MHRA-100390-PIP01-21-M01 (update)

Key Facts

Active Substance
Active Substance:
  • Highly purified single-stranded, 5'-capped mRNA encoding full length SARS-CoV2 spike protein (BNT162b2)
Invented Name
  • Comirnaty concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty 30 micrograms/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
PIP Number MHRA-100390-PIP01-21-M01 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Concentrate for solution for injection
Therapeutic area
Therapeutic area:
  • Vaccines
Conditions / Indications
Conditions / Indications:
  • Prevention of coronavirus disease 2019 (COVID-19)
Route(s) of administration
Route(s) of administration:
  • Parenteral use
PIP applicant
Decision Type
Decision Type
PM: decision on the application for modification of an agreed paediatric investigation plan.
Compliance Check
Compliance Check
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):Highly purified single-stranded, 5'-capped mRNA encoding full length SARS-CoV2 spike protein (BNT162b2).pdf
Published Date 27/04/2022