Key Facts

PIPS 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
Compliance Check Decision Date
Compliance Check Procedure Number
Compliance procedure number

Decision Document

PIPS Decision Documents
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