Major Supplier Won’t Make Flu Vaccine This Season

The company that makes nearly half the flu vaccine used in the United States said on Tuesday it will not supply any vaccine for the coming flu season because of problems at its plant in Britain.

The announcement left U.S. officials scrambling to pull together a flu vaccination program. Chiron Corp. said British regulators had forbidden them to sell its flu vaccine after checking out sterility problems at its plant in Liverpool. The U.S. had expected to get 46 million to 48 million doses from Chiron. That would leave the United States with at least an estimated 54 million doses of vaccine made by other companies — far short of the 100 million health officials had expected to have on hand. “This is serious but we are on top of it,” Health and Human Services Secretary Tommy Thompson told a news conference. The news hit just as the United States was starting its annual flu vaccine program — one that health officials had hoped would be its biggest yet. Last year’s flu season hit early and unusually hard and doctors hoped that would encourage a usually apathetic population to get the vaccine. On top of that, health officials had added babies aged 6 months to 23 months to the list of people who should get the vaccine, and they need two doses each to be fully protected. Influenza kills 36,000 people in the United States and 500,000 worldwide in an average season. Dr. Julie Gerberding, head of the U.S. Centers for Disease Control and Prevention, urged Americans to save the flu vaccine for people who needed it the most. That includes infants, people over 65, patients in nursing homes, people with chronic illnesses, pregnant women, and those caring for or in contact with these groups. Realistically, Gerberding said, only a percentage of those who should get the vaccine every year usually do.”We estimate that the 50-some million doses that we have on hand now will come close to meeting the demand of this group,” Gerberding told a news conference. “One problem is the number of doses and another problem is where is it. We will be working on it.” “We currently anticipate having approximately 54 million doses of influenza vaccine from Aventis and about another 1 million to 2 million doses of FluMist nasal spray,” HHS said in a statement. FluMist, made by MedImmune Inc., is given nasally and is not approved for those in most need of the flu vaccine. It takes months to make influenza vaccine, which is reformulated every year to match the strains that scientists believe are the most likely to make people sick each season. Nonetheless HHS said it was looking at possible ways to make more doses in time for this year. “This includes working with Aventis on its ability to provide more vaccine,” HHS said. Thompson said HHS would try to redouble efforts to develop quicker and better ways to make flu vaccine. He said HHS would also look at the possibility of diluting the vaccine to stretch it out for certain groups. Chiron had suspended shipment of its vaccine in August, saying it had some problems with purity at the Liverpool plant where it makes all of its flu vaccine. The company declined to say precisely what the problem was but Dr. Jesse Goodman, director of the Center for Biologics Evaluation and Research at the U.S. Food and Drug Administration said he believed the vaccines had been contaminated with a bacteria called serratia, a type of enterobacteria. Thompson said the FDA would send a team of experts to Britain to talk to regulators there about why they had suspended Chiron’s license and to inspect the plant themselves. Chiron cut its 2004 earnings forecast to 35 cents to 45 cents per share, down from its previous forecast of $1.50 a share to $1.60 a share. Its shares fell more than 16 percent to $37.98. Shares of MedImmune rose nearly 6 percent. Chiron Chief Executive Officer Howard Pien said he had been surprised by the decision of Britain’s Medicines and Healthcare Products Regulatory Agency. “(They) said in their letter to us … that they believe that there are overall issues of the system and the process of our manufacturing facility,” Pien told reporters. “The products will be destroyed in due course,” Pien said. Aventis-Pasteur, the unit of Aventis that manufacturers the flu vaccine, says it has already shipped 30 million doses of vaccine and plans to produce a total of 52 million doses for this season.(Source: Reuters, Oct 2004)