Chiron Resumes Production of Flu Vaccine, Does Not Predict Manufacturing Capabilities

Chiron this year likely will produce less flu vaccine than the 46 million to 48 million doses it manufactured but did not ship last year, despite making extensive improvements to its Liverpool, England, facility, Chiron CEO Howard Pien said in a news conference Thursday, the Contra Costa Times reports (Silber, Contra Costa Times, 3/4).

The British Medicines and Healthcare Products Regulatory Agency on Wednesday lifted a five-month manufacturing suspension on Chiron's Liverpool plant, which would allow the company to manufacture flu vaccine for the U.S. market next season if FDA gives approval. MHRA officials in October 2004 suspended the plant's manufacturing license for three months because of contamination issues and later extended the plant's suspension from January to April 2005. Prior to the regulatory action, Chiron was expected to produce about half of the United States' 100 million-dose flu vaccine supply for the 2004-05 season (California Healthline, 3/3).

Pien said that the exact number of doses the plant can produce will be contingent on the number of manufacturing days, how many chicken eggs the factory can safely process without contamination and how much flu virus can be grown in the chicken eggs (Contra Costa Times, 3/3). The company has not determined the "optimal number of eggs" the factory could process and still "avoid contamination," Pien said (Gellene, Los Angeles Times, 3/4). He added that the company aims to produce the maximum number of doses (Schmit, USA Today, 3/4).

Pien said, "Our goal is not to get our license back alone. Our goal is that once we achieve the restoration of the license that we'll be able to sustain it." He said he thinks about the company's stock price "from time to time," but he said the company's priority rests with improving public health, which is "more important ... than the gain or loss of one year's worth of sales." According to the Contra Costa Times, Pien "acknowledge[d] that the competitive landscape has changed" in the vaccine market, with at least one additional company likely to receive FDA approval to market flu vaccine in the United States for the 2005-06 season (Contra Costa Times, 3/4).

Pien said the company will have production estimates in April. Deutsche Bank analyst Jennifer Chao estimated that Chiron will produce about 35 million Fluvirin doses and have earnings of $1.62 per share in 2005 (Tansey, San Francisco Chronicle, 3/4).

In related news, CDC officials said Thursday that the number of pediatric deaths from the flu virus decreased from 153 children in the 2003-04 season to nine children to date this season, in large part because of increased efforts to immunize children, the Washington Times reports.

Overall, the current flu season appears to be less severe than last season, although the virus still could peak at a later point, officials said. Data from 11 metropolitan areas participating in the Emerging Infections Program show that the flu hospitalization rate for children four years old and younger between Oct. 1, 2004, and Feb. 5, 2005, was 0.81 per 10,000 children. For those children ages five to 17, the rate was 0.11 hospitalizations per 10,000 children. In comparison, EIP hospitalization rates for the 2003-04 flu season were 7.8 per 10,000 for children four or younger and 0.8 hospitalizations 10,000 children ages five to 17 (Howard Price, Washington Times, 3/4).

Lynnette Brammer of the CDC influenza branch said of the overall flu season, "It doesn't look like it's as severe as last year, but it's too early to tell" (AP/Las Vegas Sun, 3/4).

NPR's "Talk of the Nation/Science Friday" in the second hour of the program will include a discussion on the science and economics of vaccine production, including flu vaccine. Guests on the program are scheduled to include Dr. Eric Larson, director of the Center for Health Studies at the Group Health Cooperative; Dr. Gary Nabel, director of the Vaccine Research Center at NIH's National Institute of Allergy and Infectious Disease; Jeffrey Romoff, president of the University of Pittsburgh Medical Center; and Frank Sloan, professor of health policy, law, management and economics at Duke University (Flatow, "Talk of the Nation/Science Friday," NPR, 3/4). The complete segment will be available online in RealPlayer after the broadcast.