Strategy Needed to Combat Vaccine Shortages (2002)

At a time when U.S. Department of Health and Human Services officials are debating whether and for whom to revive smallpox vaccination, there is an equally serious vaccine problem. Over the past year and a half, the U.S. supply of five vaccines against eight of the 11 vaccine-preventable diseases has proven inadequate to protect American children, said Lance E. Rodewald, MD, the Director of the Immunization Services Division of the National Immunization Program, Centers for Disease Control and Prevention. “Rationing across children is very difficult, but it is really all we have right now.” Dr. Lance Rodewald “The U.S. vaccine supply falls seriously short,” said Dr. Rodewald at a news briefing sponsored by the National Foundation for Infectious Diseases in Washington, D.C. “Children are being turned away from their doctor's office or clinic unprotected.” The CDC official said the United States has an unreliable, uncoordinated, and disjointed vaccine distribution system composed of some 35,000 private provider sites and 10,000 public clinics. The result of the unreliability, he said, is shortages. “State immunization programs have been forced to suspend the highly effective school immunization laws because of the lack of vaccine,” he said. “Parents and their children's immunization providers have been upset and disappointed over the inability to supply these vaccines.” Dr. Rodewald noted that 48 percent of states had to suspend tetanus and diphtheria vaccinations, while 10 percent had to suspend varicella vaccinations. “Rationing across children is very difficult,” he said, “but it is really all we have right now.” Short Supplies Routinely given vaccines that have been in short supply are diphtheria, tetanus, and pertussis (DTaP); tetanus and diphtheria (Td); measles, mumps, and rubella (MMR); varicella; and pneumococcal conjugate vaccines, said Dr. Rodewald. There is still a shortage of pneumococcal vaccines. Dr. Rodewald said it is vitally important to maintain records for all children who miss any dose of vaccine so they may be vaccinated when supplies return to normal. If these children continue unprotected by recommended vaccines, they put themselves and others at risk, he warned. But, he noted, records are likely to be incomplete, and “there will be a group of kids who won't have been scrutinized for vaccine status,” he said. This at-risk unvaccinated pool could become sick and infect others. Forty-eight percent of states had to suspend tetanus and diphtheria vaccinations while 10% had to suspend varicella vaccinations Dr. Rodewald said it is unfortunate that at a time when the safety profile of recommended vaccines is “incredibly high,” there should be shortages. But there is no one factor to blame, he said. “Unlike the shortages of DTP vaccine in the early to mid-1980s that had the single cause of liability, the current shortages have several different causes that vary from vaccine to vaccine and manufacturer to manufacturer,” he said. He said among the reasons for the recent vaccine shortages are these: No incentives for pharmaceutical companies to manufacture vaccines because it is more lucrative to sell prescription drugs. Insufficient stockpiles of vaccines in pharmaceutical companies. Business decisions by corporate chief executives not to manufacture vaccines. Production problems at manufacturing plants. The costs of compliance with federally required regulations on good manufacturing practices. Incentives for Manufacturers Dr. Rodewald said the General Accounting Office (GAO), a watchdog agency that reports to Congress, is currently studying the vaccine shortage problem and should issue its report soon. In addition, he said the National Vaccine Advisory Committee is studying strategies for HHS to prevent vaccine shortages in the future. The CDC official said there are a number of ways to ensure an adequate supply of U.S. vaccines, including: Creating financial incentives for research, development, production, and administration of vaccines. Streamlining the regulatory process. Expanding stockpiles of routinely recommended vaccines. Working toward better communication among key government and private sector agencies and providers with a stake in vaccine policy and practices. The National Vaccine Injury Act, which compensates those allegedly harmed by adverse effects from vaccines, went into effect in 1986, and Dr. Rodewald called it “very successful” in dealing with medical liability. He noted, however, that personal injury lawyers can find ways of going around the act through legal loopholes to gain higher court awards for clients. He said the act may need to be strengthened to provide incentives for vaccine manufacturers. For more information, call the CDC's Immunization Information Hotline at (800)232–2522 or visit its web site at www.cdc.gov/nip. Reasons for Vaccine Shortages Lack of incentives for pharmaceutical companies to manufacture vaccines because it is more lucrative to sell prescription drugs. Insufficient stockpiles of vaccines in pharmaceutical companies. Business decisions by corporate chief executives not to manufacture vaccines. Production problems at manufacturing plants. The costs of compliance with federally required regulations on good manufacturing practices.