MHRA paediatric investigation plan
COVID-19 vaccine Janssen (RECOMBINANT REPLICATION-INCOMPETENT ADENOVIRUS SEROTYPE 26 VECTOR ENCODING THE SARS-COV-2 SPIKE PROTEIN PER.C6 CELL LINE)
MHRA paediatric investigation plan MHRA-100029-PIP01-21-M01 (update) · Waiver
Key facts
| PIP number | MHRA-100029-PIP01-21-M01 (update) |
|---|---|
| Product names | COVID-19 vaccine Janssen, Jcovden (previously COVID-19 Vaccine Janssen) |
| Active substances | RECOMBINANT REPLICATION-INCOMPETENT ADENOVIRUS SEROTYPE 26 VECTOR ENCODING THE SARS-COV-2 SPIKE PROTEIN PER.C6 CELL LINE, COVID-19 vaccine (Ad26.COV2-S [recombinant]) |
| Therapeutic areas | Infectious diseases, Vaccines |
| Conditions | Prevention of coronavirus disease-2019 (COVID-19) |
| Decision | W: decision granting a waiver in all age groups for the listed condition(s). |
| Published | Jun 30, 2023 |
| 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: