Hyderabad: Covaxin Emergency Use Authorization by Bharat Biotech and Covishield by Serum Institute of India will be reviewed by the subject matter expert committee on January 1.
Both companies have submitted additional data and information on the phase 3 trials. A review of the data was carried out and will be analyzed further by the subject matter expert committee of the Central Organization for Medicines Standards Control. Bharat Biotech has carried out phase 3 trials on more than 13,000 volunteers. Their goal is 26,000 volunteers.
Meanwhile, on January 2, a Covid-19 vaccination trial will be held in all state capitals to test the links between planning and implementation and to identify challenges. It is proposed that the activity be carried out in at least 3 session sites in each capital.
The trial is a mock drill to ensure that all requirements of participants, healthcare workers, data uploading to the website, and preparation for adverse events are met.
There will be 25 beneficiaries of the test who will be health workers. Your data must be uploaded to the Co-WIN (Covid Vaccine Intelligence Network) app. Public health center space, waiting room, logistics arrangement, internet connectivity, electricity, and security should be calculated at the model sites.
Covid 19 safety protocols regarding masks and social distancing must be followed. The designated center must have a cold chain for the storage and administration of vaccines.
An important focus of the test is the management of any adverse events after vaccination. Therefore, there must be an emergency team to handle the situation.
In a peer-reviewed journal, data published by Bharat Biotech states that long-term antibody and T-cell memory responses were observed three months after vaccination in phase 1 trials. In Phase 2, the vaccine was found to it is safe and there was an enhanced cell-mediated immune response. After the vaccine doses, the immune response is found to be good and that will provide the safety net.
Serum Institute of India has provided additional data to the SEC for review. Emergency clearance from the UK Medicines and Health Products Regulatory Agency has also helped the company push the vaccine in India.
Pfizer has asked for more time to provide data and for that reason only these two vaccines will be taken for review.
Dr. Sanjay Reddy, Lead Pharmacologist, said: “The committee is going to review the data from the last 40 days. The experts will debate it and decide what is best. This is new research and there are new strains emerging that pose a great challenge. The clinical contributions of both companies are very important for an EUA. The decision will be based on what the clinical outcome of these vaccines is. “
Pharmacologists who are studying the different data and reports of compliance and adverse reactions in different countries claim that it is a “wait and see” policy.
A senior pharmacologist, on condition of anonymity. said. “We have a new strain that is also cause for concern. In light of these mutations, the most important thing is safety and efficacy. Both aspects should be considered before making the decision. Emergency use authorization is a new concept in India and the mentality of people to accept a vaccine is a concern. We have to hope for the best. “
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