An event-driven study of 130 symptomatic Covid-19 patients reported at least two weeks after the second dosage was used in phase 3 clinical trials. They were carried out at 25 different locations across India. During Covaxin studies, 12% of individuals suffered generally recognised side effects, while fewer than 0.5% encountered significant adverse events.
Covaxin has a 77.8% efficacy against symptomatic Covid-19 and a 93.4% efficacy against severe illness, according to Bharat Biotech’s final analysis of the vaccine’s efficacy from phase 3 clinical trials, which was reported in a pre-print publication. “Through an examination of 130 verified cases, Covaxin was shown to be 77.8% effective against symptomatic Covid-19, with 24 observed in the vaccination group vs 106 in the placebo group. “Efficacy analysis shows that Covaxin is 93.4% effective against severe symptomatic Covid-19,” according to the study article, which has yet to be peer-reviewed and was published in the open-access journal medRxiv.
The data’s safety analysis also shows that the reported adverse events were similar to placebo, with 12% of individuals suffering generally known side effects and fewer than 0.5% experiencing severe adverse events.
The effectiveness statistics of the entire virion inactivated vaccine provide 63.6% protection against asymptomatic illness and 65.2% protection against the Sars-Cov-2, B.1.617.2 Delta variant, according to the research.
An event-driven study of 130 symptomatic Covid-19 patients reported at least two weeks after the second dosage was used in phase 3 clinical trials. They were carried out at 25 different locations across India.
Covaxin contains a new Algel+IMDG adjuvant, which is a TLR7/8 agonist known to generate memory T cell responses as well as powerful neutralising antibodies.
Activation of cell-mediated immune responses is especially important in a multi-epitope vaccination like Covaxin, where immune protection can be obtained from S, receptor-binding domain, and N proteins.
The vaccination was well-tolerated, and the Data Safety Monitoring Board found no safety concerns about it. Covaxin’s overall rate of adverse events was lower than those of previous Covid-19 vaccines.
According to the firm, Covaxin’s safety profile is now well established based on inactivated vaccine technology, in large part thanks to Bharat Biotech’s Vero cell production platform’s lengthy 20-year safety track record.
“The successful safety and effectiveness readouts of Covaxin as a consequence of performing the biggest ever Covid vaccination trials in India confirms India’s and developing world nations’ capacity to focus on innovation and innovative product development.” In a statement, Krishna Ella, chairman and managing director of Bharat Biotech, stated, “We are happy to announce that innovation from India will now be available to safeguard worldwide populations.”
“The total effectiveness of Covaxin in the phase III clinical study was 77.8%, which is fantastic news. Sera from Covaxin patients were also tested for viral variations seen in India, including Alpha, Beta, Zeta, Kappa, and Delta. The fact that this vaccine was developed wholly on Indian soil is a source of tremendous satisfaction for every Indian,” said Priya Abraham, head of the National Institute of Virology.
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