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US BARDA extends contract with Protein Sciences to support development of flu vaccines

Meriden, Connecticut
Thursday, June 19, 2014, 13:00 Hrs  [IST]

Protein Sciences Corporation, a vaccine development and protein production company, announced that BARDA, within the US Department of Health and Human Services, exercised Option Period 2 of its contract with the company (contract number HHS0100200900106C) to support development, scale-up and expanded licensure of the company's influenza vaccines, Flublok (seasonal) and Panblok (pandemic).  

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.

BARDA funds supported the initial licensure of Flublok, the world's first recombinant influenza vaccine, which was approved by FDA in January 2013.  The recombinant technology used to make Flublok and Panblok is the pandemic solution; these vaccines can be made safely, accurately and much faster than they could by using other technologies.  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.    

Manon Cox, president and CEO of Protein Sciences said, "We are fortunate to have been able to build a strong partnership with BARDA."  She added, "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."

Flublok, the world's first recombinant protein-based vaccine for the prevention of seasonal influenza disease, 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.

Protein Sciences is a vaccine development and protein production company that is dedicated to saving lives and improving health through the creation of innovative vaccines and biopharmaceu­ticals.

 

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