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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

Record of Telephone Conversation - Cervarix, December 7, 2007

(System Info - 107576 SHONE DEANNA 10/13/2009 17:20:57 SHONEDE)

RECORD OF TELEPHONE CONVERSATION     

Submission Type:    BLA    Submission ID:  125259/0        Office:  OVRR

Product:                     

Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant

Applicant:                   

GlaxoSmithKline Biologicals  

Telecon Date/Time:  07-Dec-2007 12:00 AM            Initiated by FDA? Yes

Telephone Number:        

Communication Categorie(s):  

1. Other - null              

Author:                     MANETTE NIU

Brief Description:            

Clarification of Pharmacovigilance questions as per GSK request for

clarification                

FDA Participants:            

Non-FDA Participant(s):      

Trans-BLA Group :                 No

Related STNS :               

Related PMCs :               

Telecon Body:                

Sent: Friday, December 07, 2007 2:02 PM

To: 'Matt.Whitman@gsk.com'

Cc: Sharon.W.Shapowal@gsk.com

Subject: RE: CBER's Aug 21 Pharmacovigilance Comments - Clarification

Sorry for the delay in our reponse to you on this. Here is the response from Dr. Niu for your clarification of our August 21, 2007 request for information.

Please note that these are our initial comments. Depending on subsequent CBER evaluation & final labeling, CBER may request additions.

Response to #3a:

The agency is requesting VAERS forms (for domestic reports), and CIOMS forms (international reports for serious-expected, and non-serious-unexpected adverse event reports at each of these monthly periodic reports.

The agency is not specifically requesting nonserious-expected adverse event reports from outside the U.S. Please include as 15 day reports: All of the following adverse events whether or not they meet the regulation requirements for serious, including neuroinflammatory diseases (transverse myelitis, multiple sclerosis, optic neuritis, GBS), autoimmune diseases (rheumatoid arthritis, SLE), thrombotic events (deep venous thrombosis, pulmonary emboli), thrombocytopenia, seizure, syncope, spontaneous abortion, congenital birth defects (including ventricular septal defects).

As 30 day (monthly reports): All serious adverse events whether or not they meet the regulatio requirements for serious, including arthritis, arthralgia, arthropathy, proteinuria.

Response to #3d:

No further comments RE: Pregnancy registry.