Infectious Disease

FDA approves Pfizer’s first tick encephalitis vaccine in the United States

August 24, 2021

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Pfizers Ticovac, a vaccine against tick-borne encephalitis, was recently approved by the FDA – the first 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 the United States, Pfizer noted. Occasionally, however, cases are reported among civilians and military personnel who have traveled abroad.

The FDA approved a vaccine against tick-borne encephalitis for the first time in the United States. Source: Adobe Stock

According to a 2010 report by the MMWR, five TBE cases were reported in US travelers to Europe and Asia between 2000 and 2009. A 2019 study by the Military Surveillance Monthly Report found eight TBE cases among U.S. service members and beneficiaries between 2006 and 2006, with seven of those cases occurring in the last 2 years of the study period. The latter report called the disease risk “low but not negligible”.

According to Pfizer, clinical studies have shown the vaccine to be safe and immunogenic, with seropositivity rates of 99.5% in participants aged 1 to 15 years and 98.7% to 100% in participants aged 15 and over after three doses. “No unexpected adverse events or vaccination-related serious adverse events were observed in the participants,” the drug manufacturer said.

The company also cites other studies carried out in Austria in which the vaccine was between 96% and 98.7% effective against TBE after at least three doses.

“We are proud to deliver the first vaccine to protect people in the US from TBE when they travel to risk areas.” Nanette Cook, PhD, Global President of Vaccines at Pfizer, according to a press release. “This vaccine has helped protect millions of people in TBE endemic areas since it was first approved outside the US 45 years ago. This approval helps people from the USA to receive this vaccination if necessary, which reflects our commitment to the health of all. “

The CDC Advisory Committee on Immunization Practices is expected to discuss recommendations for the vaccine during its October 20-21 meeting, although an official agenda has not yet been published.

References:

CDC. MMWR Morb Mortal Wkly Rep. 2010; 59 (11); 335-338.

Mancuso JD et al. MRS MR. 2019; November 26 (11): 4-10.

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