By Julie Donnelly

Worcester-based synthetic vaccine company Antigen Express Inc. is hard at work making the next generation of vaccines against both avian and swine flu.

The company wasn’t among the five pharmaceutical giants to be approved to produce the H1N1 vaccine that will be distributed throughout the U.S. in the next few weeks. In fact, Antigen Express is still waiting for the FDA to approve protocols for clinical trials of its H1N1 vaccine — company President Eric von Hofe said he expects those conversations to happen in the next few weeks. Von Hofe said the company is currently doing trials in Lebanon and is seeking approval to do clinical trials from European Union regulators as well.

The FDA has never approved a synthetic vaccine for prophylactic use. But von Hofe said that he thinks the regulator is starting to warm up to the novel technology.

“Back when there was the H5N1 (avian flu) scare, the FDA was very skeptical of synthetic vaccines. But then they tried to make a vaccine out of eggs and they just couldn’t do it because it was so toxic. Now I think they may be more open new technologies,” von Hofe said.

Antigen Express uses a combination of three peptides, which are strands of linked amino acids, to develop its vaccines. Von Hofe said the company discovered that one of the peptides the company is using for its H5N1 vaccine, also in development, is from a part of the virus that is identical with H1N1. So now the company has to identify the other two peptides for the combination, get approval from U.S. and/or EU regulators to start trials and do the trials. This whole process should take more than a year, which means the company won’t be a player in this year’s fight against pandemic flu.

… Unless things go horribly, horribly wrong. Von Hofe said that if the swine flu mutates halfway through the season, and the vaccines being manufactured now are ineffective, the government could push up the time lines for other vaccines in development, including, perhaps, Antigen Express’ vaccine.