British Regulatory Officials Lift Flu Vaccine Manufacturing Suspension Imposed on Chiron
Officials for the British Medicines and Healthcare Products Regulatory Agency on Wednesday lifted a five-month manufacturing suspension imposed on California-based Chiron's Liverpool, England, plant -- "clearing the way" for the company to manufacture flu vaccine for the U.S. market next season if FDA gives approval, USA Today reports (Manning/Schmit , USA Today, 3/3).
MHRA officials in October 2004 suspended the plant's manufacturing license for three months because of contamination issues. Chiron was expected to produce about half of the United States' 100 million-dose flu vaccine supply for the 2004-05 season, but subsequently it did not ship any doses. MHRA in December 2004 extended the plant's suspension from January to April 2005, an action that regulatory officials said was anticipated.
In a letter FDA sent after the suspension extension, regulators requested more information about the plant's contamination issues, details about flaws regulators found during an October 2004 inspection of the plant and the steps the company was taking to mitigate problems. The inspection report cited violations of bacterial contamination of vaccine batches; inadequate cleaning procedures; microbial growths on equipment used to fill vaccine vials; unacceptable levels of bacterial toxins in some vaccine preparations; and contamination in some viral seed cultures used to produce the vaccine (California Healthline, 12/13/04).
MHRA officials on Wednesday said that the agency believed "satisfactory progress has been made" toward fixing contamination problems (Manning/Schmit , USA Today, 3/3). MHRA spokesperson Vicky Wyatt said, "We are happy to have them resume manufacturing" (Gellene, Los Angeles Times, 3/3).
FDA officials must approve Chiron's Fluvirin vaccine before distributors can sell it in the United States. Jesse Goodman, director of the FDA Center for Biologics Evaluation and Research, said the company "still ha[s] a number of things to do to convince the FDA and make us comfortable" that the vaccine is safe and effective (Pollack/Altman, New York Times, 3/3). He added that regulators will "continue to closely monitor Chiron's progress as manufacturing proceeds" (CQ HealthBeat, 3/2).
Goodman said the agency considers the suspension lift to be an "extremely important milestone" in the company's efforts to resume production for the next flu season. He said the agency will conduct a "comprehensive inspection" when "all critical stages of manufacturing are in full swing" (Manning/Schmit , USA Today, 3/3).
FDA has said it will inspect flu vaccine manufacturing plants annually instead of every two years, as was its previous policy. Officials also have said they plan to stay in "closer contact" with health regulatory officials in other countries, the New York Times reports.
Jeanne Santoli of CDC called Wednesday's announcement "good news" but added, "We absolutely cannot count on Chiron being able to supply vaccine for the U.S." based on MHRA's decision alone (New York Times, 3/3).
Chiron spokesperson Alison Marquiss said the company plans to resume production "immediately," the AP/Long Island Newsday reports.
Experts have said the company would need to start production by April to prepare shots for the upcoming flu season (AP/Long Island Newsday, 3/2). Some analysts have said the company is resuming production "somewhat late," and production could be limited by future inspections and a "desire not to strain" the company's facilities, the New York Times reports.
Chiron CEO Howard Pien said, "Our employees have worked tirelessly, and we are extremely proud of this result. In this new beginning, we remain focused on continuing to remediate and improve so Chiron can successfully deliver on the results required" to meet demand next season (New York Times, 3/3). Pien added, "We are grateful for the guidance and effort from the regulatory agencies" (Sarkar, San Francisco Chronicle, 3/3).
Despite the announcement, "the company still faces a host of challenges," the Wall Street Journal reports (Hamilton, Wall Street Journal, 3/3).
U.S. government agencies continue to investigate the company, and Chiron's director of vaccine business operations recently resigned (Los Angeles Times, 3/3). Even if Chiron resumes full production, "it may not do as well as it once hoped," in part because of new competition from other manufacturers, the New York Times reports.
GlaxoSmithKline and ID Biomedical are seeking FDA approval to sell their flu vaccines in the United States. GSK has said it could produce up to 15 million doses for the next flu season. According to the New York Times, Sanofi Pasteur -- the United States' other approved manufacturer -- has said it can manufacture 50 million to 60 million doses per year for the U.S. market (New York Times, 3/3).
Chiron has not specified how much vaccine it aims to produce, but analysts' estimates range from 35 million to 55 million doses (Manning/Schmit , USA Today, 3/3).
According to USA Today, Chiron's return to the U.S. market "might help keep a lid on prices" for all flu vaccine. The company might "not need to be the lowest-priced vaccine" to draw customers because "the scrutiny it has received may win some customers," USA Today reports. Chiron would not comment on pricing (Manning/Schmit , USA Today, 3/3).
Santoli said, "We don't know the impact this year's flu season will have on people's willingness to purchase from Chiron in the future" (Manning/Schmit , USA Today, 3/3).
Deutsche Bank analyst Jennifer Chao said Chiron could set the "gold standard" for flu vaccine production (Manning/Schmit , USA Today, 3/3).
According to the Washington Post, "That the [current] flu season ended with as many as five million unused doses raised questions about demand and will complicate planning for company executives who have to decide now how much vaccine to produce for next year."
Walter Orenstein, former director of the CDC National Immunization Program, said, "There will be people who didn't get the flu shot this year, who then didn't get the flu, who may think they won't need it anymore. That would be a big problem."
Scott Gottlieb, a former FDA official now with the American Enterprise Institute, said that if several vaccine manufacturers enter the U.S. market, oversupply problems could result. "If that happens, and next year turns out to be another business debacle for the producers, it will make it even harder to entice people into this market down the road. This is becoming a very hard business to be in," Gottlieb said (Rosenwald, Washington Post, 3/3).
While the 2004-05 flu season has been "relatively mild" to date, many scientists and health officials believe a potential avian flu pandemic poses "a much greater flu threat," NIH's National Institute of Allergy and Infectious Diseases Director Anthony Fauci writes in a Washington Times opinion piece.
According to Fauci, the H5N1 virus strain that first emerged in 1997 in Hong Kong is "[m]ost worrisome" because it has recently "re-emerged with a vengeance" in Asia. Fauci states that WHO, CDC and other health agency officials are "carefully monitor[ing]" H5N1 outbreaks.
He adds that scientists also are "developing techniques for rapidly isolating and identifying new viral strains and cell-culture methods," researching "reverse genetics" techniques, examining ways to "rapidly sequence influenza genomes derived from multiple sources," researching antiviral medications and investigating "dose-sparing approaches" in an effort extend vaccine supplies.
According to Fauci, "[W]ithout a robust research program to develop the technology to rapidly detect and monitor evolving pathogens, to understand their disease-causing mechanisms and to develop measures to block transmission, we are doomed to relive the pandemics of the past."
However, he concludes, "In developing the tools and infrastructure to identify and study H5N1, and rapidly produce and scale up vaccine production, we are developing the capabilities to respond to any novel virus that may emerge" (Fauci, Washington Times, 3/3).