Chiron Allows FDA To Share Company Information on Flu Vaccine Production Process
In an effort to "preven[t] the kind of communication breakdown that contributed" to the recent national flu vaccine shortage, California-based Chiron will allow FDA in its ongoing joint investigation to share with the British Medicines and Healthcare Products Regulatory Agency confidential documents that could include industry secrets, the Los Angeles Times reports (Peterson, Los Angeles Times, 11/13).
The shortage emerged Oct. 6 when Chiron -- which produces half of the United States' flu vaccine supply -- announced that contamination found in the manufacturing process at a facility in Liverpool, England, caused MHRPA to suspend the plant's manufacturing license. As a result, Chiron will not send any flu vaccine doses to the United States this season. U.S. officials expected to have about 100 million flu vaccine doses this year. France-based Aventis Pasteur will provide the United States with 56 million flu vaccine doses, and Maryland-based MedImmune will provide about three million doses of the nasal-spray flu vaccine FluMist (California Healthline, 11/10).
Some observers said that the information provided to British officials likely is related to the company's production process, rather than marketing or sales information.
Meanwhile, FDA officials are also seeking "a broader agreement" with British public health officials to allow "more direct dealings and communication" between the countries' public health agencies, the Times reports. According to the Times, "[t]here is growing precedent for such accords" -- FDA since 2002 has been cultivating arrangements to share regulatory information with other countries -- despite "inherent technical challenges."
However, both U.S. and British officials are concerned that more information sharing could expose trade secrets. FDA Acting Commissioner Lester Crawford said, "We want information sharing, and we're committed to doing that through whatever means we can." He added, "I don't want other countries to have trade secrets unless they can keep them secure" (Los Angeles Times, 11/13).
CDC Director Julie Gerberding in an Atlanta Journal-Constitution interview discussed the agency's role in collecting and disseminating information about Chiron's manufacturing problems and distributing remaining vaccine doses to U.S. residents. According to the Journal-Constitution, the flu vaccine shortage has "sparked strong criticism" of CDC's actions, which have received "mixed reviews" from several state officials.
Pat McCannon, executive director of the Council of State and Territorial Epidemiologists, touted the agency's cooperation with Aventis to redirect unshipped vaccine doses, but other state officials have "expressed frustration with the CDC for attempting tasks that the states could do," according to the Journal-Constitution.
In the interview, Gerberding said that "FDA, the CDC and Chiron had regular discussions, and I had regular discussions, with the CEO of Chiron. Just the week before their license was suspended, they (Chiron) were testifying in Congress that they fully expected the problem would be resolved."
She added, "I wish that I had agitated more, and drawn more attention to our fragile vaccine supply situation. It was hard to do in the context of expecting to receive the largest number of vaccine doses we have ever received and worrying that we wouldn't use them all because that is the usual scenario."
Gerberding continued, "We are accountable for protecting the people's health and we have accountability for assuring we make prudent use of resources like vaccines to protect the people's health." However, she noted, "We don't manufacture vaccine at the CDC, and we don't make decisions about who does manufacture vaccine."
She also said, "If people aren't criticizing you, you are not doing your job as the head of a (federal agency). I don't have any defensiveness about what we are doing here" (McKenna, Atlanta Journal-Constitution, 11/14).
The Washington Post on Saturday examined how the availability of the nasal spray vaccine FluMist "may be as uneven as that of flu shots," despite MedImmune's increased production in light of this season's shortage. FluMist is approved for healthy people ages 5 years to 49 years. The nasal vaccine is more expensive than the traditional vaccine and must be shipped and stored frozen until it is used.
According to the Post, such restrictions have "limited public acceptance" since its introduction in 2003. In addition, FluMist is produced from a live, weakened strain of flu virus, which has made some people "wary" about its safety, the Post reports.
MedImmune spokesperson Jamie Lacey said the company on Friday received FDA approval to ship about 200,000 doses to military personnel, hospitals and pharmacies. It is unknown when remaining doses will be sent as they must undergo FDA review (Levine, Washington Post, 11/13).
Two newspapers recently published articles related to the vaccine shortage. Headlines of the articles appear below.
USA Today: "Looking North for Flu Vaccine" (Rubin, 11/15).
- Atlanta Journal-Constitution: "Flu Cases Low, But Officials Stay Wary" (Wahlberg, 11/13).
The flu vaccine shortage has illustrated "just how precarious the health care system really is" and has shown many U.S. residents "what life is like for people without health care insurance," columnist Ellen Goodman writes in a Boston Globe opinion piece. Goodman continues that U.S. residents "rarely talk about the basics, like vaccines, as a public good."
Goodman writes, "Americans have long been told that national health care would mean long lines, rationing and second-class medicine," adding, "Despite spending more of our gross national product on health care than any other country we rank 29th in life expectancy. ... And what do we have? Long lines and rationing. Not to mention lotteries and a shot in the arm for Canadian tourism" (Goodman, Boston Globe, 11/14).