Sanofi’s Quadrivalent flu vaccine approved

FDA has approved the supplemental biologics license application (sBLA) for licensure of its 4-strain influenza vaccine, Fluzone Quadrivalent vaccine (Sanofi Pasteur).

Fluzone Quadrivalent vaccine is the first and only 4-strain influenza vaccine option for patients as young as 6 months of age, as well as adolescents and adults.

“The importance of the licensure of this new vaccine for managed care and hospital decision-makers is that the introduction of a Quadrivalent vaccine means that there is now a way to have broader coverage against more strains of influenza vaccine with the seasonal flu shot, which better helps to protect patients from influenza and its resulting complications,” Donna K. Cary, director, public relations, Sanofi Pasteur, told Formulary.

“Because there are only 2 types of B lineage influenza virus that circulate in the United States, in the past, even if the vaccine was a good match to the predominate circulating viruses, people were vulnerable to the virus of the other B lineage not in the vaccine,” Cary said. “About 50% of the time over the past 12 years the B lineage selected for the trivalent vaccine was not the dominate B linage that ended up circulating which left patients unprotected.”

Influenza B affects all ages, but it is a common cause of influenza-related morbidity and mortality in children and has been associated with pneumonia and other respiratory illnesses, nervous system disease, muscle pain, and inflammation, and other complications.

In order for healthcare providers to help protect their patients with Fluzone Quadrivalent vaccine, there are steps that need to be taken now to order the vaccine for the upcoming season and to put the necessary formulary and reimbursement processes in places, according to Cary.

Sanofi Pasteur is currently accepting orders for Fluzone Quadrivalent vaccine. Healthcare providers can order Fluzone Quadrivalent vaccine by calling the company’s order center at (800) VACCINE or (800) 823-3463, or online at Vaccineshoppe.com, or via the Sanofi Pasteur sales representative who calls on their facility. Because of the timing of its licensure, only a limited number of Fluzone Quadrivalent vaccine doses is being manufactured for this season.

“We are expecting high demand for these doses and, unfortunately, we cannot guarantee that we will have Fluzone Quadrivalent vaccine doses remaining for order in-season. As such, we are making doses available on a first-come, first-served basis now and healthcare providers who wish to use Fluzone Quadrivalent vaccine should order for their anticipated needs now,” Cary said.

For the 2013-2014 influenza season, there are 2 new CPT codes that can be used for Fluzone Quadrivalent vaccine. In addition to coding for the vaccine, providers should also remember to bill for the vaccine administration.

1. CPT 90685 Influenza virus vaccine, quadrivalent, split virus, preservative free, when administered to children 6-35 months of age, for intramuscular use (used for the 0.25-mL dose)

2. CPT 90686 Influenza virus vaccine, quadrivalent, split virus, preservative free, when administered to individuals 3 years of age and older, for intramuscular use (used for the 0.5-mL dose)