NEW DELHI: The Subject Matter Experts Committee (SEC) of the Indian Drug Controller will hold a meeting to consider the Serum Institute of India’s request for approval of the emergency use of its Covid-19 vaccine, said a government official .
According to sources, only the Serum Institute application will be considered.
The SEC recommendation will be submitted for approval by the drug regulator later today after the meeting.
Covishield is being manufactured on the Chimpanzee Adenovirus platform and by SII in Pune. The partner company is AstraZeneca.
“The regulator had allowed them phases 2 and 3 of the clinical trials of the vaccine and they have requested authorization for emergency use,” he said.
IBS is the first indigenous company to apply for emergency approval for the vaccine developed together with the global pharmaceutical giant AstraZeneca and the University of Oxford.
The Pune-based company previously stated that the ChAdOx1 nCov-2019 coronavirus vaccine, developed by teams at the University of Oxford, has been shown to trigger a robust immune response in healthy adults aged 56 to 69 and in those over 70. .
After Prime Minister Narendra Modi visited the company’s pandemic-level facility in Pune last month, SII Chief Executive Officer (CEO) Adar Poonawalla had said the Center could purchase between 300 and 400 million doses for July 2021.
In addition, he said that IBS has already produced between 40 and 50 million doses of the vaccine per month, and the pharmaceutical giant plans to roll it out to 100 million doses of the vaccine per month by February.
According to sources, only the Serum Institute application will be considered.
The SEC recommendation will be submitted for approval by the drug regulator later today after the meeting.
Covishield is being manufactured on the Chimpanzee Adenovirus platform and by SII in Pune. The partner company is AstraZeneca.
“The regulator had allowed them phases 2 and 3 of the clinical trials of the vaccine and they have requested authorization for emergency use,” he said.
IBS is the first indigenous company to apply for emergency approval for the vaccine developed together with the global pharmaceutical giant AstraZeneca and the University of Oxford.
The Pune-based company previously stated that the ChAdOx1 nCov-2019 coronavirus vaccine, developed by teams at the University of Oxford, has been shown to trigger a robust immune response in healthy adults aged 56 to 69 and in those over 70. .
After Prime Minister Narendra Modi visited the company’s pandemic-level facility in Pune last month, SII Chief Executive Officer (CEO) Adar Poonawalla had said the Center could purchase between 300 and 400 million doses for July 2021.
In addition, he said that IBS has already produced between 40 and 50 million doses of the vaccine per month, and the pharmaceutical giant plans to roll it out to 100 million doses of the vaccine per month by February.
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