MHRA paediatric investigation plan
COVID-19 vaccine Janssen (COVID-19 vaccine (Ad26.COV2-S (recombinant)))
MHRA paediatric investigation plan MHRA-100029-PIP01-21 · Agreement
Key facts
| PIP number | MHRA-100029-PIP01-21 |
|---|---|
| Product names | COVID-19 vaccine Janssen |
| Active substances | COVID-19 vaccine (Ad26.COV2-S (recombinant)) |
| Therapeutic areas | Infectious diseases, Vaccines |
| Conditions | Prevention of coronavirus disease-2019 (COVID-19) |
| Decision | P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) |
| Published | Nov 29, 2021 |
| 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: