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SII Awaits Govt Order To Restart Exporting Of Vaccines As Company Possess Billion-Dollar Backlog

Serum Institute of India CEO Adar Poonawalla said on Monday that the company is waiting for an order from the central government to resume exporting Covid-19 vaccines to the rest of the globe, citing a billion-dollar backlog of vaccine doses. Poonawalla told in an exclusive interview that the company plans to file for Covovax emergency use authorization in India by the end of 2021.

“Government of India got approval in many European countries but others have to also play ball. Western nations are struggling to find a way out with regard to vaccine certificate systems. The SII has a backlog of billion dollar vaccine doses that has still not been exported. We will wait for directive from government on when and how Covid-19 vaccine exports will resume. We have invested Rs 3,000-4,000 crore in building Covid vaccine capacities in India Rs 1,500 crore advance payment from the government has helped us,” he said.

Earlier in the day, Union Health Minister Mansukh Mandaviya stated that India will resume exporting surplus Covid-19 vaccines next month via the ‘Vaccine Maitri’ programme in order to satisfy its COVAX global pool obligation, but that vaccination its own citizens remains the government’s first priority. The minister told reporters that the government will receive more than 30 crore doses of Covid-19 vaccine in October and more than 100 crore doses in the next three months.

“We expect to apply for Emergency Use Authorisation of Covovax in India by the end of 2021,” Poonawalla said, adding that there is no delay on India’s part.

“Covovax has shown good response against the delta variant. We have been scaling up vaccine capacities. Vaccination coverage in India will change drastically by December, on track to deliver 200 million Covishield doses per month. Covovax vaccine is delayed owing to some regulatory issues,” he said.

Poonawalla also stated that Covishield data has been submitted for approval to the UK MHRA and EU regulators. “Covishield is identical to AstraZeneca vaccine and data has been submitted to the UK MHRA and EU regulators. I have had personal consultations with regulators in the UK and EU and expect a response shortly. We will ensure vaccines made in India are approved in other countries. We will be making investment in stocks and partnerships agreements in the UK to manufacture products,” he said.

This occurred at a time when the UK government issued a new Covid travel advisory stating that fully vaccinated Indians would still be treated as unvaccinated, implying that Indians vaccinated with Covishield, a SII-produced Oxford/AstraZeneca vaccine, would still be required to undergo a pre-departure PCR test and further tests on landing in the UK.

During the interview, the SII CEO also stated that the Covid vaccine for children under the age of 18 will be available shortly, as child trials are expected to be completed by February.

“Trial for children to be over by February, post which vaccine for under 18 years will be ready. Our focus on Covishield as 700 million have been vaccinated without any major serious effects. Erratic supply of raw materials will decide the range of vaccine supplies we make. We will be able to deliver anywhere in between 160-210 million doses of Covishield. We have decided to do parallel trials on Covovax in India. It has helped even before Covovax is approved in the UK or US. We can roll out in India if authorised,” he said.

Poonawalla further stated that the SII will invest in expanding Covovax and Russia’s Sputnik V capacity in India. “We will collaborate and partner with companies for bulk fill and finish capacities for Covovax and Sputnik V. Investments will be made over three-four months. We have built sales facility in the UK to help enter regulated markets,” he said.

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