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Cervarix, INN-Human Papillomavirus Vaccine [Types 16, 18] (Recombinant, Adjuvanted, Adsorbed)

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Cervarix, INN-Human Papillomavirus Vaccine [Types 16, 18] (Recombinant, Adjuvanted, Adsorbed) 14 May 2020 EMA/267086/2020 Committee for Medicinal Products for Human Use (CHMP) Assessment report Cervarix International non-proprietary name: human papillomavirus vaccine [types 16, 18] (recombinant, adjuvanted, adsorbed) Procedure No. EMEA/H/C/000721/II/0106 Note Variation assessment report as adopted by the CHMP with all information of a commercially confidential nature deleted. Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000 An agency of the European Union © European Medicines Agency, 2020. Reproduction is authorised provided the source is acknowledged. Status of this report and steps taken for the assessment Current Description Planned date Actual Date Need for step discussion Start of procedure 14 Jan 2020 14 Jan 2020 CHMP Rapporteur Assessment Report 17 Feb 2020 18 Feb 2020 PRAC Rapporteur Assessment Report 24 Feb 2020 18 Feb 2020 PRAC members comments 28 Feb 2020 28 Feb 2020 CHMP members comments 02 Mar 2020 02 Mar 2020 Updated PRAC Rapporteur Assessment 03 Mar 2020 05 Mar 2020 Report Updated CHMP Rapporteur Assessment 05 Mar 2020 05 Mar 2020 Report Start of written procedure 10 Mar 2020 10 Mar 2020 PRAC endorsed relevant sections of the 10 Mar 2020 10 Mar 2020 assessment report Request For supplementary information 12 Mar 2020 12 Mar 2020 Start of procedure 16 April 2020 16 April 2020 CHMP Rapporteur Assessment Report 29 April 2020 29 April 2020 PRAC Rapporteur Assessment Report 30 April 2020 29 April 2020 PRAC members comments 04 May 2020 n/a CHMP members comments 04 May 2020 n/a Updated PRAC Rapporteur Assessment 05 May 2020 n/a Report Updated CHMP Rapporteur Assessment 07 May 2020 06 May 2020 Report Start of written procedure 12 May 2020 12 May 2020 PRAC endorsed relevant sections of the 12 May 2020 12 May 2020 assessment report Opinion 14 May 2020 14 May 2020 Assessment report EMA/CHMP/PRAC/20445/2020 Page 2/43 Procedure resources Rapporteur: Christophe Focke PRAC Rapporteur: Jean-Michel Dogné Assessment report EMA/CHMP/PRAC/20445/2020 Page 3/43 Table of contents 1. Background information on the procedure .......................................................... 5 2. Overall conclusion and impact on the benefit/risk balance ................................. 5 3. Recommendations .............................................................................................. 8 4. EPAR changes ..................................................................................................... 8 5. Introduction ...................................................................................................... 11 6. Clinical Efficacy aspects .................................................................................... 11 6.1. HPV-019.......................................................................................................................... 11 6.2. Discussion ....................................................................................................................... 19 6.3. HPV-073.......................................................................................................................... 22 6.4. Discussion ....................................................................................................................... 23 7. Clinical Safety aspects ...................................................................................... 24 7.1. HPV-019.......................................................................................................................... 24 7.2. HPV-073.......................................................................................................................... 27 8. Risk management plan ...................................................................................... 29 8.1. Safety Specification .......................................................................................................... 30 8.2. Summary of the safety concerns ........................................................................................ 32 8.3. Pharmacovigilance plan ..................................................................................................... 32 8.4. Risk minimisation measures ............................................................................................... 34 8.5. Elements for a public summary of the RMP .......................................................................... 34 8.6. Annexes .......................................................................................................................... 