WHO's emergency use approval for Covaxin delayed; more data sought from Bharat Biotech

The World Health Organization's decision on granting emergency use approval for Covaxin has been delayed for a few more days as it has asked for more data from Bharat Biotech, sources revealed. Though Bharat Biotech had submitted the data required for the WHO's approval for Covaxin on July 9, the UN health agency was scheduled to take up the proposal for consideration on October 5. So far, Covaxin has been approved only in select countries such as India, Estonia, Iran, the Philippines, Mauritius, Mexico, Nepal, Guyana, Paraguay and Zimbabwe. 

In a statement, Bharat Biotech commented, "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. We are diligently working with the WHO to obtain Emergency Use List at the earliest". 

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. Speaking to the media on September 24, Union MoS Health Bharati Pawar remarked, "There is a procedure of submitting the documents for approval. WHO's emergency use authorization to Covaxin is expected soon". 

Covaxin demonstrates high efficacy

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.

The supply of Bharat Biotech's COVID-19 vaccine is set to be ramped up from 3.5 crore doses in September to 5.5 crore doses in October. Meanwhile, the Phase 2 and 3 clinical trials of Covaxin for use in the age group of 2 to 18 years have been completed. Apart from Covishield and Covaxin, the Drugs Controller General of India (DCGI) has also approved Sputnik V, Moderna, and the Johnson & Johnson vaccine. In India, a total of 64,18,45,931 persons have been inoculated whereas 23,13,98,730 of them have received the second dose of the vaccine too.