Fluzone Quadrivalent Flu Vaccine Approved for Young Children
The use of the 0.5 mL dose of Fluzone® Quadrivalent influenza vaccine for children between the ages 6 months through 35 months was approved by the U.S. Food and Drug Administration (FDA) on January 23, 2019.
Sanofi Pasteur will have the 0.5 mL dose, in addition to the 0.25 mL dose, available for the 2019-20 flu season for this expanded age range.
This is important news since there were 185 influenza-related, pediatric deaths confirmed by the Centers for Disease Control and Prevention (CDC) during the 2017-18 flu season.
The CDC recommends a yearly flu vaccine for everyone 6 months of age and older as the first and most important step in protecting against this serious disease.
"Offering pediatricians the convenience of the same 0.5 mL dose option for children, may help streamline immunization efforts," said Dr. David P. Greenberg, Regional Medical Head North America, Sanofi Pasteur.
"The potentially life-threatening effects of influenza in children reported during the 2017-18 season, especially among those who were not vaccinated, is sobering.”
Today's approval is supported by clinical data from a Phase IV clinical trial conducted in nearly 2,000 children.
This FDA approval follows the UK’s authorization on January 21, 2019, for the Trivalent Influenza Vaccine High Dose (TIV High Dose) for people 65 years of age and older against influenza disease.
In addition to Fluzone Quadrivalent vaccine, Sanofi’s product portfolio includes Flublok® Quadrivalent (influenza vaccine) and Fluzone® High-Dose (influenza vaccine), the only two flu vaccines proven to help prevent more cases of flu in older adults, compared to their standard-dose flu vaccine comparators in randomized controlled trials.
In these same clinical trials, the most common local and systemic adverse reactions to Flublok Quadrivalent and Fluzone High-Dose vaccines include pain at the injection site, headache, and myalgia.
Flublok Quadrivalent, Fluzone Quadrivalent, and Fluzone High-Dose vaccines should not be given to anyone who has had a severe allergic reaction (eg, anaphylaxis) to any component of the vaccine (including egg or egg products for Fluzone Quadrivalent and Fluzone High-Dose) or after a previous dose of the corresponding vaccine.
Additionally, Fluzone Quadrivalent and Fluzone High-Dose should not be given to anyone who has had a severe allergic reaction after a previous dose of any influenza vaccine.
In the USA, antiviral medications and various flu vaccines are available in most pharmacies.
The CDC Vaccine Price List provides the private sector vaccine prices for general information.
And, flu vaccine discounts can be found here.
Vaccines, like any medicine, can have side effects. You are encouraged to report negative side effects of vaccines to the CDC.
- FDA approves use of 0.5 mL dose of Fluzone® Quadrivalent (influenza vaccine) in children as young as 6 months of age
- Safety and Immunogenicity of Fluzone® Quadrivalent Vaccine Administered to Healthy Children
- Time to Change Dosing of Inactivated Quadrivalent Influenza Vaccine in Young Children: Evidence From a Phase III, Randomized
- High-Dose Flu Vaccine Approved for UK Seniors
- Quadrivalent inactivated influenza vaccine (VaxigripTetra™)