MHRA paediatric investigation plan
Vidprevtyn (SARS CoV2 prefusion Spike delta TM (CoV2 preS dTM) protein, recombinant adjuvanted with AS03)
MHRA paediatric investigation plan MHRA-100038-PIP01-21-M01 (update) · Modification
Key facts
| PIP number | MHRA-100038-PIP01-21-M01 (update) |
|---|---|
| Product names | Vidprevtyn |
| Active substances | SARS CoV2 prefusion Spike delta TM (CoV2 preS dTM) protein, recombinant adjuvanted with AS03 |
| 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 | May 17, 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: