Protein Sciences Corporation, a vaccine development and protein production company based in Meriden, Conn., this week announced the U.S. Department of Health and Human Services (HHS) has exercised a contract option to support development, scale-up and expanded licensure of the company’s influenza vaccine, Flublok (seasonal) and Panblok (pandemic).
The contract Option Period 2 has a budget of $50.6 million and will run through December 31, 2015. The total value of the contract, originally awarded in 2009, is $146.9 million.
The funding is administered through the Biomedical Advanced Research and Development Authority (BARDA), which supported the initial licensure of Flublok, which was approved by FDA in January 2013.
Flublok is the only flu vaccine made in a 100% egg-free system using modern cell culture technology, making it unnecessary to use an infectious influenza virus or antibiotics in manufacturing. Flublok is highly purified and does not contain any preservatives (e.g., thimerosal, a mercury derivative), egg proteins, gelatin or latex. In addition, Flublok is triple the strength of conventional influenza vaccines. Flublok is a perfect copy of the virus coat and is not subject to the egg-adapted mutations associated with low vaccine effectiveness.
The Option Period 2 funds will support licensure of Protein Sciences’ newly acquired larger-scale manufacturing facility in Pearl River, New York that manufactures Flublok and is planned to have the capacity to produce 50 million doses of Panblok within 6 months of declaration of a pandemic as required by the BARDA contract. The funds will also be used for clinical studies to support licensure of Panblok and a quadrivalent formulation of Flublok.
The recombinant technology used to make Flublok and Panblok offers a platform for pandemic preparedness: the vaccines can be made safely, accurately and much faster than they could by using legacy technologies.
“We are fortunate to have been able to build a strong partnership with BARDA,” said Manon Cox, President and CEO of Protein Sciences. “An analysis of past pandemics revealed that vaccines were available too late and in short supply. Recombinant technology such as that used to make Flublok and Panblok ensures abundant vaccines with the correct sequence are available when they are needed.”