Prepare for a Vaccine Controversy

A few years ago public health officials set up a time share in Pennsylvania hens. Under contracts signed with several farmers, the hens continued to lay for their regular customers until the moment this past spring when the federal government requisitioned their eggs to grow flu vaccine.

Strategic hen reserves are part of a success story: the government’s readiness for the current H1N1 flu pandemic. Public health officials had already stockpiled millions of doses of antiviral drugs, created diagnostic kits that detected the virus as soon as it appeared in California in April and enrolled five companies to make vaccine. By mid-October we may have as many as 80 million doses ready for a mass immunization program.

But if there’s a weak link in this chain of preparedness, it is the federal bureaucracy’s torpor in explaining the risks of the vaccination program to the public. There is a chance, for example, that the H1N1 flu will sweep through cities before the vaccine is ready, causing serious illness and many deaths. (By the same token, H1N1 may turn out to be so mild as to seem harmless.)

And there is a possibility that the vaccine itself might provoke side effects; for example, about one in 100,000 people who received the 1976 swine flu vaccine developed Guillain-Barré syndrome, a crippling nerve disorder.

Public health officials have grown more vigilant since then. In 1999, for instance, doctors reported cases of intussusception, a sometimes deadly intestinal disorder, in a few infants given a new vaccine against rotavirus. After a causal link was confirmed, the vaccine was withdrawn.

Six years later, there were more reports of Guillain-Barré, in patients who had received a new vaccine against meningococcal bacteria. This time, vaccine safety sleuths found that the association was rare or even coincidental, and the Food and Drug Administration kept the vaccine on the market.

The need for good safety monitoring is more important than ever in this risk-averse age, in which a discredited link to autism has shaken confidence in childhood vaccination. It’s equally important that officials communicate the difference between correlation and cause.

It is statistically inevitable that some of the millions of people vaccinated this fall will become ill or die. And there’s a high risk that the vaccine will be blamed for any coincidental health problems. For example, pregnant women will be urged to get the vaccine because doctors have seen how H1N1 can cause especially nasty infections during pregnancy. But about one in seven pregnancies ends in a miscarriage, so nearly 1,500 of 10,000 women in early pregnancy will miscarry this fall — whether or not they get the H1N1 vaccine.

This all needs to be clearly explained by someone, and our new surgeon general nominee, Regina Benjamin, is a good person for the job. When schools open in September, Dr. Benjamin should make it her full-time job to explain the logic and unknowns of inoculation. If a vaccination campaign reduces deaths and illnesses caused by the H1N1 virus, it could also increase rates of vaccination against seasonal flu and other diseases. But if the campaign causes more people to lose any more faith in vaccines, it will have done more harm than good

Arthur Allen, the author of Vaccine: The Controversial Story of Medicine’s Greatest Lifesaver.