Monovalent polio immunisation--a strategy for India.

For the global eradication of poliomyelitis to succeed it is necessary to address the problem of type 1 poliovirus infection in those last remaining regions and countries where type 1 disease remains endemic. By general consensus among experts, prevention and eradication of type 1 infection would not be achieved using the currently available trivalent oral poliovirus vaccine (tOPV). Monovalent OPV1 (mOPV1) will be necessary for the purpose. mOPV1 was developed by Panacea Biotec Ltd, a United Nations prequalified producer of tOPV of proven efficacy and safety, by removal from the formulation of the mOPV2 and mOPV3 components with no change whatever in the quality, chemistry and stability of the monovalent product, and the virus content of the mOPV1 vaccine unchanged from the original approved tOPV product. This article summarises the development and regulatory strategy for the World Health Organisation proposal for such development with scrupulous provision being made for the safety of the vaccinees, and for their seroprotective responses.