EMEA-003077-PIP01-21 - paediatric investigation plan

SARS-CoV-2 virus, beta-propiolactone inactivated adjuvanted with CpG 1018 (VLA2001)

Key facts

• Invented name:
  COVID-19 Vaccine (inactivated, adjuvanted) Valneva
• Active Substance:
  SARS-CoV-2 virus, beta-propiolactone inactivated adjuvanted with CpG 1018 (VLA2001)
• Therapeutic area:
  Vaccines
• Decision number:
  P/0018/2023
• PIP number:
  EMEA-003077-PIP01-21
• Pharmaceutical form(s):
  Suspension for injection
• Condition(s) / indication(s):
  Prevention of Coronavirus disease 2019 (COVID-19)
• Route(s) of administration:
  Intramuscular use
• Contact for public enquiries:

  Valneva Austria GmbH

  E-mail: [e-mail]; Tel. [phone]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  31/01/2023

Decision

P/0018/2023 : EMA decision of 31 January 2023 on the acceptance of a modification of an agreed paediatric investigation plan for SARS-CoV-2 virus, beta-propiolactone inactivated adjuvanted with CpG 1018 (VLA2001) (COVID-19 Vaccine (inactivated, adjuvanted