado-based Inviragen is collaborating with the University of Texas and federal agencies to develop a novel recombinant chikungunya virus vaccine. Vaccines are under development for schistosomiasis, hookworm, rabies, and Ebola virus. Earlier this year, Merck and Britain's Wellcome Trust announced a joint project to design an oral rotavirus vaccine that will be cheaper and easier to use than current shots.

Several groups are working on new malaria vaccine projects. The most advanced describes dozens of vaccine candidates in development to prevent this disease. The most advanced is GSK's RTS,S vaccine candidate, now in Phase III studies in Africa under the auspices of the PATH Malaria Vaccine Initiative. In addition, the Infectious Diseases Research Institute (IDRI) is collaborating with the US Agency for International Development and the Walter Reed Army Institute of Research to develop an antimalarial vaccine that combines new antigens.

Despite numerous failures in developing an AIDS vaccine, scientists remain optimistic that success is possible. Researchers point to advances in understanding the complexities of an AIDS vaccine and are developing new vectors, delivery technologies, adjuvants, and immune assays to address these challenges. For example, the International AIDS Vaccine Initiative (IAVI), Scripps Research Institute, and several biotech companies recently reported the isolation of novel antibodies capable of neutralizing a broad spectrum of variants of HIV. Researchers were encouraged that this could provide new targets for the design of vaccine candidates that can elicit similar antibodies to protect against the virus.

New cancer vaccines are on everyone's wish list, encouraged by success in developing HPV vaccines for cervical cancer and the prostate cancer treatment, Dendreon's Provenge. A recent announcement from the Mayo Clinic in Rochester, Minnesota, cites plans for Phase I clinical trials for new vaccines to prevent the recurrence of ovarian and breast cancer.

Bioterrorism threats also are spurring vaccine development. Last year, the HHS Biomedical Advanced Research and Development Authority (BARDA) awarded approximately $50 million to organizations seeking to reduce the time and cost of testing new medical countermeasures. Projects aim to increase the shelf life of influenza vaccine stockpiles for future use in a pandemic and to develop adjuvant formulations to enhance influenza vaccine immunogenicity and cross-protection to new viral strains. BARDA is providing Emergent BioSolutions with $100 million over several years to develop a state-of-the-art production facility for its anthrax vaccine. More than $1 billion in contracts during the past six years have gone to manufacturers developing cell-based technology for seasonal influenza production, plus recombinant technology and adjuvented influenza vaccines. The expectation is that these innovations will foster development of other commercial products and medical countermeasures, such as next-generation smallpox vaccine.


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