Updated September 18th, 2020 at 19:35 IST

Centre briefs Lok Sabha on COVID-19 vaccine trials in India; 7 manufacturers shortlisted

Informing the Lok Sabha of the Coronavirus (COVID-19) vaccine trial procedure, the Ministry of Health on Friday, submitted a written reply on trial updates

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Informing the Lok Sabha of the Coronavirus (COVID-19) vaccine trial procedure, the Ministry of Health on Friday, submitted a written reply regarding the stages of vaccine research, as approved by the Indian Council of Medical Research (ICMR). The reply lists the six steps of vaccine research - identification of vaccine strain, experiments' characterization, preclinical trials on animals, Phases - 1,2,3 human trials, and Phase- 4 or post-market surveillance. Four COVID-19 vaccine candidates are currently in various human trial phases.

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The Central Drugs Standard Control Organisation (CDSCO) has listed 7 Indian manufacturers permitted for COVID-19 vaccine manufacturing - Serum Institute of India (SII), Cadila Healthcare, Bharat Biotech, Biological E, Reliance Life Sciences, Aurbindo Pharma, and Gennova Biopharmaceuticals. 

As informed by the Centre, the three vaccine candidates are currently at:

  • Bharat Biotech - ICMR (BBV 152): Phase I trials along with studies in hamsters and rhesus macaques completed, revealing its safety. Phase- 2 clinical trials are ongoing along with immunogenicity testing
  • Cadila-Zydus (ZyCOV-D): Phase I clinical trials completed, revealing its safety. Phase-2 clinical trials are ongoing along with immunogenicity testing
  • Serum-ICMR & Oxford-AstraZeneca (ChAdOx1-S): Globally, this vaccine is undergoing phase-3 clinical trials in Brazil. In India Phase-2,3 trials led by ICMR has been initiated in 14  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
  • Serum-ICMR & Novavax: Trials will be initiated in the second half of October after the vaccine is manufactured by SII.

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India is in talks with Russia about its COVID-19 vaccine - 'Sputnik -V', with Dr. Reddy's lab selected as manufacturers to provide 100 million doses in India. The Centre has also met with the three potential candidates to track the vaccines' progress. While India hopes to get a vaccine ready by 2020 end, the Centre is readying a blueprint for mass production and vaccine distribution.

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India's total COVID cases have risen to 52,14,677 of which 10,17,754 are active while 41,12,551 people have recovered. 84,372 people have died till date. Unlock 4 has been extended till September 30, as India ramps up testing 10 lakh samples - 6,15,72,343 samples have been tested till date.

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Published September 18th, 2020 at 19:35 IST