Demand for Flu Vaccine Surges; Doctors Remain Concerned About Access to Doses for High-Risk Patients

About half of local health departments in the United States have no flu vaccine, and 85% have canceled or delayed flu clinics despite rising demand for the inoculations, according to a survey of 150 local health departments by the National Association of County and City Health Officials, USA Today reports (Manning [1], USA Today, 10/8). The shortage comes after California-based Chiron, the maker of half of the U.S. flu vaccine supply, informed U.S. health officials Tuesday that it would not ship any influenza vaccines this year. In a letter to Chiron this week, Britain's Medicines and Healthcare Products Regulatory Agency said it was suspending for three months the license of the company's Liverpool, England, plant because of the factory's "issues with systems and processes," according to Chiron Chair and CEO Howard Pien. The plant manufactures Chiron's entire supply of flu vaccine for the United States. Prior to Tuesday's announcement, the United States expected to have 100 million doses of flu vaccine, up from 87 million last winter. Now, federal health officials expect to have about 56 million doses produced by Aventis Pasteur and another one to two million doses of nasal flu vaccine spray manufactured by Maryland-based MedImmune. Following Chiron's announcement, a panel of experts convened by CDC issued new, temporary guidelines for flu vaccinations that say those most in need of vaccination should be inoculated first. Under the new recommendations, high-priority groups include all people ages 65 years and older; people between the ages of two and 65 who have chronic illnesses; pregnant women; nursing home residents; children taking aspirin; health care workers; those who have close physical contact with infants younger than six months; and infants ages six months to 23 months. CDC data show that an estimated 95 million adults and children -- nearly one-third of the United States' population -- fall into the high-risk category (Kaiser Daily Health Policy Report, 10/7).

Working To Find Extra Supplies
According to the Wall Street Journal, federal health officials are "racing to find additional supplies." FDA officials are negotiating with GlaxoSmithKline, which does not supply the U.S. market, about importing some of its flu vaccine for this season, according to company spokesperson Danielle Halstrom. She said, "We absolutely intend to get into the flu vaccine market in the U.S. and are in ongoing discussions with the FDA about both short-term and long-term solutions." Halstrom added, "I think we'll be able to do something," although it "may not have a huge impact" (Wysocki/McKay, Wall Street Journal, 10/8).

MedImmune Vaccine
Meanwhile, MedImmune, which had originally planned to manufacture only 1.1 million doses of its FluMist vaccine, said Thursday that it will make another one million doses to help ease the shortage. The company said it has enough frozen bulk vaccine to create the extra doses, which could reach the market by late November (Patalon, Baltimore Sun, 10/8). However, health officials on Thursday said they "held out no hope" that enough extra supplies of flu vaccine could be manufactured for the upcoming flu season, according to USA Today (Manning [2], USA Today, 10/8). "It's not part of the solution we're aiming toward," CDC Director Julie Gerberding said. She urged healthy U.S. residents to consider alternatives to inoculations this year, including antiviral flu drugs and "common sense," such as washing hands and staying home when sick (Wahlberg, Atlanta Journal-Constitution, 10/7).

Chiron Doses
In a telephone news conference Thursday, William Egan of FDA's Center for Biologics Evaluation and Research also "did not rule out the possibility" that Chiron's 42 million doses of unshipped vaccine could be declared usable eventually, but he added that such a decision would require more than simply testing for contamination, the Washington Post reports. He said, "There are multiple layers of review that must be taken to ensure safety" (Brown, Washington Post, 10/8).

Voluntary Redistribution
Prior to Tuesday's announcement, Aventis already had shipped 30 million of its doses to providers, private companies and local health departments. Another 22 million doses already have been promised to private distributors. CDC cannot force Aventis to break its contracts with the private distributors, so the agency has implemented a voluntary redistribution system (Kaiser Daily Health Policy Report, 10/7). Aventis and CDC are working together to ask consumers who purchased extra vaccine doses to return part of their orders so that vaccines can be redirected to people most in need of inoculation, according to Gerberding. According to the Journal-Constitution, the voluntary redistribution system prompted a number of private distributors on Thursday to cancel planned vaccination clinics or restrict vaccinations to those in high-risk categories (Atlanta Journal-Constitution, 10/7).

Price Gouging
Amid the increased demand for the vaccines, reports of price gouging surfaced Thursday, the New York Times reports. At a news conference, Dr. Bruce Gellin, director of the National Vaccine Program Office for HHS, said the government had "heard ... stories" of suppliers selling single flu shots for as much as $65. One pharmacist in Orange County, Calif., said he had been contacted by a vendor about purchasing Aventis' flu vaccine for 10 times the usual amount -- $700 for a vial of 10 doses that normally costs $67. "Obviously, this is a great concern to all of us and these are the stories that we need to track down because it is immoral," Gellin said. He said officials would investigate the reports but did not specify how the problem would be solved (Altman, New York Times, 10/8).

