MONDAY, May 18, 2009 (HealthDay News) -- The current swine flu outbreak is raising critical questions about the timing of bringing a new vaccine to market and the logistics of getting it to the people who need it.
If vaccine manufacturers shift gears immediately, it could cut into this fall's production of seasonal influenza vaccine, experts say. If they wait too long, the H1N1 influenza (swine flu) virus could become more virulent.
Global vaccine experts, as part of a series of meetings convened by the World Health Organization (WHO), met Thursday to weigh the evidence that will lead to a recommendation to manufacturers.
"These are enormously complicated questions, and they're not something that anyone can make [decisions about] in a single meeting," Dr. Keiji Fukuda, the WHO's interim assistant director-general for health security and environment, said during a Thursday press briefing.
The WHO is expected to issue advice to vaccine manufacturers and the World Health Assembly this week, the Associated Press reported.
Six manufacturers currently supply vaccine to the U.S. market, according to data from the U.S. Centers for Disease Control and Prevention. Those same facilities would be the ones to produce swine flu vaccine, experts say.
At present, most U.S. flu vaccine is produced in Europe, noted Dr. Holger Rovini, lead analyst for infectious diseases at Datamonitor, a London-based market research firm.
However, the U.S. Food and Drug Administration recently licensed vaccine maker Sanofi Pasteur's new influenza vaccine manufacturing facility in Swiftwater, Pa., expanding the company's capacity to produce seasonal flu vaccine in the United States from 50 million doses to 150 million doses annually.
"That is enough to supply the whole of the U.S. market at current demand," Rovini pointed out. Of course, if H1N1 became more of a threat, demand would exceed that of a typical flu season.
Ravi S. Harapanhalli, principal consultant at PAREXEL Consulting, which serves clients in the biopharmaceutical industry, agreed that the United States should be able to produce enough H1N1 vaccine for the whole country.
"The U.S. government regulates vaccines on a routine basis as well as in the event of a pandemic, such as with the H1N1 flu strain," he said. "FDA has a variety of regulatory tools it can use in the case of a pandemic to help step up production and stockpiling."
In a pandemic, though, getting vaccine to those who need it around the world may be the real challenge, according to a new Datamonitor analysis.
Vaccine distribution requires a "continuous cold chain," Rovini explained. "That means we need lots of cooler trucks and refrigerator trucks," he said. "And then if we really want to immunize the whole population of countries such as the U.S. within a short period of time, say just a couple of weeks, it throws up a whole range of different issues," he added, from who can give the shots to whether there is sufficient cooler transportation and storage capacity.
"Then," he added, "if there is a shortage of vaccine, will it create a black market? Do we have to guard vaccine stores from robberies? There may have to be tough choices as to where and to whom vaccines will be distributed."
In a statement, the Healthcare Distribution Management Association, whose member companies deliver seasonal flu vaccine to hospitals, clinics, physician offices and other health-care facilities, said that the United States has a very efficient supply chain. As evidence, the association cited distributors' response to the recent spike in demand for antiviral drugs.
"In any pandemic outbreak in the U.S., the primary pharmaceutical distribution supply chain, working closely with the manufacturers of antiviral drugs and vaccines and the CDC, will be the quickest and most effective way to deliver product wherever it is needed," the group added.
Christine M. Layton, a public health scientist with RTI International, a Research Triangle Park, N.C.-based research institute, said the response to the 1976 swine flu outbreak illustrates that the United States is capable of immunizing a large number of people in a short period of time.
And while she believes the United States is better prepared today than it was 33 years ago, a new vaccination program doesn't turn on a dime.
"If everybody starts lining up tomorrow, they're going to be waiting a really long time," Layton said.
Get more facts about swine flu from the U.S. Centers for Disease Control and Prevention.