
Record of Telephone Conversation, October 19, 2012 - Flublok

 
 

Submission Type: BLA    Submission ID: 125285/0    Office: OVRR

Product:

Influenza Vaccine

Applicant:

Protein Sciences Corporation

Telecon Date/Time: 19-Oct-2012 01:07 PM        Initiated by FDA? Yes

Telephone Number: Communicated via e-mail

Communication Categorie(s):

1. Advice

2. Information Request

Author: TIMOTHY FRITZ

Telecon Summary:

Pregnancy registry comments/requests.

FDA Participants: Timothy Fritz

Non-FDA Participants: Penny Post

Trans-BLA Group: No

Related STNs: None

Related PMCs: None

Telecon Body:

From:                    Fritz, Timothy

Sent:                      Friday, October 19, 2012 1:07 PM

To:                         'Penny Post'

Subject:                 CBER Information Request STN 125285

 

Importance:           High

Dear Dr. Post-

 

Our review of your Flublok BLA submission (STN 125285) is ongoing. We have reviewed your September 21, 2012, submission (Amendment 62) and have the following comments and requests for information:

 

1. The proposal for a pregnancy registry states that the Patient Information Sheet will include contact information “for women to report pregnancies within 2 months of receipt of FluBlok.” Please clarify whether, in addition to including pregnancies that begin within 2 months following FluBlok vaccination, PSC plans to include all pregnancies during which FluBlok vaccination occurs. For example, if someone is vaccinated in the 7th month of pregnancy, will that person be included? Also, please clarify whether vaccine recipients must report pregnancies within 2 months of vaccination or whether pregnancy reporting is permitted if more than 2 months have elapsed since vaccination.

 

2. The proposal mentions only fetal/infant outcomes. Please consider also evaluating medical conditions in pregnant women (e.g., eclampsia, pre-term labor, placenta abruptio, etc.). 

 

3. Please clarify whether the “Annual Report for FluBlok” is the same as the Periodic Safety Update Report (or Periodic Adverse Event Report), or is a document specifically for pregnancy outcomes.

 

Please provide your response as an Amendment to STN 125285. In your reply, we recommend that you restate our request and follow it with your explanation or

clarification. Use of this format helps organize the relevant information and provides a self-contained document that facilitates future reference.

 

If you have any questions, please contact the Regulatory Project Chair, Dr. Timothy Fritz, at 301-796-2640.

 

Thank you.

Timothy A. Fritz, Ph.D. 
Microbiologist 
FDA/CBER/OVRR/DVRPA/CMC2 
WOC2 HFM-478
1451 Rockville Pike 
Rockville, MD 20852 
Phone: 301-796-2640 
Fax: 301-827-1597

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