What Are the Main Concerns With COVAXIN’s Approval?

“There should be more transparency and detailed data being made available about the approval process,” says Dr Bhan

Updated

(Video Editor: Hera Khan)

“We are all supporters of Indian innovation and science but the worrying part about covaxins approval is that the process is opaque.”
Dr Anant Bhan, Adjunct Professor & Researcher in Bioethics at Mangaluru’s Yenepoya University

On Sunday, January 3, COVAXIN became India's first indigenously produced vaccine against the novel coronavirus to get 'emergency approval for public health interest.' The vaccine has been developed by pharma major Bharat Biotech in collaboration with Indian Council of Medical Research (ICMR) and National Institute of Virology (NIV).

But this approval raises many questions, especially since phase 3 clinical trials are still ongoing and no efficacy data has been published so many are worried about the public health effects of this 'rushed' approval.

We speak to Dr Anant Bhan, Adjunct Professor & Researcher in Bioethics at Mangaluru’s Yenepoya University, to find out more.

AIIMS director Dr Randeep Guleria, in an interview with NDTV, said that Serum Institute's Covishield will be India's main go to vaccine. He said that Covaxin vaccine has been given "a limited approval to be used incase the Serum vaccine appears to be not that effective, or in case the UK mutant virus causes the number of cases to go up dramatically." He also mentioned that data will continued to be collected and studied.

“There have been emergency approvals in India, for example during Ebola. But the usual requirement is more transparency around data. There should be more transparency and detailed data being made available about the approval process so that people can make an independent, informed decision about the vaccine.”
Dr Anant Bhan, Adjunct Professor & Researcher in Bioethics

What efficacy does the vaccine offer? Has the data been peer reviewed?

We don't exactly know. The company has submitted multiple data to the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO). They've been asked to keep the SEC updated with all new information, data as it emerges. An efficacy of a vaccine can only be determined after it has gone through large scale phase III trials, which are still ongoing.

Covaxin has released phase 1 data which showed success in inducing an immune response and no serious adverse events in any of their 375 volunteers.

The interim findings of the phase 1 trial data were published in Medrexiv, and revealed promising results indicating a successful, tolerable vaccine.

The most common adverse event was pain at the site of infection, and as per the paper, this was resolved immediately.

The study is a preprint and has not been peer-reviewed.

Earlier, a preprint of an animal study was released that also showed 'robust immune response.'

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