Protein Sciences, a company developing vaccines and biopharmaceuticals for the prevention and treatment of a variety of diseases, has announced that the Biomedical Advanced Research and Development Authority (BARDA), a division of the US Department of Health and Human Services, will continue to support the company’s influenza vaccines programme.
BARDA held an internal review of the Protein Sciences programme and made a decision to modify its contract with the Company to support certain activities associated with scaling up manufacturing to meet the capacity metrics in the contract and to be able to expand the age indication of Flublok and Panblok influenza vaccines. Flublok is a revolutionary new seasonal influenza vaccine that was granted US FDA approval in January for use in adults 18-49 years old.
The company expects to have approval for use of Flublok in people 50 years and above in time for the 2013/14 influenza season. Flublok’s sister vaccine, Panblok, is being developed to protect against pandemic influenza.
Protein Sciences and BARDA entered negotiations to provide additional support for the establishment of Flublok large-scale manufacturing in Pearl River, NY and help fund clinical studies required to secure US FDA approval of Flublok for use in populations not included in the initial approval. Thirteen new employees have already been hired to begin operations in Pearl River, and the Company plans to add approximately 30 more within the next year.
“We are pleased that BARDA has continued their commitment to support our influenza vaccine programme,” said Manon Cox, CEO of Protein Sciences. “We could not have brought Flublok to market without their support, and their continued commitment will enable us to provide more doses of this important vaccine to more people in less time and to develop Panblok as an effective vaccine against pandemic influenza.”
Flublok and Panblok are the world’s first recombinant vaccines for the prevention of influenza. They are made using Protein Sciences’ egg-free BEVS technology, a platform that enables rapid production of vaccine without the use of live influenza virus, an important feature in the face of a pandemic. Protein Sciences’ Pearl River facility will enable large-scale production of either vaccine depending on need. This is the first occasions where Flublok was available for immunization of the public.