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Quadrivalent Influenza Vaccine Gains FDA Approval

Quadrivalent Influenza Vaccine Gains FDA Approval

By: Sarah Hand, M.Sc.

Posted on: in News | Pharmaceutical Marketing News

Protein Sciences Corporation’s quadrivalent Flublok influenza vaccine has been approved by the US Food and Drug Administration (FDA). This latest version of the influenza vaccine protects against three of the same strains found in the previous trivalent Flublok, in addition to a fourth B strain of the virus.

According to a press release issued by the company, Flublok Quadrivalent is the only influenza vaccine approved by the FDA which contains a high antigen content. The vaccine is well-suited to the elderly and those with a compromised immune system as it contains three times more of the active ingredient, compared to other approved quadrivalent vaccines.

To test the efficacy of Flublok Quadrivalent in people over the age of 50, Protein Sciences conducted a 9,000 participant clinical trial. They found that adults given the Flublok Quadrivalent had a 40 percent lesser chance of contracting influenza, compared to those that were administered the leading quadrivalent vaccine.

“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.”

Flubok Quadrivalent has been approved by the FDA for use in patients 18 and older and will be available in early 2017. As a protein-based vaccine, it contains no infectious influenza virus, antibiotics, egg products or preservatives. Approved in 2013, the trivalent version of the vaccine is available in pharmacies throughout the US.


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