Quadrivalent Influenza Vaccine Approved by the FDA

Syringe in small bottle
Syringe in small bottle
Studies have shown that vaccines made to protect against four flu viruses have a safety profile similar to seasonal flu vaccines made to protect against three viruses

Patients with rheumatic disease including rheumatoid arthritis and systemic lupus erythematosus are at increased risk of infection as compared to healthy individuals, in part from the underlying immunologic pathophysiology itself and also secondary to immunosuppressive therapy use to control disease.  In these patients, vaccination plays a particularly important role. 

Officials with the US Food and Drug Administration (FDA) have recently green-lighted the first four-strain cell culture-derived, inactivated seasonal flu vaccine (Flucelvax Quadrivalent, Seqirus) for people aged 4 years and older.1,2  The traditional seasonal influenza vaccine is a trivalent formula consisting of two strains of influenza A viruses and a single strain of influenza B virus. 

However, since 1985, two distinct lineages of influenza B virus have co-circulated with varying dominance. The use of a four-strain influenza vaccine like may now provide protection against both B lineages, which may lead to a decrease in the influenza burden.3

“Despite strong recommendations for everyone in the US 6 months of age and older to be vaccinated against the flu every year, fewer than half of eligible people did so in the 2014-2015 season. This includes children, the group with the highest incidence during community outbreaks,” Gary S. Marshall, MD, Chief of Pediatric Infectious Diseases at the University of Louisville, said in a press release about the drug approval. “Even healthy people are at risk—they should be vaccinated to protect themselves and to prevent transmission to others.”

This vaccine is an evolution of the trivalent influenza vaccine Flucelvax. 

In clinical studies of adults aged 18 to 49 years, Flucelvax has been shown to be efficacious against influenza caused by vaccine-like strains (83.8%) and by all circulating influenza strains (69.5%).2 Its quadrivalent formulation was also shown to be immunogenic against the flu in adults aged 18 years and older (Study 1) and children aged 4 through 17 (Study 2).2

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1. FDA press release. FDA approves first seasonal influenza vaccine manufacture using cell culture technology. 2012. Accessed May 2016.  

2. Flucelvax quadrivalent prescribing information. 2016. 

3.Hartvickson R, et al. Non-inferiority of mammalian cell-derived quadrivalent subunit influenza virus vaccines compared to trivalent subunit influenza virus vaccines in healthy children: a phase III randomized, multicenter, double-blind clinical trial. International J Infect DIs. 2015;41:65-72. http://dx.doi.org/10.1016/j.ijid.2015.11.004

This article originally appeared on Infectious Disease Advisor