India-made Covaxin showed 81% interim efficacy: Bharat Biotech on Phase 3 results
New Delhi, Mar 03: Bharat Biotech's coronavirus vaccine - Covaxin has shown an interim vaccine efficacy of 81% in late-stage clinical trials, the Hyderabad-based company said on Wednesday.
"Covaxin demonstrated 81% interim efficacy in preventing Covid-19 in those without prior infection after the second dose," the company said in a statement.
The trials involved 25,800 participants and were conducted in partnership with ICMR, the Indian government's medical research body.
The Phase 3 study enrolled participants between 18-98 years of age, including 2,433 over the age of 60 and 4,500 with comorbidities, it added.
"Clinical trial to continue through to final analysis at 130 confirmed cases in order to gather further data and to evaluate the efficacy of COVAXIN in additional secondary study endpoints," the company further said.
The first interim analysis is based on 43 cases, of which 36 cases of COVID-19 were observed in the placebo group versus 7 cases observed in the COVAXIN group, resulting in a point estimate of vaccine efficacy of 80.6 per cent, Bharat Biotech said.
'Today is an important milestone in vaccine discovery, for science and our fight against coronavirus. With today's results from our Phase 3 clinical trials, we have now reported data on our COVID-19 vaccine from Phase 1, 2, and 3 trials involving around 27,000 participants,' Bharat Biotech Chairman & Managing Director Krishna Ella said.
Covaxin demonstrates a high clinical efficacy trend against COVID-19 but also significant immunogenicity against the rapidly emerging variants, he added.
COVAXIN and the AstraZeneca vaccines were approved by India's regulator in January.
Covishield had shown an efficacy rate of 70 per cent after two full doses. However, one of the regimens with a half dose and a full dose showed 90 per cent efficacy against the virus.
Bharat Biotech said the interim analysis of its vaccine included a preliminary review of the safety database, which showed that severe, serious, and medically attended adverse events occurred at low levels and were balanced between vaccine and placebo groups, the company said.
The trial's conduct and monitoring are as per good clinical practice guidelines and have been outsourced to IQVIA, it added.
'Analysis from the National Institute of Virology indicates that vaccine-induced antibodies can neutralize the UK variant strains and other heterologous strains,' Bharat Biotech said.
The company expects to share further details of the trial results as additional data becomes available, it noted.
Additional interim analysis is planned for 87 cases, and the final analysis is planned for 130 cases, the company said. All data from the second interim and final analyses will be shared via pre-publication servers as well as submitted to a peer-reviewed journal for publication, it added.
Bharat Biotech said more than 40 countries globally have expressed their interest in Covaxin.
Covaxin Side effects: Those with history of allergies, bleeding disorder, fever or blood thinner are immune compromised or are on a medicine that affects the immune system, pregnant, breastfeeding or have received another COVID-19 vaccine must not take Covaxin.
The side-effects are injection site pain, inspection site swelling, injection side redness, injection site itching, fever, malaise, weakness, rashes, nausea, vomiting, stiffness in the upper arm, weakness in injection arm, body ache, headache.