A shot in the arm

The federal government last week drew praise for its efforts so far to combat the H1N1 flu outbreak even as officials worried about the nation’s ability to cope with the disease.

A delay in vaccine production against the deadly H1N1 flu virus placed HHS Secretary Kathleen Sebelius in the hot seat last week as she testified before a Senate committee about the nation’s response to the pandemic. Meanwhile, more than 50 states and regions must wait longer to receive their allotments; plan for distribution with a limited dose supply; and manage a jittery public—just as flu season gets under way.

In a hearing of the Senate Homeland Security and Governmental Affairs Committee on Oct. 21, Sebelius joined Homeland Security Department Secretary Janet Napolitano and Education Department Secretary Arne Duncan to apprise committee members of the three federal agencies’ individual and coordinated efforts to manage the global H1N1 flu pandemic that the World Health Organization reports has caused nearly 5,000 deaths around the world as of Oct. 17. Sen. Joseph Lieberman (I-Conn.), the committee’s chairman, said the agencies have responded to the outbreak “as aggressively and effectively as possible.”

He then asked the three cabinet secretaries to address his concerns about a disease that he said may be surpassing the nation’s ability to both prevent it and respond to it. First among Lieberman’s worries was recent news from the Centers for Disease Control and Prevention that the agency expects there to be about 25% fewer doses of the H1N1 vaccine available by late October, when the agency expected there would be about 40 million doses.

“The production is slower than we would have hoped at this point,” Sebelius said, “but I want to put this in a little context: The virus first identified in April has a robust vaccine available, which is fairly remarkable. We have five producers, so capacity for the vaccine has been built. We’re now up to 150,000 sites where the vaccine is automatically delivered,” she said, adding that the earlier, more robust estimates were based on information provided by the manufacturers.

Also, those predictions were based on expectations that two doses would be needed with a three-week gap in between doses. Instead, everyone over the age of 10 years old needs only one vaccine, and the response is happening in an eight to 10-day period, which is faster than projected.

There are two primary reasons for the delay, according to Sebelius: The production of antigen—a substance that prompts the generation of antibodies that can cause an immune response—was yielding slower results than anticipated; and there were some issues with new production lines. Both problems have since been corrected. But the secretary emphasized two other areas that could hasten production in the future.

“A lot of planning has been done, but we’re still too dependent on vaccination production in other countries, and old technology,” Sebelius said in her remarks. Of the H1N1 vaccine-producing manufacturing companies, only one—MedImmune—is based in the U.S., while the others—CSL, Novartis Vaccines & Diagnostics, GlaxoSmithKline, and Sanofi Pasteur, the vaccines division of Sanofi-Aventis Group—are located in other countries. As for updated research methods, Sebelius said HHS is committed to cell-based, rather than egg-based, technology. The current process is egg-based.

Sebelius told committee members that the H1N1 virus has not changed significantly since it appeared in April, meaning the vaccine target is appropriate and getting a good response. While that is good news, there is still the problem of the delay in vaccine production as the U.S. moves closer to the busiest months of the flu season. Earlier this month, a study from researchers at Purdue University highlighted a model that showed a significant autumn wave of H1N1 will peak so early that the CDC’s vaccination campaign will likely not have a large effect on the total number of people infected by the virus.

According to the CDC, distribution for the H1N1 vaccine builds on the program used for the Vaccines for Children, or VFC, program, in which vaccine orders are submitted by “project area” health departments on behalf of vaccine providers. There are more than 50 project areas, which include all 50 states, the District of Columbia, eight U.S. territories and freely associated states, and three metropolitan health departments. Those orders are transmitted to the CDC, and are then processed and forwarded to the CDC’s contractor for centralized distribution. Finally, distributors ship the vaccine directly to the user.

‘Disappointed’

“We were disappointed,” said Frank Welch, medical director for pandemic preparedness at the Louisiana Health and Hospitals Department in Baton Rouge, about the delay in production. Welch said he understands that initial estimates were based on projections, and he does not fault the CDC. Even so, the delay places another burden on the state’s health department. “Our distribution allocation model is based on what they said their projections were.”

Welch said the department has allocated every single one of the 180,000 doses made available to Louisiana so far. And with funding from the federal stimulus package, the department is planning mass vaccination exercises, or MVEs, at its 85 locations, called “public-health units,” for early November. This will allow all residents—not just persons at higher risk for infection—to receive the vaccine, Welch said.

In Chicago—one of the three metropolitan project areas—the health department is solely responsible for the H1N1 distribution vaccine program, which differs from the seasonal flu vaccine program that allows providers to order the vaccine directly, according to Julie Morita, a pediatrician who is the medical director for the Chicago Public Health Department’s immunization program.

“When we were notified in the spring, until now, we’ve been working very hard to establish systems to get providers enrolled to receive them,” Morita said of the vaccine. This is handled through a Web-based system in which hospitals, clinics and retail pharmacies can register.

“The healthcare providers are interested in protecting their patients and doing things as efficiently as they can,” Morita said. “The limitation right now is the vaccine supply. When they get it, they will use it as best they can,” she said, adding that people should be comforted knowing that more vaccine becomes available each day.

