Expert panel to review Biotech and Serum data
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. Their target is 26,000 volunteers.
Meanwhile, on January 2, a dry run for Covid-19 vaccination will be conducted at all state capitals to 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 model sites.
Safety protocols of Covid 19 in terms of masks and social distancing have to be followed. 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. After doses of the vaccine it is found that the immune response is good and that will provide the safety net.
Serum Institute of India has 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 review.
Dr Sanjay Reddy, senior pharmacologist, said, “The committee is going to review the data of the last 40 days. 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. Decision will be based on what is the clinical output of these vaccines.”
Pharmacologists who are studying the different data and the reports of compliance and adverse reactions across different countries state that it is a ‘wait and watch’ policy.
A senior pharmacologist, on condition of anonymity. said. “We have a new strain which is also a concern. 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. We have to hope for the best."