New Delhi [India]: German Ambassador to India, Walter J Lindner, on Thursday hailed the German government for perceiving the WHO-recorded Bharat Biotech’s COVID antibody, COVAXIN, for movement to the nation beginning June 1.
World Health Organization (WHO) in November last year gave a crisis use posting (EUL) for COVAXIN, adding to a developing arrangement of immunizations approved for the counteraction of COVID-19 brought about by SARS-CoV-2.
Taking to Twitter, the Ambassador to Germany and Bhutan 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).”
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) pic.twitter.com/LFKqlyYzaW
— Walter J. Lindner (@WalterJLindner) May 26, 2022
WHO’s EUL method surveys the quality, wellbeing and viability of COVID-19 immunizations and is an essential for COVAX antibody supply. It additionally permits nations to speed up their own administrative endorsement to import and manage COVID-19 antibodies.
“This crisis use posting extends the accessibility of antibodies, the best clinical instruments we need to end the pandemic,” said Dr Mariangela Simao, WHO Assistant-Director General for Access to Medicines and Health Products said.
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).
The Drugs Controller General of India (DCGI) in April additionally allowed a crisis use authorisation (EUA) to Covaxin for the age gathering of 6-12 years.
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.”
