SHOULD WE HAVE been surprised there is insufficient supply of flu vaccine for Americans? Not particularly. Many factors and experience predicted that the current problems likely were inevitable.
In the 1918 influenza pandemic, before flu vaccine, 21 million people, including 549,000 Americans, died. Treatment was bed rest. Disease transmission was prevented by using gauze masks and hand-washing. Now we use vaccine to prevent the flu. It is clear that it is effective.
There have been three other pandemics since 1918 -- in 1957, 1968 and 1977. The problem remains serious because 36,000 Americans die annually and 200,000 are hospitalized due to influenza or its complications. In addition, the disease and its complications cost the U.S. economy an estimated $4.6 billion annually in direct medical costs.
We learned Oct. 5 that nearly half of the 100 million ordered doses of flu vaccine would be unavailable because vaccine in an American manufacturer's English plant was contaminated and subsequently judged by the Food and Drug Administration as unsalvageable. This event likely resulted from failures at multiple levels and a weak infrastructure. We should have predicted that this predicament eventually would occur for the following reasons:
There have been flu vaccine shortages or other missteps for the last four years.
Flu vaccine manufacturing and supply in the United States have been entrusted to only two major companies.
The technology for manufacturing flu vaccine is cumbersome and requires six months' lead time. There is no time to correct problems.
There is no national policy regarding flu vaccine production or distribution.
Because influenza can be a tool of bioterrorism, and should have the same, if not greater, concern as SARS, smallpox and anthrax, our inability to ensure supply and track distribution of a key preventive agent is worrisome. SARS -- severe acute respiratory syndrome -- in 2003 and anthrax in 2001 were warning signals to the medical and public health communities. Yet the current crisis with inadequate supplies of flu vaccine resounds of unlearned lessons.
Policy-makers, the media and the pharmaceutical industry had opportunities to use those events to promote efforts to help society and health care providers prepare not only for emerging infectious diseases or the possibility of a bioterrorism attack but also for an annual event such as the flu, which is known to kill many.
Why didn't the medical and public health communities, which have a responsibility to warn the public and policy-makers of potential health risks, deliver the message effectively? Because it's a complex issue. Flu and corona viruses (which cause SARS) are resilient and particularly worrisome because of their ability to change. A slight mutation, which occurs nearly every year, causes a new epidemic. A more complex change leads to a pandemic.
More worrisome, the flu virus, like SARS, can combine with cousin viruses that cause disease in animals and sometimes change sufficiently to cause a particularly virulent strain and severe disease. Perhaps policy-makers have not completely understood these difficult concepts.
Equally important, why does our national policy (or the lack of one) allow for only two companies, California-based Chiron Corp., which has a plant in Liverpool, England, and Aventis Pasteur, to be responsible for 98 percent of vaccine supply? A third company, MedImmune, supplies about 2 million vaccines.
The consolidation of drug manufacturers has led to less flexibility in the system. In the anthrax case, we learned that we had limited options in a national emergency when, initially, only one company was approved by the FDA to produce a preventive.
Given the limitations in vaccine production, the inability to project demand, poor profit margins in the manufacture of vaccines and unattractive business risk, the free market cannot satisfactorily address national public health needs. Our Canadian colleagues, in a measure of foresight and planning, understood this and have a flu vaccine surplus.
Given its lethality, the flu virus should receive the same attention being paid to other significant bio-threats. Funding similar to that devoted to anthrax vaccine development should go toward new methods of flu vaccine production. Government should be involved in the purchasing and distribution of such vaccines, if not in its outright production.
Manufacturers should receive sufficient incentives to ensure adequate yearly supply. National efforts aimed at near-universal flu vaccination of schoolchildren, who usually have a mild form of the disease but transmit the virus, should be considered.
We hope that additional vaccine can be acquired from Canada and other sources and that those most vulnerable receive the limited supply available. Otherwise, we will find ourselves relying on the technology used by our colleagues in 1918 -- hand-washing and masks.
If we are fortunate, the limited supply of vaccine will go to those most in need, and this year's epidemic will not be overwhelming.
Dr. Trish M. Perl is an associate professor of medicine and hospital epidemiologist at Johns Hopkins Medicine, and Dr. Gabe Kelen is a professor of emergency medicine and director of the Johns Hopkins Office of Critical Event Preparedness and Response.