New Delhi: An expert panel in the Central Drugs Standard Control Organisation (CDSCO) will hold a key meeting today to consider ’emergency use’ authorisation applications by the Serum Institute of India (SII) for the Oxford-AstraZeneca vaccine ‘Covishield’ and Bharat Biotech for its COVID-19 vaccine ‘Covaxin’.Also Read - Pfizer-BioNTech Becomes First COVID-19 Vaccine to Get WHO Clearance For Emergency Use
On Wednesday, the Subject Expert Committee (SEC) on COVID-19 deliberated and analysed the additional data and information submitted by SII and Bharat Biotech Pvt. Ltd. Also Read - China Grants Conditional Approval to Homegrown COVID-19 Vaccine; To Provide it Free For All Citizens
“The SEC in the CDSCO met today in the afternoon to consider the emergency use authorisation (EUA) request of Pfizer, SII and Bharat Biotech,” the Health Ministry said in a statement on Wednesday. Also Read - Coronavirus: All States To Begin Vaccine Dry Run From January 2, Details Here
“Further time was requested on behalf of Pfizer. The additional data and information presented by SII and Bharat Biotech Pvt. Ltd was perused and analysed by the SEC. The analysis of the additional data and information is going on. The SEC will convene again on January 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’.
While considering SII’s application, the SEC on December 9 had recommended that the firm should submit updated safety data of phase 2 and 3 clinical trials in the country, immunogenicity data from the clinical trial in the UK and India, along with the outcome of the assessment of the UK MHRA for grant of EUA.
As for Hyderabad-based Bharat Biotech, after detailed deliberation, the committee had recommended that the firm should present the safety and efficacy data from the ongoing phase 3 clinical trial in the country for further consideration.
SII had applied to the Drugs Controller General of India (DCGI) for emergency use authorisation for Covishield on December 6 while the Hyderabad-based Bharat Biotech had sought a similar nod for its its indigenously developed Covaxin on December 7.
Pfizer had applied for a similar approval for its vaccine on December 4.
Vaccine Approval Meet Comes Day Before Pan-India Dry Run:
The meeting comes a day before the dry run for COVID-19 vaccination which will be conducted by all states and union territories on January 2 to test the linkages between planning and implementation and to identify the challenges.
The dry run is proposed to be conducted in all state capitals in at least 3 session sites.
The central government has also asked all states and UTs to ensure effective preparedness for the COVID-19 vaccine roll-out.
The dry run will also equip the state and UT administration in management of vaccine supply, storage and logistics including cold chain management.
As the vaccine administrators will play an important role in the vaccination process, training of trainers and those who shall administer the vaccine has been taken up across various states.
The first round of the dry run was conducted in Andhra Pradesh, Assam, Gujarat, Punjab on 28-29 December in two districts each where five session sites with 25 beneficiaries each were identified.
(With inputs from PTI)