SII Ready With Stockpile of 40-50 Mn Covishield Vaccine Doses

The first six months of next year would perhaps see a shortage of vaccine doses globally, Adar Poonawalla has said.

Photo for representational purposes.

(Photo: iStock)

Adar Poonawalla, CEO of Pune-based Serum Institute of India (SII), said on Monday, 28 December, that the firm is ready with a stockpile of around 40-50 million doses of the COVID-19 vaccine ‘Covishield’.

The SII along with Bharat Biotech had applied for the emergency authorisation of their COVID-19 vaccines with the DCGI earlier this month.

“India is a part of COVAX. We will keep giving 50% of everything we make to India & to COVAX at the same time,” he said.

“Initially for the first month, we may give most of the volumes to India, because, in order to export, we have to go through the WHO pre-qualification procedure, which may take another month or so after it is licensed in India. That way, India will have priority,” he added.

India has such a large population that we will probably end up giving the majority of those 50 million doses to India first.

Adar Poonawalla, Serum Institute of India

Covishield has been developed at SII's laboratory in Pune with a master seed from Oxford University/AstraZeneca.

The Serum Institute of India, as well as Oxford-AstraZeneca, are awaiting approval from the Indian and the UK drug regulators respectively. SII had submitted additional data required by the Drug Controller General of India (DCGI) for determining the safety and immunogenicity of its COVID-19 vaccine candidate.

Poonawalla shared that this approval is expected anytime by the end of December or beginning of January 2021 in the UK and “simultaneously, we hope to get that in India as well.”

“But it is entirely in the purview of the Indian drug controller, who needs to be given enough time to review the data from the global multi-centric trials,” he added.

We must respect the process by which the eminent and learned regulators are evaluating all the data. Nobody wants to compromise on the safety and efficiacy of the vaccine. The SII, Oxford-AstraZeneca and all other companies developing COVID vaccines want to adhere to the highest levels of safety and efficacy.

Adar Poonawalla, Serum Institute of India

“Once we get regulatory approvals in a few days, it'll be down to the government to decide how much they can take and how fast. We will be producing around 300 million doses by July 2021,” he said.

Speaking of availability of the vaccine, Poonawalla stated that the first six months of 2021 would perhaps see a shortage of vaccine doses globally. “Nobody can help that. But we will see easing off by August-September 2021 as other vaccine manufactures also being able to supply,” he said.

(The article was first published in FIT and has been republished with permission)