Covaxin Vaccine Triggers Immune Response In Phase 1 Trial
The most common adverse event was pain at the site of infection which was resolved immediately.
India’s indigenous vaccine candidate 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 The study is a preprint and has not been peer-reviewed.
“Only one serious adverse event was reported, which was found to be unrelated to vaccination. Local and systemic adverse events were predominantly mild/moderate in severity & resolved rapidly, without prescribed medication.”Bharat Biotech officials as quoted in Medrexiv
The most common adverse event was pain at the site of infection, and as per the paper, this was resolved immediately,
Currently, Bharat Biotech and Indian Council of Medical Research (ICMR)'s Covaxin is simultaneously undergoing Phase 3 human trials across 22 sites in India with around 26,000 volunteers. According to a top official from the company, it will be at least 60 per cent effective based on earlier trial results. It has also applied for emergency use authorisation (EUA) to the Drug Controller General of India (DCGI) on 7 December - but an independent expert committee of the Central Drugs Standard Control Organisation (CDSCO) sought additional safety and efficacy data.
Earlier, Dr Sanjay Roy, principal investigator (PI) heading its clinical trial at AIIMS, told IANS the vaccine is likely to be available for use of the general public by the end of February 2021.
A big concern for vaccine developers is cold-chain logistics, but Covaxin needs to be stored between 2°C and 8°C which makes it compatible with the national immunization programme cold chain requirements
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