Archived Content

The content on this page is provided for reference purposes only. This content has not been altered or updated since it was archived.

Vaccines, Blood & Biologics

Filing Memo - Cervarix, May 18, 2007



Department of Health and Human Services
Public Health Service
Food and Drug Administration
Center for Biologics Evaluation and Review
Office of Vaccines Research and Review


Re: STN #125259/0
Title: “Cervarix® (Human Papillomavirus Vaccine, AS04 Adjuvant-Adsorbed)
Intramuscular Injection”
Sponsor: GlaxoSmithKline Biologicals
Date: May 18, 2007
To: File
From: Gopa Raychaudhuri, Ph.D.
Chairperson, BLA Review Committee

The filing meeting was conducted via e-mail on May 3, 2007 (see attachment). Each member of the review team was asked to evaluate whether the information included in the BLA in his/her area of expertise was adequate to allow the reviewer to conduct a meaningful review. Each member of the review team responded that the sections in the BLA relevant to his/her area of review were acceptable for filing (see list below). Based on input from reviewers, as well as the assessment of the chairperson (Dr. Gopa Raychaudhuri) and the regulatory co-ordinator (Ms. Helen Gemignani), the review team agreed that the Cervarix BLA can be filed. CBER will issue a Filing letter by May 28, 2007 (Filing Action milestone).

The following reviewers indicated his/her concurrence with the decision to file the BLA:

Nancy Miller, MDClinical
Robin Levis, Ph.D.Product, Facility, Pre-clinical immunogenicity
Martha Lee, Ph.D.Statistics (clinical)
Lev Sirota, Ph.D.Statistics (assay validation)
Steve Kunder, Ph.D.Pre-clinical toxicology (standard toxicology studies)
Liz Sutkkowski, Ph.D.Pre-clinical toxicology, Product (adjuvant)
Marion Gruber, Ph.D.Pre-clinical toxicology (reprotoxicology studies)
Rebecca OlinFacility inspection
Manette Niu, MDEpidemiology (post-marketing commitments)
Solomon YimamBioresearch monitoring
Vada Perkins, RNElectronic format of BLA document
Helen SullivanLabeling


Page Last Updated: 04/14/2015
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English