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Caterpillar-based flu shot could be on horizon
The FDA's Vaccines and Related Biological Products Advisory Committee today will determine whether Protein Sciences' flu vaccine FluBlok, which can be produced in less than two months by inserting flu genes into an insect virus and growing it in caterpillar ovary cells, warrants approval.
FluBlok can be produced in a third of the time it takes larger drugmakers, including Sanofi-Aventis, GlaxoSmithKline and Novartis, to make their chicken egg-based shots, according to a Bloomberg article. If approved, FluBlok would represent the first cell-culture derived influenza vaccine licensed in the U.S., according to FDA briefing documents posted ahead of the committee meeting.
FDA documents also revealed that the vaccine was as safe and effective as other shots. The agency made this assessment based on data from four studies of 3,231 adults.
Protein Sciences has grown to 63 employees from 40 in the last three months, and if the vaccine is approved, it may be the smallest company to receive an FDA drug approval, Daniel Adams, Protein Science's CEO, tells Bloomberg. The company may have shots ready for next flu season, he adds.
- read the Bloomberg story
- check out the FDA briefing documents
Related Articles:
Hamburg offers chicken/egg solution
Protein Sciences wins $150M contract for gene-based vax program
Comments
By Anonymous | Posted 10:53pm | November 19, 2009
The 6-5 vote from the FDA advisory panel stating that PSC had not demonstrated safety of FluBlok is obviously a dissapointment to PSC. Your article is entitled "Catepillar-based flu shot on the horizon", and the question now is how far away is that horizon? It would be interesting to hear the FDA advisory panel's thoughts on the suitable size for a safety database for this product.
By PAL | Posted 1:13am | November 22, 2009
"FDA recommended several additional post-licensure studies on pregnant women...children with compromised immune systems." We nearly lost our son at 4 now 6, because of a booster shot, CDC was involved, MRI etc. He no longer receives vaccines because he is immune compromised. FDA thinks that my son should be part of additional trials ... and so should pregnant women. Nice, really brilliant.
Please make certain the there is full efficacy for adults, then perhaps even teenagers before giving it to children or pregnant women.
FDA should provide a license to experiment on adults only ... my son can wait couple of years. And yes, I know the challenges of the industry after 20 years of in it (hence this site)
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