The Subject Expert Committee of the Central Drug Standard Control Organisation on Friday has held that the data provided by Bharat Biotech for its coronavirus vaccine ‘Covaxin’ is not sufficient for grant of emergency use approval and has asked for more information, top sources informed news agency IANS.
Earlier on Friday, the expert committee, which is tasked with vetting covid-19 vaccine proposals, recommended emergency licensure for the Serum Institute of India-manufactured ‘Covishield’. It became the first vaccine to secure recommendation for emergency use in India.
The Pune-based Serum Institute has partnered with Oxford-AstraZeneca for conducting clinical trials and manufacturing ‘Covishield’ while Bharat Biotech has collaborated with the Indian Council of Medical Research (ICMR) for ‘Covaxin’.
The committee had convened a meeting to take a call on the emergency use authorisation sought by the Serum Institute, Bharat Biotech and America`s Pfizer for their coronavirus vaccines candidates.
Pfizer was the first one to apply for the accelerated approval on December 4, followed by the Serum Institute and Bharat Biotech on December 6 and 7, respectively.
The meeting comes a day before dry run of the vaccine is slated to commence in all the states and Union Territories to equip the administration in management of vaccine supply, storage and logistics including cold chain management.
The Central government plans to vaccinate nearly 30 crore people in the first phase of drive. It will be offered to one crore healthcare workers, along with 2 crore frontline and essential workers and 27 crore elderly, mostly above the age of 50 years with co-morbidities.
While granting emergency use approval for the Oxford COVID-19 vaccine, the panel imposed certain regulatory provisions, including that the shot is indicated for active immunisation in individuals of 18 years or more to prevent the disease and that it should be administered intramuscularly in two doses at an interval of 4 to 6 weeks.