Serum Institute Can Apply for Emergency Use Authorisation, Says AIIMS Director Randeep Guleria

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In an important statement, Dr Randeep Guleria, Director of AIIMS, told News18 that given the fact that Serum Institute of India is developing a vaccine against Covid-19 in partnership with AstraZeneca and Oxford University, the company can apply for EUA or emergency use authorisation. “SII will have to wait for data to be authorised in the UK; based on that SII can approach Indian authorities for EUA. We can’t do that unless UK regulatory approves.”

The coronavirus vaccine being developed by Oxford University and British pharma giant AstraZeneca is 70% effective, results from large-scale trials have shown. Dr Guleria, who is the member of the task force on vaccines, said that if the data submitted by AstraZeneca to authorities in the UK is accepted, Serum Institute of India need not wait for its own data to be generated. Covishield, the vaccine candidate being developed by SII, is currently in the third phase trials stage.

Dr VK Paul , member of the Expert Group on Vaccines told News18 that the data will be generated and shared after the completion of phase III of the trials .

Adar Poonawalla , the CEO of SII wrote on twitter “ I am delighted to hear that, Covishield, a low-cost, logistically manageable & soon to be widely available, COVID19 vaccine, will offer protection up to 90% in one type of dosage regime and 62% in the other dosage regime.” Earlier he spoke to News18 and confirmed that the company is awaiting data from the UK. He said that the Serum Institute of India may apply for an emergency licence for Covid-19 vaccine ‘Covishield’ based on safety data and results from the Oxford-AstraZeneca candidate’s trials in the United Kingdom.

On Tuesday, Prime Minister Narendra Modi is holding a high level meeting with all stakeholders including members of the Task Force on Vaccines. Highly placed sources have said that the government is dialling Indian Vaccine manufacturers, asking for early completion of trials and data so that the doors to emergency muse authorisation open up .