BBL's Covaxin's phase-1 trial's interim findings indicate vaccine 'well-tolerated'

As both Serum Institute of India (SII) and Bharat Biotech Ltd (BBL) await the Drug Controller of India (DGCI)'s approval of emergency use of their Coronavirus (COVID-19) vaccines, interim findings from phase-1 trials of BBL's 'Covaxin' was well-tolerated in all dose groups with no serious adverse events. Moreover, after the first vaccination, local and systemic adverse events were predominantly mild/moderate in severity. Currently, the Subject Expert Committee of the Central Drugs Standard Control Organisation (CDSCO) is mulling approving SII's 'Covishield', BBL's 'Covishield', and Pfizer's vaccine for emergency use of their COVID vaccines. 

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Covaxin's phase-1 trial: 'Vaccine well-tolerated'

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The Centre asserted that the DGCI  seeking more data from the three above-mentioned companies will not impact the vaccine-rollout timeline. "This situation was factored-in from before as it is emergency use authorisation. There should be more than reasonable satisfaction about the safety, immunogenicity and effectiveness of the vaccine," told NITI Aayog member (health) Dr V K Paul. 

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On December 7, Union Health Secretary Rajesh Bhushan said that there are six COVID-19 vaccine candidates in different clinical trial stages being developed by various manufacturers in Indian namely - SII's Covishield, BBL's Covaxin, Zydus Cadila's vaccine,  Sputnik V, Novavax and Biological E Ltd's mRNA vaccine. Besides this, three COVID-19 vaccine candidates are in the pre-clinical stage of which one of the Coronavirus vaccine candidates is in the pre-development stage being researched by Aurobindo Pharma, the official said. On December 2, the UK became the first country in the world to authorise the use of Pfizer and BioNTech for emergency purposes, thus, paving way for the delivery of the vaccines.

India's vaccine candidates

• Bharat Biotech - ICMR (BBV 152): Phase I & Phase- 2 clinical trials have completed. Phase-3 trials are ongoing at 25 centres across India with a total of 26,000 participants. Application for emergency use filed. 
• Cadila-Zydus (ZyCOV-D): Phase I clinical trials completed, revealing its safety. Enrolment and dosing of 1,000 volunteers for Phase-2 clinical trials completed, is likely to enter Phase III final stage of clinical trials by December.
• Serum-ICMR & Oxford-AstraZeneca (ChAdOx1-S): Globally, this vaccine is undergoing phase-3 clinical trials in Brazil. In India, enrollment for phase-3 clinical trials completed with 1,600 participants at 15 locations. The trials were halted briefly when AstraZeneca paused trials due to a volunteer inflicted with a strange disease. After Oxford conducted safety evaluations, DCGI allowed India trials to resume. Application for emergency use filed.

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