INSUBCONTINENT EXCLUSIVE:
Hyderabad: The emergency use authorisation of Covaxin by Bharat Biotech and Covishield by Serum Institute of India will be taken up by the
subject expert committee on January 1.Additional data and information about Phase 3 trials has been submitted by both the companies
A review of the data was carried out and the subject expert committee of Central Drugs Standard Control Organisation will analyse it further
Bharat Biotech has carried out Phase 3 trials in more than 13,000 volunteers
test the linkages between planning and implementation and to identify the challenges
The activity is proposed to be conducted in at least 3 session sites in each capital.The dry run is a mock drill to ensure that all the
requirements of participants, healthcare workers, uploading data on website and preparing for adverse events is in place.There will be 25
test beneficiaries who will be healthcare workers
Their data has to be uploaded in Co-WIN (Covid Vaccine Intelligence Network) app
Public health centre space, waiting room, logistical arrangement, internet connectivity, electricity and safety have to be calculated at the
The designated centre must have a cold chain for storage and administration of vaccines.An important focus of the dry run is management of
any adverse events following immunisation
Hence there must be an emergency team in place to handle the situation.In a peer reviewed journal, the data published by Bharat Biotech
states that long-term antibody and T-cell memory responses were noted three months after the vaccination in Phase 1 trials
In Phase 2, it was found that the vaccine is safe and there was enhanced cell-mediated immune response
provided additional data to the SEC for review
The emergency authorization by United Kingdom Medicines and Healthcare Products Regulatory Agency has also played a role for the company to
push for the vaccine in India.Pfizer has asked for more time to give data and for that reason only these two vaccines will be taken up for
Experts will debate it and decide what is best
It is new research and there are new emerging strains which are posing a lot of challenge
The clinical inputs from both companies are very important for an EUA
on condition of anonymity
In the light of these mutations what is most important is safety and efficacy
Both these aspects have to be considered before taking the decision
The emergency use authorisation is a new concept in India and mindset of people to accept a vaccine is a concern
