The US Food and Drug Administration (FDA) has accepted for priority review Pfizer’s tick-borne encephalitis (TBE) vaccine to prevent TBE in children and adults aged one year or older.
The vaccine, marketed as TicoVac and FSME-Immun in Europe, could be the first vaccine in the US to help protect children and adults who are visiting and living in TBE endemic areas, if approved.
The FDA, as per the priority review process, will aim to make a decision on approval within six months of the application submission date.
An anticipated prescription drug user fee act (PDUFA) action date is expected for August 2021, Pfizer said in a statement.
In clinical trials of the vaccine, the safety and immunogenicity of TicoVac was assessed across two age groups – 1-15 years of age and 16-65 years of age.
In these studies, the pooled seropositivity rates were 99-100% in the younger age group and 94-99% in people aged 15 years and older following three doses.
Additional real-world studies have also shown that the vaccine is 96-99% effective in people who have received at least two doses of the vaccine, and two to three doses of the vaccine were show to be sufficient to provide a long-lasting immune memory.
“For many years, our TBE vaccine has helped protect millions of people in Europe from this potentially serious disease,” said Nanette Cocero, global president, vaccines, Pfizer.
"We are proud that today’s US FDA priority review acceptance acknowledges the potential value that our vaccine candidate can bring,” she added.