Covaxin animal trials generated ‘robust immune response’: Bharat Biotech

New Delhi, Sep 12: Animal trials of Bharat Biotech's Covid-19 vaccine candidate, Covaxin, has helped develop a strong immune response to the highly infectious coronavirus.

"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," Bharat Biotech posted on its website.

"These results demonstrate the protective efficacy in a live viral challenge model," the company tweeted.

"One group was administered with placebo, while 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 the second dose," Bharat Biotech said.

"The results showed protective efficacy, increasing SARS-CoV-2 specific IgG and neutralising antibodies, reducing replication of the virus in the nasal cavity, throat, and lung tissues of monkey. No evidence of pneumonia was observed by histopathological examination in vaccinated groups, unlike the placebo group. Adverse events were not seen in animals immunised with a two-dose vaccination regimen," the drug company said.

Bharat Biotech started human trials in July after getting approval from the country's drug regulatory body.

Another indigenous vaccine candidates -- Zydus Cadila has finished phase 1 of human trials and have moved to phase 2.

The Serum Institute of India (SII) on Thursday announced that it has paused clinical trials of AstraZeneca Oxford COVID-19 vaccine candidate in the country

Earlier this week, pharma giant AstraZeneca had said it had paused the trials because of ''an unexplained illness'' in a participant in the study.

The Drugs Controller General of India had issued a show-cause notice to the SII for not informing it about AstraZeneca pausing the clinical trials of the Oxford vaccine candidate for COVID-19 in other countries and also for not submitting a casualty analysis of the "reported serious adverse events".