Serum Institute of India ready for Covid-19 vaccine rollout: Official

MUMBAI: Serum Institute of India (SII) is ready for an end-to-end rollout of its Covid-19 vaccine and will start the distribution as soon as it receives marketing approval from the drug regulator, a company official told ET.

SII has already manufactured around 50 million doses of its Covid vaccine called Covishield, which is based on the technology from drugmaker AstraZeneca and Oxford.

“Everything is ready for rollout; we are only waiting for regulator’s review... which city will get the vaccine first depends on the government,” said the official, who did not wish to be quoted.

SII earlier this week submitted data from its phase-3 trials; the subject expert committee will be examining the data on safety and whether the vaccine managed to induce immune response in its participants.

In November, the company had approached the SEC for marketing authorisation, but was asked to provide data from the AstraZeneca-Oxford study that was submitted to the UK regulator. A nod from the UK regulator to the Astrazeneca-Oxford vaccine could speed up SII’s approval in India, officials aware of the development told ET.In an email response to ET last week, the UK regulator — Medicines and Healthcare Products Regulatory Agency — said its rolling review of the AstraZeneca- Oxford Covid-19 vaccine was ongoing.