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Food and Drug Regulations

Version of section C.04.128 from 2006-03-22 to 2018-04-03:

 Poliovirus Vaccine, Live, Oral or Poliovirus Vaccine, Live, Oral (Naming the strains) shall be prepared from living poliomyelitis virus types I, II and III that

  • (a) have been obtained directly from a source acceptable to the Director;

  • (b) are shown to be genetically stable by an acceptable method;

  • (c) are shown to be non-pathogenic when given orally to humans;

  • (d) are proved to be capable of multiplying in the human alimentary tract and of producing type specific neutralizing antibodies when administered orally; and

  • (e) have a history of successful use in the production of polio-virus vaccine, live, oral.

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