HYDERABAD: A week after the World Health Organisation (WHO) granted Emergency Use Listing (EUL) to Covaxin, a prestigious medical journal Lancet has stated 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 variants of SARS-CoV-2.
Covaxin’s efficacy was arrived at through the 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 along with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV) Pune.
The efficacy analysis showed Covaxin (BBV152) is 93.4% effective against severe symptomatic Covid-19 and offers 63.6% protection against asymptomatic Covid-19. It is also 65.2% effective against the Delta variant, 90.1% effective against the Kappa variant, Lancet said.
“BBV152 was well tolerated; the same proportion of participants reported adverse events in the vaccine group [1597 out of 12879 (12.4%)] and placebo group [1597 of 12874 (12.4%)] with no clinically significant differences in the distributions of solicited, unsolicited, or serious adverse events between the groups, and no cases of anaphylaxis or vaccine-related deaths,” the peer-reviewed journal observed.
Covaxin safety analysis demonstrates that the adverse events reported were similar to placebo, with 12% of the subjects experiencing commonly known side effects and less than 0.5% of subjects experiencing serious adverse events, Bharat Biotech said, adding: “Covaxin was well tolerated and the Data Safety Monitoring Board has not reported any safety concerns related to the vaccine. The overall rate of adverse events observed in Covaxin was lower than that seen in Covid-19 vaccines. The safety profile of Covaxin is now well established”.
In a separate comment in The Lancet, Chinese experts Jing-Xin Li and Feng-Cai Zhu of the Nanjing-based Jiangsu Provincial Center for Disease Control and Prevention pointed out that with the Delta variant outcompeting all SARS-CoV-2 variants as the most predominant variant of concern globally, with substantially higher transmissibility than other VOCs, the BBV152 Phase 3 results reported by Raches Ella and colleagues were a “welcome advance”.
“…in a phase 3 trial of an inactivated SARS-CoV-2 vaccine (BBV152) based on an Asp614Gly variant, the authors found a substantial reduction in symptomatic Covid-19… In the study by Ella and colleagues, in all the delta-positive cases, the viral load in vaccine recipients was significantly lower than in placebo recipients,” they said while pointing to the reduced vaccine effectiveness being reported in real-world studies of other vaccines like the ones developed by Pfizer and AstraZeneca.
Though Li & Zhu observed that the BBV152 study cohort was less ethnically diverse as only Indian participants were involved, they said: “the study provides evidence of protection against asymptomatic infection that might be of public health significance, which has not been reported in previous trials of other SARS-CoV-2 vaccines.”
“Generally, the apparent protection against severe Covid-19 is most crucial, but the capability of preventing asymptomatic infection would also protect against mild disease, transmission, and eventually might lead to a reduction in subsequent cases of severe Covid-19,” the Chinese experts said.
Zhu and Li also said that the roll-out of the vaccine might ease the ultra-cold chain requirements of other SARS-CoV-2 vaccine platforms, increase the finite global manufacturing capacity, and improve the insufficient supply of vaccines which disproportionately affects low-income and middle-income countries.
Meanwhile, Bharat Biotech said Lancet peer-review confirms the efficacy analysis that demonstrates Covaxin to be effective against Covid-19 and that Covaxin is the only Covid-19 vaccine to have demonstrated efficacy data from phase III clinical trials against the Delta variant at 65.2%.
“The peer-review of Covaxin phase III clinical trial data in The Lancet, an authoritative voice in global medicine, validates our commitment to data transparency and meeting the stringent peer-review standards of world-leading medical journals,” said Bharat Biotech chairman & managing director Dr Krishna Ella.
He said with this, data from Covaxin’s product development and clinical trials have been published in 10 peer-reviewed journals, making Covaxin one of the most highly published Covid-19 vaccines in the world.
Terming the partnership between Bharat Biotech, ICMR and NIV as one of the most successful public-private partnerships, ICMR director-general Dr Balram Bhargava said the publication of the efficacy data in Lancet speaks highly about the strong position of Covaxin among the global front-runner Covid-19 vaccines.
“The bench to bedside journey of Covaxin in less than 10 months showcases the immense strength of `Atmanirbhar Bharat’ along with the Indian academia and industry in fighting against the odds and carving a niche in the global community,” Bhargava said.
The Phase III efficacy and safety study involved around 25,800 volunteers across 25 sites in India. So far, over 150 million doses of Covaxin have been manufactured and supplied and it is now being evaluated in controlled clinical trials in children aged 2-18 years.
The company has submitted data of the children’s trials to the Indian drug regulator and its partner Ocugen has applied to the US Food & Drug Administration (USFDA) for emergency use authorisation for paediatric use of Covaxin.




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