The high transmissibility associated with Delta variant has led to second wave of pandemic in India and many other parts of the world, affecting millions of people. Besides this, variant of concerns has been reported to show lower neutralization to several approved vaccines. This has led to breakthrough infections after completion of vaccination regimen.
The good news is, India’s home grown vaccine COVAXIN researched, developed and manufactured by Bharat Biotech which conducted the largest Phase 3 clinical trials for any covid vaccine in India has demonstrated it has 65.2 % efficacy against SarsCoV-2 and the Delta variant.
Bharat Biotech, which announced safety and efficacy analysis data from Phase III clinical trials of COVAXIN®, showed 65.2% protection against SARS CoV2, and delta variant, probably the first COVID-19 vaccine in the world to report vaccine efficacy against the coronavirus. The Indian vaccine is a whole virion inactivated vaccine against SARS-CoV2, was developed in partnership with ICMR and NIV Pune.
The Hyderabad-based Bharat Biotech has released its data from the final analysis of Covaxin efficacy as part of phase 3 clinical trials. The company said on Friday that the indigenous vaccine demonstrates overall efficacy of 77.8% against symptomatic infection.
COVAXIN Claims it is first in the world to report vaccine efficacy against the coronavirus.
Phase 3 clinical trials of COVAXIN® was an event driven analysis of 130 symptomatic COVID-19 cases, reported at least two weeks after the 2nd dose, conducted at 25 sites across India. COVAXIN® is formulated with a novel Algel+IMDG adjuvant. IMDG is a TLR7/8 agonist known to induce memory T cell responses along with strong neutralizing antibodies.
The activation of cell mediated immune responses is especially valuable in a multi epitope vaccine such as COVAXIN®, where immune protection can be achieved from S, RBD and N proteins alike. IMDG was developed under partnership between Virovax and NIAID, National Institutes of Health USA.
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 otherCovid-19 vaccines.
The safety profile of COVAXIN® is now well established based on inactivated vaccines technology, and in large part due to the extensive 20-year safety track record of Bharat Biotech’s vero cell manufacturing platform.
No licensed SARS-CoV-2 vaccine has reported efficacy against asymptomatic infection in a randomised controlled trial, based on qPCR testing. COVAXIN® is the first to report promising efficacy against asymptomatic infections based on qPCR testing that will help in reducing disease transmission.
India had sequenced 30,000 samples until June, but experts believe more needs to be done.
Dr. Krishna Ella, Chairman & Managing Director, Bharat Biotech, said, “The successful safety and efficacy readouts of COVAXIN® as a result of conducting the largest ever COVID Vaccines trials in India 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.”
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. It is also formulated to adhere to a multi-dose vial policy, thereby reducing open vial wastage, saving money to procurement agencies and governments alike.
Prof. (Dr) Balram Bhargava, Secretary Department of Health Research & Director General Indian Council of Medical Research, 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. COVAXIN® will not only benefit the 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.”
Bharat Biotech’s commitment to continued improvement of COVAXIN® is well under way with additional clinical trials to establish safety and efficacy in children between 2-18 years of age. A clinical trial to determine the safety and immunogenicity of a booster dose is also in process. Several research activities are being carried out to study variants of concern and to assess their suitability for follow up booster doses.
Prof. (Dr) Priya Abraham, Director National Institute of Virology ICMR said, “The overall efficacy of 77.8 % following the phase III clinical trial of COVAXIN® is wonderful news. ICMR-NIV and BBIL have had very fruitful interactions during this exhilarating journey. Sera from COVAXIN® recipients have also been evaluated against viral variants detected in India i.e., the Alpha, Beta, Zeta, Kappa and Delta. The making of this vaccine entirely on Indian soil is a matter of great pride to every Indian”
COVAXIN® has now received emergency use authorizations in 16 countries including, Brazil, India, Philippines, Iran, Mexico, etc. with EUA’s in process in 50 countries worldwide. The company is in discussions with WHO to obtain emergency Use Listing for COVAXIN®. The product has been exported to several countries with additional requests for supplies being received.
Bharat Biotech has established COVAXIN® manufacturing at 4 facilities within India, further expansions are in process to reach an annualized capacity of 1 billion doses by the end of 2021. Technology transfer activities are in progress to companies in United States, and other countries.
Read the full Pre-Print Publication here: https://www.medrxiv.org/content/10.1101/2021.06.30.21259439v1