U.S. Begins Stockpiling Vaccines in Policy Shift

The federal government, shifting policy on a major public health issue, has begun to stake out an activist agenda to stockpile vaccines and inoculate Americans against a range of viruses and infections, from anthrax to smallpox to influenza.

For the last 25 years, federal officials have been reluctant to push vaccines on the public after a debacle involving swine flu inoculations in 1976.

Now, under the pressure of anthrax attacks that have caused widespread fears of bioterrorism, that stance is shifting.

In the last two days, officials have said they are considering for the first time whether to inoculate civilians--postal workers deemed at high risk for anthrax exposure.

Health and Human Services Secretary Tommy G. Thompson also said Thursday that he will pressure pharmaceutical companies to speed up flu vaccine production, which has been hobbled by one company dropping out and another experiencing manufacturing problems.

“Flu and anthrax poisoning have the same symptoms and we want to make sure that we minimize the people coming down with flu this year, if we possibly can,” to avoid a rush for anthrax tests, Thompson said.

“I’m going to have a stern discussion with them,” he said, referring to the companies, “to see if I can’t accelerate that.”

Thompson also has begun aggressively pushing companies to begin producing enough smallpox vaccine, 300 million doses, for all Americans. Some of those new doses could begin arriving this year to supplement the existing government stockpile of 15.4 million doses, he said.

Ten companies have submitted proposals to make smallpox vaccines, Thompson said.

Until now, vaccine production has been plagued by a widespread lack of manufacturing capacity.

The nation’s sole anthrax vaccine plant has been idled by production problems for three years. Even the military can’t get supplies to vaccinate all 2.4 million active and reserve troops; only limited overseas forces are receiving shots.

Experts say it could take months to begin production of the anthrax vaccine. To achieve full immunity, a person must receive six doses over 18 months, plus annual booster shots.

“I suppose if everybody really gave a shove-push to it, maybe they could get everything going within one year,” said Dr. Philip Brachman, an Emory University public health professor who worked on development of the anthrax vaccine. “Whatever they want to do, they can’t [begin vaccinating] right now.”

Thompson said the terrorist attacks may have been the catalyst needed to motivate companies to make vaccines, even though they are not as profitable as most prescription drugs. There are shortages in vaccines for tetanus, flu and children’s meningitis.

“We have not had enough companies practicing in this area and producing vaccines,” he said. Now, under government and public pressure, “we’ve got companies really interested in getting into this business.”

As the deaths of two postal workers in Washington, D.C., showed, it is impossible to pinpoint all sources of anthrax contamination. And yet, from a practical standpoint, it is also impossible to protect the entire population with antibiotics or provide everyone with inoculations.

Smallpox, should it reemerge, would present an even more daunting problem because it is highly contagious.

“What we’re really dealing with as a society is how to prevent a first case,” said Dr. David Witt, chief of infectious diseases for the Northern California arm of the Kaiser Permanente health system. “In all candor, I’m not sure we can.”

Thompson said he doesn’t want to take any chances. He has already ordered 54 million doses of smallpox vaccine from the British firm Acambis, and he is negotiating with 10 other companies for another 250 million doses.

“You’ve got to realize that we’re moving very rapidly here and we want this stockpile as soon as possible,” he said. “The terrorists, if they have any capacity, are not going to wait until we get a stockpile.”

Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said the government has no choice but to place such a great emphasis on vaccines.

“If you look at the potential consequences of a massive bioterrorism attack with smallpox, there is no other option but to do what we did,” Fauci said. “There’s no other option but to be prepared.”

The anthrax vaccine poses a different set of problems. The only U.S. manufacturer, BioPort Inc. of Lansing, Mich., can’t begin shipping doses until the U.S. Food and Drug Administration approves its vaccine, and that could take months. BioPort has already failed two inspections in the last two years.

BioPort has said it is ready for another inspection, and an FDA spokeswoman said it will be given priority.

There’s also a heated debate over the safety of the vaccine, which some say can have deadly side effects. A lawsuit filed this week on behalf of one dead and one injured soldier claims that BioPort failed to sufficiently test the efficacy and safety of the vaccine used to immunize about 150,000 U.S. military personnel.

“I wouldn’t necessarily say it’s wrong to talk about the possibility of a vaccine for people at risk,” said Alan C. Milstein of Pennsauken, N.J., a lawyer for the plaintiffs. “There’s got to be some explanation of all of the risks that this vaccine poses so that whoever is going to receive the vaccine can make an informed decision about whether or not to take it.”

Some scientists say the anthrax vaccine is perfectly safe for adults, causing only minor side effects such as a lump that can remain for several days and soreness at the injection site. Some people also experience fever and nausea.

“This is a fairly safe vaccine,” said Philip Hanna, an assistant professor of microbiology at the University of Michigan.

Hanna said if the vaccine were more widely available, it would “make sense” to characterize postal workers, police officers and firefighters as high-risk professionals who are eligible for the vaccine.

Right now, according to most experts, it is not practical or desirable to vaccinate large populations for anthrax or smallpox. Anthrax cases are still quite limited, and there have been no cases of smallpox. That means the likelihood of contracting either ailment is so small that it would be more dangerous to take the vaccine than to risk exposure to the disease.

But in the event of a major bio-terrorist attack, that could change, making the risk of side effects from vaccine less than that of exposure.