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Covaxin, Bharat Biotech's vaccine, cleared for Phase 3 trials

Covaxin, the coronavirus vaccine being developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR), has been cleared for the third phase of clinical trials.
The Hyderabad-based vaccine maker had applied to the Drugs Controller General of India (DCGI) on October 2, seeking its permission.
The study would cover 28,500 subjects above the age of 18, and would be conducted in 19 sites - including Delhi, Mumbai, Patna and Lucknow.
Besides, Bharat Biotech, an indigenously developed vaccine candidate by Zydus Cadila Ltd is also in Phase 2 of human clinical trials.

Covaxin & Bharat Biotech's vaccine, cleared for Phase 3 trials

Covaxin, the coronavirus vaccine being developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR), has been cleared for the third phase of clinical trials.
The Hyderabad-based vaccine maker had applied to the Drugs Controller General of India (DCGI) on October 2, seeking its permission.
The study would cover 28,500 subjects above the age of 18, and would be conducted in 19 sites - including Delhi, Mumbai, Patna and Lucknow.
Besides, Bharat Biotech, an indigenously developed vaccine candidate by Zydus Cadila Ltd is also in Phase 2 of human clinical trials.

India gives go ahead for trials of Russia's Sputnik vaccine

India's drug controller has given a go ahead to Dr Reddys Laboratories and Russian Direct Investment Fund for the phase 2 and 3 human clinical trial for Russia's Sputnik V Covid vaccine&nbsp;

India's drug controller has given a go ahead to Dr Reddys Laboratories and Russian Direct Investment Fund for the phase 2 and 3 human clinical trial for Russia's Sputnik V Covid vaccine in India. The Hyderabad-based drug maker said in a press release that this will be a multi-center and randomised controlled study. Earlier in September, Dr&nbsp;Reddys and RDIF entered into a partnership to conduct clinical trials of Sputnik V vaccine and its distribution in India. As part of the partnership, RDIF shall supply 100 million doses of the vaccine to Dr.Reddys upon regulatory approval in India.

India's drug controller has given a go ahead to Dr Reddys Laboratories and Russian Direct Investment Fund for the phase 2 and 3 human clinical trial for Russia's Sputnik V Covid vaccine in India. The Hyderabad-based drug maker said in a press release that this will be a multi-center and randomised controlled study, which will include safety and immunogenicity study. Earlier in September, Dr&nbsp;Reddys and RDIF entered into a partnership to conduct clinical trials of Sputnik V vaccine and its distribution in India. As part of the partnership, RDIF shall supply 100 million doses of the vaccine to Dr.Reddys upon regulatory approval in India.

Serum India told to halt recruitment for vaccine trials

India's drug regulator has directed Serum Institute of India to suspend recruitment of new volunteers for phase 2 and 3 clinical trials of the Oxford Covid-19 vaccine candidate

India's drug regulator has directed Serum Institute of India to suspend recruitment of new volunteers for phase 2 and 3 clinical trials of the Oxford Covid-19 vaccine candidate. The directive came in the backdrop of pharma giant AstraZeneca pausing the trials in other countries. The DCGI on Friday also directed Serum Institute to increase the safety monitoring of the subjects already vaccinated as part of the trial, and submit the plan and report. The drugmaker&nbsp;had on Thursday hit a pause after AstraZeneca put the trials on hold following an unexplained illness in a volunteer in the UK.

New Delhi, PTI: Drugs Controller General of India (DCGI) has directed Serum Institute of India to suspend till further orders new recruitment in phase 2 and 3 clinical trials of the Oxford Covid-19 vaccine candidate in the backdrop of pharma giant AstraZeneca pausing the trials in other countries.
In an order, a copy of which has been accessed by PTI, DCGI Dr V G Somani on Friday also directed Serum Institute of India (SII) to increase the safety monitoring of the subjects already vaccinated as part of the trial, and submit the plan and report.
Somani also asked the firm to submit clearance from Data and Safety Monitoring Board (DSMB) in the UK as well as in India to obtain clearance from his office (DCGI) prior to resumption of future recruitment in the trial. The central drug regulator DCGI had issued a show-cause notice to SII on September 9 for not informing it about AstraZeneca pausing clinical trials of the vaccine candidate in other countries and also for not submitting casualty analysis of the "reported serious adverse events".
Following which the Pune-based firm, which has partnered with the British-Swedish biopharmaceutical giant AstraZeneca for manufacturing the Oxford vaccine candidate, on Thursday said it is pausing the clinical trials in India.
Earlier this week, AstraZeneca said it had paused the trials because of 'an unexplained illness' in a participant in the study. "We are reviewing the situation and pausing India trials till AstraZeneca restarts the trials," SII said in a statement on Thursday. According to the DCGI's order issued on Friday, the SII in its reply stated that DSMB has noted no safety concerns from the Indian study (part 1-phase-2 study) with the first dose and seven days post vaccination safety data. In its reply, SII also stated that DSMB further recommended "to pause further enrolment into the study until ongoing investigations of SAE reported in the UK study is completed and the sponsor and the UK DSMB are satisfied that it doesn't pose any safety concerns".
"In the view of the above, I Dr V G Somani, Drugs Controller General of India, Central Licensing Authority, after careful examination of your reply and the recommendations of the DSMB in India, in exercise of the powers vested under Rule 30 of the New Drugs and Clinical Trials Rules, 2019, direct to you suspend any new recruitment in the phase 2 and 3 clinical trial till further orders," the order read.
"Increase the safety monitoring of the subjects already vaccinated with the vaccine under trial and submit the plan and report," the order further stated.

Oxford vaccine India trial on hold after DGCI notice

Phase 2 of Covid-19 trials being conducted across 17 sites in India have now been paused till further instructions from the regulator.

Serum pauses COVID vaccine trials till further DGCI instructions

Phase 2 of Covid-19 trials being conducted across 17 sites in India have now been paused till further instructions. &nbsp;DCGI on Wednesday issued a show-cause notice to Serum Institute of India for not informing about AstraZeneca suspending the clinical trials of the Oxford vaccine candidate in other countries, and also for not submitting casualty analysis of the "reported serious adverse events".&nbsp;&nbsp;
Following a scathing show-cause notice from the drug regulator, the Serum Institute of India has paused trials till further instructions from the Drug Controller General of India.

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