SII, Bharat Biotech Emergency Covid-19 Vaccine Authorisation
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Drug Controller General of India (DCGI) has kept vaccine on hold, pending more evidence, proposals by the Serum Institute of India (SII) and Bharat Biotech requesting emergency use authorisation (EUA) for their vaccine candidates Covishield and Covaxin.

The committee said referring to the SII’s Covishield vaccine that the firm should submit updated safety data of the Phase II/III clinical trial in the country, Immunogenicity data from the clinical trial in UK and India and the outcome of the assessment of UK-MHRA for grant of EUA.

It had a similar response to the data presented by Bharat Biotech on Covaxin, saying that data generated after the completion of Phase 3 trials was needed to make an evaluation.

India’s law allows a potential vaccine or drug to be commercially approved even without trials on Indians, provided the same has been approved in another country. The SII is testing a vaccine candidate on 1,600 volunteers in India, and Bharat Biotech on 28,500 volunteers across the country.

The Union Health Ministry termed as fake news, a media report said that SII and Bharat Biotech’s applications had been rejected. However, a Ministry spokesperson did not offer additional clarification.

Both SII and Bharat Biotech are relatively ahead of other vaccine companies in India developing potential vaccines for COVID-19, having initiated large human trials, or Phase-3 trials.

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