Congressional Investigation Into Flu Vaccine Shortage Continues, FDA Requests More Time
FDA Acting Commissioner Lester Crawford on Wednesday said FDA officials need more time to provide the documents requested last week by House Committee on Government Reform Chair Tom Davis (R-Va.) and ranking member Henry Waxman (D-Calif.) related to problems at Chiron's Liverpool facility, the Los Angeles Times reports (Peterson, Los Angeles Times, 10/25).
California-based Chiron on Oct. 6 announced that the company, which manufactures half of the U.S. flu vaccine supply, will not ship doses manufactured at its plant in Liverpool, England. The British Medicines and Healthcare Products Regulatory Agency suspended the manufacturing license held by Chiron for the Liverpool facility -- which produces all of the company's flu vaccine -- because of "issues with systems and processes," according to company Chair and CEO Howard Pien. A weeklong U.S. investigation into the British decision to suspend Chiron's manufacturing license found that none of the flu vaccine made there is safe for use.
Prior to the announcement, the United States expected to have 100 million flu vaccine doses for the current season, compared with 87 million last season. As a result of the problems with Chiron, the United States will have about 56 million standard flu vaccine doses manufactured by France-based Aventis Pasteur, the other U.S. supplier. Maryland-based MedImmune will produce about three million doses of its nasal-spray flu vaccine FluMist for this influenza season, while federal health officials are looking into acquiring additional doses of injectable vaccine from Canada and Europe (American Health Line, 10/22).
The lawmakers requested that FDA officials by Oct. 20 produce, among other materials, the results of a June 2003 FDA inspection that "turned up signs of contamination," along with communications between Chiron and FDA officials and British health authorities, according to the Times. FDA did not meet the deadline. Crawford, in a letter to Davis, wrote, "My team that is working hard to secure more flu vaccine, antiviral medication and complete its investigational work at Chiron Corp.'s manufacturing plant is the same team that maintains the responsive materials that you have requested." Waxman in a letter to Davis urged that he seek a subpoena for the documents. Waxman said, "What is happening is obvious. The administration is trying to delay the release of the vaccine documents until after the election." Davis in a letter to Waxman late Friday wrote, "Frankly, I am concerned that your push to subpoena the FDA is more about politics than fulfilling our oversight responsibility" (Los Angeles Times, 10/25).
About 42% of U.S. residents say they are at high risk of contracting the flu or have family members that are in the high-risk group, according to an Associated Press poll, the AP/San Francisco Chronicle reports. Ipos-Public Affairs surveyed 1,000 adults between Oct. 18 and 20 and found that one-third of all U.S. residents say they are concerned that someone in their family who needs a flu shot will not be able to get one.
Women and people over the age of 50 were most likely to say they are worried. Two-thirds of people surveyed said they are generally concerned about the shortage. About 28% of respondents said they plan to get the vaccine, and 7% say they already have gotten the vaccine this year. About 42% of respondents say they got the flu vaccine last season. Of that group, more than 50% of those over age 50 received the flu vaccine last season and 75% of those 65 and over received the vaccine (Lester, AP/San Francisco Chronicle, 10/22).
The national flu vaccine shortage "may trigger efforts to attach remedies to an omnibus spending bill" in the lame duck legislative session, CQ Today reports. A Government Accountability Office report issued one week before Chiron's announcement noted that there has been little official action to implement GAO recommendations issued in 2001 to prepare for the flu season.
Sens. Edward Kennedy (D-Mass.), Hillary Clinton (D-N.Y.) and Olympia Snowe (R-Maine) have introduced legislation that would give CDC authority to require that vaccine be made available to high-risk populations in emergencies and to distribute the vaccine through public health agencies. Rep. Rahm Emanuel (D-Ill.) and Sen. Evan Bayh (D-Ind.) have lobbied for legislation (HR 3758 and S 2038) that would require the federal government to purchase any unused flu vaccine at the end of the flu season. Bayh has said he hopes to attach the measure to legislation such as the omnibus appropriations package (Schuler, CQ Today, 10/22).
According to the Washington Post, the United States seems "headed toward ... an arrangement" similar to Canada's, in which the federal government contracts with vaccine manufacturers to supply a determined amount of vaccine, regardless of how much is used. Such a shift could encourage other manufacturers to re-enter the vaccine market, "making the supply less easily disrupted," the Post reports (Washington Post, 10/25). Bush administration officials "are reluctant to interfere with the free-market nature of the drug supply chain," CQ Today reports. A Republican aide said, "We don't want to go down the road where you have the government as a single purchaser deciding who gets what where" (Schuler, CQ Today, 10/22).
Chiron's announcement "has had little to no effect on the distribution of flu shots throughout Britain" -- highlighting some "sharp differences in the two countries' public health systems," Long Island Newsday reports (Maier, Long Island Newsday, 10/24). According to the Times, most countries contract with several vaccine manufacturers to supply a smaller amount than that ordered by U.S. officials (Rosenthal, New York Times, 10/23).
Federal public health officials in a news conference last week said that the government does not plan to assume control over the remaining flu vaccine. HHS Deputy Secretary Claude Allen said, "We want the public to know we do have the ability to deal with the coming flu season. ... There's no need for anyone to panic. There's no sign of an epidemic." HHS Deputy Assistant Secretary Howard Zucker said, "We need to take a deep breath. ... There's no need to stand in line at this point." CDC spokesperson Karen Hunger said that the agency will not control remaining vaccine supplies. She said, "We are not a regulatory agency." She added that the reallocation of vaccine "is voluntary and collaborative" (FitzGerald/McCullough, Philadelphia Inquirer, 10/23).
CDC spokesperson Thomas Skinner said the agency intends to "tell the American people firsthand that the flu vaccine is on the way and that they need to be patient and persistent. We just don't want people rushing out and standing in line" (Lerner, Minneapolis Star-Tribune, 10/24). In addition, NIH's National Institute of Allergy and Infectious Diseases Director Anthony Fauci said that early signs indicate that the flu season could be mild this year (Condon, Hartford Courant, 10/24).
A "late season surge" of a flu strain called A/Wellington is "raising questions" about the effectiveness of the United States' flu vaccine, according to the San Francisco Chronicle. The strain has emerged in New Zealand and Norway. The predominant flu virus strain found in the United States is called A/Fujian, which is a "perfect match" with the flu vaccine supply being distributed throughout the county, the Chronicle reports.
According to CDC's Influenza Branch Director Nancy Cox, there is no way of knowing whether the A/Wellington strain will hit the United States this season. Cox said, "We would not anticipate that the Wellington strain will cause an enormous problem" (Russell, San Francisco Chronicle, 10/24).
International Vaccine Institute Director John Clemens in South Korea on Friday warned that the international community is not prepared to deal with a flu pandemic. Clemens said, "We are talking about a killer influenza that would kill probably tens of millions of people. We're not talking about if, we're talking about when." Clemens added, "The current shortage of vaccine in the United States can be attributed to reliance on too few producers. Globally, in terms of vaccine development and production that could respond quickly to a killer influenza pandemic, we're inadequately prepared" (Jung, AP/Las Vegas Sun, 10/22).
Members of Congress on Friday announced that they would redistribute to Washington, D.C., hospitals and public health officials about 3,000 doses of flu vaccine that Capitol Hill attending physician John Eisold had reserved for lawmakers and their staffs. Eisold until Oct. 20 recommended that all members of Congress and their staffs be vaccinated because of their contact with constituents. Eisold had administered about 2,500 shots (Schuler/Adams, CQ Today, 10/22).
NPR's "All Things Considered" on Friday reported on the flu vaccine shortage. The segment includes comments from Crawford; Bruce Gellin, director of the National Vaccine Program Office; CDC Director Julie Gerberding; and HHS Secretary Tommy Thompson (Prakash, "All Things Considered," NPR, 10/22). The complete segment is available online in RealPlayer.This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.