Covaxin Well-Tolerated, Induces Immune Response: Phase 1 Findings

“The vaccine was well tolerated in all dose groups with no vaccine-related serious adverse events.”

Bharat Biotech on Tuesday, 16 December, released the interim findings from the phase 1 trial of Covaxin, its vaccine candidate against COVID-19, saying it "induced (a) neutralising antibody (an immune response)“ and "was well-tolerated in all dose groups with no vaccine-related serious adverse events”.

"After the first vaccination, local and systemic adverse events were predominantly mild/moderate in severity and were resolved rapidly, without prescribed medication. The most common adverse event was pain at injection site which resolved spontaneously," the firm said as part of its interim findings.

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 The study is a preprint and has not been peer-reviewed.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

Bharat Biotech officials, as quoted in Medrexiv

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 percent effective based on earlier trial results.

Earlier, Dr Sanjay Roy, principal investigator (PI) heading its clinical trial at AIIMS, told IANS that the vaccine is likely to be available for use by 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 immunisation programme cold-chain requirements

Covaxin is among the three vaccine candidates that have applied for emergency use authorisation (EUA) to the Drug Controller General of India (DCGI). The other two are Pfizer's vaccine candidate and Covishield, the vaccine candidate of Oxford-AstraZeneca, which is being produced in collaboration with the Serum Institute of India.