NEW DELHI: Hyderabad-based leading vaccine Bharat Biotech has announced that its Covid-19 vaccine candidate, Covaxin, during its tests on animal rhesus macaques, has developed a “robust immune response” to the highly infectious coronavirus, “preventing infections and diseases in primates after large amounts of exposure to the live SARS-CoV-2 virus ”.
The animal tests, the detailed results of which have now been made public, came ahead of the human tests, which began on July 15. In the phase 1 human trials, 375 were volunteers and in the phase II trial, which is still being done in this manner, approximately 1,200 volunteers are being given injections of Covaxin, according to reports from the volunteers.
Explaining the animal tests, Bharat Biotech stated on Friday: “A two-dose vaccination regimen of inactivated SARS-CoV-2 vaccine candidates was administered to 20 rhesus macaques (divided into four equally groups). One group was given placebo, while three groups were immunized with three different candidate vaccines at 0 and 14 days. All the macaques were exposed to the viral challenge 14 days after the second dose. ”
Regarding the results of the animal tests, he said: “The results showed a protective efficacy, increasing the specific IgG of SARS-CoV-2 and neutralizing antibodies, reducing the replication of the virus in the nasal cavity, throat and lung tissues. monkey. No evidence of pneumonia was observed by histopathological examination in the vaccinated groups, unlike the placebo group. No adverse events were observed in animals immunized with a two-dose vaccination regimen. “” These results demonstrate protective efficacy in a live viral challenge model, “the company tweeted.
Additionally, by developing Covaxin in collaboration with NIV-Pune, Bharat Biotech is simultaneously working on the CoroFlu nasal vaccine against Covid-19 in collaboration with American researchers from the University of Wisconsin, Madison, and is also leading a CSIR-approved project to develop human monoclonal antibodies. as therapy for Covid infection.
Each stage of the Covaxin clinical trial is designed to test its safety and ability to develop an effective immune response. The phase 1 trial focused on determining safety and dosage in a small group of healthy participants, while phase II looked at the efficacy of the vaccine. Phase III, which has not yet begun, will look at these issues in a much larger population that would represent a broader demographic.
With the Serum Institute halting trials in India on its vaccine, which is being developed in collaboration with AstraZeneca and the University of Oxford, following an illness in a study subject in Britain, Covaxin is supposed to be leading the race in development. of a native Covid vaccine.
On video: Covaxin animal trial elicits strong immune responses, says Bharat Biotech
The animal tests, the detailed results of which have now been made public, came ahead of the human tests, which began on July 15. In the phase 1 human trials, 375 were volunteers and in the phase II trial, which is still being done in this manner, approximately 1,200 volunteers are being given injections of Covaxin, according to reports from the volunteers.
Explaining the animal tests, Bharat Biotech stated on Friday: “A two-dose vaccination regimen of inactivated SARS-CoV-2 vaccine candidates was administered to 20 rhesus macaques (divided into four equally groups). One group was given placebo, while three groups were immunized with three different candidate vaccines at 0 and 14 days. All the macaques were exposed to the viral challenge 14 days after the second dose. ”
Regarding the results of the animal tests, he said: “The results showed a protective efficacy, increasing the specific IgG of SARS-CoV-2 and neutralizing antibodies, reducing the replication of the virus in the nasal cavity, throat and lung tissues. monkey. No evidence of pneumonia was observed by histopathological examination in the vaccinated groups, unlike the placebo group. No adverse events were observed in animals immunized with a two-dose vaccination regimen. “” These results demonstrate protective efficacy in a live viral challenge model, “the company tweeted.
Additionally, by developing Covaxin in collaboration with NIV-Pune, Bharat Biotech is simultaneously working on the CoroFlu nasal vaccine against Covid-19 in collaboration with American researchers from the University of Wisconsin, Madison, and is also leading a CSIR-approved project to develop human monoclonal antibodies. as therapy for Covid infection.
Each stage of the Covaxin clinical trial is designed to test its safety and ability to develop an effective immune response. The phase 1 trial focused on determining safety and dosage in a small group of healthy participants, while phase II looked at the efficacy of the vaccine. Phase III, which has not yet begun, will look at these issues in a much larger population that would represent a broader demographic.
With the Serum Institute halting trials in India on its vaccine, which is being developed in collaboration with AstraZeneca and the University of Oxford, following an illness in a study subject in Britain, Covaxin is supposed to be leading the race in development. of a native Covid vaccine.
On video: Covaxin animal trial elicits strong immune responses, says Bharat Biotech
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