Nearly half the USA's expected supply of flu vaccine won't be delivered because British health authorities suspended Chiron Corp.'s (CHIR) license to make it, company officials said Tuesday.
The announcement, which caught U.S. health officials by surprise and came roughly a month before flu season starts, raises concern about whether there will be enough vaccine to protect children, older Americans and others who are at greatest risk.
Healthy people should "forgo vaccination at this time" to allow people at high risk of flu complications and death to be immunized first, said Julie Gerberding, director of the Centers for Disease Control and Prevention.
Health officials are asking doctors to prioritize patients, giving vaccine first to babies ages 6 months to 23 months; people 65 and older; anyone with chronic health problems, such as heart or lung disease; and pregnant women. Health care workers and people in close contact with anyone in the high-risk groups also should be vaccinated.
Gerberding said Aventis Pasteur, the only other major maker of flu shots, expects to meet its production goal of 54 million doses, and health officials are working to assure that it is evenly distributed.
"We don't want to create a rush for vaccine," Gerberding said. "Take a deep breath. This is not an emergency. We'll work through this as we have with other shortages in the past."
Only last week Chiron said it planned to begin shipping about 48 million doses of vaccine to the USA from its Liverpool plant this month. But on Tuesday, British regulators suspended for three months the release of vaccine. In August, Chiron announced that it would delay delivering vaccine because some lots did not meet sterility requirements.
"This is a much bigger hit, and it's going to cause serious problems," said Martin Blaser, chairman of medicine at New York University and president-elect of the Infectious Diseases Society of America. Very little extra vaccine is made each year.
"One of the problems is we don't have a national policy" on vaccine production, Blaser said. "It's just based on whether companies want to be in or not."
In an average year, flu kills 36,000 people in the USA and causes more than 200,000 hospitalizations. The season typically runs from November through March.
Officials have said the flu strain expected this season, the same one that circulated last year, is known to cause more hospitalizations than other strains. Add to that a vaccine shortage, and Blaser predicted that "this will be a worse flu year than usual."
Tommy Thompson, secretary of the U.S. Department of Health and Human Services, said U.S. scientists would visit the Chiron plant and meet with U.K. regulators to evaluate the British report and "see what other recommendations can be made."