If you've been to your doctor, been by a school, picked up a newspaper or turned on the TV anytime in the last week, the chances are great that you've heard that there will be a tremendous shortage in flu vaccine doses this year. The immediate cause of the shortage is contamination in the manufacturing plant that Chiron used to produce the vaccine doses. But the problem isn't only that Chiron's plant was contaminated - it seems that an overhaul on the way vaccine doses are manufactured and approved.
One issue that seems to have contributed to the abrupt shortage is that the FDA had no idea it was coming, as it did not contact its British counterpart, the Medicine and Healthcare Products Regulatory Agency (MHPRA). It seems the FDA talked only with the plant itself, and didn't call up the MHPRA to see what action(s) they were taking, and thus were stunned to hear that the British agency suspended the factory's license. Oops. But, the FDA and the MHPRA aren't in the habit of sharing that sort of information, and to be fair, the article above notes that:
It is not clear how much the F.D.A. might have learned had it contacted its British counterpart. The British agency has said it was prohibited from telling others it would shut the plant until it first told Chiron.
To FDA Commissioner Lester Crawford's credit, he concedes in the article that:
the F.D.A. did not have an agreement with the British agency that would have compelled data sharing. Such agreements might be needed in the future because flu vaccine plants are becoming "international resources, not just national resources," he said.
Life happens, and unfortunately, it often takes events like this for companies and regulatory agencies to notice chinks in the system.
With only 55 million doses able to be distributed now, there is a scramble going on at the CDC to distribute those doses and obtain other vaccines from other sources. While they likely won't suddenly increase the prices for their flu vaccines (that would prove to be a major fiasco - holding the flu vaccines hostage until they got their ransom), this episode is likely to help out ID Biomedical, Aventis Pasteur and GlaxoSmithKline PLC (Fluarix). The latter is now working with the FDA to speed through approval for their own vaccine so it can be provided to the American market.
In case you missed it, Ira Flatow did a good interview on Talk of the Nation - Science Friday last week about the economics behind getting flu vaccines out into the public marketplace. I thought the ideas of how to make sure there were always enough flu vaccine doses available were interesting (having the government pre-order millions of them, even if they don't always force delivery of them if demand isn't as high).
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