Bharat Biotech International Limited has stated that clinical trials to determine the safety and immunogenicity of Covaxin's booster dose are in process.
The Hyderabad-based vaccine maker on Saturday announced that its two-dosed Covid-19 vaccine is showing an overall efficiency of 77.8% against Covid-19 and is 93.4% effective in severe infection cases.
“Our commitment to improve 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,” Bharat Biotech said, while releasing the final Phase-3 trial results.
Covaxin's trials on children began in June. The vaccine's suitability is being tested on 525 volunteers at medical centres like AIIMS New Delhi and Patna.
The Phase-3 results, based on trials on 25,800 participants between 18-98 years of age, also claim that the vaccine is offering 63.6% security in asymptomatic cases, and is also demonstrating 65.2% protection against the Delta variant infection. The results are yet to be peer reviewed.
“It is a momentous day for everyone at Bharat Biotech,” Suchitra Ella, Joint Managing Director said.
Covaxin, given emergency use authorization in the country in January, has till now now received EUAs in 15 other nations, including, Brazil, Philippines, Iran, Mexico. EUA is in process in 50 countries worldwide. The company is in discussions with WHO to obtain emergency use listing.
“The successful safety and efficacy readouts of Covaxin as a result of conducting the largest ever Covid-19 vaccines trials in India establishes the nation's ability to focus on innovation and novel product development. We are proud to state that Indian Innovation will now be available to protect global populations,” Dr Krishna Ella, Chairman & Managing Director, Bharat Biotech, said.
Bharat Biotech said it has established Covaxin manufacturing at four facilities in India, and “further expansions are in process to reach an annualized capacity of one billion doses by the end of 2021.” Technology transfer activities are in progress to companies in the United States, and other countries, the biotech firm said.