Serum Institute of India (SII) CEO Adar Poonawalla on December 28 said he was hoping for the emergency use approval of AstraZeneca-Oxford University COVID-19 vaccine 'Covishield' by the end of this month or January in the UK and India.
"The emergency use licensure is expected to come by December or may be January in the UK, and simultaneously we hope to get approval in India as well," Poonawalla told the media.
The subject expert committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO), India's drug regulator, is likely to meet later this week to examine SII's emergency-use authorisation (EUA) application for Oxford-AstraZeneca’s vaccine.
Oxford COVID-19 vaccine may become the first to get Indian regulator's nod for emergency use
"It is entirely in the purview of the regulator. There is a lot of data coming from global multi-centric trials. It's not reviewing India data, but UK and South Africa data as well," Poonawalla said.
"There are no concerns at all (with the vaccine safety and efficacy), we will be hearing some good news very soon. All the data has been submitted to the UK and Indian regulators. We must respect the process adopted by the regulators," Poonawalla added.
On supply situation
Poonawalla said the company had been adding 40-50 million doses every month, and will be reaching production capacity of about 300 million doses by July 2021.
Poonawalla said 50 percent of the vaccine supplies will go to India, and the rest will go to COVAX. However, during the initial months India would prioritize supplies.
The COVAX advance market commitment was launched on June 4 to ensure rapid, fair, and equitable access to COVID-19 vaccines worldwide. COVAX will enable countries to have access to the world’s largest and most diverse COVID-19 vaccine portfolio.
Poonawalla expects shortages in the first six months, but the supply situation is expected to ease by the middle of next year.
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