
Information Request Email, Vaccination Campaign Results, October 8, 2014 - BEXSERO
 

 
RECORD OF TELEPHONE CONVERSATION

Submission Type: BLA     Submission ID: 125546/0     Office: OVRR 

Product:
 Meningococcal Group B Vaccine 

Applicant:
 Novartis Vaccines and Diagnostics, Inc. 

Telecon Date/Time: 08-Oct-2014 03:04 PM     Initiated by FDA? Yes

Telephone Number: 

Communication Categorie(s): 
 1. Information Request

Author: KIRK PRUTZMAN

Telecon Summary: 
IR to submit the results of the Bexsero vaccination campaign in the Saguenay-Lax St. Jean region of Quebec to the BLA

FDA Participants: KIRK PRUTZMAN, ED WOLFGANG, RAMACHANDRA NAIK

Non-FDA Participants: PATRICIA STOEHR

Trans-BLA Group: No

Related STNs: None

Related PMCs: None

Telecon Body: 


From: Prutzman, Kirk C 
 Sent: Wednesday, October 08, 2014 1:57 PM
 To: 'Stoehr, Patricia'
 Cc: Wolfgang, Edward; Naik, Ramachandra
 Subject: RE: Bexsero BLA 125546 - Question on Safety Data

Dr. Stoehr,

Please submit the certified English translated version of the interim report of the Bexsero vaccination campaign in the Saguenay-Lax St. Jean region of Quebec to the BLA as soon as it becomes available. You should submit this report to section 5.3.5.3 Post Marketing Reports as indicated below.

Please let me know if you have any questions.

Regards,

Kirk Prutzman, PhD
 Primary Reviewer/Regulatory Project Manager 
 CBER/OVRR/DVRPA/CMC3 
 Food and Drug Administration
 10903 New Hampshire Avenue
 Building 71 and Room 3041
 Silver Spring, MD 20993-0002
 Phone: (301) 796-2640
 Fax: (301) 595-1244 

From: Stoehr, Patricia [mailto:patricia.stoehr@novartis.com] 
 Sent: Monday, October 06, 2014 7:06 PM
 To: Prutzman, Kirk C
 Cc: Wolfgang, Edward; Naik, Ramachandra
 Subject: Bexsero BLA 125546 - Question on Safety Data

Dear Kirk,

As discussed last Thursday, 02Oct14, the interim report of the Bexsero vaccination campaign in the Saguenay-Lax St. Jean region of Quebec has now been published by the Institut National De Sante Publique Du Quebec. Novartis had informed CBER about this vaccination campaign in Quebec in a document sent via secure email to Ed on June 12, 2014 (Please see attached). 

This interim report could provide additional safety information about Bexsero in the North American population. For your information I am attaching the report, in French, as originally published by the Institut National De Sante Publique Du Quebec. We are also including a draft English translation of this report and will follow up with a certified translated English report as soon as possible. 

Can you please let me know if Novartis should submit this report to the Bexsero BLA? 
 If yes, I would suggest that we submit this to section 5.3.5.3 Post Marketing Reports. Do you agree? 

Kind regards,
 Patricia

*********************************
 Patricia Stoehr
 Director Regulatory Affairs 
 Novartis Vaccines & Diagnostics
 350 Massachusetts Avenue
 Cambridge, MA 02139
 USA
 Phone: +1 617 871-8060
 Fax: +1 617 871-4711
 Email : patricia.stoehr@novartis.com
