FDA Approves Concomitant Administration of Zostavax and Flu Vaccines
The Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for Zostavax (varicella zoster vaccine, live, attenuated; Merck) to include safety and immunogenicity data supporting the concomitant use of Zostavax and inactivated trivalent and quadrivalent influenza vaccines.
Zostavax is a vaccine indicated for the prevention of herpes zoster (shingles) in adults aged ≥50 years. It boosts varicella zoster virus-specific immunity, which is thought to be the mechanism by which it exerts protection against zoster and its complications.
The BLA approval was based on data from the interventional, randomized, parallel-assignment NCT02519855 study that randomized 882 patients to one of two vaccination groups: concomitant vaccination versus nonconcomitant vaccination with influenza vaccine.
A measure of the geometric mean titer (GMT) of varicella-zoster virus glycoprotein enzyme-linked immunosorbent assay (gpELISA) antibody in the concomitant vaccination group was 206.0 units/mL (95% CI: 185.6–228.6) at baseline and 395.6 units/mL (95% CI: 363.7–430.4) at Week 4. In the non-concomitant vaccination group, the gpELISA antibody level was 230.5 units/mL (95% CI: 208.4–255.0) at baseline and 482.0 units/mL (95% CI: 446.4–520.4) at Week 4. The GMT ratio of 0.87 (95% CI: 0.80–0.95; P<0.001) indicated a statistically significantly non-inferior difference to the prespecified clinically relevant decrease of 1.5-fold.
Zostavax vaccine is available in single-dose vials in 1- or 10-count packages.
For more information call (877) 888-4231 or visit Zostavax.com.