Not long ago, vaccines were Big Pharma's neglected stepchild—cheap, one-time treatments that scarcely made a profit. The pharmaceutical
industry was moving away from them in a hurry.
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.
These trends were visible at the May annual meeting of the Biotechnology Industry Organization (BIO), which highlighted vaccine
development and global health initiatives. A sign of the times: At the event, BIO announced plans to sponsor an annual conference
called Partnering for Global Health, starting next year, to build on private-sector expansion in this area.
Investing in Vaccines
Pharma companies traditionally have promoted third world health by donating drugs that often were discovered by chance (see
"Fighting River Blindness"). Today, third world product development is "a strategic responsibility" for industry, said Genzyme
Senior Vice President James Geraghty. Finding new medical solutions for third world killers can benefit a company's basic
development program and also provide a valuable psychological boost for employees, he explained. But while hundreds of new
drugs are in development to treat cancer, asthma, and other conditions prevalent in the West, pharma is supporting relatively
few for third world diseases, Geraghty added.
Fighting River Blindness
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
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.