Smallpox:  CDC Says It Never Aimed For 500,000 in First Phase

By David McGlinchey
Global Security Newswire

WASHINGTON — The U.S. smallpox immunization plan, which has been slowed by a lack of volunteers, was never intended to reach an often-reported, 30-day goal of inoculating 500,000 health workers, a spokesman from the Centers for Disease Control and Prevention said today (see GSN, Feb. 6).

On Dec. 13, 2002, U.S. President George W. Bush announced an initiative to prepare the United States for a possible smallpox attack (see GSN, Dec. 13, 2002). 

That day, U.S. health officials described a two-part program in which an estimated 500,000 smallpox response personnel would first receive the vaccine followed by up to 10 million emergency responders.

In that briefing, Health and Human Services Secretary Tommy Thompson said, “There are 439,000 individuals that we’ve designated right now in order to receive the vaccination in the first tranche,” adding that the plan was “a voluntary program and not every one of those individuals will receive it.”

CDC Director Julie Gerberding added that she was encouraging states to implement the first wave quickly.  “In our planning guidance, we recommended that they try to accomplish this in 30 days from the point at which they actually open the clinics and begin the immunization,” she said.

The program began Jan. 24 and the Washington Post reported that participation has been limited to 4,200 people, as of Feb. 24.  Potential volunteers are concerned about sicknesses associated with the vaccine and several medical unions have delayed endorsing the plan until a compensation plan is provided for patients who experience the vaccine’s side effects.

CDC spokesman Tom Skinner told Global Security Newswire that the “the 500,000 number was floated around,” but that the immunization plan’s sole goal was to prepare the United States to respond to a smallpox attack.

“We’re trying to do a better job of clarifying what the purpose of this program is, and the purpose of this program is to better prepare our country to respond to a bioterrorism event involving smallpox,” Skinner said.

The plan’s two phases still exist, he said, but they are “seamless.”

CDC officials will determine when to begin immunizing firefighters, police and other emergency workers — phase two — and the progress of the plan will not depend on passing a fixed number of immunized volunteers or a set date, according to Skinner.

He denied that health officials had set 500,000 immunized first responders as a target for the first phase.  In planning their separate vaccination scenarios, states and major cities collectively estimated they would need between 400,000 and 500,000 inoculated personnel in phase one, but federal health officials never adopted that number as a target, according to Skinner.

“This is a tremendous amount of backpedaling.  This is very embarrassing for them, and it should be,” said Yale University professor Ed Kaplan, a vocal critic of the CDC’s smallpox vaccination plans (see GSN, July 29, 2002).

U.S. officials began distancing themselves from the 500,000 figure in early February, when it became apparent that the program was plagued by low turnout.

“It would be a success if no one receives the vaccine, but we offered this opportunity to all the right people,” said Joe Henderson, CDC associate director for terrorism preparedness, at a Feb. 5 bioterrorism conference hosted by the National Governors Association.

Some medical experts said it was reasonable to work without using the 500,000 figure as a benchmark.

That figure “is more of a planning number and somehow it became the goal,” said Patrick Libbey, executive director of the National Association of County and City Health Officials.

Libbey said that the CDC’s discussion of readiness, instead of numbers, “is not throwing me a curve.”

“The exercise has always been about readiness, the 500,000 was a number out of the air,” said Georges Benjamin, executive director of the American Public Health Association.

“The number issue really is a moving target,” he added.

Kaplan said the CDC is not solely to blame for the low turnout, or the slowly moving immunization plan, but health officials are stuck with the shortfalls in the plan.

“We haven’t seen too much senior discussion of this plan since it was discussed in December,” he said.

Being Prepared Is The Goal

Experts agreed that readiness is the ultimate goal, and they said that the United States is not yet prepared.

The smallpox vaccination program has not been widely accepted despite strong White House support, said Paul Offit, chief of the Philadelphia Children’s hospital’s infectious diseases section and a member of the CDC’s Advisory Committee on Immunization Practices.  “If the intent was a first line of defense, that intent is not being met, it’s at best a very leaky first line of defense,” he said.

Offit, and other experts said preparing an effective plan to respond to a smallpox attack was more important than immunizing limited numbers of first responders today.

“The more pressing issue is, what would we do if there was an event in the United States … what plans are there in place to distribute that vaccine in large numbers?” Offit asked.

Skinner said the CDC is working with states to develop a mass vaccination plan, which he described as “evolving.”

“We might tweak this plan a little bit as we go,” he said.

Experts said they did not believe the United States is prepared to respond to a smallpox attack with mass vaccinations.

The United States needs to immunize “a hell of a lot more than 4,000 people,” Kaplan said.  He applauded CDC Director Gerberding’s assessment that the United States will be prepared when officials can vaccinate the entire country in 10 days, but he estimated that effort would require more than a million immunized medical workers.

“It’s disconcerting … the bottom line is that I’m quite worried,” Kaplan said.

The CDC does not know what is needed to immunize the entire country in 10 days, according to William Bicknell, a former Massachusetts public health commissioner who is now a professor of public health at Boston University and a member of the state’s smallpox working group.

“Right now I do not think the nation is adequately protected,” Bicknell said.

He called for an examination of how many immunized personnel and vaccination sites would be needed for a nationwide vaccination campaign.

“I don’t believe anybody has calculated that number.  That’s a mistake.  That’s an oversight,” he said.

Kaplan suggested that the United States attempt to immunize 50,000 volunteers in one day, “just to see if you can do it.”

“The machinery needs to be ready.  Somebody needs to test these things out,” he said.

Experts and officials have acknowledged that it will be difficult to know when the nation is ready because it is hard to predict what form an attack would take.

“I don’t think anybody knows what an actual event might look like,” Skinner said.

U.S. officials do not know what to expect and do not know if they have prepared sufficiently, and because of that fact, the CDC should plan for the worst possible scenario, Bicknell said.

“It’s always hard to measure ready,” said the APHA’s Benjamin.

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Smallpox II:  Contracts Awarded for Safer Vaccine Development

The United States yesterday awarded contracts to two companies to develop a safer smallpox vaccine, the Washington Post reported (see GSN, Feb. 21).

A safer vaccine might even be appropriate to inoculate people with depressed immune systems.  The new vaccine uses a virus called “modified vaccinia Ankara” and is a weakened version of the original smallpox vaccine, according to the Post.

Acambis, of Cambridge, Mass., and Bavarian Nordic, of Copenhagen, each received about $10 million to develop the virus.  The process of growing the virus, testing it on animals, and testing it in humans, should be finished by the end of 2003, according to Gordon Cameron, of Acambis.

The virus was developed in Germany and used in the 1970s on eczema patients, who are susceptible to regular vaccine.  The virus did not sicken the patients, but there was no smallpox outbreak in the area so researchers do not know how effective it is against the disease.

“Whether at the end of the day there will be an effective vaccine to protect them, I don’t know,” said Mark Feinberg, an AIDS vaccine researcher at Emory University.  “Coming up with an effective vaccine to protect immunodeficient people will be a difficult task,” he added (David Brown, Washington Post, Feb. 26).

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U.S. Response:  New York Law Enforcement to Receive New Equipment, Funding

New York State is set to begin distributing to law enforcement agencies this spring 113 trailers equipped to combat biological and chemical terrorism, according to the New York Post (see GSN, Feb. 13).

The trailers, which cost about $200,000 each and are funded through a $25 million grant, are equipped with hazardous-materials suits, chemical and biological detection equipment and sample collection kits.  New York City will receive 17 of the trailers, with the rest going to New York State Police and other local law enforcement agencies (Kenneth Lovett, New York Post, Feb. 25).

Meanwhile, the U.S. Congress has appropriated $4 million to help the New York City Police Department purchase new protective equipment, such as gas masks, Senator Hillary Rodham Clinton (D-N.Y.) said yesterday.  The funding, included in an appropriations bill approved Feb. 13, would enable the department to purchase about 15,000 masks, according to the New York Times.  The department could also use the money to purchase other protective equipment, officials said.

The city and its Police Department, however, still need an additional $900 million to cover adequately the costs of preparing for a possible future terrorist attack, Clinton and police union officials, said.  The Police Department has requested $261 million, the Times reported.

“We need more help from the federal government for the additional burdens that are being imposed on the N.Y.P.D., the burdens that require the constant vigilance that this city is known for,” Clinton said.  “But we’re not getting the help we need, and it is a grave concern throughout the city and at every level of government,” she added.

Ed Mullins, president of a union that represents police sergeants, echoed the call for more funding.  “To continue to go about putting cops on the street without preparing them for a disaster is no different than sending canaries into a coal mine,” Mullins said (William Rashbaum, New York Times, Feb. 25).

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United States:  On-The-Lam Monkey Raises Fears Over Proposed Laboratory

The recent escape of a research monkey from a University of California at Davis facility has raised concerns among area residents about the security of a proposed Biosafety Level 4 laboratory the university is seeking to build, the Associated Press reported yesterday (see GSN, July 18, 2002).

The 2-year old female rhesus macaque, which was to be used for breeding purposes, escaped the California National Primate Research Center Feb. 13 when handlers were cleaning cages.  The macaque went behind the cages, and the center’s employees reported hearing a slurping sound, as if the monkey had went down a small drain, according to the AP.  A search of the center’s plumbing using fiber-optic cameras, however, failed to find the monkey. 

In the 41 years that the primate center has been in operation, 82 monkeys have been able to escape and enjoy life on the outside before being quickly captured or return voluntarily, said UC-Davis spokeswoman Lisa Lapin. 

The primate center would supply research animals to the proposed laboratory, for which UC-Davis submitted a grant application this month to the National Institutes of Health.  The at-large monkey is disease-free because the primate center raises research animals for Biosafety Level 2 and 3 diseases, which have treatments available, university officials said.  They added that the monkey would not have been able to break out of the proposed laboratory, which would employ armed guards.

Still, area residents who oppose the Biosafety Level 4 facility said the escape raised questions about the proposed laboratory’s security. 

“If they can’t manage these monkeys when they’ve got level two and three diseases, how will they manage monkeys with level four diseases?” said Joshua English.

California National Primate Research Center Director Dallas Hyde said the security levels between the primate center and the proposed laboratory would be very different.  “Animals that go in there don’t come out alive,” he said (Brian Melley, Associated Press/Yahoo.com, Feb. 23).

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