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Covaxin’s overall efficacy 77.8%, 65.2% effective against Delta variant: Bharat Biotech – Times of India

HYDERABAD: India’s first indigenously developed Covid-19 vaccine Covaxin is overall 77.8% effective against Covid-19 and 65.2% effective against the deadly Delta (B.1.617.2) variant, its developer Bharat Biotech said on Saturday.
Revealing the final analysis results of its Phase III efficacy trial that was conducted on 25,800 participants, Bharat Biotech said while Covaxin is 93.4% effective against severe symptomatic Covid-19, it offers 63.6% protection against asymptomatic Covid-19.
The company said it arrived at the overall efficacy figure of 77.8% after the evaluation of 130 confirmed cases of Covid-19 among the participants, which included 24 participants who had received the vaccine and 106 who had received the placebo shots.
Bharat Biotech also said Covaxin was well tolerated with the Data Safety Monitoring Board not reporting any safety concerns related to the vaccine. “Safety analysis demonstrates adverse events reported were similar to placebo, with 12% of subjects experiencing commonly known side effects and less than 0.5% of subjects feeling serious adverse events. The overall rate of adverse events observed in Covaxin was lower than that seen in other Covid-19 vaccines,” it said.
The company also said Covaxin was the first to report promising efficacy against asymptomatic infections based on qPCR testing that will help in reducing disease transmission. “No licensed SARS-CoV-2 vaccine has reported efficacy against asymptomatic infection in a randomised controlled trial, based on qPCR testing,” it said
The final results of the Phase-III trials were also uploaded on MedRxiv, a server that carries preprints of research work before it is peer-reviewed.
Commenting on the results, Bharat Biotech chairman and managing director Dr Krishna Ella said: “The successful safety and efficacy readouts of Covaxin establishes the ability of India and developing world countries to focus towards innovation and novel product development. We are proud to state that innovation from India will now be available to protect global populations.”
He said Covaxin has been specifically designed to meet the needs of global distribution chains, the requirements for which are more critical in low- and middle-income countries. It has been formulated to enable shipping and long-term storage at 2-8ºC and to adhere to a multi-dose vial policy, thereby reducing open vial wastage, saving money to procurement agencies and governments alike, he added.
Dr Balram Bhargava, secretary of the department of health research & Director General of the Indian Council of Medical Research (ICMR), said: “I am delighted to note that Covaxin, developed by ICMR and BBIL under an effective public private partnership, has demonstrated an overall efficacy of 77.8% in India’s largest Covid phase 3 clinical trial thus far. Our scientists at ICMR and BBIL have worked tirelessly to deliver a truly effective vaccine of highest international standards.”
Bhargava said Covaxin will not only benefit Indian citizens but would also immensely contribute to protect the global community against the deadly SARS-CoV-2 virus. “I am also pleased to see that Covaxin works well against all variant strains of SARS-CoV-2. The successful development of Covaxin has consolidated the position of Indian academia and Industry in the global arena,” Bhargava said.