Categorical Exclusion - Cervarix

To: STN: 125259/0

From: Rebecca Olin, CSO, CBER/OCBQ/DMPQ/MRB2, HFM-676

To: John A. Eltermann, Jr. , R.Ph., M.S., Director, DMPQ, HFM-670

Through: Chiang Syin, PhD, Chief, OCBQ/DMPQ/MRB2, HFM-676

Applicant: GlaxoSmithKline Biologicals, License #1617

Product: Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant – Cervarix ™

Subject: Review Memo – Categorical Exclusion under 21 CFR 25.31(c) for Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant

This is a request for a categorical exclusion from an Environmental Assessment under 21 CFR § 25.31(c).

This categorical exclusion request was submitted by GlaxoSmithKline as part of Biologics License Application 125259/0. The request for categorical exclusion has been reviewed and we conclude the request is justified as the product is composed of naturally occurring substances and that no extraordinary circumstances exist.

Cervarix is composed of recombinant HPV-16 and HPV-18 proteins assembled into virus-like particles and constitute the active ingredient of the vaccine. The HPV proteins are produced with a recombinant Baculovirus expression system. The adjuvant used in Cervarix is ASO4 which is composed of an aluminium salt, Al(OH) 3 and 3-O-desacyl-4’-monophosphoryl lipid A (MPL). MPL is a detoxified derivative of the lipopolysaccharide of the gram negative bacterium Salmonella Minnesota R595.

Other products manufactured at the Wavre Nord and Rixensart facilities include:

• Hepatitis A Inactivated & Hepatitis B Vaccine (Recombinant) - Infanrix®
• Hepatitis B Vaccine (Recombinant) - Engerix-B®
• Hepatitis A Vaccine, Inactivated - Havrix®
• Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine, Adsorbed - Twinrix®
• DTaP & Hepatitis B (Recombinant) & Inactivated Polio Virus Vaccine - Pediarix®
• Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed - Boostrix®
• Influenza Virus Vaccine - Fluarix®

___________________________________________
Rebecca Olin, CSO
CBER/OCBQ/DMPQ/MRB2

___________________________________________
Chiang Syin, PhD
Chief, CBER/OCBQ/DMPQ/MRB2

Concurrence:

___________________________________________
John A. Eltermann, Jr. , R.Ph., M.S.
Director, CBER, OCBQ, DMPQ