FDA approves TicoVac™ tick-borne encephalitis (TBE) vaccine
Posted: 16 August 2021 | Anna Begley (European Pharmaceutical Review) | No comments yet
The FDA has approved Ticovac, a tick-borne encephalitis (TBE) vaccine, for people aged one year and older when travelling to TBE endemic areas.
The US Food and Drug Administration (FDA) have approved Pfizer’s tick-borne encephalitis (TBE) vaccine, TicoVac™, for active immunisation to prevent TBE in individuals one year of age and older. TicoVac is the only FDA-approved vaccine to help protect US adults and children against the TBE virus when visiting or living in TBE endemic areas.
“We are proud to deliver the first vaccine to help protect people in the US against TBE, if they are traveling to any risk areas,” said Dr Nanette Cocero, Global President of Vaccines at Pfizer. “This vaccine has helped to protect millions of people in TBE endemic regions since its first approval outside the US 45 years ago. This authorisation helps to ensure that people from the US are also able to receive this vaccination if needed, reflecting our commitment to provide health for all.”
Pfizer’s TBE vaccine was developed using a master ‘seed’ virus that is similar to the TBE virus. It is able to induce neutralising antibodies against the natural TBE virus as the sequence and structure of the virus subtype match those found in nature.
In clinical trials, the safety and immunogenicity of TicoVac were assessed across two age groups, one to 15 years of age and more than 16 years of age. In these studies, seropositivity rates were 99.5 percent in one to 15 year olds and 98.7 to 100 percent in adults older than 15 years following three doses.
Clinical studies also demonstrated that TicoVac was generally well-tolerated with no unexpected adverse events (AEs) or vaccine-related serious AEs observed. The most common AEs across both age groups were local tenderness, local pain, fever and restlessness.
Real-world studies from Austria have shown that the vaccine is 96 to 98.7 percent effective in people who have received at least three doses of the vaccine. However, the FDA stated that vaccination with TicoVac may protect all vaccine recipients against TBE. Furthermore, safety and effectiveness have not yet been established in pregnant women.
