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FDA Approves Flublok Quadrivalent Influenza Vaccine

By PR Newswire | October 12, 2016

Protein Sciences Corporation announced that the FDA has approved its quadrivalent formulation of Flublok® influenza vaccine. Flublok Quadrivalent protects against four strains of influenza, three of the same strains found in trivalent Flublok plus an additional B strain. 

Significantly, Flublok Quadrivalent is the first and only high antigen content quadrivalent flu vaccine approved by FDA. It contains 3x more active ingredient than all other quadrivalent vaccines, making it a great choice for seniors and those with compromised immune systems, among others. In a clinical study of 9,000 adults 50 years of age and older, people who received Flublok Quadrivalent were over 40 percent less likely to get cell-culture confirmed influenza than those that received a leading egg-produced quadrivalent flu vaccine. These results are relevant for trivalent Flublok, as the H3N2 component of the vaccine that is shared between trivalent and Flublok Quadrivalent predominately contributed to the improved efficacy. This data can be found in the updated Package Insert for trivalent Flublok.

Flublok Quadrivalent is approved for adults 18 and older and will be available in pre-filled syringes beginning in 2017. Flublok Quadrivalent has the same purity advantages as trivalent Flublok, containing pure protein made without infectious influenza virus, antibiotics, eggs, thimerosal, preservatives, gelatin or latex. Trivalent Flublok is available at hundreds of pharmacies across the United States.

“The U.S. has been trending toward the use of quadrivalent flu vaccines in recent years,” said Manon Cox, President and CEO of Protein Sciences Corporation. “We are pleased to bring Flublok Quadrivalent to market to give consumers additional options, especially seniors who have no other high antigen content quadrivalent vaccine available to them.  We are looking forward to launching the vaccine next year and, in the meantime, continuing to make trivalent Flublok available this year.” 

To view the full press release, click here. 

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