Serum says made 40 mn doses of AstraZeneca's COVID vaccine, to make Novavax shot soon

Mumbai: Serum Institute of India (SII) has already made and kept aside 40 million doses of the AstraZeneca-Oxford Covid-19 vaccine, under the at-risk manufacturing and stockpiling licence from the Drug Controller General of India. It will be in a position to supply these doses once phase 3 clinical trials are successfully concluded.

In the announcement on Thursday, the world’s largest vaccine maker also said it completed enrolments of 1,600 participants for phase 3 clinical trials in India, by October 31. The trials are being conducted in collaboration with the Indian Council of Medical Research (ICMR), which is funding the clinical trial site fees.

“Based on phase 2-3 results, SII, with the help of ICMR, will pursue early availability of the product for India. The strategic SII-ICMR alliance will advance India’s role in the global race to develop Covid-19 vaccines,” said a company statement.


Trials for Covishield — developed at the SII Pune laboratory with a master seed from the AstraZeneca-Oxford vaccine — are being conducted at 15 centres.

‘Most Advanced’
The AstraZeneca-Oxford candidate, considered one of the most promising Covid-19 vaccines, is being tested for efficacy in large trials in the UK, Brazil, South Africa and the US.
Earlier this week, Pfizer became the first company to release successful interim data for large-scale Covid-19 vaccine trials, raising hopes of an early launch. But no clinical trials for the Pfizer vaccine are being carried out in India, and local health authorities are pinning their hopes on a quick launch of the AstraZeneca-Oxford vaccine.

“Promising results of the trials so far give confidence that Covishield could be a realistic solution to the deadly pandemic. It is by far the most advanced vaccine in human testing in India,” said Adar Poonawala, chief executive, SII.

An SII official told ET that if all goes well, phase 3 trial results will be available by December.

Meanwhile, SII also said it had received bulk vaccine and Matrix-M adjuvant from US-based Novavax, which it would fill into vials. The company will soon apply for permission to conduct phase 3 clinical trials. Novavax has initiated late phase clinical trials in South Africa and the UK, and is expected to commence them in the US too.