Pfizer has received the US Food and Drug Administration (FDA) approval for Ticovac, its tick-borne encephalitis (TBE) vaccine for immunisation in people aged one year and above.
The vaccine is developed using a master seed virus, similar to the TBE virus found in nature.
It is capable of inducing neutralising antibodies against the natural TBE virus, as the sequence and structure of the virus subtype match those found in nature.
Pfizer claimed that Ticovac is the only approved vaccine in the US to protect adults and children against the TBE virus.
The European Centre for Disease Prevention and Control (ECDC) recommends TBE vaccination for people who live in or are traveling to risk areas.
With the approval, the US Centres for Disease Control and Prevention (CDC)’s Advisory Committee on Immunization Practices (ACIP) is expected to recommend the use of Ticovac.
Pfizer vaccines global president Nanette Cocero said: “We are proud to deliver the first vaccine to help protect people in the U.S. against TBE, if they are traveling to any risk areas.
“This vaccine has helped to protect millions of people in TBE endemic regions since its first approval outside the U.S. 45 years ago.
“This authorization helps to ensure that people from the U.S. are also able to receive this vaccination if needed, reflecting our commitment to provide health for all.”
TBE is a viral infection of the brain and spine, transmitted to humans through the bite of an infected tick, and less frequently by ingestion of unpasteurised milk from infected animals.
The disease that can affect people of all ages, may initially be mistaken for summer flu, but can be a serious in long-term.
Long-term consequences include cognitive changes, muscle weakness or permanent paralysis, and may cause death in rare cases.
The safety and immunogenicity of Ticovac were assessed in clinical studies across the population aged between 1 to 15 years and those above 16 years of age.
In the studies, the vaccine was generally well-tolerated with no unexpected adverse events or vaccine-related serious adverse events observed.
The most common adverse reactions across both age groups include local tenderness, headache, local pain, fever, restlessness, fatigue, and muscle pain.
Also, real-world studies conducted in Austria shown that the vaccine is 96-98.7% effective in people who have received at least three doses of the vaccine.
In June this year, Pfizer’s Pneumococcal 20-valent conjugate vaccine – Prevnar 20 has been approved by the US FDA, for use in people aged 18 years and above.
The vaccine offers protection against invasive disease and pneumonia caused by 20 serotypes of Streptococcus pneumoniae in adults.
