MHRA paediatric investigation plan
Bimervax (Selvacovatein (INN) - SARS-CoV-2 virus recombinant spike (S) protein receptor binding domain (RBD) fusion heterodimer (B.1.351 and B.1.1.7 strains) (beta-alpha variants))
MHRA paediatric investigation plan MHRA-100966-PIP01-23-M01 (update) · Modification
Key facts
| PIP number | MHRA-100966-PIP01-23-M01 (update) |
|---|---|
| Product names | Bimervax, BIMERVAX |
| Active substances | Selvacovatein (INN) - SARS-CoV-2 virus recombinant spike (S) protein receptor binding domain (RBD) fusion heterodimer (B.1.351 and B.1.1.7 strains) (beta-alpha variants), SARS-CoV-2 virus recombinant spike (S) protein receptor binding domain (RBD) fusion homodimer - XBB.1.16-XBB.1.16 variant |
| 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 | Jan 6, 2025 |
| 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: