Only Third of Supply Is Expected for First Round of Vast Effort
By Rob Stein
Washington Post Staff Writer
Sunday, August 23, 2009
Government health officials are mobilizing to launch a massive swine flu vaccination campaign this fall that is unprecedented in its scope — and in the potential for complications.
The campaign aims to vaccinate at least half the country’s population within months. Although more people have been inoculated against diseases such as smallpox and polio over a period of years, the United States has never tried to immunize so many so quickly.
But even as scientists rush to test the vaccine to ensure it is safe and effective, the campaign is lagging. Officials say only about a third as much vaccine as they had been expecting by mid-October is likely to arrive by then, when a new wave of infections could be peaking.
Among the unknowns: how many shots people will need, what the correct dosage should be, and how to avoid confusing the public with an overlapping effort to combat the regular seasonal flu.
To prepare, more than 2,800 local health departments have begun recruiting pediatricians, obstetricians, nurses, pharmacists, paramedics and even dentists, along with a small army of volunteers from churches and other groups. They are devising strategies to reach children, teenagers, pregnant women and young and middle-aged adults in inner cities, suburban enclaves and the countryside.
“This is potentially the largest mass-vaccination program in human history,” said Howard Markel, a professor of medical history at the University of Michigan who is advising the Centers for Disease Control and Prevention as it spearheads the effort.
Public health officials describe the effort as crucial to defend against the second wave of the Northern Hemisphere’s first influenza pandemic in 41 years.
As schools reopen, the number of cases could jump sharply within weeks, sparking a second wave potentially far larger than the outbreak last spring. Although the swine flu appears no more dangerous than the typical seasonal flu, the new virus — known as H1N1 — is likely to infect many more people because most have no immunity against it.
The vaccine effort carries political risks for the Obama administration. “If the outbreak fizzles, they will be susceptible to being criticized for spending billions of dollars,” said Harvey V. Fineberg, president of the National Academy of Sciences’ Institute of Medicine, which advises Congress about medical issues. “On the other hand, if this outbreak is early and severe and there isn’t enough vaccine, they’ll be criticized for under-preparation.”
Officials stress that they are proceeding cautiously. A final decision to move forward will not be made until they get the results of clinical trials — testing to determine safety and dosing — and assess the virus’s threat. But officials are confident the vaccine will pass muster and expect a campaign will be launched as soon as manufacturers deliver the first vials.
“There’s little doubt we’re going to vaccinate people,” said Anthony S. Fauci of the National Institute of Allergy and Infectious Diseases, who is leading the government’s testing of the vaccine. “Who and when and exactly how — we have to figure out.”
The campaign is haunted by memories of the government’s ill-fated 1976 effort to vaccinate against swine flu. The epidemic fizzled, but the vaccine was given to 40 million people and blamed for causing a rare paralyzing disorder known as Guillain-Barré Syndrome.
Another wild card will be whether the vaccine will be delivered with an “adjuvant” to boost its effectiveness or stretch limited supplies into more doses. Adjuvants have been used in Europe, but the Food and Drug Administration has not authorized their use in the United States.
“This is an overreaction,” said Barbara Loe Fisher of the National Vaccine Information Center, which opposes many vaccine policies. “There is no national security threat here. Why are we operating like this? This is not polio. This is not smallpox.”
Fears and misinformation about the vaccine are circulating, including inaccurate claims that it will be mandatory.
“I’m very concerned about the dangers of vaccines,” said Janice Smith, 58, of Misawaka, Ind., who attended a public hearing Aug. 15, one of a series of meetings the CDC has sponsored to gauge public sentiment about the vaccine.
Authorities are adamant that vaccination will be voluntary, and they say there is no reason to think the vaccine will be any less safe than the usual flu vaccine. An adjuvant will be used only if necessary and proven safe, they say.
To address concerns of pregnant women and parents with young children, some vaccine is being produced without a mercury additive. And because the short-term studies can identify only common, immediate side effects, the CDC will step up monitoring for rarer, serious complications such as Guillain-Barré.
“We’re putting into place systems that are as good as we can have to identify problems quickly if they do occur,” CDC Director Thomas R. Frieden said.
On Friday, officials reported that no “red flags regarding safety” had emerged in the clinical trials. “We are continuing oversight on the quality and safety of the vaccine being produced, and the production process itself,” said Jesse Goodman of the FDA. “That’s going well so far, but our oversight is continuing.”
In the meantime, local officials are drafting plans tailored to their communities. The shots in the arms and squirts up the nose will happen in schools, medical offices, hospitals, public health clinics, workplaces, drug stores and at mass vaccination events, possibly including drive-through clinics in parking lots where people would stick their arms out their car windows for a stab.
“It is clearly what we would call an all hands on deck,” said James Blumenstock of the Association of State and Territorial Health Officials. “We’re not starting from scratch, but we also don’t have everything on the shelf that we can just pull off and put in place. It’s a full-court press in moving forward to have everything in place when we’re ready to go.”