COVID-19: No Emergency Use Approval granted to Oxford-AstraZeneca vaccine in India

SEC in Central Drugs Standard Control Organisation on Wednesday did not grant EUA to COVID-19 vaccine developed by Oxford-AstraZeneca for use 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. The additional data and information presented by SII and Bharat Biotech Pvt Ltd. was perused and analysed by SEC. The analysis of the additional data and information is going on. SEC will convene again on January 1,” the expert panel said in a statement.

Britain on Wednesday (December 30) approved Oxford-Astrazeneca coronavirus vaccine for use against COVID-19. The UK government took the decision at a time when the country is battling a new, highly contagious variant of COVID-19.

"The government has today accepted the recommendation from the Medicines and Healthcare products Regulatory Agency (MHRA) to authorise Oxford University/AstraZeneca's COVID-19 vaccine for use," the Health Ministry said.

"Authorisation recommends 2 doses administered with an interval of b/w 4 and 12 weeks. This regimen was shown in clinical trials to be safe & effective at preventing symptomatic COVID-19, with no severe cases & no hospitalisations more than 14 days after second dose," AstraZeneca said in a statement.