A US company said it would consider making its innovative flu vaccine abroad after a panel of experts advising the US drug regulator voted not to recommend it for approval.
A panel of 11 experts who sit on the Vaccines and Related Biological Products Advisory Committee failed the seasonal flu vaccine that Protein Sciences produces using caterpillar cells, saying they wanted more evidence that the vaccine was safe and expressing concerns about its efficacy in the over-50 age group.
AdvertisementThe panel said it was not slamming the door on the new vaccine for seasonal flu, which would be the first cell-based flu vaccine in the United States and could come to market much more quickly than vaccine made using the traditional egg-based method, but wanted to see more evidence it was safe.
But Protein Sciences' chief operating officer Manon Cox said the company might take its innovative technology for producing vaccine elsewhere.
"Other countries - Australia, for example, and Europe - have already said they feel that our vaccine meets the criteria (for safety), but we have always focused on the US," Cox told AFP.
"Now I'm wondering if that's the right strategy," she said.
The panel's comments will be passed on to the US Food and Drug Administration, which is not bound by the experts' opinions but usually follows them, an FDA official told AFP.
All the flu vaccines currently available in the United States, whether for swine flu or seasonal flu, are developed using chicken eggs.
But the egg-based technology is outdated, inefficient and vulnerable to a complete breakdown in the event that bird flu should sweep across the United States, just as swine flu has this year.
A massive campaign to vaccinate millions of Americans against swine flu has been hampered by a severe shortage of vaccine, and that has been blamed in part on the slow rate at which the (A)H1N1 virus grows in eggs.
Lawmakers have questioned whether vaccine production has also been held up by the fact that only one of the five companies producing flu vaccine does so in the United States.
Protein Sciences said its vaccine could be rolled out within 75 days after the start of development.
Theodore Eickhoff of the University of Colorado said at Thursday's meeting that the Protein Sciences vaccine had a huge advantage over chicken-egg-based vaccine because it can be produced quickly.
"This would have been a breakthrough for the United States and it would certainly have been helpful to have this available this fall," said Eickhoff, who was largely in favor of recommending that the FDA license the new-technology vaccine.
The panel did praise the nimbleness of Protein Sciences' vaccine production method, saying it would allow the United States to "move quickly when we need to."
But the vaccine stumbled and fell at the jump on safety concerns, and the panel asked Protein Sciences to come back at a later date with more data.
"Clinical trials of our swine flu vaccine went very well in Australia. What can I say? We will probably do licensure in Australia," said Cox.