A medic fills a syringe with Covaxin before administering it to a health worker during its trials (Reuters)
Several experts have raised questions on the approval process of the two Covid-19 vaccines, Covishield of Serum Institute and Covaxin of Bharat Biotech by the drug controller general of India (DCGI).
Former president of the International Association of Bioethics, Dr Anant Bhan, pointed out that the only other countries to approve vaccines without making the efficacy data public were Russia and China. "It is important to build confidence in the regulatory process. But here, a lot of clinicians are unsure and they are asking which vaccine actually works. There is no confidence in the way the approvals were done and in a language that seems to be more creative writing than based on any law," said Dr Bhan.
Those who waited for clarification from the briefing by DCGI this morning were disappointed as no questions were allowed after a statement was read out by the DCGI.
"In the case of each approved vaccine, there is no information regarding the specific provision of the law under which the DCGI is granting Restricted Emergency Use (REU) approval. Neither has information been provided regarding the conditionalities attached to either approval," said Malini Aisola of the All India Drug Action Network (AIDAN). AIDAN has issued a statement requesting the regulator to make all the data and analyses that were the basis of these decisions publicly available so that they can be independently verified.
Dr Gangandeep Kang, noted vaccine expert and AIDAN have questioned the claim that Covaxin would work against the UK strain of Covid pointing out that there was no data or scientific basis to back the claim.
"What is the local efficacy data on the basis of which the expert committee recommended approval for the two vaccines? It is shocking that while Bharat Biotech is struggling to complete recruitment of volunteers for phase-3 trial, the approval was given. So what did the SEC base the approval on?" asked Dr Amar Jesani, editor of the Indian Journal of Medical Ethics.
"We need to wait for at least the early results from that Bharat Biotech phase-3 trial before approval. Yes, there is a pandemic, and we need vaccines. But it is equally important that the public have absolute trust in a vaccine that is approved," said Dr JN Rao, an independent public health physician, researcher, and visiting professor at Staffordshire University.