Bharat Biotech’s covid-19 vaccine, Covaxin, has demonstrated 65.2% efficacy against the delta variant in phase III clinical trials, the manufacturer said on Friday. The peer-reviewed efficacy analysis, published in The Lancet, also showed that Covaxin is 77.8% effective against symptomatic covid-19 and 93.4% effective against severe symptomatic patients.
The evaluation was done on 130 confirmed cases, with 24 observed in the vaccine group versus 106 in the placebo group. “Safety analysis demonstrated adverse events reported were similar to placebo, with 12% of subjects experiencing commonly known side effects and less than 0.5% of subjects experiencing serious adverse events,” said the Hyderabad-based company in a statement. “Efficacy data demonstrated 63.6% protection against asymptomatic Covid-19, 65.2% protection against the SARS-CoV-2, B.1.617.2 Delta and 70.8% protection against all variants of SARS-CoV-2 virus,” the company said.
Covaxin is India’s indigenous covid-19 vaccine developed under a partnership with the Indian Council of Medical Research (ICMR) and the National Institute of Virology, with Bharat Biotech receiving the SARS-COV-2 strains through this collaboration.
Bharat Biotech had established an ongoing collaboration with ViroVax since 2019, through the Indo-U.S. Vaccine Action Program, to develop and evaluate IMDG (Alhydroxiquim-II), a novel TLR7/8 agonist molecule, which is formulated as part of the adjuvant in Covaxin. The Adjuvant Program of the U.S. National Institute of Allergy and Infectious Diseases (NIAID) has supported ViroVax since 2009.
“The data from our 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. The phase 3 trial Efficacy and Safety Study involving 25,800 volunteers across 25 sites in India is India’s largest-ever clinical trial conducted for a Covid-19 vaccine,” Dr Krishna Ella, CMD, Bharat Biotech, said.
The Hyderabad-based drugmaker said that 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, it said.
“Following successful isolation of the SARS-CoV-2 virus at ICMR – NIV, Pune, ICMR and Bharat Biotech International Ltd (BBIL) embarked upon one of the most successful public-private partnerships to develop the virus isolate into an effective Covid-19 vaccine,” Dr. Balram Bhargava, Director General, ICMR said.
Recently, the World Health Organization (WHO) granted emergency use listing to Covaxin enabling countries to expedite their regulatory approval to import and administer doses. It has also received emergency use authorizations in several countries with applications in process in more than 50 countries worldwide. Bharat Biotech has partnered with Ocugen to obtain approvals for Covaxin in the United States and Canada.
With more than 150 million doses manufactured, supplied, and with an excellent safety and efficacy profile, Covaxin is a major contributor to the global fight against the Covid-19 pandemic, the company said in the statement. Covaxin is also currently being evaluated in controlled clinical trials in children 2-18 years of age, with results available during Q4 2021. Bharat Biotech is poised to achieve its goal of an annualized capacity of 1.0 billion doses of Covaxin by the end of 2021.
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