EMEA-002987-PIP01-21 - paediatric investigation plan

CpG 1018/Alum-adjuvanted recombinant SARS-CoV-2 Trimeric Spike (S) protein subunit vaccine (SCB- 2019)

Key facts

• Active substance:
  CpG 1018/Alum-adjuvanted recombinant SARS-CoV-2 Trimeric Spike (S) protein subunit vaccine (SCB- 2019)
• Therapeutic area:
  Vaccines
• Decision number:
  P/0070/2022
• PIP number:
  EMEA-002987-PIP01-21
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Prevention of Coronavirus disease 2019 (COVID-19)
• Route(s) of administration:
  Intramuscular use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  11/03/2022
• Compliance check done:
  No

Decision

P/0070/2022 : EMA decision of 11 March 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral for CpG 1018/Alum-adjuvanted recombinant SARS-CoV-2 Trimeric Spike (S) protein subunit vaccine....(EMEA-002987-PIP01-21)

Adopted Reference Number: EMA/70884/2022