MHRA-100021-PIP01-21

Key Facts

Active Substance
Active Substance:
  • Recombinant SARS-CoV-2 spike (S)-protein virus-like particle
Invented Name
Not yet available
PIP Number MHRA-100021-PIP01-21
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Sterile suspension for intramuscular (IM) 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:
  • Intramuscular use
PIP applicant
Decision Type
Decision Type
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)
Compliance Check
Compliance Check
Yes
Compliance Check Decision Date
Compliance Check Procedure Number
Compliance procedure number
MHRA-100021-PIP01-21-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):Recombinant SARS-CoV-2 spike (S)-protein virus-like particle.pdf
Published Date 03/11/2021