PATH has been awarded a $5.2 million contract from the Biomedical Advanced Research and Development Authority (BARDA), a division of the US Department of Health and Human Services, to develop stable formulations of both live and subunit influenza vaccines. In collaboration with Arecor Limited and Aridis Pharmaceuticals, PATH will focus its work on extending the product shelf life of pandemic influenza vaccines to facilitate vaccine stockpiling and rapid deployment of fully potent vaccines independent of the vaccine cold chain, activities that could significantly help to contain future influenza pandemics. Following a base period of project work, options exist for PATH to receive further funding from BARDA—up to $4.2 million more—to advance the stabilization efforts.
Influenza is a virus that causes mild to severe respiratory illness and can lead to death in particularly vulnerable individuals. It occurs in seasonal patterns worldwide, causing 250,000 to 500,000 deaths and up to 5 million cases of severe illness each year. If a highly virulent pandemic strain were to emerge in today’s interconnected world, influenza could have the potential to kill millions of people, especially in low-resource settings.
“The benefits of a stable influenza vaccine are manifold. 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” said Dexiang Chen, PhD, senior technical officer at PATH and principal investigator for influenza vaccine stabilization work conducted under the BARDA contract.
“Vaccines are the best way to prevent influenza infection. 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,” added Dr. Kathleen Neuzil, director of the Influenza Vaccine Development Project at PATH and an advisor to the influenza vaccine stabilization project work led by Dr. Chen. “Enhancing availability independent of the vaccine cold chain will markedly improve global pandemic preparedness.”
Pandemic influenza preparedness, as detailed in the US Government’s Implementation Plan for the National Strategy for Pandemic Influenza, includes the establishment and maintenance of stockpiles of influenza vaccine to allow for rapid immunization when an outbreak occurs. The US Government has stockpiled approximately 23 million doses of H5N1 split and subunit vaccines. Currently, there are no stockpiled H5N1 live attenuated influenza vaccines due to their extremely short shelf lives.
Under the BARDA contract, using multiple advanced vaccine formulation designs and stabilization technologies, 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 (foam drying), and spray-drying process technologies. PATH will also work to investigate the manufacturability of selected stable vaccine formulations as well as the regulatory pathways and economic benefits of improved formulations when adopted and used at large scale.
Arecor is an enabling technology company based in Cambridge, England, providing formulation solutions for recombinant proteins and vaccines for application in drugs, medical devices, and diagnostics. Arecor regularly collaborates with major pharmaceutical and biotech companies—providing heat stable liquid formulations of drugs to improve shelf life, liquid formulations of drugs currently formulated as powders, high liquid concentrations of drugs for more convenient dosing, and stabilization of proteins and vaccines in the presence of ionizing radiation used for sterilization. Alone or in partnership with its collaborators, Arecor has successfully developed stable, pharmaceutically accepted formulations of over 30 proteins and vaccines. Arecor is backed by Unilever PLC., a major life science and consumer goods company. For more information, please visit: www.arecor.com.
Aridis is a privately held biotechnology company located in San Jose, California. Aridis has a strong portfolio of anti-infective product candidates and formulation platform technologies. Its proprietary formulation and drying technologies—including plasticization stabilization technology, sonic spray drying, and foam drying—have been applied to produce heat-resistant vaccines, including live attenuated influenza virus, live respiratory syncytial virus, live parainfluenza virus, live salmonella Ty21a, live listeria-vectored vaccine, live attenuated rotavirus, live attenuated adenovirus, and live measles virus. For more information, please visit: www.aridispharma.com.
Posted September 15, 2010.