WHO approval for Covaxin COVID-19 vaccine likely this week: Govt expert

NEW DELHI: The World Health Organisation is set to recognise Covaxin, India’s first home-grown Covid19 vaccine, within a week bringing relief to millions of its recipients who have been in a fix over the restricted opportunity for international travels.

Covishield, the other Covid-19 vaccine being used majorly in India’s national Covid vaccination drive had received the emergency use listing by the WHO several months back but Sputnik V, another vaccine being used in India is also not recognised yet.  

Covaxin maker Bharat Biotech had shared the relevant data from the clinical trials with the world health agency over the past few months, sources said.

The WHO approval procedure for a vaccine consists of four steps including acceptance of the vaccine maker’s expression of interest, a pre-submission meeting between WHO and manufacturer, acceptance of the dossier for evaluation by the agency, the decision on the status of assessment, and final approval based on data submitted.

The WHO and Bharat Biotech had both earlier said that a decision on the recognition of the whole inactivated virus-based vaccine was likely in August as near-complete trial data had been submitted. 

Covaxin is yet to be authorised in the Western countries, leading to a hassle for thousands of students, their parents, and other professionals who have taken the vaccine in India but are moving to these countries for long-term stays.

Due to lack of WHO approval, those who have received both doses of Covaxin are being seen as without vaccination in many countries—and have been approaching public authorities in various states to get the issue resolved.

The Union health ministry too, officials confirmed, has been pushing for the WHO approval of the vaccine, jointly developed by the ICMR, and last month in his meeting with its chief scientist Soumya Swaminathan health minister Mansukh Mandwiya had a discussion over the issue.

As per the data released by Bharat Biotech from its late-stage clinical trials, the vaccine, developed jointly with ICMR, was found to be nearly 78% effective against symptomatic infection but many experts say its real-world efficacy and efficacy against more transmissible variants still need to be assessed.

The WHO has approved COVID-19 vaccines by Pfizer-BioNTech, AstraZeneca, Johnson and Johnson, Moderna, and Sinopharm.