Bharat Biotech’s Covaxin Well Tolerated, Shows 65% Efficacy Against Delta Variant: Lancet Study

More than 12 crore doses of Covaxin have been administered so far since the beginning of the vaccination campaign in January.

Written by: India.com News Desk Edited by: Analiza Pathak

Updated: November 12, 2021, 8:40 AM IST

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https://www.india.com/news/india/bharat-biotechs-covaxin-shows-78-efficacy-against-covid-delta-varient-presents-no-safety-concerns-lancet-study-5092518/ Copy

Bharat Biotech's Covaxin Shows 78% Efficacy Against Covid, Presents No Safety Concerns: Lancet Study

New Delhi: Bharat Biotech’s indigenous Covid-19 vaccine is highly efficacious, well tolerated and presents no safety concerns, a new study published in The Lancet has said. The medical journal said that Covaxin has been found to have a 77.8% efficacy rate against symptomatic Covid-19 patients.

Covaxin, which uses traditional, inactivated-virus technology, “induces a robust antibody response” two weeks after two doses are given. The study further added that no severe-vaccine-related deaths or adverse events were recorded during a randomized trial involving 24,419 participants aged 18-97 years between Nov. 2020 and May 2021 in India.

It said that the this phase 3 study was done during the second wave of Covid-19 infections in India, with a peak of more than 400 000 new cases per day when Covaxin was assessed against all ciruclating variants.

“The study confirms our previous observations on the safety and immunogenicity profiles of BBV152 in phase 1 and 2 trials. No safety concerns were raised, no anaphylactic events after BBV152 administration were reported, and all adverse events (solicited, unsolicited, and serious adverse events) were well balanced between the BBV152 and placebo groups,” it said.

During the study only one serious adverse event occurred in the vaccine group; a case of immune thrombocytopenic purpura 39 days after the second dose in a vaccine recipient who was SARS-CoV-2-seropositive at baseline. However, the event resolved in 4 days, it said. “All other serious adverse events were deemed unrelated to vaccine or placebo. Long-term safety monitoring is ongoing and will continue for 1 year after administration of the first dose of BBV152,” the Lancet said.

Here are the main findings from the journal:

• Covaxin shows a 77.8 percent efficacy against symptomatic COVID-19 and a 63.6 percent protection against asymptomatic COVID-19
• The analysis demonstrates Covaxin to be 93.4 percent effective against severe symptomatic COVID-19
• Covaxin demonstrates a 65.2 percent efficacy against the easily transmissible Delta variant of coronavirus
• Efficacy data demonstrates 70.8 percent protection against all variants of SARS-CoV-2 virus
• Data also revealed that only 12 percent subjects experienced side effects on taking Covaxin and less than 0.5 percent experienced serious adverse events

The Lancet publication comes a week after Covaxin received the World Health Organisation’s (WHO) approval for emergency use listing, easing the life for lakhs of Indians whose international travel plans were hit due to the non-recognition of the shot.

More than 12 crore doses of Covaxin have been administered so far since the beginning of the vaccination campaign in January.

No severe vaccine-related adverse events were observed during the trial as most adverse events were mild and included headache, fatigue, and injection site pain.