Bharat Biotech to submit additional data for vaccine's emergency approval (IANS Special)

New Delhi, Dec 23 (IANS) Hyderabad-based Bharat Biotech, which is developing the country's indigenous coronavirus vaccine in collaboration with the Indian Council of Medical Research (ICMR), will submit the additional data sought by the Drug Controller General of India (DCGI) for grant of emergency use authorisation to its vaccine in a "week or two".

COVAXIN, an inactivated vaccine candidate, is currently undergoing Phase III human clinical trials on 26,000 volunteers at 25 centres across India, after having undergone Phase I and II trials involving 1,000 volunteers.

Bharat Biotech had applied for the emergency use authorisation of its vaccine on December 7 and presented their proposal for the grant, along with the interim safety and immunogenicity data of Phase I and II clinical trials.

The Central Drugs Standard Control Organization's (CDSCO) expert panel had, however, recommended that the firm should present the safety and efficacy data from the ongoing Phase III clinical trial in the country for further consideration.

"The company has yet not submitted the data. It will take another week or two," a company source told IANS on the condition of anonymity. There was, however, no official confirmation from the CDSCO.

Meanwhile, the Serum Institute of India (SII) has submitted the additional data sought by the DCGI for determining the safety and immunogenicity of its Covid-19 vaccine candidate, Covishield.

India is likely to have a Covid-19 vaccine approved for emergency use before December end as the Central Drugs Standard Control Organization's expert panel is set to review the applications of Serum Institute of India and Pfizer for the emergency use authorisation for their vaccine candidates.

If SII receives approval, then India could be the first country to give regulatory approval to AstraZeneca's vaccine even as the medicine regulator of the UK, Medicines and Healthcare products Regulatory Agency (MHRA), continues to examine data from the trials.

America's Pfizer was the first to apply on December 4, followed by Pune-based Serum Institute of India and Hyderabad-based Bharat Biotech who applied on December 6 and 7, respectively. Pfizer had, however, requested more time to make a presentation before the committee.

Pfizer, whose vaccine has been authorized in the US, UK and Canada, has written to the DCGI seeking a fresh date to present its case for the EUA of their vaccine candidate BNT162b2, after it failed to present its data before the vaccine reviewing committee of the CDSCO earlier.

(Aakanksha Khajuria can be contacted at aakanksha.k@ians.in)

--IANS

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