Guwahati: Hyderabad-based firm Bharat Biotech has announced that the animal trials of its Covid-19 vaccine candidate Covaxin have been successful, adding that it has demonstrated protective efficacy and immunogenicity in non-human primates in Phase I clinical trials held in India.
"Bharat Biotech proudly announces the animal study results of COVAXIN - These results demonstrate the protective efficacy in a live viral challenge model," the firm twitted via its official handle.
According to a statement attached to the tweet, the Hyderabad-based firm Bharat Biotech developed and assessed the efficacy and immunogenicity of an inactivated SARS-CoV-2 vaccine (BBV152) or Covaxin in rhesus macaques (Macaca mulata).
Twenty macaques who were tested on were divided into four groups of five animals each.
While one group was administered a placebo, three groups were immunized with three different vaccine candidates at 0 and 14 days.
All the macaques were challenged with SARS-CoV-2 14 days after the second dose.
The protective response was observed with increasing SARS-CoV-2 specific IgG and neutralizing antibody titres from third-week post-immunisation, the firm said in its statement.
It added that viral clearance was observed from bronchoalveolar lavage fluid, nasal swab, throat swab, and lung tissues at 7 days post-infection in the vaccinated groups.
Bharat Biotech said that "the vaccine candidate was found to generate robust immune responses, thus preventing infection and disease in the primates upon high amounts of exposure to live SARS-CoV-2 virus."
The ICMR and Bharat Biotech International are working together on developing the COVID-19 vaccine candidate Covaxin. A phase I/II clinical trial of Covaxin on 1,125 patients at 12 institutes across India is currently being conducted.
Bharat Biotech early this month received approval from the Central Drugs Standard Control Organisation to conduct the Phase-II trials of its vaccine candidate.
On June 29, the Hyderabad-based firm had announced that it had successfully developed Covaxin in collaboration with the ICMR and the NIV.