H1N1 vaccine problems prompt government to review emergency preparedness

Physicians raise concerns about distribution procedures that left practices in some parts of the country unable to vaccinate patients.

By Christine S. Moyer — Posted Dec. 14, 2009

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West Virginia family physician Stephen Sebert, MD, is waiting for vaccine that may not arrive.

In early October, his multispecialty practice received influenza A(H1N1) vaccine for about 100 employees who interact with patients. But that was it. His patients still need to be immunized, and Dr. Sebert wonders if he will get another shipment of vaccine.

"We were telling patients, 'Get [the vaccine] any place you can.' But now I don't think anyone has it," he said.

Similar scenarios of vaccine shortages and distribution woes have played out from New England to the West Coast as the H1N1 virus spread nationwide. Even as the epidemic begins to wane and states prepare to lift restrictions on H1N1 vaccinations, some physicians lack supplies of vaccine.

The government has taken note. On Dec. 1, Health and Human Services Secretary Kathleen Sebelius called for a review of the federal government's system for handling public health emergencies.

In a speech to the AMA's National Congress on Health System Readiness in Washington, D.C., she told several hundred physicians and public health experts that the nation's outdated vaccine technology is a "fundamental problem" and that gaps exist at every stage of the vaccine development process. The goal, she said, is to modernize production to improve stockpiling and manufacturing, and to create more advanced distribution practices.

The government review -- expected to be completed in early 2010 -- will examine all aspects of public health emergencies, including terrorist attacks and natural disasters. But the catalyst for the call to action was H1N1, said Nicole Lurie, MD, MSPH, assistant secretary for preparedness and response at HHS, who is leading the review.

Dr. Lurie urged physicians and the public not to expect sweeping reform immediately.

"In four months we can't fix everything. ... But we can take a systems perspective, look at where the most vulnerable points in the system are, and look at the kinds of policies and investments we need to make to address those things," she said in an interview.

Vaccine distribution gaps

HHS was expecting 189 million doses of H1N1 vaccine to be created and delivered. As of Dec. 7, 63.9 million doses had been shipped to the states; another 72.6 million doses are available and waiting for state orders, according to the Centers for Disease Control and Prevention. The remainder is still in production.

Although vaccine production and distribution has increased in recent weeks, the CDC remains short by millions of doses. Government officials point to a virus that grew too slowly in outdated egg-based vaccine technology.

The shortage was no surprise to John J. Lanza, MD, PhD, MPH, director of the Escambia County Health Dept. in Florida.

"Most of us were saying to ourselves, 'This [projection] is too good to be true. They're never going to be able to get it out this quickly,' " said Dr. Lanza, noting that manufacturers were swamped by balancing production of vaccines for both seasonal flu and H1N1.

During her Dec. 1 speech, Sebelius noted the recent opening of America's first cell-based vaccine plant. Novartis is scheduled to begin the plant's operation in 2011 in North Carolina. The facility will be able to produce vaccine for a significant number of Americans within six months of the onset of a pandemic and will help end the nation's reliance on egg-based technology, she said. "This is a big step. But it's only one step."

With seasonal flu vaccine, physician practices order and receive shipments directly from the manufacturer or distributors. But H1N1 vaccine allocation is managed by state and local health departments. State health departments send orders to the CDC, then a CDC contractor ships vaccine to the health departments, which in turn distribute it to physicians.

Vaccine allocation is based on a state's population. Each week, the CDC prepares a report on the amount of vaccine available for order. Distribution methods differ by state and county.

In Florida, Dr. Lanza said vaccine distribution ran so smoothly that the state health department wants to open H1N1 vaccination to people outside the CDC's high-risk groups. He said priority was given to physicians, followed by schools. Only recently did the department begin allocating vaccines to pharmacies, he said.

Similarly, the North Dakota Dept. of Health announced Dec. 7 that physicians and public health units with sufficient H1N1 vaccine supplies could offer vaccinations to the general public.

Shortages still exist

But elsewhere, some doctors continue to struggle to get vaccine. Physicians in Kentucky do not have enough doses to vaccinate their high-risk patients, including pregnant women and children, said Ardis Dee Hoven, MD, chair-elect of the AMA Board of Trustees and an infectious disease specialist in Lexington, Ky.

"There are doctors in my community, including me, who are very frustrated. We don't know when we're going to get doses of the medicine. ... Our patients are equally distraught," Dr. Hoven said.

She supports the government's review of how public health emergencies are handled but said the process should include discussions on what can be improved at the community level.

As the latest round of the H1N1 epidemic begins to wane, health care leaders are reminding physicians and the public of the continued importance that everyone -- particularly those in priority groups -- be vaccinated against the virus. On Dec. 7, HHS launched a new national public service announcement campaign with the Ad Council that features television, radio, online banners and outdoor advertisements in English and Spanish, encouraging Americans to get vaccinated.

"The concern is we're probably in for another wave of H1N1," Dr. Hoven said. "What we don't want to have happen is complacency."

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H1N1 vaccine supply

Although production and distribution of influenza A(H1N1) vaccine has increased in recent weeks, the CDC has fallen short of its supply goals by millions of doses. Doses are allocated to states based on population size. Here are the states with the largest and smallest gaps between vaccine doses allocated and shipped, as of Dec. 7:

Doses allocated Shipped Still needed
Largest gaps
California 8,426,800 7,831,100 595,700
Ohio 2,666,600 2,299,200 367,400
Georgia 2,160,000 1,839,300 320,700
Texas 5,133,800 4,898,300 235,500
Alabama 1,053,700 831,900 221,800
Smallest gaps
Maine 333,900 333,900 0
North Dakota 152,700 152,500 200
Delaware 189,100 188,100 1,000
Nevada 517,600 516,300 1,300
New Hampshire 263,500 260,100 3,400

Source: Centers for Disease Control and Prevention, "2009 H1N1 Influenza Vaccine Supply Status," Dec. 7 (link)

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