PFE · Earnings call · 2026Q3T · Full report

Regulatory Approval Milestones

PFIZER INC · 2026-11-03 · Importance 34 · Surprise 42

Pfizer and Valneva’s Lyme disease vaccine candidate has had its marketing authorization application validated by the European Medicines Agency, allowing the CHMP assessment to begin. The CHMP is expected to issue an opinion on marketing authorization in 2027. Pfizer has also filed in Canada and continues discussions with the FDA, with an update expected in Q4 2026.

Key facts

• The EMA validated the marketing authorization application for Pfizer and Valneva's Lyme disease vaccine candidate; the CHMP assessment is beginning and an opinion on marketing authorization is expected in 2027.
• Pfizer filed its Lyme disease vaccine candidate in Canada and is continuing discussions with the FDA; it expects to provide an update in Q4 of this year.
• Pfizer is discussing its Lyme disease vaccine candidate with the FDA and intends to conclude those discussions and submit its file.
• Pfizer reported two key regulatory decisions, one key pivotal readout, and eight key pivotal study starts in recent months.