New Delhi, May 26, 2022: 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 1. The Hyderabad-based vaccine maker confirmed this in a tweet. “Germany has approved Covaxin COVID19 vaccine. The entrants will no longer need proof of vaccination as the Federal Cabinet relaxes restrictions,” Bharat Biotech said on Twitter.
World Health Organization (WHO) in November last year issued an emergency use listing (EUL) for COVAXIN, adding to a growing portfolio of vaccines validated for the prevention of COVID-19 caused by SARS-CoV-2.
COVAXIN has been approved by Germany. The entrants will no longer need proof of vaccination as the Federal Cabinet relaxes restrictions.#BharatBiotech #COVID19 #COVID19Vaccine #COVAXIN #covaxinapproval #germanytravel #vaccination pic.twitter.com/TMrQUbxK1F— BharatBiotech (@BharatBiotech) May 26, 2022
Taking to Twitter, the German Ambassador to India and Bhutan Walter J Lindner wrote, "Very happy that GER government just decided to recognize WHO-listed Covaxin for travels to GER, starting June 1! This Embassy has been pushing very actively for such decision (because of Covid-backlogs visa sections have longer waiting periods than normal, please have patience)."
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.
"This emergency use listing expands the availability of vaccines, the most effective medical tools we have to end the pandemic," said Dr Mariangela Simao, WHO Assistant-Director General for Access to Medicines and Health Products said. The Drugs Controller General of India (DCGI) in April also granted an emergency use authorisation (EUA) to Covaxin for the age group of 6-12 years.
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.
The clinical trials conducted in the paediatric population between June 2021 to September 2021 have shown robust safety, reactogenicity, and immunogenicity.
Covaxin is formulated uniquely such that the same dosage can be administered to adults and children alike. Covaxin is a ready-to-use liquid vaccine, stored at 2-8 degrees Celsius, with 12 months shelf life and a multi-dose vial policy.
Moreover, Biotechnology company Ocugen on Monday announced that the US Food and Drug Administration (FDA) lifted the clinical hold on the Company`s Phase 2, 3 clinical trials for COVAXIN (BBV152).
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."
Courtesy: Zee News