SUNDAY, SEPTEMBER 25, 2016

Positive Phase I clinical trial results for Novartis H7N9 vaccine

Novartis, a Basel, Switzerland-based pharmaceutical company, announced positive interim results on Thursday from a Phase I clinical trial of its novel H7N9 avian influenza vaccine candidate.

In a study involving 400 healthy volunteers, 85 percent of subjects achieved a protective immune response after two doses of the MF59 adjuvanted vaccine. Just six percent of subjects received a protective response when given two doses of the un-adjuvanted vaccine.

Novartis produced the vaccine using full-scale, cell-culture manufacturing technology, an alternative to traditional egg-based methods. The technology uses a mammalian cell line rather than chicken eggs to grow the vaccine strains.

"This rapid response underscores our leadership position in pandemic preparedness," Andrin Oswald, the division head of Novartis Vaccines, said. "Thanks to our investments into innovative production technologies and adjuvants, we are now able to offer a protective solution for a potentially deadly pandemic virus within a few months after the emergence of the H7N9 virus."

The full data set from the study will be submitted to a peer-reviewed journal for publication sometime in the near future.

China first reported cases of H7N9 infection in March. Novartis, along with partners at the Craig Venter Institute, synthesized the viral strain several days after the Chinese Centers for Disease Control shared the strain with global researchers. Novartis began clinical trials in August.

The study was funded in part by the Biomedical Advanced Research and Development Authority.