Bharat Biotech, maker of Covaxin, applies for emergency approval, again

Hyderabad-based Bharat Biotech, which is developing the country’s indigenous coronavirus vaccine in collaboration with the Indian Council of Medical Research, on Wednesday again applied to the Drug Controller General of India for the emergency use authorisation. “The company applied for the emergency use authorisation in the evening,” a company source told IANS.

Emergency Use Authorisation is a mechanism to facilitate the availability and use of medical countermeasures, including vaccines, during public health emergencies.

Bharat Biotech had first applied for the emergency use authorisation of its vaccine on December 7 and presented its proposal, along with the interim safety and immunogenicity data of Phase 1 and 2 clinical trials.

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The Central Drugs Standard Control Organisation’s (CDSCO) expert panel had, however, recommended that the firm should present the safety and efficacy data from the ongoing Phase 3 clinical trial in the country for further consideration.

Bharat Biotech’s COVAXIN, an inactivated vaccine candidate, is currently undergoing Phase 3human clinical trials on 26,000 volunteers over 25 centres across India, after having undergone Phase 1 and 2 trials involving 1,000 volunteers.

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

America’s Pfizer was the first to apply on December 4, followed by Pune-based SII and Bharat Biotech who applied on December 6 and 7, respectively. Pfizer had, however, requested more time to make presentation before the committee.

Pfizer, whose vaccine has been authorized in the US, the UK and Canada, has written to 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.

India is likely to have a Covid-19 vaccine approved for emergency use before December end as CDSCO’s expert panel is set to review the application of SII, Bharat Biotech and Pfizer for emergency use authorisation.

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