Serum Institute, Bharat Biotech covid vaccines get emergency use authorisation
04 January 2021
The union ministry of health and family welfare has granted conditional approval for restricted emergency use of corona vaccines developed by Serum Institute of India and Bharat Biotech International Ltd.
The grant of permission for restricted emergency use of Covishield vaccine manufactured by Serum Institute of India, Pune, in collaboration with Oxford University and AstraZenica is subject to multiple regulatory conditionalities, while the grant of permission for restricted use of Covaxin developed indigenously by Bharat Biotech International Ltd, Hyderabad in collaboration with the Indian Council of Medical Research (ICMR) is for emergency situation in public interest.
Bharat Biotech’s Covaccine is in Phase III clinical trials and the emergency use permission has been granted as an abundant precaution, specially in the context of infection by mutant strains, the health ministry stated in a public announcement.
The SEC also granted permission for conduct of Phase-III Clinical Trial Protocol to Cadila Healthcare Ltd, Ahmedabad.
The Subject Expert Committee (SEC) of Central Drugs Standards Control Organisation (CDSCO) which met on 1 and 2 January 2021 considered accelerated approval process request of Serum Institute of India and Bharat Biotech International Ltd as well as about Phase-III Trials of Cadila Healthcare Ltd.
States and union territories have also successfully conducted the dry run of the vaccination drive on 2 January and have expressed confidence in carrying out the vaccination drive.
The activities starting from beneficiary data upload, session site allocation and micro planning, vaccine allocation, session site management with test beneficiaries, reporting mechanism etc were covered in this one day dry run to execute the nearest possible simulation of the actual day.
The preparation to handle any adverse events following immunization (AEFI) at all session sites and functionality of the call centers was also tested.
The states/UTs have expressed complete satisfaction on the successful conduct of the dry run which included the operational process and its linkages with the Co-WIN Software.
The Co-WIN software has been developed by MoHFW for real time information of vaccine stocks, their storage temperature and individualised tracking of beneficiaries for Covid-19 vaccine. This software will assist the programme managers across all levels through automated session allocation for pre-registered beneficiaries, their verification and a digital certificate will be generated upon successful completion of the vaccine schedule.
More than 7.5 mllion beneficiaries have been registered on Co-WIN software till date.
The cold chain infrastructure is sufficient to ensure last mile delivery of Covid-19 vaccine in a temperature controlled environment across the country. Sufficient supplies of syringes and other logistics have also been ensured to begin Covid-19 vaccination drive.
Around 1,14,100 vaccinators have been trained on the process to be followed at the vaccination sites which includes beneficiary verification, vaccination, cold chain and logistics management, bio-medical waste management, AEFI management and uploading the information on Co-WIN software.
The entire operational planning and IT platform has been field tested in four states which include Andhra Pradesh, Assam, Punjab and Gujarat on 28 and 29 December 2020; and on the basis of feedback received, minor enhancements have been made in the IT system.