FDA approves Pfizer’s first-in-US tick-borne encephalitis vaccine
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Pfizer’s Ticovac, a vaccine for tick-borne encephalitis, was recently approved by the FDA, the company announced — the first vaccine of its kind to be approved in the United States.
Tick-borne encephalitis (TBE), which is transmitted to humans through tick bites, is endemic in more than 35 countries in Asia and Europe but not in the United States, Pfizer noted. However, cases are occasionally reported among civilians and members of the military who have traveled abroad.
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According to a 2010 report in MMWR, five cases of TBE were reported among U.S. travelers to Europe and Asia between 2000 and 2009. A 2019 study in Military Surveillance Monthly Report said eight cases of TBE were present in U.S. military personnel and beneficiaries from 2006 to 2018, with seven of those cases occurring in the last 2 years of the study period. The latter report called risk of the disease “low, but not negligible.”
According to Pfizer, clinical trials have shown that the vaccine is safe and immunogenic, with seropositivity rates of 99.5% among participants aged 1 to 15 years and 98.7% to 100% among participants aged 15 years or older after three doses. Participants experienced “no unexpected adverse events or vaccine-related serious adverse events observed,” the drug maker said.
The company also cited further studies conducted in Austria in which the vaccine was between 96% and 98.7% percent effective against TBE after at least three doses.
“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,” Nanette Cocero, PhD, global president of vaccines at Pfizer, said in a news release. “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.”
The CDC’s Advisory Committee on Immunization Practices is expected to discuss recommendations for the vaccine during its Oct 20-21 meeting, although an official agenda has not yet been released.
References:
CDC. MMWR Morb Mortal Wkly Rep. 2010;59(11);335-338.
Mancuso JD, et al. MSMR. 2019;Nov;26(11):4-10.
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