Hyderabad: A week after the World Health Organization (WHO) approved the Emergency Use List (EUL) covaxinThe Lancet, a reputed medical journal, has said that the Phase 3 data of India’s first indigenously developed vaccine demonstrates 77.8% efficacy against symptomatic COVID-19. Its efficacy data also demonstrates 70.8% protection against all forms of SARS-CoV-2.
The efficacy of Covaxin was ascertained through evaluation of 130 confirmed cases, of which 24 were observed in the vaccine group and 106 cases were in the placebo group. The two-dose inactivated virus vaccine was developed from scratch in India by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV) Pune.
Efficacy analysis showed that Covaxin (BBV152) is 93.4% effective against severe symptomatic COVID-19 and provides 63.6% protection against asymptomatic COVID-19. The Lancet said it is 65.2% effective against the delta version, 90.1% effective against the kappa version.
“BBV152 was well tolerated; A similar proportion of participants reported adverse events in the vaccine group [1597 out of 12879 (12.4%)] and placebo group [1597 of 12874 (12.4%)] There are no clinically significant differences in the distribution of solicited, unwanted, or serious adverse events between groups, and no cases of anaphylaxis or vaccine-related deaths,” the peer-reviewed journal observed.
Bharat Biotech said, Covaxin safety analysis shows that reported adverse events were similar to placebo, with 12% of subjects experiencing commonly known side effects and less than 0.5% of subjects experiencing serious adverse events. The Data Security Monitoring Board has not reported any security concerns related to the vaccine. The overall rate of adverse events seen in Covaxin was lower than that seen in Covid-19 vaccines. The safety profile of Covaxin is now well established”.
In a separate commentary in The Lancet, Chinese experts jing-shin liu and fang-kai NS Nanjing-based Jiangsu Provincial Centers for Disease Control and Prevention reported that all SARS-CoV-2 variants with the delta variant are considered the most dominant variant of concern globally, with significantly higher transmissibility than other VOCs, BBV152 stage 3. by report of results of Rachel’s Ella And the coworkers were a “welcome advance.”
“…In a Phase III trial of an inactivated SARS-CoV-2 vaccine (BBV152) based on the Asp614Gly variant, the authors found a substantial reduction in symptomatic COVID-19… In the study by Ella and colleagues, all In delta-positive cases in the U.S., the viral load in vaccine recipients was significantly lower than in placebo recipients,” he said, pointing to lower vaccine effectiveness in real-world studies of other vaccines, such as the vaccines developed pfizer and AstraZeneca.
Although Li and Zhu observed that the BBV152 study cohort was less ethnically diverse because only Indian participants were included, they said: “The study provides evidence of protection against asymptomatic infection that may be of public health importance, which is consistent with previous trials.” Not reported in other SARS-CoV-2 vaccines.
“Generally, clear protection against severe COVID-19 is most important, but the ability to prevent asymptomatic infection will protect against even mild disease, transmission, and may ultimately reduce post-severe COVID-19 cases.” Chinese experts said.
Zhu and Li also noted that the roll-out of the vaccine could reduce the ultra-cold chain requirements of other SARS-CoV-2 vaccine platforms, increase limited global manufacturing capacity, and insufficient supplies of vaccines. which can improve in low-income and middle-income countries.
Meanwhile, Bharat Biotech said the Lancet peer-review corroborated the efficacy analysis that demonstrated Covaxin to be effective against Covid-19 and that Covaxin is the only COVID-19 vaccine that has developed Phase III against the Delta variant. Has demonstrated efficacy data from clinical trials at 65.2%. ,
The President of Bharat Biotech, said, “An authoritative voice in global medicine, Covaxin Phase III clinical trial data in The Lancet is being peer-reviewed, data transparency and meeting the stringent peer-review standards of world-leading medical journals. validates our commitment to Managing Director Dr Krishna Ella.
In addition, Covaxin’s product development and clinical trial data have been published in 10 peer-reviewed journals, making Covaxin one of the most published Covid-19 vaccines in the world, he said.
Terming the partnership between Bharat Biotech, ICMR and NIV as one of the most successful public-private partnerships, Dr Balram Bhargava, Director General, ICMR said that the publication of efficacy data in the Lancet is very much about Covaxin’s strong position on the global front. Tells something – Runner Kovid-19 Vaccines.
Bhargava said, “Covaxin’s bedside journey in less than 10 months has showcased the immense power of ‘Atmanirbhar Bharat’ to fight barriers and create a niche in the global community along with Indian academia and industry. ”
The Phase III efficacy and safety study involved approximately 25,800 volunteers at 25 sites in India. To date, more than 150 million doses of Covaxin have been manufactured and supplied and are now being evaluated in controlled clinical trials in children aged 2-18 years.
