If an immediate crisis strikes, the current U.S. smallpox vaccine stockpile could be diluted enough to create 150 million effective doses, which would cover half of the U.S. population, scientists reported yesterday (see GSN, March 28).

Furthermore, the dilution of the current stockpile and the release of 70 million to 90 million vaccine doses by the French pharmaceutical company Aventis Pasteur, along with current orders for more than 200 million doses are expected to provide enough smallpox vaccine for the entire United States before the end of this year, said Health and Human Service Secretary Tommy Thompson.

“We will have enough vaccine to save and protect every American should there be an outbreak,” Thompson said.

The results of the dilution study, announced yesterday in the New England Journal of Medicine, indicated that the current U.S. stockpile of 15 million doses of the smallpox vaccine remained effective even when diluted to a tenth of its original strength.

The study’s results are “great news for Americans,” Thompson said.

If there were a need for additional vaccine, the United States probably would use a fivefold dilution method, according to the Washington Post.  In the event of a smallpox bioterrorist attack in several locations at once, however, the study shows the vaccine could be diluted even further and still remain potent, according to government researchers.

“If this were an absolute emergency that we needed 150 million doses, I wouldn’t hesitate in recommending that we go with the 1-to-10” dilution, said Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, which sponsored the study (Justin Gillis, Washington Post, March 29).

Aventis Donates Doses

Aventis is expected today to announce that it will donate to the United States the more than 85 million doses of smallpox vaccine long stored in company freezers, according to company officials.

Aventis will be reimbursed for some of the costs of thawing the vaccine, testing it and placing it into vials, said Richard Markham, Aventis U.S. operations chief executive officer.  The United States has also agreed to protect the company from any liability if the vaccine causes harm, he added.

“It has lost some potency but it is still a useful vaccine,” Markham said.  “Hopefully we will never have to use it.”

Aventis had been testing the doses, which are more than 40 years old, for months and told the government about them years ago, according to company officials.  The United States did not take interest in them until last fall’s anthrax attacks, Markham said.

Aventis and the United States agreed to not release information on the stored vaccine doses to the public in case they turned out to be ineffective.

“None of us wanted to get people’s hopes up and then find out that we could not use it,” Markham said (Melody Petersen, New York Times, March 29).

Should Vaccination Program Be Restarted?

NIAID Director Fauci, along with several health experts, yesterday said the time might be right to resume voluntary smallpox vaccinations.  Restarting a mass smallpox vaccination program, however, counters current U.S. Centers for Disease Control and Prevention guidelines, according to the Los Angeles Times (see GSN, Dec. 17, 2001).

Last year, with a small U.S. smallpox vaccine supply available, the CDC recommended that a smallpox outbreak be handled through identifying cases, quarantining and vaccinating anyone exposed.  With the supply of vaccine now likely to be less of a factor, experts have called for a re-evaluating the best way to defeat a smallpox outbreak.

“Despite the fact that mass voluntary vaccination is not recommended in the CDC plan, there are many who would like to have the opportunity to make their own decision about smallpox vaccination,” Fauci said in an New England Journal of Medicine editorial yesterday.

“The strongest argument for preemptive mass vaccination is that it would eliminate smallpox as an agent of bioterrorism,” Fauci said.  “Accordingly, it would eliminate the disarray, confusion and panic that would most likely accompany simultaneous attacks at multiple locations.”

The CDC’s containment strategy is unlikely to work in the event of a bioterrorism attack using smallpox because of the large numbers of unprotected people, said several experts in the journal.

“Widespread, voluntary vaccination before exposure will greatly reduce the number of victims if an attack occurs,” said William Bicknell, former director of the Massachusetts Public Health Department.

The major risk of a mass vaccination program would be that out of every million people vaccinated, one or two would die and hundreds more would become seriously ill, Fauci said (see GSN, Nov. 21).

“In most circumstances, that would be unacceptable,” said Edward Campion, senior deputy editor of the journal, adding, however, “we now fear bioterrorism in a way seven months ago was unthinkable.”

The CDC approach would probably result in thousands of deaths before the public health system would have the chance to respond to a smallpox outbreak, said Charles Pena, a defense policy expert at the CATO Institute.

“If it’s the government’s responsibility to protect against a future attack, the best way is to take preventive measures, not responding afterwards,” Pena said.

Mass vaccinations, however, are not a foolproof method of preventing smallpox outbreaks, according to experts who have worked in the global operation to eradicate the disease.

In Bangladesh in 1972, 80 percent of the population was vaccinated but 70,000 smallpox infections were reported.  In 1976, after health officials used a containment strategy, no cases had been reported, even with only 78 percent of population vaccinated.

“At the moment, the risk of a complication from smallpox [vaccine] is far higher than the risk of smallpox,” said Stanley Foster, a former U.S. health official who headed the smallpox eradication program in Bangladesh (Ornstein/Garvey, Los Angeles Times, March 29).

Destroy Samples, Public Health Leaders Say

The deans of more than half of the U.S. schools of public health called this week for the destruction of the two known stockpiles of smallpox virus samples, kept separately at the CDC and at a Russian research institute (see GSN, March 18).

The destruction of the samples “will reduce other nations’ concerns that they must acquire and experiment with the virus to maintain parity with the U.S. and Russia,” said the statement drafted by Alfred Sommer of the Johns Hopkins Bloomberg School of Public Health.

“We strongly believe that the best defense against one particularly dangerous, potential terrorist agent, smallpox, is a global campaign to eradicate the virus from the face of the earth,” said the statement, which was signed by the deans of 18 out of 31 U.S. accredited public health schools.

Sommer said he was pleased at the support his statement received, which was prompted by reports in January that U.S. Army researchers had succeeded in fatally infecting monkeys with smallpox for the first time in an attempt to create an animal model for developing new drugs (see GSN, Jan. 29).  Somers said he had sent the statement to other public health school deans because he was concerned that the Army research could have started a biological weapons arms race.

The deans’ goal of eradicating smallpox, however, is unrealistic because some of the tons of smallpox produced by the former Soviet biological weapons program has probably made its way to other countries, said Peter Jahrling, a top Army scientist who headed the monkey study.

“The dream of global eradication was shattered by the Soviet betrayal,” Jahrling said.  “We can’t put the genie back in the bottle” (Scott Shane, Baltimore Sun, March 29).

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