Study reveals gaps in vaccine program
 

ANN ARBOR, Mich., Feb 04, 2003 (United Press International via COMTEX) -- A new study examining a shortage of the vaccine that prevents meningitis and pneumonia has revealed gaps in the nation's immunization system that leave thousands of children vulnerable to preventable, potentially devastating illnesses, researchers said Tuesday.

The heptavalent pneumococcal conjugate vaccine -- also known as Prevnar -- was recommended for all children under age 2 by the Centers for Disease Control and Prevention in 2000.

"The most interesting thing is that at a time of a vaccine shortage, the shortage has varied from state to state," said Dr. Gary Freed, director of the division of general pediatrics at the University of Michigan and lead author of the study, to be published in the Feb. 5 issue of the Journal of the American Medical Association.

The research analyzed stock shortages of the vaccine in 12 states, chosen for the study because their participation in the federal Vaccines for Children program. VFC provides free vaccines for children who are enrolled in Medicaid, are uninsured or are Alaskan or American natives.

Other states have universal purchasing plans that cover vaccines for all children in their jurisdictions or leave responsibility for buying vaccines for their privately insured patients to physicians.

A total of 405 practices in California, Florida, Kansas, Kentucky, Louisiana, Maryland, Michigan, New York, Oregon, Pennsylvania, Texas and Wisconsin participated in the study. A little over half of those practices reported Prevnar shortages for public health patients -- a shortage defined as being out of stock at least once during 2001. About 64 percent reported they ran out of private stocks at least once that same year, according to the study.

Disparities between which stock -- private or public -- ran out more often varied by state. Researchers found two out of the 12 states were low more frequently on public Prevnar supplies. In six states, private supplies ran out more than public.

The study reports shortage times lasting between one week and two months. Some study participants said they borrowed from public supplies when private supplies were down, and vice versa.

"Physicians have to keep two supplies of vaccines," Freed told United Press International. The type of insurance a child is covered by affects whether he or she has access to the vaccine, he added.

"That's the new wrinkle in the vaccine system that we have," Freed noted.

To iron this wrinkle, Freed suggested states work more closely with the CDC in Atlanta, which runs the National Immunization Program. He also said the CDC could help states develop a more equitable program.

CDC officials did not return UPI's calls for comment by press time.

The private sector also could help resolve the shortage issue by encouraging a healthier vaccine industry, which suffers because of liability issues and low profit margins, Freed said.

"Prevnar has been in short supply almost since it came out," he said, adding that actual demand exceeded the expected demand.

The study was completed at the end of 2001 but the shortage continues, physicians said.

"This morning, I was in my practice seeing patients and we had VFC supply but no Prevnar in the commercial supply," said Dr. Mark Weissman, chief of general pediatrics and community health at Washington's Children's National Medical Center.

Regulations in the nation's capital require physicians to record every dose that goes out and to whom, allowing no dipping into the public supply to make up for shortages in the commercial supply, Weissman said.

To adjust for the shortage, the CDC revised its recommendations made in 2000 on how many doses should be given and to whom.

However, Weissman said the system and shortage still affect hundreds of patients in his practice every year.

"Kids in need go without," he said. "Recommendations (to vaccinate only the most vulnerable) don't help when we have zero vaccine."

Part of the problem, Weissman noted, is the supply system is not coordinated.

"While the policy to immunize kids and adults is federal, the vaccine supply is private," he said. "There's no direct government control over vaccine production."

Someone is going to get sick with a preventable disease and the illnesses Prevnar shields against can have lifelong, profound complications, Weissman said.

Dr. Charles Prober, professor of pediatrics at Stanford University in Palo Alto, Calif., said a contributor to the manufacturing slowdown has been the beefing up of efforts by the U.S. Food and Drug Administration to enforce drug "good manufacturing practices," which control the quality of packaging, storing, labeling and other manufacturing processes.

While the vaccine system and manufacturers play catch up, an additional challenge will be for physicians to track who has been vaccinated and who has not, Prober said.

However, Prober told UPI, the shortages in the past have been resolved and the current one is in the road to resolution.

Doug Petkus, spokesperson for Wyeth, Madison, N.J., the company that manufactures Prevnar, told UPI the vaccine is difficult to make, taking nine months to produce one batch.

Wyeth hopes to resolve the shortage issue by the end of the year, Petkus said.

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(Reported by Christine Suh, UPI Science News, in Washington)

Copyright 2003 by United Press International.