WHO approval for Covaxin delayed again; final risk-benefit analysis likely on November 3

The World Health Organization's decision on including Covaxin in its Emergency Use Listing was delayed yet again after the UN health agency sought more clarifications from Bharat Biotech. In an important update on Wednesday, WHO chief scientist Soumya Swaminathan explained that the Technical Advisory Group for Emergency Use Listing required additional information to conduct a final risk-benefit assessment for global use of this COVID-19 vaccine. This is an independent advisory group that provides recommendations on whether a novel coronavirus vaccine can be listed for emergency use.

According to Swaminathan, the committee will hold another meeting on November 3 provided the necessary data is received in time. This comes even as Union Health Minister Mansukh Mandaviya revealed that a technical committee of the WHO had approved Covaxin. On Tuesday, the UN health agency's spokesperson Margaret Harris had indicated that a recommendation on the emergency use approval for Bharat Biotech's vaccine is expected within 24 hours if the committee is satisfied. 

Pertinently, Bharat Biotech had submitted the data required for the WHO's approval for Covaxin on July 9 itself. Earlier on October 18, WHO had commented, "We are aware that many people are waiting for WHO’s recommendation for Covaxin to be included in the #COVID19 Emergency Use Listing, but we cannot cut corners - before recommending a product for emergency use, we must evaluate it thoroughly to make sure it is safe and effective". It added that the timeframe for approval is dependent on how quickly a company is able to provide the data required for WHO to evaluate the vaccine’s quality, safety and efficacy. 

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. In India, a total of 72,31,51,612 persons have been inoculated whereas 31,25,52,372 of them have received the second dose of the vaccine too.