Reforming the Vaccine Supply System
As the health officials across the country work to resolve the shortage of vaccines for the upcoming flu season, "attention turned to overhauling a supply pipeline that depends on a dwindling number of producers even as demand is on the rise," the Los Angeles Times reports. According to the Los Angeles Times, "Industry consolidation, liability fears and the allure of more lucrative drugs have thinned the ranks of vaccine makers, despite wider use" (Levin, Los Angeles Times, 10/8). Merck, Pfizer and Wyeth are among the major vaccine producers that have withdrawn from the U.S. flu vaccine market in recent years, according to the Journal. Those who remain in the business have faced lawsuits over allegations that some ingredients in the vaccines can cause autism and other neurological disorders (Wysocki/McKay, Wall Street Journal, 10/8). "It is, on its face, an extraordinary circumstance that this most-developed country on the Earth has ... a very fragile supply of vaccines," Schaffner said. At a news briefing, HHS officials said they had discussed the possibility of offering incentives to lure manufacturers into the vaccine market (Los Angeles Times, 10/8).

Congressional Involvement
Congress on Friday will hold an emergency hearing to examine how critical the shortage is nationally and "how quickly anything can be done to mitigate it," according to the Post (Levine, Washington Post, 10/8). According to the Los Angeles Times, The House Committee on Government Reform hearing will also address the circumstances surrounding Chiron's license suspension. Rep. Henry Waxman (D-Calif.) said, "Public health is at risk because we are dependent on a limited number of suppliers. We need more production capacity and better vaccine technologies." He added that Congress should consider government-guarantees of vaccine purchases, as well government involvement in the vaccine business (Los Angeles Times, 10/8).

Insurers To Cover FluMist?
According to the Sun, insurers now are re-evaluating their earlier decisions not to cover MedImmune's FluMist, which is more expensive than traditional flu shots. Aetna, which has 13 million members across the United States, said it is likely to cover the nasal-spray vaccine, although a final decision had not been made as of Thursday, according to a company spokesperson. "We are seriously looking at it. We want to take the appropriate action with the best interests of our members," Aetna spokesperson Walt Cherniak said. CareFirst BlueCross BlueShield -- with 3.2 million members in Maryland, Delaware, Virginia and Washington, D.C. -- also said it is reviewing its policy not to cover FluMist. Spokesperson Jeffrey Valentine said the insurer expects to make a decision early next week. The Sun reports that insurers might be helped in their decision by the fact that MedImmune in the past year has lowered the sale price of FluMist from $46 per dose to $23.50 per dose, wholesale cost. Patients pay $10 to $15 for a regular flu shot (Baltimore Sun, 10/8).

Alternative Flu Treatments Anticipate Greater Sales
In light of the vaccine shortage, companies selling products ranging from cold remedies to surgical masks are "bracing for a potential consumer rush," USA Today reports (Hopkins, USA Today, 10/8). Roche Group, which manufactures the flu treatment Tamiflu, says it plans to increase its supply of the drug, although specific details of the plan have yet to be determined. A 10-day preventive dose of Tamiflu, which is approved both for treatment and prevention of influenza, could help caregivers of infants and the elderly, as well as health care workers, according to Dr. Edward Chapnick, director of the infectious diseases division at Maimonides Medical Center. Tamiflu costs about $66 for a typical course. GSK, which markets the flu treatment Relenza, also plans to increase its supply of the drug, which is approved only for treatment of influenza and not prevention. A course of Relenza costs about $55. Both drugs, which are often partially covered by insurance, must be taken within 48 hours of symptom onset for treatment and before symptoms start for prevention (Johnson, AP/Houston Chronicle, 10/7). Meanwhile, manufacturers of other products, ranging from cold remedy tablets to hand cleaners and surgical masks are stepping up marketing of their products in anticipation of the upcoming flu season (Hopkins, USA Today, 10/8).

Broadcast Coverage
Several broadcast programs reported on the flu vaccine shortage:

CBS' "Evening News": The segment includes comments from Dr. Ron Brus, CEO of Crucell, a biotechnology company working to develop flu vaccine in human cell cultures; Dr. Peter Gross of Hackensack University Medical Center; and Dr. Walter Orenstein of Emory University School of Medicine (Kaledin, "Evening News," CBS, 10/7). The complete segment is available online in RealPlayer.

C-SPAN: The station will broadcast the House Government Reform Committee's hearing Friday on the shortage. Witnesses are scheduled to include Fauci and Gerberding (C-SPAN, 10/8). The complete segment will be available online in RealPlayer and Windows Media after the broadcast.

NBC's "Nightly News": The segment includes comments from Dr. Greg Poland of the Mayo Clinic, physicians and patients (Bazell, "Nightly News," NBC, 10/7). The complete segment is available online in Windows Media.

NPR's "All Things Considered": The segment includes an interview with Charlotte Waters, administer of the flu shot program at the Memorial Hospital HealthLink Clinic (Block, "All Things Considered," NPR, 10/7). The complete segment is available online in RealPlayer.

NPR's "Day to Day": The segment includes comments from Howard Backer, chief of the immunization branch of the California Department of Health Services; Christine Ferguson, public health commissioner for the Massachusetts Department of Public Health; Minnesota state epidemiologist Harry Hull; Dr. Harvey Simon, an internist at Massachusetts General Hospital; and patients (Smith, "Day to Day," NPR, 10/7). The complete segment is available online in RealPlayer.

NPR's "Talk of the Nation/Science Friday": Guests on the program are scheduled to include Theodore Eickhoff, professor of medicine in the Division of Infectious Diseases at University of Colorado Health Sciences Center and Frank Sloan, chair of the IOM Committee on Evaluation of Vaccine Purchase Financing in the United States and a professor of health policy, management and economics at Duke University (Flatow, "Talk of the Nation/Science Friday," NPR, 10/8). The complete segment will be available online in RealPlayer after 6 p.m. ET.