Manufacturers Look to Vaccines for Growth and Innovation

Vaccine R&D is surging, but continues to raise manufacturing and regulatory challenges.
Feb 02, 2010
Volume 34, Issue 2

Jill Wechsler
The vaccine business is booming, spurred by worldwide efforts to contain the global influenza pandemic and to halt the spread of AIDS and other lethal infectious diseases. National health agencies ordered millions of H1N1 swine-flu vaccine doses in 2009, prompting manufacturers to ramp up production as well as investment in research and development (R&D). Since 2000, the global vaccine market has almost tripled to reach as estimated $20 billion. Yet, delays in producing the huge quantities of requested pandemic flu vaccine has raised questions about continued reliance on decades-old vaccine production methods and delivery technologies.

Robust pipeline

The good news is that a record 120 vaccines are now available to meet the health needs of people all over the world, and a significant number of vaccine candidates are moving through the R&D pipeline. More than 80 new products are in late-stage clinical testing, including some 30 that target untreated diseases, according to the "State of the World's Vaccines and Immunization" report published in October by the World Health Organization (WHO) and UNICEF.

In Washington This Month
The surge in vaccine development during the past decade has produced new vaccines for meningococcal meningitis, rotavirus diarrheal disease, pneumococcal disease and cervical cancer caused by human papillomavirus (HPV). Public-private partnerships, many funded by the Bill & Melinda Gates Foundation, are developing vaccines to counter infectious diseases that kill or disable millions of people in developing nations.

The PATH Maleria Vaccine Initiative recently announced Phase III trials for a promising antimalarial vaccine developed by GlaxoSmithKline (GSK, London), plus plans to continue the search or more effective preventives. Merck & Co. (Whitehouse Station, NJ) has linked up with Britain's Wellcome Trust to develop more affordable and heat-stable vaccines for developing countries. In addition, an initiative to develop a vaccine against Dengue fever reports several candidates ready for Phase II and III clinical trials.

There's also progress on the HIV/AIDS vaccine front, despite a let-down following initial reports last year that overhyped the benefits of an AIDS vaccine tested in Thailand. Early data indicating a low infection rate among some 16,000 participants proved to be inconclusive, but still generated optimism about moving forward research for a preventive against AIDS infection.

The burgeoning vaccine business is attracting more Big Pharma investment. Johnson & Johnson (New Brunswick, NJ) recently linked up with Crucell NV (Leiden, The Netherlands) to develop vaccines. Abbott Laboratories (Abbott Park, IL) is purchasing Solvay's (Brussels) drug and vaccine business to expand its presence in the global vaccines market. Pfizer's (New York) recent acquisition of Wyeth (Madison, NJ) makes it a lead player in the field. Sanofi-aventis (Paris) aims to double the firm's vaccine business over the next five years, according to CEO Chris Viehbacher. GSK is investing $40 million in an antismoking vaccine under development by Nabi BioPharmaceuticals (Rockville, MD). And Merck recently hired Julie Gerberding, former director of the US Centers for Disease Control and Prevention (CDC), to reinvigorate its vaccines division. Moreover, the search for cancer vaccines is going strong, supported by draft guidance from the US Food and Drug Administration on how to conduct clinical trials to test new therapies designed to simulate an immune response against tumors.

Although much of the growth in vaccine sales reflects purchases of newer, more costly products in western countries, the market expansion also supports higher immunization rates around the world. A record 106 million children were administered the traditional roster of childhood vaccines in 2008, according to WHO. Global immunization has reached 82%, up from only 20% coverage in 1980. But international health officials warn that about 24 million children still do not receive routine vaccines, a shortfall that would cost just $1 billion more per year to address. The Global Alliance for Vaccines and Immunization (GAVI), a public-private partnership, strives to fill the gaps and is currently running a campaign to immunize 130 million children against pneumonia with Haemophilus influenzae type b (Hib) and pneumococcal vaccines.

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