MHRA-101091-PIP01-23

Key Facts

PIPS Key Facts
Active Substance
Active Substance:
  • Borrelia outer surface protein A (OspA) serotypes (ST1-6) lipidated, fusion protein vaccine (VLA15 - PF-07307405)
Invented Name
Not yet available
PIP Number MHRA-101091-PIP01-23
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Suspension for injection in pre-filled syringe
Therapeutic area
Therapeutic area:
  • Vaccines
Conditions / Indications
Conditions / Indications:
  • Prevention of Lyme disease
Route(s) of administration
Route(s) of administration:
  • Intramuscular use
PIP applicant
Decision Type
Decision Type
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)
Compliance Check
Compliance Check
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

PIPS Decision Documents
Decision Document Decision Document on a Paediatric Investigation Plan (PIP):Borrelia outer surface protein A (OspA) serotypes (ST1-6) lipidated, fusion protein vaccine (VLA15 - PF-07307405).pdf
Published Date 11/02/2025