Written by Payal Banerjee | New Delhi |
Updated: December 7, 2020 10:19:17 am
The Serum Institute of India on Sunday requested the Comptroller General of Drugs of India (DCGI) for emergency use authorization for its Oxford Covid-19 vaccine in the country. (PTI file photo)
The Serum Institute of India on Sunday applied to the Comptroller General of Drugs of India (DCGI) for an emergency use authorization for its Oxford Covid-19 vaccine in the country, said official sources.
The vaccine, developed by SII with Oxford and AstraZeneca, is the first candidate being tested in India to seek emergency approval.
This comes a day after the Indian arm of the US pharmaceutical giant Pfizer sought similar approval from India’s drug regulator.r use your Covid-19 vaccine candidate in India.
Citing the IBS request, official sources said the firm has stated that data from four clinical studies, two in the UK and one in Brazil and India, show that Covishield is highly effective against symptomatic infections and, most importantly, against serious infections.
Read | Implementation of the Covid-19 vaccine in India
The results are in line with the findings from trials of other coronavirus vaccines, the company was reported to have said by citing the huge burden of disease to say that Covishield is in a good position to alleviate Covid-19 mortality and morbidity. .
“In terms of safety, Covishield was well tolerated with respect to requested adverse events and was not associated with a higher number of serious adverse events and deaths. Therefore, 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 the widespread use of Covishield, ”a source said, citing the app.
ENS adds: The Indian Express has learned that DGCI has submitted Pfizer’s application for emergency use approval to a committee of experts, which will examine data from its overseas clinical trial.
Leading government sources underscored that the regulatory process for emergency authorization approvals for candidate vaccines being tested in India, specifically the one being developed in IBS and ICMR-Bharat Biotech’s Covaxin candidate vaccine, will take place in the following days.
“The Prime Minister has already said that a vaccine tested here will be ready in the next few weeks after regulatory approvals,” the sources said.
Explained | What are emergency use authorization companies looking for for Covid-19 vaccines?
At Pfizer, sources confirmed that DCGI has now forwarded Pfizer India’s request to the Subject Matter Expert Committee for detailed scrutiny of clinical trial data. The SEC, which consists of a panel of experts, will give its recommendations to the regulator, based on which a decision will be made, the sources said.
“Pfizer’s request was presented to the expert committee on the matter Saturday night. The company submits the safety, efficacy and immunogenicity data, and also reports whether the data is complete or incomplete. The SEC examines this data, it can hold virtual meetings, or it can seek further clarification, ”the sources said.
On December 2, the UK became the first country to grant a temporary authorization for the emergency use of Pfizer’s mRNA vaccine (BNT162b2) against Covid-19.
In its request, Pfizer has requested permission to import its vaccine and also to waive the need for clinical trials in the Indian population under the relevant provisions of the New Rules for Clinical Trials and Medicines, 209. The sources said that the Exemption requested by the company will be “scrutinized by the SEC.”
On Sunday, the UK’s National Health Service said that people aged 80 and over, as well as care home workers, will be the first to get the vaccine, along with NHS workers.
An expert explains | India’s path to mass vaccination against Covid-19
On November 20, Pfizer said it had applied to the US Food and Drug Administration for an emergency use authorization for its candidate vaccine. The US regulator will meet on December 10 to make a decision on granting approvals to Pfizer.
Pfizer has said that the final efficacy analysis from its ongoing phase 3 clinical trial indicates a 95 percent efficacy rate in volunteers with no prior SARS-CoV-2 infection. “Efficacy was consistent across all age, gender, race and ethnic demographics. The efficacy observed in adults over 65 years of age was higher than 94%, ”said the company.
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