Decision on Covaxin's emergency use approval to be taken in October, announces WHO

In a big announcement, the World Health Organization declared that it will decide on including Covaxin in its Emergency Use Listing in the month of October. While the Strategic Advisory Group of Experts on Immunization is set to meet at the WHO on October 5 to consider this proposal, sources told ANI earlier that the UN health agency had sought more data from Bharat Biotech. Responding to this, Bharat Biotech stated, "As a responsible manufacturer with past approvals for our other vaccines, we do not find it appropriate to speculate or comment on the regulatory approval process its timelines".

Notably, it had submitted the data required for the WHO's approval for Covaxin on July 9 itself. As per the latest information available on the WHO website, the Covaxin maker's dossier has been accepted for review. Without mentioning a specific date, the WHO has made it apparent that the emergency use approval for this COVID-19 vaccine is unlikely to be delayed beyond October. In India, a total of 64,71,52,176 persons have been inoculated whereas 23,58,19,230 of them have received the second dose of the vaccine too.

Covaxin- an efficacious vaccine

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 overall 77.8% efficacy and 93.4% efficacy against severe COVID-19 disease as per the final results. 

On the other hand, efficacy data demonstrates 63.6% protection against asymptomatic COVID-19 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). The Haffkine Biopharmaceutical Corporation Ltd, Mumbai; Indian Immunologicals Limited in Hyderabad and Ankleshwar, Bharat Immunologicals Biologicals Limited in Bulandshahr and the Biovet facility in Bengaluru have also been permitted to produce Covaxin.

So far, Covaxin has been approved only in select countries such as India, Estonia, Iran, the Philippines, Mauritius, Mexico, Nepal, Guyana, Paraguay and Zimbabwe. The emergency use approval can be a gamechanger amid the COVID-19 crisis as it is likely to encourage countries to import the vaccine, facilitate its manufacturing abroad and ease global travel for those vaccinated with it. The supply of Covaxin is set to be ramped up from 3.5 crore doses in September to 5.5 crore doses in October.