Expert panel to reconvene and further deliberate on vaccine approval tomorrow
New Delhi: The United Kingdom (UK) yesterday approved Coronavirus vaccine developed by University of Oxford and AstraZeneca, paving way for its rollout at a time when the country is in the grip of its worst wave of infections, and offering an important endorsement that will likely be taken into account in India, where authorities are reviewing the inoculation.
While the UK said it will begin administering the first shots from next week, Indians must wait a little longer since the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) – which is vetting the data from safety and efficacy trials – is yet to reach a decision.
The CDSCO that met last afternoon to consider emergency use authorisation applications by the Serum Institute of India (SII) for the Oxford COVID-19 vaccine and Bharat Biotech’s Covaxin will reconvene on Jan. 1 to further deliberate on the matter.
The SEC on Covid-19 deliberated and analysed the additional data and information submitted by SII and Bharat Biotech.”The SEC in the CDSCO met in the afternoon to consider the emergency use authorisation (EUA) request of Pfizer, SII and Bharat Biotech Pvt. Ltd,” the Health Ministry said.
“Further time was requested on behalf of Pfizer. The additional data and information presented by SII and Bharat Biotech was perused and analysed by the SEC. The analysis of the additional data and information is going on. The SEC will convene again on Jan. 1, 2021,” it said.
The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) on Wednesday approved the COVID-19 vaccine developed by scientists at Oxford University and produced by AstraZeneca for human use.
The Pune-based Serum Institute of India, the world’s largest vaccine manufacturer, has entered into a tie-up AstraZeneca to manufacture Covishield. Incidentally, the Phase II clinical trials for Covishield were conducted at JSS Medical College and Hospital in Mysuru in August this year.
In Karnataka, JSS Hospital is the only institute that has been selected for the clinical trial. Covishield was administered to about 25 volunteers at JSS Hospital after Phase II trials began on Aug. 29.