Covaxin emergency authorisation delayed, WHO likely to discuss granting EUA on Oct 5

The World Health Organization (WHO) is expected to grant emergency use authorisation (EUA) to Bharat Biotech's Covaxin in October, sources have revealed. The Strategic Advisory Group of Experts (SAGE) on Immunization (SAGE) will meet at the WHO to discuss granting emergency use authorisation to the 'Made in India' vaccine on October 5. The vaccine is expected to be granted the EUA status after the meeting of the SAGE, which is responsible for advising WHO on overall global policies and strategies including vaccines and immunization. 

Earlier sources had reported that Covaxin will get emergency authorisation by the last week of September. The speculations came after Union Health Minister Mansukh Madaviya met Dr Soumya Swaminathan, the chief scientist at the World Health Organisation (WHO). Following the meeting, Mansukh Madaviya stated that he had held a productive discussion on the WHO's approval for Bharat Biotech's Covaxin. 

Data from the Covaxin clinical trials was entirely compiled and made available by June 2021. Hyderabad-based Bharat Biotech had notified that the necessary data for Emergency Use Listing (EUL) Application was sent to the WHO in early July. The WHO's assessment of Covaxin is at an advanced stage, as per Dr. Mariangela Simao, the WHO Assistant Director-General for Access to medicines, vaccines, and pharmaceuticals.

Covaxin's efficacy data 

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).