The animal experiments show that COVAXIN protects against SARS-CoV-2 and increases two types of antibodies that are necessary for a strong immune response against the virus.
An example of COVAXIN, the vaccine candidate for COVID-1
Indian vaccine maker Bharat Biotech recently released the results of its COVID-19 vaccine candidate safety trials on animals on September 13th. The experimental shot called “COVAXIN” was found to be safe in rhesus monkeys that had been vaccinated and exposed to SARS-CoV-2.
The Drugs Controller General of India (DCGI), India’s regulator, approved Phase I and II trials of the vaccine in June.
Co-developed with the Indian Council for Medical Research (ICMR) and the National Institute of Virology (NIV), Covaxin is an inactivated vaccine candidate. The inactivated vaccine is designed to produce unique elements of the SARS-CoV-2 virus that are used by the immune system to detect a threat if the entire virus is ever encountered in the real world.
Here are ten things we learned about the COVAXIN animal testing.
- The animal experiment (part of phase I) was a Test of how safe (three different formulations) of the inactivated COVID-19 vaccine was in rhesus monkeys. That was also measured Shot ability to provide protection against exposure to the SARS-CoV-2 virus.
- The experimental COVAXIN recordings are supposed to elicited “robust” immune responses in monkeys. It prevented SARS-CoV-2 infection and COVID-19 in all monkeys given the vaccine. The vaccinated monkeys did not develop COVID-19 even when exposed to high levels of live SARS-CoV-2 virus through artificial stress.
- The vaccine was tested in 20 rhesus monkeys, which were divided into 4 groups of 5 people each. One group received a placebo, while the other three groups were immunized with 3 different vaccine candidates on day 0 and day 14. A fortnight after the second shot the macaques became scientists challenged her with living SARS-CoV-2 virus.
- The Two-dose regimen (which consists of a 3 µg dose of the vaccine candidate along with an adjuvant that boosts the immune response) produced a “significant immune response” and offered protection against the SARS-CoV-2 virus, experts said.
- The results from animal experiments show that COVAXIN protected monkeys against the SARS-CoV-2 virus. There has been an increase in two types of antibodies that are needed for a strong immune response – antibodies that can neutralize the SARS-CoV-2 virus and an important class of antibodies that are used to fight infection (SARS-CoV -2-specific IgG). This indicates that the experimental vaccine might be similar Reduce the amount of virus Replication in the airways and organs such as the nasal cavity, throat, and lung tissue.
- The protective response of COVAXIN appears to be much better by the third week of immunization, according to the report. This was the point in time when the levels of SARS-CoV-2 specific IgG and neutralizing antibodies were significantly higher than at other points in time in the study.
- No pneumonia after viral infection. There was no evidence of pneumonia in the vaccinated macaques. Pneumonia has proven to be a key indicator in severe COVID-19 cases. When the placebo group was challenged with the SARS-CoV-2 virus, the monkeys showed interstitial pneumonia and virus particles in the lung tissue, indicating that the infection was ongoing.
- Side effects. The study report claims that no adverse effects were observed in the animals with the two-dose vaccination schedule, which is an encouraging finding for the ongoing human safety studies.
- Phase I studies in humans are still ongoing. The information gathered from the Phase I trial demonstrates the immunogenicity of the vaccine candidates and BBV152 is being evaluated in Phase I clinical trials in India (NCT04471519). The Phase I study involved 375 volunteers at 12 locations across the country, including the PGI and the All India Institute of Medical Sciences (AIIMS) in Delhi. It is expected to be completed by the end of this month.
- The report will be peer-reviewed. The study was pre-published in Nature researchand is still waiting for peer review.