New Delhi: In a significant development, the German government on Thursday recognised the WHO-listed Bharat Biotech`s Covid-19 vaccine, COVAXIN, for travel to the country starting June 1st. The Hyderabad-based vaccine maker confirmed this news. “Germany has approved Covaxin COVID19 vaccine. The entrants will no longer need proof of vaccination as the Federal Cabinet relaxes restrictions,” Bharat Biotech said.
WHO`s EUL procedure assesses the quality, safety and efficacy of COVID-19 vaccines and is a prerequisite for COVAX vaccine supply. It also allows countries to expedite their own regulatory approval to import and administer COVID-19 vaccines.
The Hyderabad-based Pharma company Bharat Biotech in a statement said that it had conducted phase II/III, open-label, and multicenter studies to evaluate the safety, reactogenicity, and immunogenicity of Covaxin in healthy children and adolescents in the 2-18 age group.
Chairman, CEO, and Co-Founder of Ocugen Inc, Dr Shankar Musunuri said, “We`re extremely pleased that we can proceed with our clinical trials for COVAXIN, our whole virus inactivated COVID-19 vaccine candidate. The need for delivering an additional, differentiated vaccine option, we believe, remains a priority.”