Serum Institute expects DCGI’s approval for COVID-19 vaccine’s emergency use

Serum Institute of India, which is also manufacturing the Oxford-AstraZeneca Coronavirus vaccine in India, said on Monday it expected the government to approve the shot for emergency use in a few days, Reuters reported.

Serum Chief Executive Adar Poonawalla also told reporters that the company had already made 40 million to 50 million doses of the vaccine.


The Indian government is likely to approve Oxford-AstraZeneca’s Coronavirus vaccine for emergency use by next week after its local manufacturer submitted additional data sought by authorities.

Meanwhile, British medicine regulator is still examining the data from the trials.

Currently, three COVID-19 vaccines candidates of Bharat Biotech, Serum Institute of India and Pfizer are under active consideration of India’s drug regulator and there is hope that early licensure is possible for all or any of them, according to the Union Health Ministry.

Serum’s Poonawalla had earlier said that if they get on-time approvals from regulatory bodies for emergency use of AstraZeneca-Oxford vaccine then we can expect the vaccine to be available in India by January 2021 (only if it is proven immunogenic and efficacious).

As part of various partnerships and collaborations for vaccine candidates, SII will keep aside 50 per cent of whatever quantity of the vaccine candidates are produced for India and the remaining quantity will go to low and middle-income countries, he noted.

About the price of the vaccine, he said, “We want the vaccine to be affordable and accessible to all. The Government of India will receive it at a far more affordable price of USD 3-4 since they will be buying in a larger volume. The priority is going to be India and the GAVI countries, after which only, the private market will open up where the pricing would be USD 6-8 per dose”.

Poonawalla said that Covishield is an extremely viable and important vaccine for India and other low-and-middle-income countries It is efficient in terms of affordability and composition due to which it easier to transport and store for long periods at 2-8°C, that is, normal refrigerator temperatures. For countries with warm climates, this will help to ensure equitable distribution and sustainable affordability.

The Oxford vaccine, which also has a tie-up with the Serum Institute of India, is expected to win approval in the UK before Thursday, speeding up the provision of the jab to the most vulnerable groups.

“The first priority is to vaccinate the 12 to 15 million people who would need hospitalisation if they caught COVID-19. Approval for the AstraZeneca vaccine would mean we are well on course to do that by the spring,” a senior government official was quoted by The Sunday Times as saying.