The city’s health department is encouraging residents to first contact their family physician or other medical provider about the vaccine. But for those residents who do not have a physician, or for those who have a physician who is not administering the vaccine, the department this week will offer the H1N1 vaccine for people at increased risk for flu at six locations in the city. Those targeted populations are pregnant women, all children and young adults between the ages of 6 months and 24 years, people who live with or care for infants younger than 6 months old, and people between the ages of 25 and 64 who have chronic health conditions.

“I think there is no right way of getting this vaccine out,” Morita said. “I think there are multiple approaches. Everybody has different resources and different populations,” she said, adding that “having alternative approaches is appropriate.”

Arizona’s method for distributing vaccines is similar to Chicago’s in that the Arizona Health Services Department coordinates the H1N1 vaccine process, while the seasonal flu vaccine distribution process is what Laura Oxley, the department’s communications director, called “very free market.”

According to Oxley, the department has received complaints from individuals who are not in the priority groups to receive the vaccine first, something she attributes to the department’s own messaging.

“We’ve been telling people to get shots. We’re also trying to remind people that it’s influenza and it can kill,” Oxley said. “There are people who are at more risk for complications,” she added. “And if they aren’t, we ask them to stand back and wait.”

The virus has provided the state an opportunity to test its pandemic plan, Oxley said, and the department is pleased with the federal government’s handling of the situation despite the delay in vaccine production.

“In our mind, we’re getting our share as it’s available,” Oxley said. “It would be great if there was more available now. They’re paying for it; they’re sending supplies. I think the federal government really stepped up to the plate,” she added. “They tapped the manufacturers early. And the manufacturers did the best they could,” she said, adding that vaccine manufacturers have had to produce both a seasonal flu and H1N1 vaccine this year.

As state and local health departments focus on allocating their limited supply of the H1N1 vaccine to those at increased risk for infection, there has been debate in some parts of the country regarding one targeted group: healthcare workers. On Sept. 24, New York’s state health commissioner announced that all of the state healthcare workers would be required to get both the seasonal and H1N1 vaccines, only to rescind that requirement late last week because of the lack of supply. (See related editorial, p. 23.)

Also in late September, the California Nurses Association/National Nurses Organizing Committee issued a policy to use both as a bargaining demand with hospital management and as guidance to regulators and legislators.

In it, the groups said “at the heart of this policy is the belief that every RN should be vaccinated against the H1N1 influenza virus, but nurses should maintain their right to decline for personal reasons.” In other words, the release said, “encourage, don’t mandate.”

On Oct. 30, about 16,000 registered nurses from three large Catholic hospital chains in California and Nevada are expected to take part in a one-day strike and picket to protest “poor readiness by many hospitals to confront the H1N1 swine flu pandemic,” the association said. But according to the California Hospital Association, the strike is more about contract negotiations than it is about H1N1 preparedness.

“Hospitals are doing all they can to obtain the supplies and equipment they need, but there is only so much hospitals can do,” said C. Duane Dauner, president of the California Hospital Association, in a news release. “The nurses union should call a halt to the disruptive strike and instead focus its resources on working collaboratively with hospitals and public health officials to put the needs of patients first.”

Vaccinating healthcare workers is seen as both a “professional and ethical responsibility” at Nashville based HCA, said Jonathan Perlin, the for-profit hospital chain’s chief medical officer. HCA requires its workers to receive the seasonal flu vaccine, but has not issued that same requirement for the H1N1 vaccine.

“If H1N1 had been earlier, it would have been part of the vaccine,” Perlin said. “But right now, production has been so slow, despite heroic efforts by five manufacturers and all good intents, that it’s difficult to mandate something that is simply not available.”

There are three reasons why HCA workers can refuse a flu vaccine: an allergy to eggs; a history of Guillain-Barre Syndrome—an uncommon disorder in which the body’s immune system attacks the nerves; or religious beliefs that prohibit taking medications.

In Seattle, 289-bed Virginia Mason Medical Center announced in early October that it will require all staff to receive both the H1N1 and seasonal flu vaccine by Nov. 30. The medical center said it was the first hospital in the country to require staff immunizations for seasonal influenza, a policy it established in 2004. It was not implemented until 2005, however, because of a shortage in seasonal flu vaccine.

“Healthcare workers have said they understand while it’s an occupational risk to catch something from a patient, they shouldn’t have to worry about catching it from another employee,” said HCA’s Perlin.

All of these efforts to vaccinate the population against the swiftly spreading H1N1 virus come at a cost, both to the federal government—which is paying for the vaccine itself—and state and local health departments (Oct. 19, p. 28).

“You can’t hire state and local health officials with money that comes and goes,” said Rich Hamburg, director of government relations for the Trust for America’s Health. “The investment in supply and vaccine-manufacturer capacity and anti-viral purchases—that’s all very important, but we need to have a regular, reliable source of funding to make sure that state and local public health officials plan—and exercise their plans.”

Meanwhile, public health departments—and the general public—will have to make the best with what they have for the time being.

“This is a new experience for all of us,” said Morita of the Chicago Public Health Department. “There will be mistakes made and inefficiencies identified,” she said. “It’s a matter of people being patient with a few problems that arrive.”

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