Pfizer picks Europe as likely first market for Lyme vaccine

US filing update due this quarter

Pfizer confirmed on the call that talks with the FDA about a US submission are continuing, and Chris Boshoff, its chief scientific officer and president of R&D, said an update would come this quarter. CEO Albert Bourla said US awareness is "skyrocketing right now because we do have an increase of severity and incidence." The vaccine has also been filed in Canada. Executives declined to give a European launch date.

Why Europe is likely first

Alexandre de Germay, Pfizer's chief international commercial officer, gave the commercial reason for starting in Europe. Pfizer already sells a tick-borne encephalitis (TBE) vaccine portfolio there, bought long ago. "We know how to activate tick-borne populations in those endemic areas because we have a sales force, we have a commercial play with pharmacies," he said on the call. Lyme is far better known than TBE, which he said helps.

EMA review and CHMP timing

Pfizer and Valneva said on 14 August 2026 that the European Medicines Agency had validated the marketing authorization application for PF-07307405 and would begin assessing it. Validation starts scientific review; it is not an approval. The Committee for Medicinal Products for Human Use, which recommends new medicines for approval in Europe, is set to deliver its opinion in 2027. A positive opinion would make this Europe's first approved human Lyme vaccine. None is approved in Europe or the US.

What VALOR showed

The filing rests on the phase 3 VALOR trial, short for Vaccine Against Lyme for Outdoor Recreationists. It enrolled 9,437 people aged five and older at sites with high Lyme incidence in the US, Canada and Europe, split 1:1 between the vaccine and a saline placebo. Participants received four doses: at months 0, 2 and 5 to 9, then a year later before the next Lyme season. The companies reported efficacy of more than 70% and no safety concerns. The candidate has been evaluated for efficacy, safety, tolerability, immunogenicity and manufacturing lot consistency.

PF-07307405 is a six-valent OspA-based vaccine covering six of the most prevalent OspA serotypes in North America and Europe. Vaccinated people make antibodies that ticks take up in a blood meal, which are meant to stop the bacterium leaving the tick. Pfizer calls it the most advanced Lyme vaccine candidate in development, with two phase 3 trials completed.

Disease burden

Annaliesa Anderson, Pfizer's chief vaccines officer, said Lyme disease "remains the most common vector-borne illness in Europe, affecting more than 100,000 people each year." Untreated cases can involve the skin, joints, nervous system and heart. Thomas Lingelbach, Valneva's chief executive, called the MAA acceptance a major milestone, "especially considering that more than 200 million people live in Lyme disease risk areas in Europe." The companies cite CDC estimates of about 476,000 people in the US diagnosed and treated each year and 132,000 cases reported annually in Europe from countries with surveillance systems. Under their April 2020 collaboration and license agreement, Pfizer would exclusively manufacture and commercialize the vaccine if regulators approve it.