MHRA paediatric investigation plan
Comirnaty concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified) (Highly purified single-stranded, 5'-capped mRNA encoding full length SARS-CoV2 spike protein (BNT162b2))
MHRA paediatric investigation plan MHRA-100390-PIP01-21-M01 (update) · Modification
Key facts
| PIP number | MHRA-100390-PIP01-21-M01 (update) |
|---|---|
| Product names | 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) |
| Active substances | Highly purified single-stranded, 5'-capped mRNA encoding full length SARS-CoV2 spike protein (BNT162b2) |
| Therapeutic areas | Vaccines |
| Conditions | Prevention of coronavirus disease 2019 (COVID-19) |
| Decision | PM: decision on the application for modification of an agreed paediatric investigation plan. |
| Published | Apr 27, 2022 |
| MHRA record | cms.mhra.gov.uk |
About MHRA paediatric investigation plans
A paediatric investigation plan sets out the studies a company must run in children to support authorisation of a medicine in the UK, or records a waiver or deferral.
Source: UK Medicines and Healthcare products Regulatory Agency (MHRA). Contains public sector information licensed under the Open Government Licence v3.0 · Source date: