Serum Institute of India, the world’s largest vaccine maker by number of doses produced, has sought government approval for emergency use authorisation of the coronavirus vaccine that it is developing with the University of Oxford and British drugmaker AstraZeneca, sources have said. The Pune-based pharma firm is the second to do so, say sources, after American firm Pfizer sought approval from the drug regulator – the DCGI (Drugs Controller General of India)- for its COVID-19 vaccine, cleared by the United Kingdom and Bahrain.
Serum Institute of India (SII) partnered with AstraZeneca Plc to conduct trials on its Covishield vaccine in India. “Covishield is safe and well-tolerated and can be used effectively for prevention of COVID-19 in the targeted population. Thus, the benefit to risk ratio strongly supports the widespread use of Covishield,” news agency PTI quoted a source as saying, citing the application to the drug regulator.
The phase-three clinical trial of Covishield, co-sponsored by Indian Council of Medical Research (ICMR), is being conducted in various parts of the country in addition to clinical studies being carried out by Oxford-AstraZeneca in the UK and Brazil.
The government last week said it had found no reason to stop the Oxford vaccine trials in India after reviewing a Chennai volunteer’s allegation of serious adverse effects, including memory loss and change in behavior. The Adar Poonawalla-led Serum Institute of India (SII) also said the vaccine was “safe and immunogenic” and the Data and Safety Monitoring Board and the Ethics Committee had “independently cleared” the trials after examining the complaint.
Last month, AstraZeneca had said an interim analysis of clinical trials of its COVID-19 vaccine in the UK and Brazil showed that it was 70 per cent effective on average, becoming the third drugmaker after US firms – Moderna and Pfizer – to announce promising results to contain the deadly virus, which has affected over 96 lakh people in India and over 6.6 crore people across the world.
The company had also said that the vaccine, developed with the University of Oxford, showed 90 per cent efficacy in one dosing regimen when the vaccine was given as a half dose, followed by a full dose at least a month later, while another dosing regimen showed 62 per cent efficacy when given as two full doses at least one month apart.
Covishield has drawn an immune response even in the elderly, who are among the groups vulnerable to the disease, Adar Poonawalla had earlier told NDTV. The first batch of 100 million doses should be available by the second or third quarter of 2021, he had said.
Covidshield can be stored in 2 Celsius to 8 Celsius unlike Pfizer vaccine that needs to be stored and transported at -70 degrees. Many experts have expressed concern over the logistical issue linked to distribution of the Pfizer vaccine.
Nearly a week after his visit to top vaccine hubs including the SII, Prime Minister Narendra Modi on Saturday said India can hope to get a vaccine in the next weeks.