Flu Vaccine Supplies From Other Nations Not Likely This Year, HHS Secretary Tommy Thompson Says
FDA likely could not approve influenza vaccine manufactured in Canada or Germany for use in the United States in time to address the shortage for the current flu season, HHS Secretary Tommy Thompson said on Thursday, despite comments from President Bush on Wednesday in the presidential debate that indicated such a possibility, the New York Times reports (Pollack, New York Times, 10/15).
Officials for California-based Chiron, which produces half the U.S. flu vaccine supply, last week announced that the company would not ship vaccine doses manufactured in a facility in Liverpool, England. The British Medicines and Healthcare Products Regulatory Agency suspended the manufacturing license held by Chiron for the Liverpool facility because of "issues with systems and processes," according to company Chair and CEO Howard Pien.
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 only 56 million flu vaccine doses manufactured by France-based Aventis Pasteur, the other U.S. supplier, and one to two million nasal flu vaccine spray doses manufactured by Maryland-based MedImmune (California Healthline, 10/14).
Bush on Wednesday in the presidential debate said in response to a question about the U.S. flu vaccine shortage, "We're working with Canada to hopefully ... help us realize the vaccine necessary to make sure our citizens have got flu vaccinations during this upcoming season" (California Healthline, 10/14).
After the debate, "Bush aides made it sound as if help from Canada was a good bet," the Philadelphia Inquirer reports (Borenstein/Douglas, Philadelphia Inquirer, 10/15).
FDA officials on Wednesday held a conference call with officials for Health Canada, the Canadian equivalent of the agency, to discuss the criteria that Health Canada uses to approve vaccines (New York Times, 10/15).
Michele Roy, a spokesperson for Quebec-based vaccine manufacturer ID Biomedical, also said that the company has discussed the availability of flu vaccine doses with U.S. health officials. However, the discussions were focused on flu vaccine supplies for next year, Roy said. FDA has not approved the flu vaccine manufactured by ID Biomedical, and the company currently has only about one million to 1.5 million unallocated doses. Roy said that the amount is "not much to you because you need over 45 million" for the United States.
GlaxoSmithKline also manufactures a flu vaccine in Germany that FDA has not approved, but the company has almost no unallocated doses, according to company spokesperson Danielle Hallstrom (Borenstein/Douglas, Philadelphia Inquirer, 10/15).
Thompson in a press conference on Thursday said that FDA could allow use of unapproved flu vaccines on an experimental basis under certain conditions, although such a move could not likely occur in time for the current flu season (AP/Long Island Newsday, 10/14). Such a move could require each patient to provide informed consent and remain under observation to determine the safety and effectiveness of the experimental flu vaccines (New York Times, 10/15). Thompson said, "It doesn't look promising" (AP/Long Island Newsday, 10/14).
According to the Inquirer, "this year's vaccine shortage is taking on political overtones" because the Bush administration has opposed the reimportation of prescription drugs from Canada, a practice supported by Democratic presidential nominee Sen. John Kerry (Mass.).
Andy Troszok, president of the Canadian International Pharmacy Association, said that the decision by U.S. health officials to seek flu vaccine supplies from Canada and at the same time oppose reimportation indicates "the hypocrisy of the current administration." However, Senate Majority Leader Bill Frist (R-Tenn.) said, "The Canadian government will not certify drugs coming into this country as safe," and FDA "will not certify, so there is no way we're going to allow those drugs to come into this country when Canada says they can't certify safety."
Baylor Medical Center flu researcher W. Paul Glezen said that the Bush administration should have relied on more than two companies to supply the United States with flu vaccine. Glezen said that administration officials "didn't display any comprehension of what the problem was and what should be done about it." HHS spokesperson Bill Pierce said that the administration has spent more than $50 million on technology to reduce the time required to manufacture flu vaccine, has worked with pharmaceutical companies to increase the number of suppliers and recently awarded new liability protection for flu vaccine manufacturers (Philadelphia Inquirer, 10/15).
U.S. health officials on Thursday said that they might make "commitments" to purchase a set number of flu vaccine doses every year "to help bolster supplies and avoid severe shortages like the current one," the Times reports. Thompson told reporters that Congress should authorize the purchase of 100 million flu vaccine doses annually. Thompson called the proposal a "BioShield for flu," according to an HHS spokesperson.
In addition, Anthony Fauci, director of the NIH National Institute of Allergy and Infectious Diseases, said that the federal government might guarantee purchase of excess flu vaccine doses manufactured by pharmaceutical companies to encourage more production. The government "would not buy all the vaccines and would allow most to use private channels," the Times reports. According to the Times, the practice "could be controversial because it could be perceived as a subsidy to drug companies," and some experts said that "government takeover purchasing" could discourage flu vaccine production because a "single government buyer would likely result in extremely low prices."
Officials for Chiron said that company plans to manufacture flu vaccine doses next year, provided that repairs to the Liverpool facility are completed in time. However, "the government would like to have new suppliers and would like to have a cushion in case of another disruption," according to the Times. ID Biomedical officials said that the company next year could manufacture 20 million to 25 million doses of flu vaccine, which would leave more than 10 million doses to sell to the United States under certain conditions (New York Times, 10/15).
Several newspapers on Friday published articles related to the U.S. flu vaccine shortage. Summaries of the articles appear below.
Los Angeles Times: The Times examined the increased number of physicians nationwide who are "finding themselves in the uncomfortable role of vaccine cop" as they attempt to comply with new voluntary flu vaccination guidelines developed by a committee of CDC experts. According to the Times, compliance for physicians is more difficult than for vaccine clinics "because of the relationship they have with patients" (Saillant, Los Angeles Times, 10/15).
Philadelphia Inquirer: The Inquirer examined how some prescription drug wholesalers are "seizing the chance to make big bucks by selling flu vaccine at vastly inflated prices." Wholesalers that have sought to sell flu vaccine for as much as $900 for a 10-dose vial often are smaller, secondary suppliers that "eschew traditional advertising" and prefer direct mail or contact by telephone, e-mail or fax, according to the Inquirer (Smith, Philadelphia Inquirer, 10/15).
USA Today: USA Today examined how thousands of individuals who last year "used their airport down time to get vaccinated against the flu" at in-airport clinics cannot this year because of the flu vaccine shortage. At least 10 major U.S. airports last year offered flu vaccine clinics; however, many airports this year do not plan to advertise flu vaccine clinics and have cancelled planned clinics for airport employees (Baskas, USA Today, 10/15).
- USA Today: USA Today also examined how the supply of flu vaccine that Aventis Pasteur plans to ship to United States in the next six to eight weeks "will go out in a trickle, not a flood." In addition, "details on where it's going are sketchy," and many individuals at high-risk for flu are "struggling to find a flu shot" (Manning, USA Today, 10/15).