Licensing of monovalent OPV1 vaccine.
The key steps in the successful accelerated licensure of monovalent type 1 oral polio vaccine (mOPV1) of Sanofi Pasteur in Egypt required innovative parallel track evaluation from the National Regulatory Authorities (NRA), both in producing and receiving countries. The standard package of regulatory data was requested and submitted simultaneously in France and Egypt, and to WHO for prequalification purposes. The main concern of the Egyptian NRA has been thermal stability of the vaccine because it will be used in very hot conditions. However, data from the field suggest that mOPV1 has a stability profile similar to trivalent OPV (tOPV). Surveillance for Vaccine Associated Paralytic Polio (VAPP) will be important in development in tropical countries during the early introduction of mOPV since little or no recent data are currently available.
Farag
May Mahmoud
MM
Egyptian National Regulatory Authority, Cairo, Egypt.