Vaccine policy: a shot in the dark


Princeton, N.J. -- IN A TERRIFYING reminder of the Middle Ages, the pneumonic plague -- the deadliest form of the bacterial disease once known as the Black Death -- has broken out in India.

Pneumonic plague is a lethal airborne contagious disease that was supposedly eliminated by modern medicine.

The plague will be stopped, because today its victims can be cured with antibiotics. But what if there had been an outbreak of an airborne virus?

Viruses don't respond to antibiotics, and can cause what experts call a chain of lethal transmission. That happened in 1918-19, when a mutant influenza virus spread quickly around the world and killed 20 million people.

The AIDS virus, which is even more deadly but less easily transmitted, is believed to have emerged from the central African rain forest in the 1970s.

When new viruses begin to spread -- and in the modern world, they are only a plane ride away -- the best way to break the chain of transmission is with a vaccine.

Vaccines -- a killed or live microorganism that when introduced into the body provokes immunity -- are the most cost-effective treatments in the entire medical storehouse.

U.S. biotechnology companies have the resources to develop advanced vaccines, and indeed progress in genetic engineering holds out the hope of powerful "horizon vaccines" that could protect people against Lyme disease, drug-resistant tuberculosis or mutant strep. And with much hard work and some luck, there will be an AIDS vaccine.

Yet Congress and the White House seem to be obstructing the arrival of new vaccines. At the bottom of the mess is a tangled web of bureaucratic chaos, agency rivalry, conflicts between the government and biotechnology companies and an appalling lack of leadership.

On Sept. 20, a Senate-House conference committee voted to eliminate most of the research staff of the National Vaccine Program Office and to essentially wipe out its budget. Congress created the program in 1987 -- the closest thing to a national vaccine authority the country has had -- but from the beginning failed to provide enough money for it.

When the program didn't get much accomplished, Congress decided to get rid of it. That leaves a total of 24 federal agencies with authority over vaccines, some of them competing over turf.

Meanwhile, new and lethal infectious threats are emerging around the world -- incurable strains of tuberculosis, strep and malaria, along with shadowy viruses such as Ebola, dengue and Lassa fever, all of which have emerged in the past 20 years.

If a monster virus without a vaccine or cure suddenly appeared here, it is not clear that the U.S. government could coordinate its own agencies with industry to organize a crash development of a vaccine.

The United States isn't even able to handle the diseases we do have vaccines for. During the measles epidemic of 1989-91 -- which never should have happened, since there's been an effective vaccine for decades -- 55,000 children got measles; 132 died, and many more ended up with brain damage.

The Federal Centers for Disease Control maintains that 90 percent of American children are fully vaccinated. A recent study published in the Journal of the American Medical Association makes that figure look very optimistic.

The study -- of children of the employees of Johnson & Johnson -- showed that only 45 percent of those under age 2 had received all their vaccinations. Among the 6-year-olds, only 55 percent had their shots.

These are middle-class, suburban kids whose parents work in the health care industry. It's a sure bet that inner-city kids are doing much worse.

In a strong response to this problem, the administration has begun the Vaccines for Children program, with plans to distribute large amounts of free vaccines. The government-bought vaccines were originally going to be stored in a single warehouse, but this idea proved disastrously naive.

The warehouse, experts pointed out, could have burned down or lost its refrigeration, and it was far from clear that the government even had the ability to distribute the vaccines.

Providing free immunizations for poor people would be a good idea, but providing them for everyone is bad for long-term research. If the government is the major buyer of vaccines, it will set low prices for them, which will discourage companies from jumping into the race toward horizon vaccines.

It takes 10 years and $100 million to $200 million to develop and test a new vaccine, and to make the investment companies need to anticipate a profit. We may need higher prices for some vaccines.

Barry R. Bloom, a research scientist at the Albert Einstein College of Medicine who is a leading expert on new vaccines, has proposed a National Vaccine Authority. An independent board of experts and citizens, such a group would provide leadership, support research and oversee the various government agencies.

Philip K. Russell, the president of the Albert Sabin Vaccine Foundation -- founded this year with a mission to solve the vaccine mess -- has another idea: Establish a vaccine consortium that would be a partnership between the government and the vaccine companies.

Either proposal could work, because both provide the one thing we desperately lack now: leadership.

Even with all of the advances of the past 100 years in medical technology, the world may be closer to the Middle Ages than policy makers realize.

Richard Preston is author of "The Hot Zone," a book about new viral threats.

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