Categorical exclusion under 21 CFR § 25.31(a) and (c) - IXIARO


Categorical exclusion under 21 CFR § 25.31(a) and (c) - IXIARO




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Memorandum

Food and Drug Administration
Center for Biologics Evaluation and Research
Office of Compliance and Biologics Quality
Division of Manufacturing and Product Quality

To: Administrative File, BLA STN 125280, Intercell AG

From: Destry Sillivan, HFM-676

Subject: Categorical exclusion under 21 CFR § 25.31(a) and (c)

I have reviewed pertinent sections of the Biologics License Application (STN 125280) from Intercell AG submitted for the manufacture of Japanese Encephalitis Virus (JEV) Vaccine, in their new production facility in Livingston , Scotland, UK. JEV Vaccine is indicated for active immunization against JEV for persons aged eighteen years and older Intercell has requested categorical exclusion under both 21 CFR 25.31 (a) and 21 CFR 25.31 (c).

I find that the request for a categorical exclusion from an environmental assessment under only 21 CFR 25.31 (c) is justified. Intercell claims that 21 CFR 25.31 (a) is relevant because the only JEV vaccine currently licensed by FDA in the U.S., JE-VAX®, also containing formalin-inactivated JEV, is no longer being manufactured and supplies are anticipated to be depleted soon. Thus, the introduction of Intercell's JEV vaccine to the U.S. commercial market will replace, but not increase, the use of the active moiety. Intercell’s argument does not take into consideration that there could be increased sales of their product.

Intercell also claims categorical exclusion under 21 CFR 25.31 (c) because it is formalin inactivated and therefore carries minimal risk of introducing or significantly altering the concentration of infectious JEV in the environment. Furthermore, the quantity of formalin-inactivated virus per vaccine dose (6 µg) is low and generally will be administered to a select population and therefore will not alter significantly the concentration or distribution of the substance, its metabolites, or degradation products in the environment

___________ ___________________________________________
Date                 Destry Sillivan, Sr. Reg. Rev Officer, DMPQ, CBER

Concurrence:

___________ _____________________________
Date                 John A. Eltermann, Jr., R.Ph., M.S.

Director
Division of Manufacturing and Product Quality
