EMEA-002915-PIP01-20-M03 - paediatric investigation plan

SARS-CoV2 prefusion Spike delta TM (CoV-2 preS dTM) adjuvanted with AS03

Key facts

• Invented name:
  VidPrevtyn Beta
• Active substance:
  SARS-CoV2 prefusion Spike delta TM (CoV-2 preS dTM) adjuvanted with AS03
• Therapeutic area:
  Vaccines
• Decision number:
  P/0072/2024
• PIP number:
  EMEA-002915-PIP01-20-M03
• Pharmaceutical form(s):
  Solution and emulsion for emulsion for injection
• Condition(s) / indication(s):
  Prevention of Coronavirus disease 2019 (COVID-19)
• Route(s) of administration:
  Intramuscular use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  08/03/2024
• Compliance check done:
  No

Decision

P/0072/2024 : EMA decision of 8 March 2024 on the acceptance of a modification of an agreed paediatric investigation plan for SARS-CoV2 prefusion spike delta TM (CoV-2 preS dTM) adjuvanted with AS03 (VidPrevtyn Beta), (EMEA-002915-PIP01-20-M03)

Adopted Reference Number: EMA/28208/2024