The Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for TicoVac ™ (Pfizer), an investigational active immunization vaccine for the prevention of tick-borne encephalitis in people 1 year and older, for priority review.
TicoVac is an inactivated whole virus vaccine developed using a master semen virus that is similar to naturally occurring tick-borne encephalitis virus. Tick-borne encephalitis is a viral infection of the brain and spine that is transmitted through the bite of an infected tick.
The BLA is based on data from clinical trials that assessed the safety and immunogenicity of the vaccine in two age groups (1-15 years and 16-65 years). The results of these studies showed that after 3 doses of the vaccine, pooled seropositivity rates were 99 to 100% in people aged 1 to 15 years and 94 to 99% in people aged 16 and over. In terms of safety, the vaccine was found to be well tolerated with no unexpected adverse events or vaccine-related serious adverse events observed.
In addition, subsequent real-world studies showed that the vaccine was 96-99% effective in people treated with at least 2 doses and provided long-lasting immune memory after 2 to 3 doses.
“We are proud that today’s adoption of the US FDA Priority Review recognizes the potential value our vaccine candidate can bring,” said Dr. Nanette Cocero, Global President, Vaccines, Pfizer Inc. “If approved in the US, we hope this vaccine will help.” Protecting those traveling or temporarily staying in vulnerable locations, including possibly military personnel serving overseas. ”
A target date of the Prescription Drug User Fee Act (PDUFA) of August 2021 is expected for the application.
US FDA accepts Pfizer’s application for priority review for TicoVac ™ (tick-borne encephalitis vaccine). [press release]. New York, NY: Pfizer, Inc .; February 23, 2021.
This article originally appeared on MPR