The Covishield phase three clinical trial is co-sponsored by the ICMR.
New Delhi:
Serum Institute of India, the largest vaccine manufacturer in the world by number of doses produced, has requested government approval for the authorization of emergency use of the coronavirus vaccine it is developing with the University of Oxford and the British pharmaceutical company AstraZeneca. sources said. The Pune-based pharmaceutical company is the second to do so, sources say, after the US company Pfizer sought approval from the drug regulator, the DCGI (Controller of Medicines General of India), for its COVID-19 vaccine. , approved by the United Kingdom and Bahrain.
Serum Institute of India (SII) partnered with AstraZeneca Plc to conduct trials of its Covishield vaccine in India. “Covishield is safe and well tolerated and can be used effectively for the prevention of COVID-19 in the target population. Therefore, the benefit / risk ratio strongly supports its widespread use,” a source quoted PTI news agency. , citing the request. to the drug regulator.
Covishield’s phase three clinical trial, co-sponsored by the Indian Council for Medical Research (ICMR), is ongoing in various parts of the country, in addition to clinical studies being conducted by Oxford-AstraZeneca in the UK and Brazil .
The Pune-based institute has shared interim data with the DCGI from four clinical trials: one in India, two trials in the UK and one in Brazil, sources told NDTV.
The government said last week that it had found no reason to stop trials of the Oxford vaccine in India after reviewing a Chennai volunteer claim of serious adverse effects, including memory loss and behavior change. The Serum Institute of India (SII) led by Adar Poonawalla also said the vaccine was “safe and immunogenic” and that the Safety and Data Monitoring Board and Ethics Committee had “independently authorized” the trials after examining the complaint.
Last month, AstraZeneca said that an interim analysis of clinical trials of its COVID-19 vaccine in the UK and Brazil showed it was 70 percent effective on average, making it the third-largest drug maker after US firms. , Moderna and Pfizer, in announcing promising results. to contain the deadly virus, which has affected more than 96 lakh people in India and more than 6.6 million people worldwide.
The company had also said that the vaccine showed 90 percent efficacy in one dosage regimen when the vaccine was administered as a half dose, followed by a full dose at least one month later, while another dosage regimen showed efficacy of the 62 percent when given as two full doses at least one month apart.
Covishield has elicited an immune response even in the elderly, who are among the groups vulnerable to the disease, Adar Poonawalla had 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 at 2 degrees Celsius to 8 degrees Celsius unlike the Pfizer vaccine which must be stored and shipped at -70 degrees. Many experts have expressed concern about the logistical problem related to the distribution of the Pfizer vaccine, which has not conducted trials in the local population of the country.
While Pfizer has applied for permission to import the Covid vaccine for sale in India, the institute led by Adar Poonawala has applied for permission to manufacture the Covid vaccine for sale in India.
The drug regulator may grant emergency approval to Pfizer if it is satisfied with the results of trials conducted outside of India, sources told NDTV. Pfizer’s request has been forwarded to the CDSCO (Central Drug Standard Control Organization) Subject Matter Expert Committee for review of clinical trial data, sources told NDTV.
Almost a week after his visit to major vaccination centers, including IBS, Prime Minister Narendra Modi said on Friday that India can expect to receive a vaccine in the coming weeks.
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