HYDERABAD/DELHI: Bharat Biotech on Friday announced the Phase 3 trial results of COVAXIN that has placed the vaccine to be 77.8% effective against symptomatic COVID.
The study also said that Covaxin Phase 3 trials demonstrates a 70.8% overall protection against all variants of Covid. Also Read & Watch: Diwali Gift: WHO Grants Approval To Covaxin; Bharat Biotech MD Thanks PM
The results also said Covaxin is 65.2 % effective against the Delta variant of COVID.
The efficacy data has further shown COVAXIN as 63.6% protective against asymptomatic COVID-19.
The study has been peer reviewed and was published in a journal, The Lancet early morning on Friday.
The trials were held on 130 confirmed cases, with 24 observed in the vaccine group and 106 in the placebo group.
But where the Covaxin has shown remarkable result is having 93.4% efficacy against severe symptomatic COVID-19, the study has said.
Adverse effects were seen in 12% of cases where subjects saw commonly known side effects and less than 0.5% of subjects experienced serious adverse events.
COVAXIN was developed under a partnership with the Indian Council of Medical Research 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.
Dr Krishna Ella, CMD of Bharat Biotech said:
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. 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. This accomplishment reflects the undeterred commitment by my team members at Bharat Biotech, our public partners, ICMR, NIV, and the trust imposed by our trial participants who made this happen
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.
ICMR also reacted gladly to the phase3 trial results of Covaxin.
Dr Balram Bhargava, Director General, Indian Council of Medical Research (ICMR) said:
Following successful isolation of the COVID virus at ICMR -NIV, Pune, ICMR and Bharat Biotech embarked upon one of the most successful public-private partnership to develop the virus isolate into an effective COVID-19 vaccine. I am delighted to see that the phase III efficacy data has also been published in THE LANCET, one of the most reputed journals worldwide. This itself speaks high about the strong position of COVAXIN amongst other global front-runners 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
Recently, the World Health Organization (WHO) granted emergency use listing to COVAXIN enabling countries to expedite their regulatory approval to import and administer doses.
In an interview with The New Indian, Dr Ella had said his company is also bringing a nasal vaccine — that may work as a booster for covid — and also world’s first ever vaccine for kids aged 2-18.
“The Nasal vaccine that we have evolved is showing phenomenal results. This vaccine is extremely critical for us if we wish to remove the mask. We are almost done with phase two trials and are looking at the innovative phase three trials with the government,” he had said.
The Covaxin has already received emergency use authorizations in several countries with applications in process in more than 50 countries worldwide.
Bharat Biotech has also partnered with Ocugen to obtain approvals for COVAXIN in the US and Canada.
With more than 150 million doses manufactured, supplied, and with an excellent safety and efficacy profile, COVAXINis a major contributor to the global fight against the COVID-19 pandemic.
COVAXIN is currently being evaluated in controlled clinical trials in children 2-18 years of age, with results available during Q4 2021.
Bharat Biotech said it has a goal to have annualized capacity of one billion doses of COVAXIN by the end of 2021.
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