EMEA-002862-PIP01-20-M04 - paediatric investigation plan

COVID-19 vaccine (ChAdOx1-S [recombinant]) (AZD1222)

Key facts

• Invented name:
  Vaxzevria (previously COVID-19 Vaccine AstraZeneca)
• Active Substance:
  COVID-19 vaccine (ChAdOx1-S [recombinant]) (AZD1222)
• Therapeutic area:
  Vaccines
• Decision number:
  P/0273/2024
• PIP number:
  EMEA-002862-PIP01-20-M04
• Pharmaceutical form(s):
  Suspension 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:
  14/08/2024

Decision

P/0273/2024: EMA decision of 14 August 2024 on the acceptance of a modification of an agreed paediatric investigation plan and on the granting of a waiver for COVID-19 vaccine (ChAdOx1-S [recombinant]), (EMEA-002862-PIP01-20-M04)

Reference Number: EMA/307483/2024