The application will now be forwarded to the drug regulator (DCGI) for final approval before the innoculations begin. The SEC is an expert panel on Covid-19 of the Central Drugs Standard Control Organisation (CDSCO). This vaccine has been developed by AstraZeneca and will be produced here by Serum Institute of India (SII).
On Friday, after studying SII’s application, the SEC also started reviewing the EUA application by Bharat Biotech for its Covid-19 vaccine — Covaxin — but is yet to take a final decision on the matter, sources said.
“Meeting of the SEC is still going on. It will make appropriate recommendations to the DCGI. The final decision will be taken by the DCGI,” the health ministry said. The SEC, at its last meeting, held on December 30, had asked for time to deliberate on data for SII’s Covishield and Bharat Biotech’s Covaxin.
Additionally, more time was requested on behalf of Pfizer.
On December 30, the UK government approved the use of the AstraZeneca vaccine, developed by scientists at Oxford University, for emergencies after a recommendation from the Medicines and Healthcare products Regulatory Agency (MHRA). The MHRA had on Wednesday had approved the Covid-19 vaccine for human use.
Meanwhile, the government has been working to perfect the delivery mechanism for the vaccine with around 96,000 vaccinators having been trained so far. While four states had conducted a dry run in December, all states are expected to conduct dry runs on January 2 to check for any glitches in the process.
“The objective of the dry run for the Covid-19 vaccine introduction is to assess operational feasibility in the use of Co-WIN application in field environment, to test the linkages between planning and implementation and to identify the challenges and guide way forward prior to actual implementation,” the ministry had said.
Though an approval by the DCGI would not make the vaccine available for mass delivery, India will have near adequate vaccines to cover healthcare and frontline personnel like the police.
In its plan unveiled in December, the government had said it would prioritise three crore healthcare and frontline workers, followed by 27 crore people above the age of 50 and those with co-morbidities.
SII’s founder Adar Poonawalla had indicated that the vaccine maker is ready with 50 million doses. In an earlier interview, Poonawalla had said SII would be producing around 300 million doses by July.
In December, India had a storage capacity for 30 million doses and the health secretary had said the government would be adding to this capacity.