FDA Approves FluBlok Quadrivalent Flu Vaccine

The FDA has approved its quadrivalent formulation of Protein Sciences’ Flublok influenza vaccine for protection against 4 strains of influenza-3 of the same strains found in its trivalent version, along with an additional B strain. It is the first high-antigen-content quadrivalent flu vaccine approved by the FDA.

Flublok Quadrivalent contains 3 times more antigen than other traditional influenza vaccines, which makes it especially pertinent to seniors and individuals with compromised immune systems.

The FDA’s approval is based on a clinical study that evaluated individuals who received Flublok Quadrivalent compared with those who received a leading egg-produced quadrivalent vaccine. The study included 9000 adults 50 years and older. The participants who received the Flublok Quadrivalent were over 40% less likely to develop cell-culture confirmed influenza. Flublok Quadrivalent’s efficacy is attributed to the H3N2 component of the vaccine that is shared in both trivalent and Flublok Quadrivalent.

“The US has been trending toward the use of quadrivalent flu vaccines in recent years,” Manon Cox, president and CEO of Protein Sciences Corporation, said in a press release, “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.”

Flublok Quadrivalent has been approved for adults 18 years and older and will be available in prefilled syringes beginning in 2017.