Updated: October 28, 2020 9:07:15 pm
Serum Institue reservers work on a bioreactor to manufacture a possible COVID-19 vaccine (NYT)
Serum Institute of India (SII), based in Pune, which has an agreement with AstraZeneca to manufacture the Oxford University vaccine, said Wednesday that the ChAdOx1 nCoV-19 candidate vaccine, called Covishield in India, could be ready as early as December.
In an interview with NDTV, Adar Poonawalla, CEO of the Serum Institute, which is currently conducting late-stage trials of the candidate in India, further said that the first batch of 100 million doses should be available by the second or third quarter. of 2021.
“If we do not pursue an emergency license, our tests should end in December and then maybe we can launch in India in January subject to the UK test, which is nearing completion,” Poonawalla said.
However, he said that much would depend on data from UK clinical trials and, if deemed safe, the company would not hesitate to apply for an emergency use authorization from the Indian drug regulator.
“If the UK, in the next two weeks, were to unlink their study and share the data and trust that it’s safe, then we can, after two to three weeks, ask the Indian regulator to look into a possible emergency license if that’s what the government wants, ”he told the news website.
“I imagine that that checkup could take around two or three weeks and then you can have a vaccination in December. Our goal is to get 100 million doses available up front. This should be available by the second and third quarters of 2021, ”Poonawala said.
On September 16, the Comptroller General of Drugs of India (DCGI) allowed the SII to restart its combined Phase II / III clinic. trials after it was temporarily stopped following one of the participants who developed an ‘unexplained illness’ in the UK.
AstraZeneca aims to launch the vaccine, made from a weakened version of a common cold virus that causes infections in chimpanzees, by the end of the year.
Earlier this week, AstraZeneca said that the vaccine candidate for the AZD1222 or ChAdOx1 nCoV-19 vaccine “has produced a robust immune response in older adults and the elderly, those most at risk for severe disease.” Trial participants aged 56 years and older 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 in Phase III. The government had previously estimated that it is likely to receive and use between 400 and 500 million doses of the Covid vaccine and that up to 25 million people could be vaccinated by July 2021.
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