New Flucelvax Quadrivalent Influenza Vaccine Approved by FDA

Sequirus recently announced in a press release that the US Food and Drug Administration (FDA) has approved Flucelvax Quadrivalent influenza vaccine. The vaccine will be available for the 2016-2017 flu season.

According to Sequirus, Flucelvax Quadrivalent is the first four-strain, cell-culture derived, inactivated seasonal influenza vaccine for people aged four years or older. It does not rely on eggs for manufacturing. The US Department of Health and Human Services called the cell culture manufacturing technology a milestone since the vaccine can be produced rapidly in case of outbreaks or pandemics.

Flucelvax Quadrivalent is indicated for active immunization for the prevention of influenza disease caused by subtypes A and B. It has activity against two influenza A viruses and two B viruses. Trivalent vaccines are usually active against two A strains and one B strain.

Flucelvax Quadrivalent is evolved from Flucelvax, a cell-based trivalent influenza vaccine. Due to their similar manufacturing process and components, clinical data and efficacy from Flucelvax is relevant. Sequirus states in the prescribing information that “Flucelvax demonstrated efficacy against influenza caused by vaccine-like strains and all circulating influenza strains in clinical studies of adults aged 18 to 49 years. The quadrivalent formulation showed immunogenicity in adults aged 18 years or older and children 4 to 17 years old. Quadrivalent formulation displayed stronger activity against strain B that was not in the trivalent form and had similar safety profile.”

According to the prescribing information, Flucelvax Quadrivalent is contraindicated in anyone who has experienced a severe allergic reaction to any component of the vaccine. Warnings and precautions exist for this product regarding Guillain-Barre Syndrome (GBS), allergic reactions, syncope, altered immunocompetence, and vaccine effectiveness. Sequirus warns vaccine administrators to consider the risk benefit profile of giving Flucelvax Quadrivalent to a patient if GBS was experienced due to a prior injection of an influenza vaccine. Medical personnel must be equipped to handle allergic reactions and syncope reactions such as by being able to restore cerebral perfusion through a supine or Trandelenburg position. Flucelvax Quadrivalent may produce a reduced immune response in immunocompromised patients and it does not protect all vaccine recipients against influenza disease. (Please see the Table for a list of the most common adverse reactions by demographic.)

Table: Most Common Adverse Reactions

Demographic

Most common adverse reactions (>10%)

Adults, 18-64 years old

Injection site pain, headache, fatigue, myalgia, injection site erythema, and induration

Adults, ≥65 years old

Injection site pain, and injection site erythema

Children, 4 to <6 years old*

Tenderness at injection site, injection erythema, sleepiness, irritability, injection site induration, and change in eating habits

Children, 4 to 8 years old*

Pain at injection site, injection site erythema, injection site induration, headache, fatigue, and myalgia

Children and Adolescents, 9 to 17 years old

Pain at injection site, headache, injection site erythema, fatigue, myalgia, and injection site induration

*After first dose of vaccine

The Centers for Disease Control and Prevention strongly recommends all individuals ages 6 months and older be vaccinated yearly.