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SEC To Meet On January 1 To Decide On Serum Institute & Bharat Biotech's COVID Vaccines

India's Subject Expert Committee to continue analysing SII & BBL's Covid vaccine on January 1 after UK approves COVISHIELD. Pfizer requests more time for data


With the United Kingdom giving approval for emergency usage of the AstraZeneca-Oxford COVID-19 vaccine (COVISHIELD), India's Subject Expert Committee of the Central Drugs Standard Control Organisation (CDSCO) on Wednesday met to consider the request of Pfizer, Serum Institute of India (SII) and Bharat Biotech Pvt. Ltd (BBL). After the meeting, SEC informed that it has analysed and perused the additional data presented by SII and BBL and will meet again on 1 January 2021. American pharma giant - Pfizer, on the other hand, has asked for further time to provide additional data and information.

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Vaccine analysis in progress

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Earlier in the day, UK Health Secretary Matt Hancock confirmed that the Medicines and Healthcare products Regulatory Agency (MHRA) has approved the  AstraZeneca-Oxford COVID-19 vaccine. Taking to Twitter, he said, "Brilliant to end 2020 with such a moment of hope. The Coronavirus vaccine is our way out of the pandemic- now we need to hold our nerve while we get through this together". Britain has ordered 100 million doses of the vaccine, with 40 million expected to be available by the end of March.

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India's vaccines up for approval

In India, three vaccine candidates - COVAXIN, COVISHIELD and Pfizer's vaccine have applied for approval for emergency usage. On December 2, 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. Apart from UK, the US has also approved Pfizer's vaccine while China, Russia have already approved their own vaccines - Sputnik V and Cansino - with mass inoculations reportedly underway.

  • 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. Has applied to DGCI for Phase III final stage of clinical trials.
  • Serum-ICMR & Oxford-AstraZeneca (ChAdOx1-S): Globally, this vaccine has been approved by the UK government. In India, phase-3 trials are currently underway 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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