Government officials said that the approval for conducting Phase II and Phase III clinical trials by the SII was granted by DCGI Dr V.G. Somani late on Sunday after a thorough evaluation based on the recommendations of the Subject Expert Committee (SEC) on COVID-19
“The firm has to submit safety data, evaluated by the Data Safety Monitoring Board (DSMB), to the CDSCO before proceeding to phase 3 clinical trials,” a senior official said

“As per the study design, each subject will be administered two doses four weeks apart (first dose on day one and second dose on day 29) following which the safety and immunogenicity will be assessed at predefined intervals,” the official said

As a rapid regulatory response, the expert panel at the Central Drugs Standard Control Organisation (CDSCO) on Friday, after a detailed deliberation and considering the data generated on the vaccine candidate in phase 1 and 2 of the Oxford University trial, had recommended granting permission for phase 2 and 3 clinical trials of the potential vaccine, ‘Covishield’, on healthy adults in India,? the officials said.??

Currently, phase 2 and 3 clinical trials of the Oxford vaccine candidate is going on in the United Kingdom, phase 3 clinical trial in Brazil and phase 1 and 2 clinical trials in South Africa

The officials said that the SII had submitted a revised proposal on Wednesday after the SEC on July?28, following deliberation over its application, had asked it to revise its protocol for the phase 2 and 3 clinical trials besides seeking some additional information

The panel had also recommended that the clinical trial sites which have been proposed for the study be distributed across India

According to the revised proposal by the SII, 1,600 people aged above 18 years will participate in the trials across 17 selected sites, including AIIMS-Delhi,?B J Medical College in Pune, Rajendra Memorial?Research Institute of Medical Sciences (RMRIMS) in 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 and Research in Mysore

“According to the application, it would conduct an observer-blind, randomised controlled study to determine the safety and immunogenicity of ‘Covishield’ on healthy Indian adults,” the official said

The SII, which has partnered with AstraZeneca, for manufacturing the Oxford vaccine candidate for COVID-19 had submitted its first application to the DCGI on July?25 seeking permission for conducting the phase 2 and 3 trials of the potential vaccine.?

Initial results of the first two-phases of trials of the vaccine conducted in five trial sites in the UK showed that it has an acceptable safety profile and homologous boosting increased antibody response, sources had said

To introduce the vaccine, SII, the world’s largest vaccine maker by number of doses produced and sold, has signed an agreement to manufacture the potential vaccine developed by the Jenner Institute (Oxford University) in collaboration with British-Swedish pharma company AstraZeneca.
Vaccine by end November, says Serum Institute director

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Following the trail, the All India Institute of Medical Science (AIIMS),Patna has started the human trial of the vaccine starting from July 13. The trial will be conducted on 18 volunteers selected by the hospital authority.

Earlier, Bharath Biotech International Ltd and Zydus Cadila pharmaceutical companies indigenous developed prototype vaccines and has got the approval of Drug Controller General of India, for human trials. AIIMS Patna is one among the 12 institutes selected by ICMR to conduct the coronavirus trial.

The selected volunteers will first go through medical check-up and after analysing their reports they will further proceed for trial.

As per Indian Council of Medical Research (ICMR) guidelines, the first dose of the vaccine will be given to only those whose reports are good. After the first dose of the vaccine, the patient will be under doctor’s supervision for 2 to 3 hours after which they will be sent home. A total of three dosages of injection will be given to the patients to complete the trial process.

The ICMR said on Monday that a total of 2,19,103 samples have been tested for coronavirus in the last 24 hours. With this the total number of tests in India have reached 1,18,06,265.

ICMR is continuously scaling up its testing facilities for COVID-19 by giving approval to government and private laboratories. As of now a total of 688 laboratories across India have been given the approval to conduct tests for coronavirus including 480 government laboratories and 208 private laboratories’ chain.

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