No Emergency Use Approval granted to Oxford-AstraZeneca vaccine in India

In a significant development, the Subject Expert Committee (SEC) in Central Drugs Standard Control Organisation (CDSCO) on Wednesday (December 30) did not grant EUA to COVID-19 vaccine developed by Oxford-AstraZeneca for use in India. The SEC also refused to consider the Emergency Use Authorisation (EUA) request of Pfizer and Bharat Biotech Pvt Limited saying that vaccines developed by all these companies will not be given authorisation “yet” as more data is needed.

The SEC is scheduled to meet again on January 1 to hold discussions over granting approval to a COVID-19 vaccine for emergency use in India. It is to be noted that Pune-based Serum Institute of India (SII) had applied for EUA for the Oxford-AstraZeneca vaccine which was approved for use in the United Kingdom on Wednesday. It is learnt that Bharat Biotech had sought the nod for Covaxin, India’s indigenous vaccine. Further time was requested on behalf of Pfizer, while the additional data and information presented by the SII and Bharat Biotech was perused and analysed by the SEC.

America’s Pfizer was the first one to apply for the accelarated approval on December 4, followed by the SII and Bharat Biotech who applied on December 6 and 7, respectively. On December 9, the Subject Expert Committee had asked the SII and Bharat Biotech to submit more data and information to get approval. The expert panel had then recommended the SII to submit outcome of the assessment of UK regulatoe for grant of emergency use approval, the updated safety data of the Phase 2/3 clinical trial and immunogenicity data from the clinical trials in UK and India. Bharat Biotech was recommended to present the safety and efficacy data from the ongoing Phase 3 clinical trial in the country for further consideration.

Their applications were reviewed again earlier on Wednesday, hours after the UK accepted the recommendation of the Medicines and Healthcare Regulatory Agency (MHRA) to authorise Oxford University-AstraZeneca’s Covid-19 vaccine, named Covishield, for emergency use.