Poliovirus Vaccine Inactivated
»Poliovirus Vaccine Inactivated conforms to the regulations of the federal Food and Drug Administration concerning biologics (630.1 to 630.6) (see Biologics 1041). It is a sterile aqueous suspension of inactivated poliomyelitis virus of Types 1, 2, and 3. The virus strains are grown separately in primary cell cultures of monkey kidney tissue, and from a virus suspension with a virus titer of not less than 106.5 TCID50 measured in comparison with the U. S. Reference Poliovirus of the corresponding type, are inactivated so as to reduce the virus titer by a factor of 10-8, and after inactivation are combined in suitable proportions.
No extraneous protein, capable of producing allergenic effects upon injection into human subjects, is added to the final virus production medium. If animal serum is used at any stage, its calculated concentration in the final medium does not exceed 1 part per million. Suitable antimicrobial agents may be used during the production. The single strain harvests or virus pools prior to inactivation meet the requirements of the specific mouse, guinea pig, and rabbit tests for absence of B virus and Mycobacterium tuberculosis, and the tissue culture test for absence of SV-40 virus. The single strain or trivalent virus pools after inactivation meet the requirements of the specific tissue culture and monkey tests for absence of active poliovirus, the mouse test for absence of lymphocytic choriomeningitis virus, and the tissue culture safety test for absence of SV-40 virus or other active viruses. The Vaccine meets the requirements of the specific monkey potency test by virus neutralizing antibody production, based on the U. S. Reference Poliovirus Antiserum, such that the ratio of the geometric mean titer of the group of monkey serums representing the vaccine to the mean titer value of the reference serum is not less than 1.29 for Type 1, 1.13 for Type 2, and 0.72 for Type 3.
Packaging and storage Preserve at a temperature between 2 and 8.
Expiration date The expiration date is not later than 1 year after date of issue from manufacturer's cold storage (5, 1 year).
Labeling Label it to state that it is to be well shaken before use. Label it also to state that it was prepared in monkey tissue cultures.