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NEW DELHI: Hyderabad-based vaccine major Bharat Biotech has announced that its Covid-19 vaccine candidate Covaxin, during its testing on animal rhesus macaques, has develop a “robust immune response” to the highly infectious coronavirus, “preventing infection and disease in the primates upon high amounts of exposure to live SARS-CoV-2 virus”.
The tests on animals, whose detailed results were made public now, were conducted prior to the human trials, which commenced on July 15. Under the phase-1 human trials, 375 were volunteers and under the phase-II trial, which is still under way, approximately 1,200 volunteers are being administered Covaxin shots, as per reports on volunteers.
Explaining the tests on animals, Bharat Biotech stated on Friday, “A two-dose vaccination regimen of inactivated SARS-CoV-2 vaccine candidates was administered in 20 rhesus macaques (divided into four groups equally). One group was administered with placebo, while three groups were immunised with three different vaccine candidates at 0 and 14 days. All the macaques were exposed to viral challenge 14 days after the second dose.”
On the animal test results, it 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.” “These results demonstrate the protective efficacy in a live viral challenge model,” the company tweeted.
Besides, developing Covaxin in collaboration with NIV-Pune, Bharat Biotech is simultaneously working on nasal vaccine CoroFlu against Covid-19 in collaboration with American researchers of University of Wisconsin, Madison, and is also leading a CSIR-sanctioned project to develop human monoclonal antibodies as therapy for Covid infection.
Each stage of Covaxin’s clinical trial is meant to test its safety and ability to develop an effective immune response. Phase-1 trial focused on determining safety and dosage in a small group of healthy participants, while phase-II looks at the vaccine’s effectiveness. Phase III, which is yet to start, will look into these aspects in a much larger population that would represent a wider demographic.
With Serum Institute halting the trials in India on its vaccine, being developed in collaboration with AstraZeneca and Oxford University, after an illness in a study subject in Britain, Covaxin is supposed to be leading the race in the development of an indigenous Covid vaccine.
Watch Animal trial of Covaxin gets robust immune responses, says Bharat Biotech
The tests on animals, whose detailed results were made public now, were conducted prior to the human trials, which commenced on July 15. Under the phase-1 human trials, 375 were volunteers and under the phase-II trial, which is still under way, approximately 1,200 volunteers are being administered Covaxin shots, as per reports on volunteers.
Explaining the tests on animals, Bharat Biotech stated on Friday, “A two-dose vaccination regimen of inactivated SARS-CoV-2 vaccine candidates was administered in 20 rhesus macaques (divided into four groups equally). One group was administered with placebo, while three groups were immunised with three different vaccine candidates at 0 and 14 days. All the macaques were exposed to viral challenge 14 days after the second dose.”
On the animal test results, it 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.” “These results demonstrate the protective efficacy in a live viral challenge model,” the company tweeted.
Besides, developing Covaxin in collaboration with NIV-Pune, Bharat Biotech is simultaneously working on nasal vaccine CoroFlu against Covid-19 in collaboration with American researchers of University of Wisconsin, Madison, and is also leading a CSIR-sanctioned project to develop human monoclonal antibodies as therapy for Covid infection.
Each stage of Covaxin’s clinical trial is meant to test its safety and ability to develop an effective immune response. Phase-1 trial focused on determining safety and dosage in a small group of healthy participants, while phase-II looks at the vaccine’s effectiveness. Phase III, which is yet to start, will look into these aspects in a much larger population that would represent a wider demographic.
With Serum Institute halting the trials in India on its vaccine, being developed in collaboration with AstraZeneca and Oxford University, after an illness in a study subject in Britain, Covaxin is supposed to be leading the race in the development of an indigenous Covid vaccine.
Watch Animal trial of Covaxin gets robust immune responses, says Bharat Biotech
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