More safety data is needed before an experimental flu vaccine made inside insect cells should be approved, a US federal advisory committee said yesterday.
A US Food and Drug Administration (FDA) panel voted 6-to-5 that Protein Sciences, a vaccine company based in Meriden, Connecticut, hadn’t proven that its FluBlok vaccine was safe enough to enter mass production. Nine of the 11 panellists, however, said the shot was effective in adults aged 18 to 49, although the vaccine did not appear to work as well in older patients.
The vaccine is made by inserting flu genes into an insect virus and growing it in caterpillar ovary cells. This process only takes two months, compared to the five or six needed to grow virus in chicken eggs, and so it has been touted as a way to speed up manufacturing when new vaccines against potentially pandemic flu strains are urgently needed — like now. Fewer than 50 million doses of H1N1 vaccine are currently available in the US.
“This is a new vaccine,” said Pamela McInnes, a panel member of the Vaccines and Related Biological Products Advisory Committee and director of the extramural research at the National Institute of Dental and Craniofacial Research. “It will probably be fine but I’d like the data to show that.” (Wall Street Journal)
Some panel members were concerned about side-effects seen in some of the 3,231 volunteers who tested a seasonal flu variety of FluBlok. There were several accounts of face swelling, and one person was hospitalized for swelling in the chest. (Bloomberg)
The FDA is not compelled to follow the panel’s recommendations but usually adopts them.
Manon Cox, Protein Sciences’ chief operating officer, said the company might now take its technology abroad. “Clinical trials of our swine flu vaccine went very well in Australia. What can I say? We will probably do licensure in Australia,” she said. (AFP)
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