MHRA-100038-PIP01-21-M03 (update)

Key Facts

Active Substance
Active Substance:
  • Recombinant SARS-CoV-2 spike protein
Invented Name
  • VidPrevtyn Beta
  • VidPrevtyn Beta
PIP Number MHRA-100038-PIP01-21-M03 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Solution and emulsion for emulsion 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:
  • Intramuscular use
PIP applicant
Decision Type
Decision Type
W: decision granting a waiver in all age groups for the listed condition(s).
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):Recombinant SARS-CoV-2 spike protein.pdf
Published Date 15/08/2024