Today, vaccines are hot. Fear of bioterrorism and pandemic influenza have boosted government funding for R&D. Hefty contributions from the Bill & Melinda Gates Foundation have fueled partnerships to develop innovative treatments for neglected diseases. New commercial products, such as Wyeth's Prevnar pneumococcal conjugate vaccine and Merck's Gardasil vaccine for HPV (human papillomavirus), are commanding premium prices in the West and seeking distribution in the third world.
The big gains in vaccine development arise from a growing number of public–private partnerships, according to experts at BIO and the International Conference on Global Health held in Washington, DC, a few weeks later. The Malaria Vaccine Initiative organized by Seattle-based PATH (formerly known as the Program for Appropriate Technology in Health) now has a candidate vaccine from GlaxoSmithKline nearing Phase III clinical trials. PATH's Meningitis Vaccine Project is even further along, closing in on its goal to develop a low-cost vaccine (in the range of 40 cents a dose) to prevent the meningitis epidemics that plague Africa. Phase II trials have been so successful that the sponsors expect to move directly into large-scale production next year. The Aeras Global TB Vaccine Foundation is working with the Dutch biotech Crucell NV to utilize its advanced vector and large-scale cellular production systems to develop effective treatments.
Preparedness and Defense
Project BioShield also is providing R&D support for new vaccines for anthrax and smallpox, among other treatments. A sign of success is the recent contract to purchase millions of doses of a new, safer smallpox vaccine from Bavarian Nordic of Denmark. The Biomedical Advanced Research and Development Authority (BARDA), established in April, is implementing new policies to extend federal support for testing and developing medical countermeasures. FDA also has finalized guidance for developing seasonal and pandemic influenza vaccines, which describes pathways for accelerated approval of new products in case of emergency or shortage.
While vaccine R&D may have many rewards, the risks continue to rear up. MedImmune has run into trouble with FDA over manufacturing violations for FluMist. Merck's rollout of its HPV vaccine was marred by opposition to proposed vaccination mandates. FDA has raised safety concerns about Dendreon's Provenge that will delay approval of this new prostate cancer treatment vaccine at least another year. Continued litigation over an alleged vaccine–autism link threatens to deplete federal vaccine compensation funds and industry resources.