The Serum Institute of India (SII) on December 6 applied to the Drugs Controller General of India (DCGI) to seek emergency use authorisation for its COVID-19 vaccine candidate Covishield.
It is reported that the SII cited unmet medical needs in the country owing to the coronavirus pandemic and public interest at large as reasons for its application.
The SII is currently conducting phase-three trials of the Oxford-AstraZeneca vaccine candidate in different parts of the country. It is co-sponsored by the Indian Council of Medical Research (ICMR). Clinical studies of the same vaccine are being carried out by Oxford-AstraZeneca in Brazil and the UK too.
A few days prior to the SII, US pharmaceutical major Pfizer was the first to seek emergency use authorisation from the DGCA for its
COVID-19 vaccine in India. Pfizer has already got such permission in the UK and Bahrain.
The UK on December 2 was the first country to approve the Pfizer-BioNTech vaccine to be used to counter the COVID-19 pandemic.
It was earlier reported that Pfizer sought the waiver of clinical trials of its vaccine candidate on the Indian population under the provisions of the New Drugs and Clinical Trial Rules, 2019.
Pfizer, in its application on December 4, sought permission from the DCGI to import the vaccine for sale and distribution in India.
Pfizer India submitted the emergency use authorisation application in Form CT-18 for grant of permission to import and market Pfizer-BioNTech's Covid-19 vaccine in India, according to the reports.
According to the ICMR, the SII manufactured 40 million doses of its vaccine candidate in advance under the at-risk manufacturing and stockpiling license it got earlier from the DCGI.
India's COVID-19 tally continues to rise as more vaccine candidates put out their efficacy data and begin to seek permissions to bring them to the market.
