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FORUMVaccine Supply Needs Shot in the Arm
Most of us seem to take vaccines for granted. We go about our business protected from some of the most dread diseases of mankind--polio, measles, diphtheria, and even smallpox--without concern for contracting them. By the time our children enter school, they've received between 16 and 20 vaccinations. We feel confident that they won't come home from school with anything more threatening than a minor infection common in childhood. In recent years, however, shortages of critical vaccines have highlighted the fragile nature of the U.S. vaccine supply and distribution system. A variety of factors are thought to have contributed to widely publicized shortages of influenza vaccine in the 2000-2001 flu season, and recent shortages in childhood vaccines preventing diphtheria, tetanus, whooping cough, polio, Haemophilus influenzae, chickenpox, measles, mumps, rubella, and invasive pneumococcal disease. The declining number of vaccine manufacturers, low profits in the vaccine area compared with other pharmaceuticals, federal regulations, lack of coordination between public- and private-sector providers, and a growing antivaccine movement have all been cited as indicators of a failing system. As of April 2002, there were shortages of DTaP, IPV, Hib, varicella, MMR, and pneumococcal vaccines, prompting revisions in current vaccine recommendations and rationing of childhood vaccines. Together these vaccines constitute a public health arsenal against major childhood diseases and have raised concerns of outbreaks of diseases not seen in decades. In the wake of recent concern over preparedness for possible biowarfare, the inadequacies of the current system have been brought to the forefront. Ills of the SystemDeclining number of vaccine manufacturers. The private sector is primarily responsible for research and development, and manufacturing and delivery of vaccines. There are currently only four major vaccine manufacturers in the world, and only two in the U.S. Twenty years ago there were approximately four times as many firms. In 1979, eight American pharmaceutical companies held 70 percent of all licenses for vaccines in this country while foreign companies and institutes held 17 percent, with the remaining 13 percent held by state laboratories and a university.Lower profits in the vaccine industry in relation to other pharmaceutical operations. Vaccine revenues make up only a small fraction of the pharmaceutical industry's revenues, an estimated 3.5 percent. While newer vaccines and those in the pipeline may bring greater revenues to the industry, the pharmaceuticals market is much more profitable compared to vaccines and other biologics. Federal regulation of vaccines. The vaccine industry is regulated by the Center for Biologics Evaluation and Research (CBER) of the Food and Drug Administration. CBER evaluates each vaccine candidate and either accepts or rejects applications to license the vaccines. Each vaccine manufacturing plant must be licensed separately, and the FDA regularly inspects facilities to ensure high quality of the product. After licensure, the FDA continues to monitor the vaccine and manufacturing facilities as long as a manufacturer holds a license. In the case of single-source vaccines, a change in FDA requirements or the need to upgrade a plant can, and has, led to shortages. Lack of coordination between public and private sectors. Vaccines are purchased and supplied through a complex network of public and private providers. While approximately 52 percent of vaccines for U.S. children are purchased with federal funds, the rest are privately purchased (often by individual physicians or group practices). The 2000-2001 flu vaccine shortage highlighted a worrisome failure to ensure that high-risk individuals were immunized first. According to an audit by the General Accounting Office, there was no formal mechanism in place to ration the available vaccine to those most in need. In this case, according to the GAO's findings, doctors were not able to secure vaccines for at-risk elderly patients, while supermarkets were able to offer free or low-cost flu shots to customers. The antivaccine movement. The growth in the antivaccine movement in recent years has had an impact on the vaccine industry, as well as the public health sector. Fears concerning side effects of immunization (for example, autism with the MMR vaccine) as well as some parents' desire not to vaccinate their children and highly publicized concerns about mercury in vaccines have required an aggressive public awareness campaign by the public health community. This campaign has been gaining momentum in the past several years, leading to the creation of several organizations responsible for communicating both the risks and benefits of immunizations. Cures to Come?Why should we worry about an unstable vaccine supply? Vaccines are critical to the prevention of infectious diseases and are often considered the underpinning of our public health system. The enormous decline in infectious diseases due to vaccines and the reduction in attendant morbidity, mortality, and financial cost is remarkable. Yet due to their often invisible effect of preventing disease, vaccines have tended to be underfunded and underappreciated. This neglect, some claim, is manifested in the decline of the vaccine industry, its consolidation into a handful of firms, and the breakdown of the entire system of development, manufacture, delivery, and monitoring.The recent shortages, results of an unstable supply, concern public health officials, policymakers, physicians, and parents alike. Recent meetings of the National Vaccine Advisory Committee as well as others have discussed several options for shoring up the supply, including rotating stockpiles, national immunization awareness campaigns, and other initiatives aimed at addressing the current shortages and preventing them in the future. --Erica Seiguer, a third-year MD-PhD student at HMS |
