UPDATE: A FDA advisory panel has ruled that Protein Sciences' insect cell-based flu vaccine requires more safety tests before being made commercially available in the U.S. The panel said the vaccine appeared to be as safe and effective as more traditional egg-based flu vaccines, but there were concerns over a few patients who had adverse responses, according to Bloomberg. The FDA isn't required to take the panel's advice, but, considering how concerned the public is over vaccine safety already, it seems unlikely that the agency would go against the ruling. As detailed in the earlier post below, Protein Sciences received $35 million from the U.S. to develop a H1N1 vaccine last June, but the company spent the better part of last summer fighting involuntary bankruptcy.
As the start of a new school year begins, concerns over H1N1--aka swine flu--are growing. Everyone's waiting to hear when a vaccine will be available, and earlier this summer, the CDC predicted that 120 million doses of a H1N1 vaccine would be ready by mid-October. But that estimate was revised down to 45 million doses last week. One reason for the delay, according to an article in U.S. News & World Report, is that most manufacturers have been producing H1N1 vaccines using the traditional method, in chicken eggs, which is time consuming and can produce inconsistent yields.
One company that may have a faster solution is Protein Sciences, a small Connecticut-based vaccine manufacturer that has made a name for itself by specializing in an alternative approach using insect cells. Protein Science's process involves growing a fragment of the virus in insect cells, which is faster and produces a higher yield than the traditional egg method, says Ted Ross, a vaccine researcher at the University of Pittsburgh familiar with the company's work. Other groups have used insect cell lines to develop vaccines, but the technology is still relatively new, especially when it comes to large-scale production. "The advantage of using an insect cell line is that it produces a very high yield of flu protein," says Ross. On the downside, though, he notes, it's unclear whether vaccines produced in insect cells will work as well in humans as those from eggs or mammalian cells.
Protein Sciences received $35 million from the U.S. government to develop a H1N1 vaccine using their insect method back in June. And last week, the company told the Hartford Courant they had been granted FDA approval to start testing their vaccine in clinical trials in the U.S. (trials are already underway in Australia, according to the company). Unfortunately, Protein Sciences--unlike the five other companies testing vaccines in the U.S., which include giants like Novartis and Sanofi-Aventis--has also spent the past few months fighting off involuntary bankruptcy.
And even if the company does remain solvent, the vaccine probably won't be available to the public until next spring, well after the larger companies release theirs. But the insect cell method of producing vaccines is likely to grow--let's hope it does so faster than the superbugs these vaccines are fighting.