Dry trial of the vaccine January 2 in all state capitals

Hyderabad: The authorization for emergency use of Covaxin by Bharat Biotech and Covishield by Serum Institute of India will be taken up by the committee of experts on the matter on January 1.

Additional data and information on the Phase 3 trials has been submitted by both companies. A review of the data has been completed and the Central Pharmaceutical Standards Supervisory Organization’s Subject Matter Expert Committee will further analyze them. Bharat Biotech has carried out phase 3 trials on more than 13,000 volunteers. Their target is 26,000 volunteers.

Meanwhile, on January 2, a Covid-19 vaccination trial will be carried out in all state capitals to test the links between planning and implementation and identify challenges. It is proposed that the activity be carried out in at least 3 session sites in each capital.

The dry run is a mock exercise to ensure all requirements for participants, healthcare workers, website data upload, and adverse event preparedness are in place.

There will be 25 beneficiaries of the test who will be health workers. Their data must be uploaded into the Co-WIN (Covid Vaccine Intelligence Network) application. The space of the public health center, the waiting room, the logistics organization, Internet connectivity, electricity and security must be calculated on the model sites.

Covid 19 safety protocols in terms of masks and social distancing must be followed. The designated center must have a cold chain for the storage and administration of vaccines.

An important goal of the dry trial is the management of any adverse event after vaccination. Therefore, there must be an emergency team in place to handle the situation.

In a peer-reviewed journal, data published by Bharat Biotech indicates that long-term antibody and T-cell memory responses were noted three months after vaccination in phase 1 trials. 2, the vaccine was found to be safe and the cell-mediated immune response was enhanced. After doses of the vaccine, it is found that the immune response is good and that this will provide the safety net.

The Serum Institute of India has provided additional data to the SEC for review. Emergency clearance by the UK Medicines and Health Products Regulatory Agency has also played a role in promoting the vaccine in India.

Pfizer has requested more time to provide data and for this reason only these two vaccines will be reviewed.

Senior Pharmacologist Dr Sanjay Reddy said, “The committee will be looking at data from the past 40 days. Experts will debate it and decide what is best. This is new research and new emerging strains pose many challenges. The clinical contributions of the two companies are very important for an EUA. The decision will be based on the clinical production of these vaccines. “

Pharmacologists who study the different data and reports of adherence and adverse reactions in different countries say that this is a “wait and watch” policy.

A senior pharmacologist, on condition of anonymity. said. “We have a new strain which is also of concern. In light of these mutations, what is most important is safety and efficacy. These two aspects must be taken into account before making a decision. Emergency use authorization is a new concept in India and the mindset of people to accept a vaccine is a concern. We must hope for the best. “

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