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European Medicines Agency
Evaluation of Medicines for Human Use
7 Westferry Circus, Canary Wharf, London E14 4HB, UKTel. (44-20) 74 18 84 00 Fax (44-20) 74 18 85 45E-mail: mail@emea.europa.eu http://www.emea.europa.eu
©
European Medicines Agency, 2008. Reproduction is authorised provided the source is acknowledged.
Doc Ref : EMEA/285631/2008
CHMP ASSESSMENT REPORTFORPandemrix
Common Name:
Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)A/VietNam/1194/2004 NIBRG-14Procedure No. EMEA/H/C/832
Assessment Report as adopted by the CHMP withall information of a commercially confidential nature deleted.
© EMEA 2008 2/33
TABLE OF CONTENS1.
BACKGROUND INFORMATION ON THE PROCEDURE...........................................3
1.1
Submission of the dossier........................................................................................................3
1.2
Steps taken for the assessment of the product..........................................................................3
2
SCIENTIFIC DISCUSSION.................................................................................................5
2.1.
Introduction..............................................................................................................................5
2.2. Quality aspects.........................................................................................................................5
2.3. Non-clinical aspects...............................................................................................................10
2.4. Clinical aspects......................................................................................................................12
2.5.
Pharmacovigilance.................................................................................................................12
2.6.
Overall conclusions, risk/benefit assessment and recommendation......................................12
© EMEA 2008 3/33
1.
BACKGROUND
INFORMATION ON THE PROCEDURE
1.1 Submission of the dossier
The applicant GlaxoSmithKline Biologicals S.A. submitted on 2 February 2007 an application for Marketing Authorisation to the European Medicines Agency (EMEA) for Pandemrix, through thecentralised procedure falling within the Article 3(1) and point 1 of Annex of Regulation (EC) No726/2004 .The legal basis for this application refers to:A - Centralised / Article 8(3) / New active substance.Article 8.3 of Directive 2001/83/EC, as amended - complete and independent applicationThe application submitted is a complete dossier:
composed of administrative information, completequality data, non-clinical and clinical data based on applicants’ own tests and studies and/or bibliographic literature substituting/supporting certain test(s) or study(ies)
The applicant applied for the following indication: Prophylaxis of influenza in an officially declared pandemic situation.
Licensing status:
The product was not licensed in any country at the time of submission of the application.The Rapporteur and Co-Rapporteur appointed by the CHMP and the evaluation teams were:Rapporteur:
Matthew Thatcher
Co-Rapporteur:
Barbara van Zwieten-Boot
CHMP Peer reviewer(s): Germany (PEI)
1.2 Steps taken for the assessment of the product
•
The application was received by the EMEA on 2 February 2008.
•
Accelerated Assessment procedure was agreed-upon by CHMP on 14 December 2006.
•
The procedure started on 21 February 2007.
•
The Rapporteur's first Assessment Report was circulated to all CHMP members on 11May 2007. The Co-Rapporteur's first Assessment Report was circulated to all CHMP memberson 9 May 2007.
•
During the meeting on 22 May 2007, the CHMP agreed on the consolidated List of Questions to be sent to the applicant. The final consolidated List of Questions was sent to the applicant on22 May 2007.
•
The applicant submitted the responses to the CHMP consolidated List of Questions on31 October 2007.
•
The Rapporteurs circulated the Joint Assessment Report on the applicant’s responses to the Listof Questions to all CHMP members on 28 December 2007.
•
During a meeting of BWP Working Party on 14-15 January 2008, experts were convened toaddress the outstanding quality issues identified in the Joint response assessment report.
•
During the CHMP meeting on 24 January 2008, the CHMP agreed on a list of outstandingissues to be addressed in writing by the applicant.
•
The applicant submitted the responses to the CHMP list of outstanding issues on 31 January2008.
•
The Rapporteurs circulated the Joint Assessment Report on the applicant’s responses to the Listof Outstanding issues to all CHMP members on 8 February 2008.
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