Bharat Biotech’s Covaxin has 77.8% efficacy rate, presents no safety concerns
Bharat Biotech’s indigenous Covid-19 vaccine is highly efficacious, well tolerated and presents no safety concerns, a new study published in the reputed medical journal The Lancet has said.
Bharat Biotech’s Covaxin found to have a 77.8% efficacy rate against symptomatic Covid-19 patients, The Lancet added.
Covaxin “induces a robust antibody response” two weeks after two doses are given, it said.
“Covaxin’s Phase 3 efficacy results have been peer-reviewed and published in The Lancet. Another milestone for Indian science, not much more to be said,” tweeted Raches Ella, clinical lead, Covid-19 vaccines at Bharat Biotech.
According to the study, no severe-vaccine-related deaths or adverse events were recorded during a randomised trial involving 24,419 participants aged 18-97 years between November 2020 and May 2021 in India, the medical journal further said.
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.
The proportion of participants reporting any adverse events within 7 days after vaccination was lower after the second dose than after the first dose, the Lancet revealed.
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