Chiron Lowers Production Forecast for Flu Vaccines for Upcoming Season
California-based Chiron on Monday announced that it will supply fewer than the 18 million to 26 million doses of flu vaccine it had predicted in June because of ongoing production delays, the Wall Street Journal reports. The announcement marks the second time Chiron has lowered its production estimate this year. In April, Chiron said it would produce 25 million to 30 million doses of Fluvirin (Hamilton, Wall Street Journal, 10/18).
Chiron had anticipated providing about 50 million doses of its Fluvirin vaccine to the U.S. last year before its manufacturing license was suspended because of contamination problems at its Liverpool, England, plant (Pollack, New York Times, 10/18). Chiron spent $27 million through June improving its equipment and manufacturing process in an effort to provide vaccine for this year's flu season, the company said (Gellene, Los Angeles Times, 10/18). The company has begun shipping 1.5 million doses of Fluvirin approved by FDA last week (Smith, Boston Globe, 10/18).
However, because of changes at the plant -- including installation of new equipment and procedures, along with worker training -- the company will not be able to produce as much vaccine as it originally anticipated, Chiron CEO Howard Pien said. He did not specify how many doses Chiron will supply this year but said it will be a "meaningful" amount (New York Times, 10/18).
Chiron anticipates continuing to deliver vaccine through December. Some analysts have said the company might not sell all of its shots because demand decreases near the end of November. The company also lowered its sales and earnings forecast for the year but did not provide specifics. Chiron on July 27 projected operating income for the year of between $1.20 and $1.45 per share (Los Angeles Times, 10/18).
Pien attributed the altered production forecast to ongoing delays related to continued changes in its manufacturing process. He said some vaccine had to be discarded because it did not meet "all compliance requirements" but added that there is no "quality issue that leads to our current projection" (Los Angeles Times, 10/18). Pien said, "The fact is that we're late" (Wall Street Journal, 10/18). He noted, "For all intents and purposes, we've had only a third of the calendar days that we can devote to production" in a normal year, Pien said (New York Times, 10/18).
Pien continued, "[T]he most important thing is we have achieved remediation," adding, "[W]e are very hopeful in the weeks that come we can clarify the number much, much more clearly" (Boston Globe, 10/18). Pien also said Chiron expects to produce about 40 million Fluvirin doses for next year's flu season.
Pien also said that with Chiron's regular flu vaccine production schedule getting back to normal, the company is planning to return to its efforts to create an avian flu vaccine. Chiron originally had planned to have an experimental H5N1 avian flu vaccine ready by January this year for testing by NIH, but the plans were delayed because of the manufacturing problems. Pien said Chiron currently plans to deliver 8,000 doses of experimental H5N1 vaccine for testing by November.
If the tests are successful, according to Pien, the Liverpool plant could produce as many as 160 million doses of the vaccine in the next two or three years, enough to provide protection to 80 million people under current projections. Pien added that in an emergency Chiron could produce up to 240 million doses.
Meanwhile, Chiron also is working to win regulatory approval for a new technique for making vaccines in cell cultures instead of in chicken eggs, a move that could substantially reduce the six-month vaccine production cycle. The company will begin U.S. studies of the technique late this year or early next year and is hoping FDA will accept data from European trials of the technique, which are further along than the U.S. studies (Wall Street Journal, 10/18).
USA Today on Tuesday examined how patients could face a 25% increase in prices for flu shots because of "increases in the wholesale cost of the vaccines." According to USA Today, all vaccine manufacturers in the U.S. market raised wholesale prices.
Maxim Health Systems, which vaccinates two million people annually in its clinics, said it will charge $25 per shot this year, up from $20 in 2004. Steve Wright, a spokesperson for Maxim, said a 75-cent-per-dose excise tax -- which funds the National Vaccine Injury Compensation Program -- also contributes to higher prices. Costco will offer shots for $18, up from $15 last year (Appleby, USA Today, 10/18).
Meanwhile, WHO spokesperson Mike Ryan on Monday sought to calm worldwide concerns over avian flu, noting that there still are no signs of a flu pandemic in humans, according to the New York Times. He noted that recent reports of the discovery of the H5N1 virus in Europe "do present a warning" but added that the news does not directly increase risk of a pandemic. Ryan said WHO continues to be concerned about the long-term possibility that the H5N1 strain could mutate to become easily transmissible between humans, potentially causing a human pandemic (Altman, New York Times, 10/18).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.