Pune-headquartered Serum Institute of India (SII), which has an agreement with AstraZeneca to manufacture the Oxford University vaccine, said on Wednesday the ChAdOx1 nCoV-19 vaccine candidate, named Covishield in India, could be ready as early as December.
In an interview with NDTV, Adar Poonawalla, CEO of Serum Institute, which is currently conducting late-stage trials of the candidate in India, further said the first batch of 100 million doses should be available by the second or third quarter of 2021.
“If we don’t go for an emergency license, our trials should be over by December and then we can maybe we can launch in India in January subject to the UK trial, which is on the verge of being completed,” Poonawalla said.
However, he said much would depend on data from the UK clinical trials and if found safe, the firm would not dither from seeking emergency-use authorisation from the Indian drug regulator.
“If the UK, in the next two weeks, were to unbind their study and share the data and be confident that it’s safe, then we can, after two-three weeks, apply to the Indian regulator to look at a possible emergency license if that’s what the government wants,” he told the news website.
“That review could take about two-three weeks I imagine and then you can have a vaccine by December. We are aiming for 100 million available doses at first. This should be available by Q2-Q3 of 2021,” Poonawala said.
On September 16, the Drugs Controller General of India (DCGI) allowed SII to restart its combined Phase II/III clinical trials after it was halted temporarily following one of the participants developing an “unexplained illness” in the UK.
AstraZeneca is aiming to launch the vaccine, made from a weakened version of a common cold virus that causes infections in chimpanzees, by end of the year.
Earlier this week, AstraZeneca said the AZD1222 or ChAdOx1 nCoV-19 vaccine candidate “has produced a robust immune response in older adults and the elderly, those at highest risk of severe illness”. Trial participants aged 56 and over showed low-levels of adverse reactions.
According to the government, three vaccines are in advanced stages of development in India, of which one is in Phase II and two are in Phase III. The government had previously estimated that it is likely to receive and utilise 400-500 million doses of Covid vaccine and that as many as 25 crore individuals could be vaccinated by July 2021.