Le DCGI avait précédemment demandé à SII de définir clairement les phases 2 et 3 des essais et de soumettre à nouveau leur demande d'évaluation.New Delhi: Vendredi, un comité d'experts sur le COVID-19 a recommandé au régulateur pharmaceutique du pays d'accorder l'autorisation au Serum Institute of India (SII) de mener les deuxième et troisième phases des essais cliniques sur l'homme du candidat vaccin d'Oxford.
The recommendations of the Central Drugs Standard Control Organization (CDSCO) committee have been sent to the Drugs Controller General of India (DCGI) for approval, high-ranking sources said. PTI.
They said the SII submitted a revised proposal on Wednesday after Tuesday’s expert panel, following deliberations on its application, asked it to revise its protocol for the trials in addition to seeking additional information.
“An urgent meeting was convened by the COVID-19 Expert Panel on Friday to consider SII’s request. After deliberation, it recommended that authorization be granted for phase 2 and 3 human clinical trials of the potential vaccine developed by the University of Oxford. – Covishield, ”said an official source.
According to the revised proposal, 1,600 people over the age of 18 will participate in the trials at 17 selected sites, including AIIMS Delhi, BJ Medical College, Pune, Rajendra Memorial Research Institute of Medical Sciences (RMRIMS) Patna, Post Graduate Institute of Medical Education and Research in Chandigarh, AIIMS Jodhpur, Nehru Hospital in Gorakhpur, Andhra Medical College in Visakhapatnam and JSS Academy of Higher Education & Research in Mysuru.
“Depending on the app, it would conduct a randomized, blind-observer controlled study to determine the safety and immunogenicity of Covishield in healthy Indian adults,” the source said.
The DCGI had asked SII on Tuesday to clearly define the Phase 2 and Phase 3 parts of the protocol and to resubmit their application for evaluation by the committee.
The group also recommended that the clinical trial sites proposed for the study be distributed across India.
SII, which has partnered with AstraZeneca to manufacture the Oxford vaccine candidate for COVID-19, submitted its first application to DCGI on Friday for approval to conduct phase 2 and 3 trials of Covishield.
The first results of the first two-phase trials of the vaccine conducted at five trial sites in the UK showed that it had an acceptable safety profile and a homologous increase in the antibody response, the source said.
To introduce the vaccine, SII, the world’s largest vaccine manufacturer by number of doses produced and sold, signed an agreement to manufacture the potential vaccine developed by the Jenner Institute (University of Oxford) in collaboration with the Anglo-pharmaceutical company. Swedish AstraZeneca.
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