Can anyone tell me how long it typically takes to get FDA approval for
a vaccine once a Biologics License Application has been filed?

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Request for Question Clarification by pafalafa-ga on 21 Apr 2006 12:20 PDT

I did not find any recent information on FDA review times for BLA's. 
The most recent assessment seems to be this one, released in 1996:


http://www.fda.gov/bbs/topics/ANSWERS/ANS00707.html
FDA 1995 APPROVALS SHOW CONTINUED DECLINE IN REVIEW TIMES 


The agency approved for marketing 82 drugs... in the median time of
16.5 months, 13 percent below the 19 months required for approvals in
1994.

...Two new vaccines and one new therapeutic biological product were
among the 12 major biologics approvals last year which were completed
in the median time of 17.6 months. This approval time was 28 percent
below the 1994 median approval time for biologics.



Does that information meet your needs?


pafalafa-ga

Hi Jess05!

According to the information below, it typically takes between 6 and
10 months to get FDA approval for a vaccine once a Biologics License
Application has been filed.


Developing and Licensing a Vaccine

Application for Licensure

"Requests to license new vaccines are submitted to CBER and are known
as Biologic Licensure Applications (BLA). The BLA is a comprehensive
document that contains extensive information about the product, its
manufacturing process and facilities, and the data and results of all
non-clinical and clinical studies."

FDA Review

"Upon receipt of a Biologic Licensure Application, CBER issues a
unique submission tracking number to identify and track all BLA
documents and correspondence. Most vaccines are assigned a standard
10-month review. Priority review of vaccines of public health
significance may occur in a shorter time frame, usually six months. "
audited."

Source: Developing and Licensing a Vaccine
The Division of Microbiology and Infectious Diseases (DMID) 

Read the rest of the publication here:
http://www.niaid.nih.gov/dmid/vaccines/develop_vaccines.htm


============================================================



Barr Laboratories, Inc.5  

A contract to develop and manufacture the type 4 and 7 adenovirus
vaccines was awarded in 2001.

Timeline:

"September 2001 - December 2003: Develop manufacturing capability and
produce three pilot lots of each vaccine type (including one cGMP
lot).

March - September 2003: Conduct and complete the phase 1 clinical trial. 
June 2005: Manufacture the first consistency lots. 

August 2005 ? July 2006: Conduct  and complete the phase 2 clinical
trial. The second and third consistency lots will be produced during
the phase 2 clinical trial.

December 2006 ? November 2007: Conduct and complete the phase 3 clinical trial. 

February 2008: File the BLA with the FDA. Expect six month FDA review
of the BLA and subsequent approval.

Total time to develop adenovirus vaccine and obtain FDA approval is 6
to 6.5 years."

http://chppm-www.apgea.army.mil/doem/PGM34/Docs/TLedit30JulReManAdenoTerryFHP2003.ppt

OR 

http://72.14.203.104/search?q=cache:nOJJrAWDLfwJ:chppm-www.apgea.army.mil/doem/PGM34/Docs/TLedit30JulReManAdenoTerryFHP2003.ppt+%22File+the+BLA+with+the+FDA.%22++%22*+month+FDA+review%22++of+the+BLA+and+subsequent+approval.&hl=en&ct=clnk&cd=1



Search terms:
FDA approval timeline for vaccines


I hope this helps!


Best regards, 
Bobbie7

Hi Bobbie7! As always, thank you for the extremely helpful answer!