BARDA awards contract for stable influenza vaccine formulations

PATH, a Seattle-Based medical nonprofit group, has been awarded a $5.2 million Biomedical Advanced Research and Development Authority contract to develop stable formulations of both live and subunit influenza vaccines.

PATH, in conjunction with Arecor Limited and Aridis Pharmaceuticals, will continue to work on extending the product shelf life of pandemic influenza vaccines. PATH officials hope this work will facilitate vaccine stockpiling and rapid deployment of fully potent vaccines.

Further BARDA funding of up to $4.2 million may also be awarded to PATH to advance the stabilization efforts, officials said.

Dexiang Chen, senior technical officer at PATH and a principal investigator for influenza vaccine stabilization work conducted under the BARDA contract, said that if a highly virulent pandemic strain were to emerge in today’s interconnected world, influenza could have the potential to kill millions of people.

“The benefits of a stable influenza vaccine are manifold,” Chen said. “Most notably, a longer shelf life will decrease the turnover of vaccine stockpiles, reducing costs and boosting confidence in the distribution of fully potent vaccines at an outbreak’s point of origin—a key strategy for containing the virus and preventing a potential pandemic.”

Dr. Kathleen Neuzil, director of the Influenza Vaccine Development Project at PATH and an advisor to the influenza vaccine stabilization project work, agreed with Chen.

“Vaccines are the best way to prevent influenza infection,” Neuzil said. “Experiences during the recent influenza A H1N1 pandemic underscore the need to expand vaccine supplies and people’s access to them in low-resource countries as well as in the United States. Enhancing availability independent of the vaccine cold chain will markedly improve global pandemic preparedness.”

Pandemic influenza preparedness includes storing and maintaining stockpiles of influenza vaccine to allow for rapid immunization when an outbreak occurs. The U.S. has stockpiled approximately 23 million doses of H5N1 split and subunit vaccines.

Chen said, however, that there are no stockpiled H5N1 live attenuated influenza vaccines due to their extremely short shelf lives.

Under the BARDA contract, PATH and partners aim to create improved formulations for both live and subunit pandemic influenza vaccines. In addition to liquid-stable formulations, glassy solid formulations will be explored using freeze-drying, modified freeze-drying and spray-drying process technologies, according to Chen.