On Covaxin approval, Bharat Biotech 'doesn't want to speculate' on WHO's timeline

Indian biotechnology firm, Bharat Biotech is waiting in anticipation for the World Health Organisation's (WHO) approval of the COVID-19 vaccine Covaxin for Emergency Use Listing (EUL). The company informed through a series of tweets on Friday, that the COVAXIN clinical trial was entirely compiled and made available by June 2021. Bharat Biotech also notified that the necessary data for Emergency Use Listing (EUL) Application was sent to the WHO in early July itself. Union Health Minister Mansukh Mandaviya on September 9 had met WHO chief scientist, Dr Soumya Swaminathan and had a productive discussion on the WHO's approval of the vaccine. 

Bharat biotech doesn't want to speculate on WHO's approval process & timelines

Bharat Biotech maintained that the biotechnology firm had responded to all clarifications on the Covaxin vaccine that the WHO had sought concerning its approval. They said, "As a responsible manufacturer with past approvals for our other vaccines, we do not find it appropriate to speculate or comment on the approval process & its timelines." The company while stating this also said that they would continue to work diligently on obtaining WHO EUL as soon as possible.

Covaxin stats: Exhibits high efficiency

Covaxin is a Whole Virion Inactivated Coronavirus Vaccine developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV). While the phase 3 trials entailed 25,800 participants between 18-98 years of age including 10% over the age of 60, the analysis was conducted 14 days after administering the second dose of the vaccine. It has shown an overall efficacy of 77.8%, and 93.4% efficacy against severe COVID disease as per the final results. On the other hand, efficacy data demonstrates 63.6% protection against asymptomatic COVID disease.

Most importantly, it has proven to neutralise variants such as B.1.1.7 (Alpha), B.1.617 (Kappa), B.1.351 (Beta) and B.1.617.2 (Delta). Under the aegis of the ‘Mission COVID Suraksha - the Indian COVID-19 Vaccine Development Mission’, the Haffkine Biopharmaceutical Corporation Ltd, Mumbai; Indian Immunologicals Limited in Hyderabad and Ankleshwar, and Bharat Immunologicals Biologicals Limited in Bulandshahr have also been permitted to produce Covaxin. 

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