Serum Institute of India has shared interim data with the DCGI of four clinical trials.
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. The Pune-based pharmaceutical firm is the second to do so 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 to conduct trials on its Covishield vaccine in India. "As promised, before the end of 2020, @SerumInstIndia has applied for emergency use authorisation for the first made-in-India vaccine, COVISHIELD. This will save countless lives, and I thank the Government of India and Sri @narendramodi ji for their invaluable support," tweeted Adar Poonawala, who leads the SII, this morning. He had said last month the SII will ask for approval in two weeks.
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 Pune-based institute has shared interim data with the DCGI of four clinical trials - one in India, two trials in UK and one in Brazil, sources told NDTV.
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 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.
The vaccine can be stored in 2 Celsius to 8 Celsius unlike Pfizer's 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, which has not conducted trials on the country's local population.
While Pfizer has asked for permission to import Covid vaccine for sale in India, the Adar Poonawala-led institute has sought permission to manufacture Covid vaccine for sale in India.
The drug regulator may give emergency approval to Pfizer if it is satisfied by the results of the trials conducted outside India, sources told NDTV. Pfizer's application has been forwarded to the Subject Expert Committee of the CDSCO (Central Drugs Standard Control Organisation) for examination of clinical trial data, sources told NDTV.
Nearly a week after his visit to top vaccine hubs including the SII, Prime Minister Narendra Modi on Friday said India can hope to get a vaccine in the next few weeks.
Nearly a week after his visit to top vaccine hubs including the SII, Prime Minister Narendra Modi on Friday said India can hope to get a vaccine in the next few weeks.
