The Hyderabad-based Bharat Biotech, which is developing the country’s indigenous coronavirus vaccine in collaboration with the Indian Council of Medical Research (ICMR), has again applied to the Drug Controller General of India (DCGI)for the emergency-use authorisation.
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 7 December and presented its proposal, along with the interim safety and immunogenicity data of Phase 1 and 2 clinical trials.
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, said the sources in the Union Health Ministry.
Bharat Biotech’s COVAXIN, an inactivated vaccine candidate, is currently undergoing Phase 3 human 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 4 December, followed by Pune-based SII and Bharat Biotech who applied on 6 and 7 December, respectively. Pfizer had, however, requested more time to make a presentation before the committee.
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.
Meanwhile, Aurobindo Pharma Limited and Covaxx, a US-based company, have entered into an exclusive license agreement to develop, commercialize and manufacture UB-612, the first Multitope Peptide-based vaccine to fight Covid-19, for India and the UN Children’s Fund (Unicef) agency. COVAXX is currently conducting a Phase 1 clinical trial for the vaccine candidate.