Food and Drug Regulations

C.04.128 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.