Germany has recognised the WHO-listed Bharat Biotech's COVID vaccine Covaxin, for travel to the country starting June 1. 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.
The development was confirmed by German Ambassador to India, Walter J Lindner, who on Thursday took to Twitter and said, "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.
Covaxin for minors
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 pediatric 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).