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 Drug Controller of India (DGCI)'s approval of emergency use of ir Coronavirus (COVID-19) vaccines, interim findings from phase-1 trials of BBL's 'Covaxin' was well-tolerated in all dose groups with serious adverse events. Moreover, after first vaccination, local and systemic adverse events were predominantly mild/moderate in severity. Currently, Subject Expert Committee of Central Drugs Standard Control Organisation (CDSCO) is mulling approving SII's 'Covishield', BBL's 'Covishield', and Pfizer's vaccine for emergency use of ir COVID vaccines. 

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

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Centre asserted that DGCI  seeking more data from three above-mentioned companies will t impact vaccine-rollout timeline. "This situation was factored-in from before as it is emergency use authorisation. re should be more than reasonable satisfaction about safety, immugenicity and effectiveness of vaccine," told NITI Aayog member (health) Dr V K Paul. 

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