Chiron Lowers Flu Vaccine Production Estimate at German Facility

California-based Chiron on Friday announced that production of Begrivac, its German-made flu vaccine, will be "scaled back sharply" -- by about eight million doses -- because of contamination at the company's German manufacturing plant, Reuters/New York Times reports. The company also said it might delay shipments of the vaccine until early October (Reuters/New York Times, 7/16).

According to the Wall Street Journal, the announcement has "fueled suspicions among analysts that the company may have a broader quality-control problem in its vaccine-production business" (Hamilton, Wall Street Journal, 7/18). The U.S. experienced a flu vaccine shortage last flu season after the British Medicines and Healthcare products Regulatory Agency in October 2004 suspended the license of a Chiron manufacturing facility in Liverpool, England, because of contamination issues. In late February, MHRA ended the suspension, a move that will allow the facility to manufacture flu vaccine for the U.S. market for the 2005-2006 season, contingent on FDA approval.

However, Chiron last month announced plans to manufacture only 18 million to 26 million doses of Fluvirin vaccine for the 2005-2006 season, down from an April estimate of 25 million to 30 million doses (California Healthline, 6/16). Chiron sells flu vaccines Agrippal S1, Fluad and Begrivac outside the U.S. (Philadelphia Inquirer, 7/16). Prudential Securities analyst John Sonnier said he did not expect FDA to issue a decision on Chiron's Liverpool plant until early September (Reuters/New York Times, 7/16).

A Chiron spokesperson said the problem at the Marburg, Germany, plant is unrelated to issues at the Liverpool facility. According to the Journal, Chiron is considering relocating vaccine supplies from poorer nations, where the vaccine is sold at lower prices, to major markets in the United Kingdom and Germany.

The spokesperson said the company is evaluating options and will relocate vaccine only from countries where other vaccines can take the place of Begrivac (Wall Street Journal, 7/18).

The announcement "continued the uncertainty for Chiron," USA Today reports (Appleby, USA Today, 7/18). Sanford Bernstein analyst Geoff Porges said, "The news that they now have flu vaccine product problems in Germany was a surprise, and it adds to the sense that this company can't operate its own business." Chiron, after receiving a letter from U.S. regulators, also announced that more studies are needed for the company's lung transplant drug, Pulminiq (Reuters/New York Times, 7/16).

In related news, federal vaccine advisers on Tuesday will vote on a revised version of the Pandemic Influenza Preparedness and Response Plan, which outlines the response the U.S. should take in a worldwide flu pandemic. Under the "nearly completed" federal draft plan, "[f]ront-line health care workers" and vaccine and drug plant employees would be vaccinated first in a flu pandemic. The next group to be vaccinated would be those at highest risk of contracting the flu, beginning with those over age 65 with chronic medical conditions, followed by pregnant women and other groups.

Experts still must determine who would first receive limited supplies of flu vaccine and antiviral drugs and how many doses the government should purchase. Two federal vaccine advisory committees on Tuesday will take up those issues. The plan will be finalized by Aug. 1 and sent to HHS Secretary Mike Leavitt for approval, according to Carolyn Bridges of the CDC National Immunization Program and contributor to the plan (Wahlberg, Atlanta Journal-Constitution, 7/18).

If an avian influenza pandemic occurs "anytime soon," neither the U.S. nor international health authorities "will be prepared to cope with it," a Times editorial states. Vaccine and antiviral supplies are inadequate to protect "more than a handful of people," and there is "no industrial capacity to produce a lot more of these medicines quickly," the editorial continues.

Although many experts have said it would be difficult to detect and contain an outbreak of transmissible influenza before a pandemic develops, controlling the disease in poultry and other animals that might spread the virus to humans might "be the best hope we have until we are able to upgrade today's fragile and unreliable vaccine production system with new processes that can expand output quickly to meet a crisis," the editorial concludes (New York Times, 7/17).