India has recorded more than 96 lakh of coronavirus cases so far.
New Delhi:
A panel of experts will review tomorrow the request of three pharmaceutical companies, the Serum Institute of India, Pfizer and Bharat Biotech, to approve the emergency use of their coronavirus vaccines in India, sources told NDTV.
On Monday, Hyderabad-based Bharat Biotech became the third company, sources say, to submit an application for approval of its vaccine: Covaxin, India’s first indigenous candidate for the highly infectious virus.
The US company Pfizer was the first to submit its application last week to the DCGI (Comptroller General of Drugs of India), followed by the Serum Institute of India, based in Pune.
After the review, the expert panel will share its observations with the drug regulator, according to the sources. An emergency use approval of a drug may be granted after there is sufficient evidence to suggest that the medical product is safe and effective. Final approval is granted only after completion of testing and complete data analysis.
The Serum Institute of India, the world’s largest vaccine manufacturer by number of doses produced, is developing its vaccine, Covishield, with the University of Oxford and British drugmaker AstraZeneca. Last month, AstraZeneca said that an interim analysis of clinical trials of its COVID-19 vaccine in the UK and Brazil showed that it was 70 percent effective on average, adding that it is up to 90 percent effective.
Last week, the UK became the first country to phase out the Covid-19 injection jointly developed by Pfizer and German biotech partner BioNTech, which has reported 95 percent efficiency in the third stage of testing.
Experts have raised concerns about the logistical challenges related to the Pfizer vaccine, which must be stored and transported at -70 degrees Celsius. However, the pharmaceutical company has stated that it is prepared to overcome these obstacles.
Adar Poonawala’s IBS became embroiled in controversy after a Chennai volunteer alleged serious adverse effects. But the government said last week that it had found no reason to stop trials of the Oxford vaccine in India. The vaccine was “safe and immunogenic” and the Safety and Data Monitoring Board and Ethics Committee had “independently authorized” the trials after reviewing the complaint, the Pune-based firm said.
Yesterday, he tweeted: “As promised, before the end of 2020, @SerumInstIndia has applied for emergency use authorization for the first vaccine made in India, COVISHIELD. This will save countless lives, and I thank the Government of India and Sri @narendramodi ji for their invaluable support. ”
Haryana Health Minister Anil Vij, who took a single dose of Covaxin from Bharat Biotech in the third stage of testing, said on Saturday that he had tested positive for coronavirus. However, the vaccine manufacturer later clarified that Covaxin has been designed to be effective if a person takes two doses. “Covaxin clinical trials are based on a 2-dose schedule, administered 28 days apart. The efficacy of the vaccine will be determined 14 days after the second dose,” the Hyderabad firm said in an official statement.
DCGI’s emergency use authorization will allow the vaccine to be administered to people under certain conditions, for a limited period of time, or to specific groups.
India has recorded 96.7 lakh of Covid infections so far, the second highest in the world after the United States, and 1.4 lakh of deaths related to the disease.
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