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Sunday, August 01, 2021

Govt nod for Covishield in a few days: Serum

Serum has submitted additional data to India's national drug regulator while seeking emergency use authorisation (EUA).

Written by Anuradha Mascarenhas | Pune |
December 29, 2020 4:15:58 am
Covaxin has been evaluated in nearly 1,000 subjects in phase 1 and phase 2 clinical trials in India, and is currently part of a phase 3 clinical trial.

Regulatory approval for Covishield, the Indian variant of Oxford-AstraZeneca’s AZD1222 vaccine against the novel coronavirus, could come “in a few days”, Adar Poonawalla, CEO of Serum Institute of India, said on Monday.

“By January we should have the Oxford-AstraZeneca vaccine licensed in India,” Poonawalla said. Pune-based Serum has been licensed by Oxford-AstraZeneca to test, manufacture, and market the vaccine in India.

“Emergency use authorisation by the UK drug regulator for the Oxford-AstraZeneca vaccine is expected by December-end or the first week of January. In India too, we are hoping for the regulatory approval for the Covishield vaccine in a few days,” Poonawalla told reporters at an online interaction.

“We must respect the process and give the drug regulators in the UK and India enough time to review the data. No one wants to compromise on safety and we hope for some good news in the new year,” he said.

Serum has submitted additional data to India’s national drug regulator while seeking emergency use authorisation (EUA). The British Medicines and Healthcare products Regulatory Agency (MHRA) is also considering the data for grant of EUA to the Oxford-AstraZeneca vaccine. Approval by the UK regulator can make it easier for the vaccine to get regulatory clearance in India.

“India will be given priority as a majority of the stockpiled 50 million doses at Serum Institute will be for the country. India is part of COVAX and we will give 50 per cent of everything we make to India and to COVAX at the same time. Every month we can churn out more than 50-60 million doses of Covishield vaccine and we should have 100 million doses every month by March 2021,” Poonawalla said.

COVAX is a global collaborative platform coordinated by Gavi, the Vaccine Alliance, the Coalition for Epidemic Preparedness Innovations (CEPI), and the World Health Organisation (WHO), to ensure affordable and equitable access for nations around the world to a portfolio of Covid-19 vaccines.

“Everyone wants the vaccine, and we plan to give it equitably. Initially, for the first month, most of the volumes will be given to India, and to export to other countries we will have to go through the WHO prequalification procedure that will take a month or so,” Poonawalla said.

“The first six months of 2021 can see a shortage globally but that can ease by August as other vaccine manufacturers also will be able to supply,” he said. Serum, Poonawalla said, hoped to commission a third production facility by March next year, and be able to produce 300 million doses by July.

Also, he said, “We have got two more vaccine candidates after AstraZeneca and Novavax, and in another year we should have our own vaccine.”

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