CDC Director Julie Gerberding Tells Lawmakers Flu Vaccine Shortage Continues Despite Some Reports

CDC Director Julie Gerberding on Thursday told the House Committee on Government Reform that despite reports from some states about surpluses of flu vaccine, there is still a national shortage, and states should exercise "common sense" in distributing the vaccine, the AP/Las Vegas Sun reports.

In response to the shortage -- which occurred after Chiron, one of two major U.S. suppliers, announced that it would not ship any doses of the flu vaccine this season because of manufacturing problems at its Liverpool, England, plant -- CDC in October 2004 recommended states prioritize flu vaccine for high-risk individuals. Over the past few months, more than half of states dropped their restrictions, but Gerberding said CDC would not do the same because there are still vaccine shortages in some areas as the flu season enters its peak (McDonough, AP/Las Vegas Sun, 2/10).

"We have a national shortage of vaccine. No doubt about it," Gerberding testified. She added that while about 3.5 million doses of vaccine remain unused, "we still have millions of high-risk people who haven't been vaccinated." She noted that although the flu season "has been relatively moderate so far," it "continues into March and April," so people still should be vaccinated.

She added that it is "human nature" not to seek a flu shot after December, but CDC is trying to educate people to continue to receive the shots through February (Dart, Atlanta Journal-Constitution, 2/11). Gerberding said, "If you've got some vaccine in your jurisdiction that's not being used, then for goodness sakes, let the people who want it have it" (Rubin/Manning, USA Today, 2/11).

Jesse Goodman, director of FDA's Center for Biologics, Evaluation and Research, told lawmakers that federal agencies are working to prevent a repeat of the shortage next season, the AP/Sun reports (AP/Las Vegas Sun, 2/10). Goodman said the agency has reached information-sharing agreements with Britain and other countries in order to prevent another manufacturing-related shortage (USA Today, 2/11).

FDA also plans to conduct annual inspections of its flu vaccine manufacturing plants in the future (AP/Las Vegas Sun, 2/10). FDA "has learned from our mistakes," Goodman said, adding that Chiron "is making progress" in fixing problems at its Liverpool plant in anticipation of a "comprehensive inspection" of the facility by FDA this spring (CongressDaily, 2/10).

Goodman added after his testimony that officials are "not making any predictions" about next season's vaccine supply (USA Today, 2/11).

Rep. Tom Davis (R-Va.), the panel's chair, said that the "current surplus has led to confusion among Americans, where immunization recommendations varying from state to state and uncertainties of where ample supplies of vaccine exist. As the peak of the flu season approaches, it appears demand for the flu vaccine has all but disappeared and the public has lost motivation to get vaccinated" (CQ HealthBeat, 2/10).

Rep. Henry Waxman (D-Calif.) said, "There is no crisis. While there is still not enough vaccine to immunize the entire high-risk population, there appears to be enough to meet demand" (Dart, Atlanta Journal-Constitution, 2/11). Waxman also noted a recent USA Today article that detailed FDA's knowledge of the problems with Chiron's manufacturing plant. Waxman described the article as "pretty damning of the inaction of the FDA" (USA Today, 2/11).

On Thursday, USA Today reported that FDA documents recently released to Congress show that Chiron's Liverpool plant -- which had its license revoked by British regulators in October 2004 because of quality problems -- sent some "improperly made" vaccine to the United States in 2002 and that agency officials knew about the problems by mid-2003 (Schmidt, USA Today, 2/10).

Goodman responded that "there wasn't a safety concern at that time" (AP/Las Vegas Sun, 2/10).

From September through December 2004, 58.9% of U.S. residents over age 65 received the vaccine, compared with 65.5% during the same period in 2003, according to CDC's Jeanne Santoli (Dart, Atlanta Journal-Constitution, 2/11). CDC also found that 43.1% of adults in priority groups were vaccinated during that period in 2004, compared with 8.3% of adults who were not in priority groups (Howard Price, Washington Times, 2/11).

Greg Poland of the Mayo Medical School said the proportions reflected the "inconsistent" availability of the vaccine, adding, "Part of it is not stepping up, but part of it is giving up when the vaccine is not available after a certain amount of time" (McKenna, Atlanta Journal-Constitution, 2/11).

CDC spokesperson Von Roebuck noted that the reason for the drop in the percentage of elderly vaccinations is still unclear (Washington Times, 2/11).

Santoli, speaking to scientists on Thursday at a meeting of the Advisory Committee on Immunization Practices, said CDC is considering redefining or clarifying its priority groups and changing how those groups are offered the vaccine. Scientists at the meeting said stating priorities more clearly will result in more vaccinations, citing figures showing that vaccinations among children six months to 23 months increased dramatically after the committee recommended the group be vaccinated, an action it took prior to the current flu season. From September 2004 to December 2004, 57.3% of children in that group were vaccinated, compared with 7.7% in 2003 (Dart, Atlanta Journal-Constitution, 2/11).

The committee within the next two months is expected to issue a document detailing which high-risk groups should receive priority for vaccinations. CDC follows the committee's recommendations. The committee on Friday likely will approve a recommendation that would encourage healthy people ages five to 49 to use FluMist, a nasal spray vaccine manufactured by MedImmune (USA Today, 2/11).

In other flu news, a panel of flu experts at the World Health Organization on Thursday recommended that next year's vaccine include a strain that was first seen in California last month and has been identified in more than 20% of flu viruses isolated from patients in recent weeks. The strain, known as A/California/7/2004(H3N2), will replace A/Fujian as one of three strains included in the vaccine.

WHO's Klaus Stohr said, "A/California is profoundly different from what has been circulating before." U.S. officials generally follow WHO's recommendations, the New York Times reports (Altman, New York Times, 2/11).