Europe: Covid-19 CHMP Minutes for October 2022

Summary: Minutes from the EMA’s Committee for Medicinal Products for Human Use (CHMP) meeting on 10-13 October 2022 released on the 23^rd of November 2022. Items of interest listed below:

Initial applications; List of outstanding issues (Day 180; Day 120 for procedures with accelerated assessment timetable)

SARS-CoV-2 prefusion Spike delta TM protein, recombinant

• Indication: Active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 18 years of age and older.
• The Committee adopted a list of outstanding issues with a specific timetable.

Update on on-going initial applications for Centralised procedure

molnupiravir

• Indication: Treatment of coronavirus disease 2019 (COVID-19)
• Update on the status of the procedure
• The CHMP noted the update on the procedure.

Type II variations - variation of therapeutic indication procedure

Ronapreve (casirivimab / imdevimab) - Roche Registration GmbH

• Extension of indication to include treatment of COVID-19 in hospitalised patients in adults and adolescents aged 12 years and older weighing at least 40 kg for Ronapreve; as a consequence, sections 4.2, 4.4, 4.8, 4.9, 5.1 and 5.2 of the SmPC are updated. The Package Leaflet and Labelling are updated in accordance. Version 1.1 of the RMP has also been submitted.
• Request for 1 year of market protection for a new indication (Article 14(11) of Regulation (EC) 726/2004)
• The Committee discussed the issues identified in this application, concerning clinical aspects and adopted a 2nd request for supplementary information with a specific timetable.

Spikevax (elasomeran) - Moderna Biotech Spain, S.L.

• Extension of indication to include immunisation of paediatric individuals from 6 months through 5 years of age based on results from the study P204 (KidCove); this is a phase 2/3, two-part, open-label, dose-escalation, age de-escalation and randomized, observer-blind, placebo-controlled expansion study to evaluate the safety, tolerability, reactogenicity, and effectiveness of mRNA-1273 SARS-CoV-2 vaccine in healthy children 6 months to less than 12 years of age. As a consequence, sections 4.1, 4.2, 4.4, 4.8 and 5.1 of the SmPC are updated and the Package Leaflet is updated in accordance. The MAH also took the opportunity to implement minor editorial changes in the product information. The submission includes a revised RMP version 4.1.
• The Committee discussed the issues identified in this application, concerning clinical aspects and the RMP and adopted a 2nd request for supplementary information with a specific timetable

Post-authorisation issues

Evusheld (tixagevimab / cilgavimab) - AstraZeneca AB

• Update of sections 4.2, 4.8, 4.9, 5.1 and 5.2 of the SmPC in order to change the posology recommendations in the pre-exposure prophylaxis indication based on study TACKLE (D8851C00001). The Package Leaflet is updated accordingly. The RMP version 2 has also been submitted.
• The Committee discussed the issues identified in this application, concerning clinical aspects and adopted a request for supplementary information with a specific timetable.

Spikevax (elasomeran) - Moderna Biotech Spain, S.L.

• I.a.6.a (Type II): Addition of a new strain (Omicron BA.4-5) resulting in a new Spikevax bivalent Original/Omicron BA.4-5 (50 μg elasomeran/50 μg davesomeran)/mL 0.1 mg/mL dispersion for injection presentation. The Annex A, the SmPC, the Annex II, the labelling and the Package Leaflet are updated accordingly.
• The Committee discussed the issues identified in this application, concerning clinical aspects and adopted a request for supplementary information with a specific timetable.

Ronapreve (casirivimab / imdevimab) - Roche Registration GmbH

• Update of sections 4.2, 4.4, 5.1 and 5.2 of the SmPC in order to introduce the proposed dose for SARS-CoV-2 Omicron BA.2, BA.2.12.1, BA.4 and BA.5 subvariants along with dose preparation and infusion instructions for treatment of outpatients and post-exposure prophylaxis as well as to update efficacy and pharmacokinetic information based on pharmacokinetic (PK) modelling data from R10933-PK-21187-SR-01V2 and R10933-R10987-4800mgIV-KRM and in vitro viral neutralisation data from the updated virus neutralisation report R10933-PH-20091-SR-01V7 and its addendum; the Package Leaflet is updated accordingly. In addition, the MAH took the opportunity to introduce minor editorial changes to the PI.
• The Committee discussed the issues identified in this application, concerning clinical aspects and a request for supplementary information with a specific timetable.

Vaxzevria (COVID 19 Vaccine (ChAdOx1 S [recombinant])) - AstraZeneca AB

• Renewal of conditional marketing authorisation; proposal to switch to standard marketing authorisation
• The Committee adopted a positive opinion.
• Based on the review of the available information, the CHMP was of the opinion that the risk-benefit balance remains favourable and that all specific obligations have been fulfilled, therefore the CHMP recommended granting of a Marketing Authorisation not subject to specific obligations.

Comirnaty (tozinameran) - BioNTech Manufacturing GmbH

• Update of sections 4.8 and 5.1 of the SmPC of Comirnaty 30 μg concentrate for dispersion for injection and Comirnaty 30 μg dispersion for injection as well as section 4.8 of the SmPC of Comirnaty 10 μg concentrate for dispersion for injection in order to update information based on six-month post (booster) dose three interim report data in patients aged 16 years of age and above from studies C4591001 and C4591031. Study C4591001 is a phase 1/2/3, placebo-controlled, randomized, observer-blind, dose-finding study to evaluate the safety, tolerability, immunogenicity, and efficacy of SARS-CoV-2 RNA vaccine candidates against COVID-19 in healthy individuals, while study C4591031 is a phase 3 master protocol to evaluate additional dose(s) of BNT162b2 in healthy individuals previously vaccinated with BNT162b2.
• The Committee discussed the issues identified in this application, concerning clinical aspects and adopted a request for supplementary information with a specific timetable.