Flucelvax Quadrivalent Flu Vaccine Now Approved for Children
The FDA has approved Seqirus Inc's supplemental biologics license application for the use of its Flucelvax Quadrivalent influenza vaccine in patients 4 years and older.
The FDA has approved Seqirus Inc’s supplemental biologics license application for the use of its Flucelvax Quadrivalent influenza vaccine in patients 4 years and older.
Flucelvax, which comes in a 0.5-mL single-dose, prefilled syringe, can protect against influenza virus subtypes A and type B.
“As the first and only cell culture-derived seasonal influenza vaccine in the US to offer 4-strain flu protection for people aged 4 years and older, Flucelvax Quadrivalent will provide health care providers and their patients with an important option to further broaden their influenza coverage,” stated Seqirus President Gordon Naylor. “We are pleased to offer Flucelvax Quadrivalent…to our valued customers during the 2016-2017 flu season.”
Studies of Flucelvax involved 3346 children aged 4 to 17 years, and Fluvirin was used as a comparator vaccine. Trials proved the safety of Flucelvax, and noninferiority was shown in children aged 4 through 8 years for the A/H1N1 and B influenza strains, but not the A/H3N2 influenza strain.
Seqirus will continue to study the clinical benefit of Flucelvax. The manufacturer will conduct a phase 3, randomized, observer-blind study to examine the efficacy, safety, and immunogenicity of the quadrivalent vaccine compared with a noninfluenza comparator vaccine in patients aged 4 to 18 years.
For patients aged 4 to 8 years, the vaccine may be given in 1 or 2 doses of 0.5 mL each. If 2 doses are administered, they should be spaced at least 1 month apart.
Pharmacists should remember to shake the syringe vigorously and check to make sure there is no particulate matter or discoloration prior to administering the vaccine. The product should be kept around 36°F to 46°F, and it should never be frozen.
Flucelvax Quadrivalent was previously approved for use in patients aged 18 years and older in 2012.