The Serum Institute of India (SII) can apply for emergency use authorisation (EUA) of the AstraZeneca and Oxford University’s COVID-19 vaccine in India once it is approved in the UK,since it is a partner developer, Dr Randeep Guleria, Director of AIIMS, has said.
A member of the Centre’s taskforce on vaccines, Dr Guleria said if the vaccine candidate was approved by UK authorities, SII could also apply for emergency use in India based on the same data.
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“The 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,” Dr Guleria told News18.
AstraZeneca announced that its vaccine proved to be 70 percent effective in large-scale trials, giving the world's fight against the pandemic a new weapon, cheaper to make, easier to distribute and faster to scale up than rivals.
Also read: Why AstraZeneca-Oxford COVID vaccine is best suited for India over Pfizer, Moderna shots
SII’s Covidshield is in its third phase trials and data will only be generated after the phase concludes, Dr VK Paul, member of the Expert Group on Vaccines, told News18.
SII CEO Adar Poonawalla said India could approve the emergency use of Covidshield by December 2020. “Once cleared, the vaccine will be used to protect priority beneficiaries identified by the Centre, including frontline healthcare workers and elderly,” he said.
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"SII is hoping the data released earlier, along with preliminary data from the ongoing trial of the vaccine in India, will allow it to seek EUA for the vaccine by year-end, before gaining approval for a full rollout by February or March next year," said Poonawalla.
Prime Minister Narendra Modi is holding a high-level meeting with all stakeholders, including members of the Task Force on Vaccines, on November 24, sources in the government said.
The Centre, they added, was dialling manufacturers for early completion of trials and data so that the doors to emergency use open up, News18 reported.Follow our full COVID-19 coverage here