New Delhi (NVI): The Hyderabad-based pharmaceutical company Bharat Biotech announced that the animal trials of its COVID-19 vaccine candidate COVAXIN were successful and generated robust immune responses.
“Bharat Biotech proudly announces the animal study results of COVAXIN – These results demonstrate the protective efficacy in a live viral challenge model,” the Hyderabad-based firm said in a statement.
The vaccine candidate was found to generate robust immune response. Thus, preventing infection and disease in the primates upon high amounts of exposure to live SARS-CoV-2 virus, it added.
The company said no adverse effects were seen in animals who were immunised with a two-dose regimen of the vaccine.
Bharat Biotech had tested its vaccine candidate on four groups of 20 rhesus macaques. The primates were administered a two-dose vaccination regimen of inactivated SARS-CoV-2 vaccine, the company said.
One group was administered with the placebo, three groups were immunised with three different vaccine candidates at zero and 14 days. All the macaques were exposed to viral challenge 14 days after they were given the 2nd dose.
“The results showed protective efficacy, increasing SARS-CoV-2 specific IgG and neutralizing antibodies, reducing replication of the virus in the nasal cavity, throat, and lung tissues of monkey,” the statement said.
“No evidence of pneumonia was observed by histopathological examination in vaccinated groups, unlike the placebo group,” it added.
Meanwhile, the human clinical trials of Bharat Biotech’s experimental vaccine are also underway. It was the first indigenous vaccine candidate to get the Drug Controller General of India’s approval for Phase I and Phase II clinical trials on June 29.
Earlier in July, the Indian Council for Medical Research (ICMR) wrote to 12 hospitals and medical institutions to speed up the trial process and launch COVAXIN by August 15 for public use.
The move was denounced by health and medical experts who said the ICMR’s proposed timeline would compromise patient safety and ethics.
COVAXIN was developed by Bharat Biotech in collaboration with the ICMR and the National Institute of Virology. It is an inactivated vaccine created from a strain of the deadly virus.