Influenza Vaccine AFLURIA Gets FDA Approval

The US Food and Drug Administration (FDA) has approved the new influenza vaccines AFLURIA and AFLURIA QUADRIVALENT. Seqirus, the vaccines’ maker, announced the approval in a press release, making way for the vaccines to be available for the 2016-2017 flu season.

AFLURIA QUADRIVALENT is the third FDA approval within a year for new influenza vaccine provider Seqirus. The company is part of the CSL Group and was created in July 2015 from CSL’s acquisition of influenza vaccine maker Novartis AG, quickly making Seqirus the second largest influenza vaccine provider in the world.

According to the Centers for Disease Control and Prevention (CDC), human influenza types A and B are responsible for seasonal illness in the United States every year. The viruses can change genetically either gradually or suddenly, and influenza vaccine makers often update their formulations annually to respond to those changes. The current subtypes of influenza A viruses found in people are influenza A (H1N1) and influenza A (H3N2) viruses. While influenza B viruses are not divided into subtypes, they do occur within two currently circulating lineages, B/Yamagata and B/Victoria. Traditional trivalent influenza vaccines often contain a formula of two strains of influenza A viruses and a single strain of influenza B virus. Seqirus notes that their quadrivalent formulation is a four-strain influenza vaccine that may offer protection against both lineages of influenza B.

“AFLURIA QUADRIVALENT, approved for use in persons 18 years of age and older, is an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine. The vaccine comes in single-dose, preservative-free pre-filled syringes. The trivalent AFLURIA is indicated for use in persons 5 years of age and older, and is available in either prefilled syringes or multi-dose vials,” according to the press release.

In addition, Seqirus states in the release that their trivalent formulation of AFLURIA is the only flu vaccine approved by the FDA to be administered without a needle, using the PharmaJet Stratis Needle‐Free Injector. They state that this method offers a delivery that is non-inferior to an influenza vaccine given with a needle, with a device that delivers the vaccine through a narrow stream of fluid that penetrates the skin in about a tenth of a second.

Symptoms of the flu include fever, cough, sore throat, runny nose, body aches and fatigue. A person infected with the flu can become contagious one day before exhibiting symptoms and up to five to seven days after their illness has started. Young children, pregnant women, and adults age 65 years and older are at higher risk for developing complications from the flu. To prevent getting sick with the virus this flu season, CDC recommends injectable influenza vaccines as the best method of protection.