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(Video Editor: Hera Khan)
On Sunday, 3 January, Covaxin became India's first indigenously produced vaccine against the novel coronavirus to get 'emergency approval in 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.
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 in case 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.
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 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 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The study is a preprint and has not been peer-reviewed.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.'
(This story was first published on FIT and has been republished here with permission.)
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