The Promise and Perils of Vaccines - Vaccine research and development is surging, but continues to face manufacturing and regulatory challenges. - BioPharm International

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The Promise and Perils of Vaccines
Vaccine research and development is surging, but continues to face manufacturing and regulatory challenges.


BioPharm International
Volume 22, Issue 12


Jill Wechsler
The vaccine business is booming, spurred by worldwide efforts to halt the AIDS epidemic and to contain the global influenza pandemic. Government agencies have rushed to place orders for millions of H1N1 flu vaccine doses, prompting manufacturers to ramp up production along with investment in R&D. 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 third-world nations. Since 2000, the global vaccine market has almost tripled to reach more than $17 billion (2008) and is projected to top $20 billion by 2012. Yet, delays in producing the millions of doses needed to prevent a worldwide influenza pandemic this winter raised questions about continued reliance on decades-old production methods and on private-sector manufacturers.

ROBUST PIPELINE

The good news is that a record 120 vaccines now are available to meet the health needs of people all over the world, and a significant number of vaccine candidates are moving through the research pipeline. Over 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 released in October by the World Health Organization (WHO) and UNICEF. The surge in vaccine R&D over the past decade has produced new vaccines for meningococcal meningitis, rotavirus diarrheal disease, pneumococcal disease, and cervical cancer caused by human papillomavirus (HPV). The PATH Malaria Vaccine Initiative recently announced Phase 3 trials for a promising, but only partially effective, anti-malarial vaccine developed by GlaxoSmithKline (GSK), plus plans to continue the search for a more effective, four-year preventive. Merck has linked up with Britain's Wellcome Trust to develop more affordable and heat-stable vaccines for third-world countries.

There's also progress on the HIV/AIDS vaccine front, despite initial reports that over-hyped the benefits of an AIDS vaccine being tested in Thailand. Analysis of data indicated a low infection rate among 16,000 participants; the results were inconclusive, but generated optimism that they may provide insight that will lead to a preventive against AIDS infection.

The increasingly healthy vaccine business is attracting more Big Pharma investment. Johnson & Johnson has linked up with Crucell NV of Holland to jointly develop vaccines. Abbott Laboratories is buying Solvay's vaccine and drug business, and Pfizer's acquisition of Wyeth makes it a lead player in the field. Sanofi-Aventis CEO Chris Viehbacher recently announced plans to double the company's vaccine business over five years. These companies may be interested in products like the anti-smoking vaccine NicVAX being developed by Nabi BioPharmaceuticals with support from the National Institute on Drug Abuse. Moreover, the search for cancer vaccines is going strong, supported by the FDA draft guidance on how to conduct clinical trials to test new vaccines to treat cancer.

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 the WHO report. Global immunization has reached 82%, up from only 20% coverage in 1980. But international health officials warn against complacency. They note that about 24 million children still do not receive routine vaccines, a shortfall that would cost just $1 billion more a year to address. The Global Alliance for Vaccines and Immunization strives to fill the gaps, currently with a campaign to immunize 130 million children against pneumonia with Hib and pneumococcal vaccines.


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