Published 07:52 IST, September 18th 2021
Covaxin emergency authorisation delayed, WHO likely to discuss granting EUA on Oct 5
The Strategic Advisory Group of Experts on Immunization (SAGE) will meet at the WHO to discuss granting emergency use authorisation to Covaxin on October 5.
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World Health Organization (WHO) is expected to grant emergency use authorisation (EUA) to Bharat Biotech's Covaxin in October, sources have revealed. Strategic visory Group of Experts (S) on Immunization (S) will meet at WHO to discuss granting emergency use authorisation to 'Me in India' vaccine on October 5. vaccine is expected to be granted EUA status after meeting of S, which is responsible for vising WHO on overall global policies and strategies including vaccines and immunization.
Earlier sources h reported that Covaxin will get emergency authorisation by last week of September. speculations came after Union Health Minister Mansukh Maviya met Dr Soumya Swaminathan, chief scientist at World Health Organisation (WHO). Following meeting, Mansukh Maviya stated that he h held a productive discussion on WHO's approval for Bharat Biotech's Covaxin.
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Data from Covaxin clinical trials was entirely compiled and me available by June 2021. Hyderab-based Bharat Biotech h tified that necessary data for Emergency Use Listing (EUL) Application was sent to WHO in early July. WHO's assessment of Covaxin is at an vanced st, as per Dr. Mariangela Simao, 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 Indian Council of Medical Research (ICMR) and National Institute of Virology (NIV). While phase 3 trials entailed 25,800 participants between 18-98 years of including 10% over of 60, analysis was conducted 14 days after ministering second dose of vaccine. It has shown an overall efficacy of 77.8%, and 93.4% efficacy against severe COVID disease as per final results. On or 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).
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07:52 IST, September 18th 2021