35 8.7. Overall conclusion on the RMP............................................................................................ 35 9. Changes to the Product Information ................................................................. 35 10. Request for supplementary information .......................................................... 36 10.1. Other concerns ............................................................................................................... 36 11. Assessment of the responses to the request for supplementary information .. 37 11.1. Other concerns ............................................................................................................... 37 12. Attachments .............................................................. Error! Bookmark not defined. Assessment report EMA/CHMP/PRAC/20445/2020 Page 4/43 1. Background information on the procedure Pursuant to Article 16 of Commission Regulation (EC) No 1234/2008, GlaxoSmithkline Biologicals SA submitted to the European Medicines Agency on 20 December 2019 an application for a variation. The following changes were proposed: Variation requested Type Annexes affected C.I.3.b C.I.3.b - Change(s) in the SPC, Labelling or PL intended Type II I, II, IIIA to implement the outcome of a procedure concerning and IIIB PSUR or PASS or the outcome of the assessment done under A 45/46 - Change(s) with new additional data submitted by the MAH Update of sections 4.4 and 5.1 of the SmPC based on final results from study HPV-019 listed as a category 3 study in the RMP; this is a safety and immunogenicity study of Cervarix in HIV-positive female subjects aged 15-25 years as compared to HPV-4, which was already submitted in P46. In addition, the Marketing authorisation holder (MAH) took the opportunity to reflect an update in section 4.2 of the SmPC to indicate that limited clinical data is now available in 4-6 years old children based on study HPV-073 following assessment in P46/090; this is a safety and immunogenicity study of Cervarix in girls aged 4-6 years, as an alternative to the current adolescent HPV vaccination schedule. The RMP version 21.0 has also been submitted to reflect the availability of the final results of the HPV- 019 and HPV-073 studies, and the use of Cervarix in HIV-infected subjects or subjects with known immune deficiencies has been removed as missing information. In addition, the MAH took the opportunity to bring the PI in line with the latest QRD template version 10.1. The requested variation proposed amendments to the Summary of Product Characteristics, Annex II, Labelling and Package Leaflet and to the Risk Management Plan (RMP). 2. Overall conclusion and impact on the benefit/risk balance Within this type II variation, the MAH is providing the results from study HPV-019 and HPV-073, already assessed within the context of Article P46 procedures, and the consequential amendments to the product information. • HPV-019: phase IV, multi-centre, observer-blind, controlled, randomised (1:1) study, with 2 groups, stratified by HIV infection status (positive or negative) and by age (15-17 years and 18-25 years) in Brazil, Estonia, India and Thailand. • HPV-073: phase III, single-blinded, randomised, controlled, multicentre study with 2 parallel groups in healthy girls 4 to 6 years of age at the time of vaccination in Colombia, Mexico and Panama. There is evidence for multiple biological interactions between human immunodeficiency virus (HIV) and Assessment report EMA/CHMP/PRAC/20445/2020 Page 5/43 human papilloma virus (HPV)1. These interactions have several important clinical, epidemiological and public health implications. In particular, the excess burden of HPV in Person Living with HIV (PLHIV) has implications for the clinical management of PLHIV requiring more frequent screening, follow-up and management of precancerous lesions due to HPV. HPV vaccination, which has been proven to be safe and immunogenic among PLHIV2, may confer particular benefit to this group, and help to control HPV infections and related cancer more efficiently at population-level. Recent modelling studies suggest that as PLHIV are disproportionately infected with HPV they are more likely to transmit it making them an important group for focused HPV prevention. Interventions such as HPV vaccination could in theory have additional indirect benefits on HIV/AIDS, even if the relative risk of HIV acquisition due to HPV is modest. Given the burden of HPV and HIV and abundance of co-infections, HPV vaccination could prevent a non-negligible number of AIDS deaths particularly in Sub-Saharan Africa. Immunocompromised patients, particularly HIV-infected patients with CD4 cell counts <200 cells/microL, are at especially high risk for HPV-related disease3. HPV vaccination with a three-dose schedule (at 0, 1 to 2, and 6 months)
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