United States Could Import 5.2 Million Flu Vaccine Doses From Canada, Germany, HHS Secretary Says

Federal health officials could import up to 5.2 million additional flu vaccine doses from Canada and Germany to help mitigate an unexpected national flu vaccine supply shortage if manufacturing facilities in those countries pass FDA inspections, HHS Secretary Tommy Thompson announced Thursday, USA Today reports (Rubin, USA Today, 10/29).

The shortage became apparent when California-based Chiron on Oct. 6 announced that the British Medicines and Healthcare Products Regulatory Agency suspended the company's manufacturing license at its sole flu vaccine manufacturing plant in Liverpool, England, and as a result the company will not ship any doses this season. U.S. officials had expected to have about 100 million flu vaccine doses for the upcoming flu season.

France-based Aventis Pasteur, the other U.S. standard flu vaccine supplier, this influenza season will provide 56 million vaccine doses, and Maryland-based MedImmune will produce about three million doses of its nasal-spray flu vaccine FluMist (California, 10/28).

FDA officials next week will inspect a German GlaxoSmithKline manufacturing plant and a Canadian ID Biomedical manufacturing plant. If the facilities pass inspection, the United States' vaccine supply could increase to 66.2 million doses this season. FDA Acting Commissioner Lester Crawford said FDA hopes the vaccine will be imported by mid-December (USA Today, 10/29). The flu season can peak as late as February and March (Peterson/Gellene, Los Angeles Times, 10/29).

GlaxoSmithKline's Philadelphia spokesperson Patty Seif said the company has 500,000 surplus doses of vaccine in unallocated inventory and could produce and deliver an additional 3.5 million doses by January, adding that the company is "always making vaccine" because it supplies 78 countries for flu seasons in the Northern and Southern Hemispheres (Loyd, Philadelphia Inquirer, 10/29).

ID Biomedical's Quebec City plant has 1.2 million extra doses that were manufactured in case of unexpected increased demand in Canada, according to spokesperson Dean Linden (USA Today, 10/29).

Thompson said that FDA inspectors must "confirm the availability of the vaccine [and] assure the American people ... that the vaccine can be used safely" before HHS can "make arrangements to acquire them" (Los Angeles Times, 10/29). He added that such a move would not indicate that prescription drugs from other countries would be allowed in the United States. He said, "This vaccine is going to be inspected by FDA inspectors based upon efficacy, safety. Drugs that are being imported into America don't have that kind of protection" (USA Today, 10/29).

If the vaccine from abroad is approved, it would be considered a special "investigational" new drug, meaning that recipients would have to sign a consent form disclosing that the medication isn't licensed in this country (Los Angeles Times, 10/29).

Thompson said, "We're continuing to build our arsenal of vaccines and medicines to confront the coming flu season." He added, "We're growing stronger each week in our supply of vaccines and medicines, which makes us optimistic about our ability to protect the American public as we go into flu season."

He noted that HHS officials are considering looking to additional countries for more doses of the vaccine. Thompson said, "On behalf of the president, I want to extend the administration's appreciation to citizens across America, who in accordance with CDC guidelines, are forgoing the flu shot so that someone in a priority category can get one," adding, "Working together, we can make sure that the vaccine doses go to those who are most vulnerable" (HHS release, 10/28).

Allowing flu vaccine manufactured in other counties to enter the United States could "ultimately ... end the nation's reliance on just two suppliers of the scarce vaccine," as the move "open[s] the door for firms to enter" the U.S. market, according to the Los Angeles Times.

Drug industry consultant David Webster said, "It certainly means that the U.S. government views both companies as viable suppliers." He added that ID Biomedical and GlaxoSmithKline "are going to watch very carefully what happens with Chiron over the next 60 days, and if they feel there is a high likelihood that Chiron will not be there next year, I would expect them to enter." Webster said the U.S. market could support three to four flu vaccine makers.

ID Biomedical and GSK planned to enter the U.S. market before the shortage was announced. ID Biomedical in September announced a $45 million expansion of its Montreal vaccine factory, anticipating that it could sell flu vaccine in the United States by 2007. ID Biomedical has offered to provide the United States 10 million to 12 million doses next year (Los Angeles Times, 10/29).

GSK also "would like to provide a long-term solution to the flu vaccine supply in the United States," according to Seif (Philadelphia Inquirer, 10/29). GSK has not specified a time frame.

The additional flu vaccine would replace about 10% of the national vaccine shortfall (Los Angeles Times, 10/29). According to the Miami Herald, such an addition would do "little to change the situation."

Frederick Southwick, chief of infectious diseases at the University of Florida, said, "It's really a drop in the bucket," adding that his facility "may not even vaccinate a single person over 65 with a chronic disease. That's how bad our situation is" (Goldstein, Miami Herald, 10/29).

Thompson's announcement marks "the latest in an ongoing campaign by Bush administration representatives to reassure Americans that they are moving decisively" in face of the shortage, according to the Boston Globe. It also "comes in the face of withering attacks on the campaign trail and in television and radio ads" by Democratic presidential nominee Sen. John Kerry (Mass.).

Kerry, in campaign appearances, has asked, "If you can't get flu vaccines to Americans, how are you going to protect them against bioterrorism? If you can't get flu vaccines to Americans, what kind of health care program are you running?" Meanwhile, Thompson has "offer[ed] a ringing defense of the administration's performance" in press briefings in Wisconsin and Iowa, both "battleground states," the Globe reports.

Robert Blendon, a health policy professor at the Harvard School of Public Health, said Thompson "understands this thing could go bad for them right before the election and that if you show you're doing something in a crisis, voters are more forgiving."

Kevin Keane, HHS assistant secretary for public affairs, said, "We've been trying to focus on the problem and trying to educate people about why we're in this predicament. Obviously, others are choosing to play politics with this, and that's unfortunate. It creates an unnecessary sense of panic among people."

Helen Halpin, director of the University of California-Berkeley's Center for Health and Public Policy Studies, said, "It's not that this administration made the system inadequate, but they let it become more inadequate. The Bush administration didn't cause this, but I don't think it's unfair for the Kerry campaign to say that it's deteriorated under the administration's watch."

Dr. Anthony Robbins, a professor of public health at Tufts University School of Medicine and former director of the National Vaccine Program, said, "The Democrats may have been somewhat better handling the flu vaccine situation, but this problem would not have been unknown in a Democratic administration" (Smith, Boston Globe, 10/29).

The Advisory Committee on Immunization Practices voted Thursday to include MedImmune's FluMist in the federal Vaccines for Children program for next year's flu season, the Baltimore Sun reports. As many as nine million U.S. children are estimated to be eligible for the program, which administers vaccines at no cost.

Additionally, the program's age requirements -- it includes children ages five to 18 -- would mean nearly all children enrolled would be eligible for FluMist, which is approved for use in healthy residents between the ages of five and 49. The VFC approval and the increased production of FluMist this season due to the flu vaccine shortage have created "a very nice opportunity for MedImmune to explore more thoroughly the potential ... for sales of FluMist," according to Alexander Hittle, a biotechnologist who follows MedImmune for Missouri-based A.G. Edwards (Patalon, Baltimore Sun, 10/29).