Chatterjee Arani, Chawla Anil
Panacea Biotec Ltd, New Delhi 110044.
J Indian Med Assoc. 2005 Dec;103(12):682-5.
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.
为使全球根除脊髓灰质炎取得成功，有必要解决1型脊髓灰质炎病毒感染问题，这些问题存在于1型疾病仍为地方性流行的最后几个地区和国家。专家们普遍认为，使用目前可用的三价口服脊髓灰质炎疫苗（tOPV）无法实现1型感染的预防和根除。为此，单价OPV1（mOPV1）将是必要的。mOPV1由Panacea Biotec Ltd开发，该公司是联合国预认证的tOPV生产商，其产品疗效和安全性已得到验证。通过从配方中去除mOPV2和mOPV3成分来开发mOPV1，单价产品的质量、化学性质和稳定性没有任何变化，mOPV1疫苗的病毒含量与原始批准的tOPV产品相同。本文总结了世界卫生组织关于此类开发提案的研发和监管策略，并为疫苗接种者的安全性及其血清保护反应做出了审慎安排。
