FDA approves Flublok Quadrivalent for influenza- Protein Sciences Corporation

The FDA has approved its quadrivalent formulation of Flublok influenza vaccine, from Protein Sciences Corporation. Flublok Quadrivalent protects against 4 strains of influenza, 3 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 useful 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% 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.

Comment: 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.