Conntact.com - CT Business News Journal

MERIDEN — Along with a waning concern about the H1N1 flu virus comes some more challenging news for Protein Sciences Corp., developer of a novel H1N1 vaccine technology. In late November the U.S. Food & Drug Administration's (FDA) Vaccines and Related Biologic Products Advisory Committee said it needed more safety and efficacy data before it could endorse the licensing of the vaccine. Unlike most flu vaccines, which are cultured in chicken eggs, PSC employed a novel approach that included the insertion of genetic parts of the virus into caterpillar eggs. The process is claimed to be faster and does not utilize the full virus or require what to some are controversial antibiotics or preservatives.

The company submitted results from trials with more than 3,200 adults age 18 and older. The panel voted 9-2 that the vaccine was effective in one age group but more than half were not convinced about safety for adults over 65. One scientist said that although the efficacy of the vaccine was less than ideal, he was impressed by the speed with which PSC was able to develop it.

< Prev		Next >