The subject expert committee (SEC) on COVID-19 at the Central Drugs Standard Control Organisation (CDSCO) will meet soon to consider Serum Institute of India’s application for emergency use approval of its COVID19 vaccine, which is being developed in collaboration with Oxford University and pharmaceutical company Astra Zeneca.
“Drugs Controller of India to take a meeting for emergency use approval of Serum Institute of India’s COVID19 vaccine,” a government official was quoted as saying by news agency ANI.
The development comes as the UK government approves the use of the COVID-19 vaccine named Covishield. The approval came on the recommendation by Medicines and Healthcare products Regulatory Agency (MHRA). The vaccine has been designed by scientists at the University of Oxford and is being produced by AstraZeneca.
Subject Expert Committee (SEC) of Drugs Controller of India to take a meeting to consider Serum Institute of India’s application for emergency use approval of its COVID19 vaccine, says a government official
— ANI (@ANI) December 30, 2020
Earlier this month, the expert committee had sought more data on the safety and efficacy of COVID-19 vaccine candidates after deliberating on the company’s application that sought emergency use authorisation of the sots. Apart from the Serum Institute of India, Bharat Biotech had also approached the CDSCO for emergency use authorisation.
While considering the application submitted by Serum Institute of India, the committee had recommended that the firm should provide safety data of phases 2 and 3 clinical trials in the updated applications. The committed had also sought immunogenicity data from the clinical trial in India as well as in the United Kingdom along with the outcome of the assessments made by the MHRA.
Three companies have applied to the Drugs Controller General of India (DCGI) for emergency use authorisation (EUA). While the Pune-based Serum Institute of India (SII) had applied on December 6, Bharat Biotech sought the nod on December 7. The Indian arm of US pharmaceutical firm Pfizer too applied for the EUA for its vaccine on December 4.