The company has submitted data from children’s trials to the Indian drug regulator and its partner, OcuGen, has applied to the US Food and Drug Administration (USFDA) for emergency use authorization for pediatric use of Covaxin.
The efficacy of Covaxin was ascertained through evaluation of 130 confirmed cases, of which 24 were observed in the vaccine group and 106 cases were in the placebo group. The two-dose inactivated virus vaccine was developed from scratch in India by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV) Pune.
Efficacy analysis showed that Covaxin (BBV152) is 93.4% effective against severe symptomatic COVID-19 and provides 63.6% protection against asymptomatic COVID-19. The Lancet said it is 65.2% effective against the delta version, 90.1% effective against the kappa version.
“BBV152 was well tolerated; A similar proportion of participants reported adverse events in the vaccine group [1597 out of 12879 (12.4%)] and placebo group [1597 of 12874 (12.4%)] There are no clinically significant differences in the distribution of solicited, unwanted, or serious adverse events between groups, and no cases of anaphylaxis or vaccine-related deaths,” the peer-reviewed journal observed.
Bharat Biotech said, Covaxin safety analysis shows that reported adverse events were similar to placebo, with 12% of subjects experiencing commonly known side effects and less than 0.5% of subjects experiencing serious adverse events. The Data Security Monitoring Board has not reported any security concerns related to the vaccine. The overall rate of adverse events seen in Covaxin was lower than that seen in Covid-19 vaccines. The safety profile of Covaxin is now well established”.
In a separate commentary in The Lancet, Chinese experts jing-shin liu and fang-kai NS Nanjing-based Jiangsu Provincial Centers for Disease Control and Prevention reported that all SARS-CoV-2 variants with the delta variant are considered the most dominant variant of concern globally, with significantly higher transmissibility than other VOCs, BBV152 stage 3. by report of results of Rachel’s Ella And the coworkers were a “welcome advance.”
“…In a Phase III trial of an inactivated SARS-CoV-2 vaccine (BBV152) based on the Asp614Gly variant, the authors found a substantial reduction in symptomatic COVID-19… In the study by Ella and colleagues, all In delta-positive cases in the U.S., the viral load in vaccine recipients was significantly lower than in placebo recipients,” he said, pointing to lower vaccine effectiveness in real-world studies of other vaccines, such as the vaccines developed pfizer and AstraZeneca.
Although Li and Zhu observed that the BBV152 study cohort was less ethnically diverse because only Indian participants were included, they said: “The study provides evidence of protection against asymptomatic infection that may be of public health importance, which is consistent with previous trials.” Not reported in other SARS-CoV-2 vaccines.
“Generally, clear protection against severe COVID-19 is most important, but the ability to prevent asymptomatic infection will protect against even mild disease, transmission, and may ultimately reduce post-severe COVID-19 cases.” Chinese experts said.
Zhu and Li also noted that the roll-out of the vaccine could reduce the ultra-cold chain requirements of other SARS-CoV-2 vaccine platforms, increase limited global manufacturing capacity, and insufficient supplies of vaccines. which can improve in low-income and middle-income countries.
Meanwhile, Bharat Biotech said the Lancet peer-review corroborated the efficacy analysis that demonstrated Covaxin to be effective against Covid-19 and that Covaxin is the only COVID-19 vaccine that has developed Phase III against the Delta variant. Has demonstrated efficacy data from clinical trials at 65.2%. ,
The President of Bharat Biotech, said, “An authoritative voice in global medicine, Covaxin Phase III clinical trial data in The Lancet is being peer-reviewed, data transparency and meeting the stringent peer-review standards of world-leading medical journals. validates our commitment to Managing Director Dr Krishna Ella.
In addition, Covaxin’s product development and clinical trial data have been published in 10 peer-reviewed journals, making Covaxin one of the most published Covid-19 vaccines in the world, he said.
Terming the partnership between Bharat Biotech, ICMR and NIV as one of the most successful public-private partnerships, Dr Balram Bhargava, Director General, ICMR said that the publication of efficacy data in the Lancet is very much about Covaxin’s strong position on the global front. Tells something – Runner Kovid-19 Vaccines.
Bhargava said, “Covaxin’s bedside journey in less than 10 months has showcased the immense power of ‘Atmanirbhar Bharat’ to fight barriers and create a niche in the global community along with Indian academia and industry. ”
The Phase III efficacy and safety study involved approximately 25,800 volunteers at 25 sites in India. To date, more than 150 million doses of Covaxin have been manufactured and supplied and are now being evaluated in controlled clinical trials in children aged 2-18 years.
The company has submitted data from children’s trials to the Indian drug regulator and its partner, OcuGen, has applied to the US Food and Drug Administration (USFDA) for emergency use authorization for pediatric use of Covaxin.
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