Industry Expert to review data of Serum Institute, Bharat Biotech COVID-19 vaccines
The SEC meeting on 30 December could not settle on COVID-19 SII vaccine because more data were needed.
A further study of the emergency uses of the Serum Institute of India (SII) and Bharat Biotech COVID-19 vaccines is being undertaken on 1 January by the Indian Medical Regulatory Officer Topic Expert Committee (SEC).
The SEC that met with SII COVID-19 on 30 December was unable to make a decision because more details were required.
“SII and Bharat Biotech have reviewed and analyzed additional data and information. SEC will convene again on 1 January 2021 [Friday],” said CDSCO in a statement. “This data and information will be analyzed and analyzed by SEC.
The CDSCO reported that Pfizer called for more time to send its vaccine.
In a “full review of the knowledge by experts at the MHRA, who agree that it has met its stringent protection, consistency and effectiveness requirements,” on 30 December, the UK Government introduced the use of Oxford University-AstraZeneca Covid-19 vaccines.”
Britain’s nod would reinforce the case for accelerated acceptance of an application for authorization for emergency use from the Serum Institute of India. SII is a participant in the manufacture of vaccines in India at the Oxford University-AstraZeneca.
AstraZeneca said it will continue to collaborate with regulators internationally to support its roll-case evaluations of emergency supply or conditional marketing permits. AstraZeneca is also searching for the World Health Organization’s catalog making usage of emergencies in low or middle-income countries to ensure fast vaccines are accessible.