Oxford Vaccine Will Likely Be the First to Roll Out in India
Serum Institute of India, Pfizer and Bharat Biotech had also applied to the DCGI seeking emergency approval.
Amid talks of a vaccine rollout soon, the Indian drug regulator is likely to approve United Kingdom’s Oxford COVID-19 vaccine next week, before giving Pune-based Serum Institute, which is manufacturing the vaccine in India, a nod of approval.
Once the UK drug regulator gives the Oxford vaccine a nod, the expert committee on COVID-19 at the Central Drugs Standard Control Organisation (CDSCO) will meet to review the safety and immunogenicity data from evaluations done abroad and in India before approving emergency authorisation for the vaccine here, official sources said, Hindustan Times reported.
“Oxford vaccine ‘Covishield’ is likely to be the first to be rolled out in India,” a source reportedly said.
Serum Institute of India (SII), Pfizer and Bharat Biotech had also applied to the Drugs Controller General of India (DCGI) seeking emergency approval for their COVID-19 vaccines earlier this month.
However, Bharat Biotech’s candidate ‘Covaxin’ is in its phase 3 trials, while Pfizer hasn’t made a presentation before the COVID-19 committee of CDSCO yet.
Sources also informed that SII submitted some additional data required by the DCGI last week.
The expert committee had asked the firm to submit an updated safety data of phase 2 and 3 clinical trials in the country, immunogenicity data from the trial in the UK and India, along with the outcome of the assessment of the UK Medicines and Healthcare products Regulatory Agency (MHRA) for grant of EUA, Hindustan Times reported.
(With inputs from Hindustan Times)
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