Covaxin third phase clinical trials results out, 77.8 per cent effective against Covid-19

HYDERABAD: Covaxin, the Covid-19 vaccine developed by Hyderabad-based vaccine maker Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR), has been found to be 77.8 percent effective in the Phase-III clinical trials. 

Also, Covaxin has been found to be 93.4% effective against severe symptomatic form of Covid-19 and 63.6 percent effective against asymptomatic Covid-19. 

Covaxin has also been found to be 65.2 percent effective against the dreaded Delta variant of Coronavirus, which is becoming the dominant strain of the virus across the world. 

ALSO READ | Despite claims of ramping up manufacturing, Covaxin laggard in vaccine pool, shows affidavit

Bharat Biotech announced the results in a press release during the wee hours of Saturday. 

Bharat Biotech informed that the phase-III clinical trials of Covaxin was an event driven analysis of 130 symptomatic cases, reported at least two weeks after the 2nd dose, conducted at 25 sites across India. 

It said that the safety analysis of Covaxin demonstrates that the adverse events reported after vaccination with it were similar to placebo, with 12 percent of the subjects experiencing commonly known side effects and less than 0.5 percent of subjects feeling serious adverse events

It also said that Covaxin was well tolerated, the Data Safety Monitoring Board has not reported any safety concerns related to the vaccine and the overall rate of adverse events observed in Covaxin was lower than that seen in other Covid-19 vaccines. 

Bharat Biotech highlighted that no licensed Covid-19 vaccine manufacturer has reported efficacy results against asymptomatic infection in a randomised controlled trial, based on qPCR testing and that it is the publish such data. 

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.”  

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 also said that 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.    

Covaxin has been evaluated through neutralizing antibody responses against several variants of concern, namely B.1.617.2 (Delta), B.1.617.1 (Kappa), B.1.1.7 (Alpha), B.1.351 (Beta), P2- B.1.1.28 (Gamma). The data from these studies have been published in peer reviewed journals and available for review in the public domain.  

 
Dr Priya Abraham, Director of the ICMR National Institute of Virology, said, “The overall efficacy of 77.8 percent following the phase-III clinical trial of Covaxin is wonderful news. 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. 
 
Bharat Biotech has established Covaxin manufacturing at four 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.