Following the Footsteps of Pfizer, Serum Institute of India Seeks urgent approval for COVIDSHIELD

Serum Institute of India asks for approval for its COVIDSHEILD vaccine

The Serum Institute of India, the world's largest producer of vaccines, has sought approval from the government for the accreditation of the urgent use of the developing coronavirus vaccine with the University of Oxford and British AstraZeneca. The pharmaceutical company in Pune is the second to do so after the American company Pfizer sought approval from a drug regulator - DCGI (General Drug Control in India) - for its COVID-19 vaccine, which has been phased out by the United Kingdom and Bahrain.

The Serum Institute of India (SII) has partnered with AstraZeneca to conduct tests on its Covishield vaccine in India. "As promised, before the end of 2020, SII has applied for authorization for emergency use of India's first vaccine, COVISHIELD. This will save countless lives, and I thank the Government of India and Sri @narendramodi ji great support, "wrote Adar Poonawala, who leads SII, this morning. He last month said the SII would apply for approval in two weeks.

The third phase of the Covishield clinical trial, sponsored by the Indian Council of Medical Research (ICMR), is being conducted in various parts of the country in addition to Oxford-AstraZeneca clinical studies in the UK and Brazil.

The Pune-based institute shared temporary data with DCGI for four clinical trials - one in India, two in the UK and one in Brazil, sources told.

The government last week said it had found no reason to suspend Oxford vaccine trials in India after reviewing Chennai's voluntary allegations of serious side effects, including memory loss and behavioral changes. SII led by Adar Poonawalla also said the policy was "safe and immune-defensive" and the Data and Safety Monitoring Board and Ethics Committee "independently canceled" the tests after examining the complaint.

Last month, AstraZeneca had said a temporary analysis of COVID-19 clinical trials in the UK and Brazil showed that it was 70 percent effective, becoming the third drug manufacturer after American companies - Moderna and Pfizer - announced promising results to contain the deadly virus, which has infected more people. 96 lakhs in India and more than 6.6 crore people worldwide.

The company also claimed that the vaccine showed 90 percent efficiency in a single vaccine when the drug was given as a half dose, followed by a full dose at least a month later, and another type of dose showed a 62 percent efficacy when given as two full doses at least one month apart.

Covishield has drawn antibodies even for the elderly, who are among the most at risk groups, Adar Poonawalla had confirmed. The first amount of 100 million doses should be available in the second or third quarter of 2021, he said.

The Serum Institute of India shared temporary information with DCGI for four clinical trials.