Is the Vaccine Industry Ailing? Expert at The Children's Hospital of Philadelphia Analyzes Why Manufacturers Have Abandoned Vaccines

05/10/2005

PHILADELPHIA, May 10 /PRNewswire/ -- Recent shortages of vaccines, most
recently the flu vaccine during the past winter, are not short-term glitches - they reflect long-term problems in the vaccine industry. A variety of social, legal and economic forces have caused pharmaceutical companies to withdraw
their commitment to vaccines, according to pediatrician and vaccine expert Paul A. Offit, M.D., chief of Infectious Diseases at The Children's Hospital of Philadelphia.

In a commentary article in the May/June issue of "Health Affairs," Dr. Offit analyzes why pharmaceutical companies have abandoned vaccines, and urges
legislators to protect vaccines as a vital instrument of public health.

The number of companies making vaccines has declined from 26 in 1967, to
17 in 1980, to just five in 2004. Although some of these changes result from
mergers among pharmaceutical companies, for the most part, says Dr. Offit, a series of events has made the manufacture of vaccines more expensive, and their sale less profitable.

To begin with, the market for vaccines is small compared to that for drugs. “Vaccines are used at most several times in a lifetime; drugs are often used every day," writes Dr. Offit. He cites the vaccine against pneumococcal disease in children, which has annual U.S. gross sales of about $1 billion, the highest revenue generated by a vaccine. In contrast, markets for cholesterol-lowering agents, hair loss products, potency drugs, or drugs for heart disease or obesity are often $7 billion or more per drug.

Furthermore, larger pharmaceutical companies have acquired firms that
previously had vaccines as their sole or primary product. So in competing against drugs for a company's internal resources, vaccines most often lose. Among the four large pharmaceutical companies still making vaccines, says Dr. Offit, vaccines bring in 6 percent or less of their total revenue. "All four companies could stop making vaccines tomorrow without much impact on their bottom lines," he writes.

Other market forces have made vaccines less profitable. Fifty years ago, a large private market of doctors purchased polio vaccines. Today the federal government's Vaccines for Children Program is the largest single purchaser of vaccines. That program, Dr. Offit notes, creates a functional cap on vaccine prices, and also shrinks the private market - which today is mostly insurance companies.

Insurance companies, for their part, often provide low or inconsistent reimbursement to physicians for vaccines. Neither insurance companies nor the government support the infrastructure needed to schedule appointments, keep records, and hire nurses to administer vaccine shots. Broader public support for vaccines, best exemplified in the great polio vaccination campaigns of the 1950s, has declined, while anti-vaccine organizations have grown.

Finally, product liability lawsuits have sharply raised costs to vaccine manufacturers. A 1986 lawsuit claiming that pertussis vaccine caused paralysis
in a child yielded a jury award of $1.1 million - more than half of the entire
market for pertussis vaccine at the time. Although no scientific evidence backed the claim that pertussis vaccine caused paralysis, writes Dr. Offit, liability costs have caused pharmaceutical companies to flee the vaccine business.

The Vaccine Injury Compensation Program, which Congress authorized in 1986 to compensate families whose children were injured by vaccines, reduced some financial pressure on vaccine manufacturers. However, says Dr. Offit, flaws in this program limit its effectiveness. Families can choose to opt out of the program and proceed to a jury trial, the program does not cover all vaccines, and it does not cover effects on an unborn child when the mother is vaccinated. Fearful of litigation, no pharmaceutical company is willing to
produce a vaccine known to protect newborns from a group B streptococcus
infection, a disease that kills 100 U.S. newborns each year.

Dr. Offit recommends that Congress take steps to increase vaccination coverage by offering financial incentives to manufacturers and healthcare professionals. He also urges correcting weaknesses in the National Vaccine
Injury Compensation Program to lower the costs of vaccine production. Finally,
he proposes that public-private partnerships could improve vaccine
development. One successful historical model, the March of Dimes, drew on a
private national foundation that funded research and large clinical trials, and culminated in the eradication of polio in the United States.

"The technology is in hand to prevent many infections that routinely hospitalize and kill people in the United States and the world," he concludes. What is needed, he says, are social and political commitments to use that technology to its best advantage.

About the author: Paul A. Offit, M.D. is chief of Infectious Diseases at The Children's Hospital of Philadelphia and the Henle Professor of Immunologic
and Infectious Diseases at Children's Hospital and the University of Pennsylvania School of Medicine. As a researcher, he has developed a vaccine
for rotavirus, the leading worldwide cause of infant deaths from infectious disease. He also is director of the Hospital's Vaccine Education Center, which provides up-to-date, reliable information about vaccines to thousands of parents and healthcare professionals throughout the United States. Dr. Offit is a former member of the Advisory Committee on Immunization Practices, the federal panel that provides vaccine advice to the Centers for Disease Control and Prevention. He also sits on the advisory board of the Global Alliance for Vaccines and Immunization. He is the co-author of a book for parents, "Vaccines: What You Should Know," now in its third edition.

About The Children's Hospital of Philadelphia: The Children's Hospital of
Philadelphia was founded in 1855 as the nation's first pediatric hospital. Through its longstanding commitment to providing exceptional patient care, training new generations of pediatric healthcare professionals and pioneering major research initiatives, Children's Hospital has fostered many discoveries that have benefited children worldwide. Its pediatric research program is among the largest in the country, ranking second in National Institutes of Health funding. In addition, its unique family-centered care and public
service programs have brought the 430-bed hospital recognition as a leading
advocate for children and adolescents. For more information, visit http://www.chop.edu.

Contact: Rachel Salis
Phone: (267) 426-6063
salis@email.chop.edu