Animal trials of Bharat Biotech International Limited’s Covid-19 vaccine candidate, Covaxin, have been successful and results showed the injection’s “remarkable immunogenicity and protective efficacy” in phase I clinical trials in India, the manufacturer said. of medications.
Covaxin, developed by the Indian Council for Medical Research (ICMR) and Bharat Biotech, is being tested in 12 institutes in India. The Hyderabad-based firm said data from the primate study corroborates the immunogenicity of the candidate vaccine.
“Bharat Biotech proudly announces the results of the COVAXIN animal study. These results demonstrate the protective efficacy in a live viral challenge model,” Bharat Biotech tweeted on Friday.
Bharat Biotech has said in a statement that it developed and evaluated the protective efficacy and immunogenicity of an inactivated Sar-CoV-2 (BBV152) or Covaxin vaccine in rhesus macaques. Twenty macaques were divided into four groups of five animals each, he said.
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“One group was given a placebo while three groups were immunized with three different candidate vaccines at 0 and 14 days. All macaques were challenged with SARS-CoV-2 14 days after the second dose. The protective response was observed with an increase in specific IgG against SARS-CoV-2 and neutralizing antibody titers from the third week after immunization, ”said the pharmaceutical company.
He added that viral clearance was seen from “bronchoalveolar lavage fluid, nasal swab, throat swab, and lung tissues at 7 days after infection in vaccinated groups.”
“No evidence of pneumonia was observed in the histopathological examination in the vaccinated groups, unlike the placebo group that showed characteristics of interstitial pneumonia and localization of viral antigen in the alveolar epithelium and macrophages by immunohistochemistry,” he added.
“To summarize, the candidate vaccine was found to generate strong immune responses. Thus, infection and disease in primates is prevented after large amounts of exposure to the live SARS-CoV-2 virus, “he added.
Bharat Biotech had received approval from the Central Drug Standard Control Organization to conduct the Phase II trials earlier this month. In June he announced that he had successfully developed Covaxin in collaboration with ICMR and the National Institute of Virology (NIV).
The SARS-CoV-2 strain was isolated in NIV, Pune and transferred to Bharat Biotech. The inactivated native candidate vaccine has been developed and manufactured at Bharat Biotech’s high containment facility located in Genome Valley, Hyderabad.
Covaxin is one of the pioneers in the race for a Covid-19 vaccine in India. It is an “inactivated” vaccine: it works by injecting doses of the virus that have died in order to incite the body to produce antibodies against it without the virus posing a threat.
Each stage of the clinical trial of a vaccine tests its safety and ability to develop an effective immune response. Phase 1 focuses on determining safety and dosage in a small group of healthy participants, while Phase 2 looks at the efficacy of the vaccine. Phase 3 looks at these issues in a much larger population that would represent a larger demographic.
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