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 a
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