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Opaque Vaccine Approval Process: Experts | India News


Several experts have raised questions about the approval process for the two Covid-19 vaccines, Covishield of Serum Institute and Covaxin of Bharat Biotech by the Controller General of Medicines of India (DCGI).
Former President of the International Bioethics Association, Dr. Anant Bhan, noted that the only other countries that approved vaccines without releasing efficacy data were Russia and China. “It is important to build trust in the regulatory process. But here, many doctors are unsure and wondering which vaccine really works. There is no confidence in the way the approvals were done and in language that looks more like creative writing than based on any law, “Dr. Bhan said.
Those who waited for clarification from DCGI’s briefing this morning were disappointed that no questions were allowed after DCGI read a statement.
“For each approved vaccine, there is no information on the specific provision of law under which the DCGI is granting the Emergency Restricted Use (REU) approval. Nor has information been provided on the conditionality attached to any of the approvals, “Malini said. Aisola from All India Drug Action Network (AIDAN). AIDAN has issued a statement requesting the regulator to make all the data and analysis that were the basis for these decisions available to the public so that they can be independently verified.
Leading vaccine expert Dr Gangandeep Kang and AIDAN have disputed the claim that Covaxin would work against the UK strain of Covid, noting that there was no data or scientific basis to support the claim.
“What are the local efficacy data on the basis of which the expert committee recommended approval of the two vaccines? It is shocking that while Bharat Biotech is struggling to complete the recruitment of volunteers for the phase 3 trial, it has been approval granted. SEC bases approval on? “asked Dr. Amar Jesani, editor of the Indian Journal of Medical Ethics.
“We need to wait at least for the first results of that phase 3 trial of Bharat Biotech before its approval. Yes, there is a pandemic and we need vaccines. But it is equally important that the public have absolute confidence in a vaccine that is approved,” he said Dr JN Rao, Independent Public Health Physician, Researcher and Visiting Professor at the University of Staffordshire.

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