The Serum Institute of India on Sunday applied to the Drugs Controller General of India (DCGI) for emergency use authorisation for its Oxford Covid-19 vaccine in the country, official sources said.
The vaccine, developed by SII with Oxford and AstraZeneca, is the first candidate that’s being tested in India to seek emergency approval.
This comes a day after the Indian arm of US pharmaceutical giant Pfizer sought a similar approval from India’s drug regulator to use its Covid-19 vaccine candidate in India.
Citing the SII application, official sources said the firm has stated that data from four clinical studies, two in the UK and one each in Brazil and India, shows that Covishield is highly efficacious against symptomatic and most importantly against severe COVID-19 infections.
The results are in line with findings from trials of other anti-coronavirus vaccines, the firm is learnt to have said while citing the huge disease burden to say Covishield is well placed to alleviate Covid-19 mortality and morbidity.
“In terms of safety, Covishield was well tolerated with respect to solicited adverse events and was not associated with an increased number of severe adverse events and deaths. Therefore, Covishield is safe and well-tolerated and can be used effectively for prevention of Covid-19 in the targeted population. Thus, the benefit to risk ratio strongly supports the widespread use of Covishield,” a source said quoting the application.
ENS adds: The Indian Express has learnt that DGCI has placed Pfizer’s application for emergency use approval before a committee of experts, which will examine the data of its clinical trial conducted abroad.
Top government sources underlined that the regulatory process of emergency authorisation approvals for vaccine candidates being tested in India, specifically the one being developed at SII and ICMR-Bharat Biotech’s Covaxin vaccine candidate, are set to take place in the next few days.
“The Prime Minister has already said that a vaccine tested here will be ready in the next few weeks after regulatory approvals,” sources said.
On Pfizer, sources confirmed that DCGI has now forwarded the application submitted by Pfizer India to the Subject Expert Committee for detailed scrutiny of the clinical trials data. The SEC, which consists of a panel of experts, will be giving its recommendations to the regulator, on the basis of which a decision will be taken, sources said.
“The request by Pfizer has been placed before the subject expert committee late Saturday evening. The company submits the safety, efficacy, and immunogenicity data, and also informs whether the data is complete or incomplete. The SEC examines this data, can hold virtual meetings or can seek further clarifications,” sources said.
On December 2, UK became the first country to grant temporary authorisation for the emergency use of Pfizer’s mRNA vaccine (BNT162b2) against Covid-19.
In its application, Pfizer has sought permission to import its vaccine and also to waive the need for clinical trials on the Indian population under relevant provisions of the New Drugs and Clinical Trial Rules, 209. Sources said the waiver sought by the firm will be “scrutnised by the SEC”.
On Sunday, UK’s National Health Service said people aged 80 and above as well as care home workers will be the first to receive the vaccine, along with NHS workers.
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On November 20, Pfizer said it had requested the US Food and Drug Administration for emergency use authorisation for their vaccine candidate. The US regulator is scheduled to meet on December 10 to take decision on granting approvals to Pfizer.
Pfizer has said that the final efficacy analysis of their ongoing Phase 3 clinical trial indicates an efficacy rate of 95 per cent in volunteers without prior SARS-CoV-2 infection. “Efficacy was consistent across age, gender, race, and ethnicity demographics. The observed efficacy in adults over 65 years of age was over 94%,” the company has said.x
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