WHO's Covaxin approval will come soon, assures Foreign Secy Harsh Vardhan Shringla

Amid reports that the WHO will likely take a much-awaited decision on Covaxin, India's Foreign Secretary Harsh Vardhan Shringla expressed hope that the approval will come soon. However, Shringla also informed reporters that the approval of the COVID-19 vaccine is a technical process and not an administrative or a political process. Shringla's statement comes amid reports that the WHO will take a decision on Covaxin's approval soon.

WHO to decide on approval for Covaxin after risk/benefit analysis 

The WHO and an independent committee of specialists are expected to meet soon to carry out risk/benefit analysis following which they will take a final decision on whether to issue Covaxin the Emergency Use Listing. The world health body informed that the vaccine's manufacturer, Indian pharma major Bharat Biotech has been submitting data on a rolling basis along with additional information following a WHO request on September 27.

Therefore, the WHO had assured that their experts are currently reviewing the info provided by Bharat Biotech.  The WHO had further informed that if the data and the info addresses all questions raised, the vaccine's assessment will be finalised by this week. As per the world health body, the Emergency Use Listing process done by it and the Technical Advisory Group of independent experts is centred on determining if a manufactured vaccine is quality-assured, safe and effective. 

Covaxin approved for children aged 2-18 years 

In a big development, India's Subject Expert Committee (SEC) approved Bharat Biotech's Covaxin for children aged 2-18 years. The vaccine trials are taking place on 525 subjects at various sites, including AIIMS, Delhi, AIIMS, Patna, and Meditrina Institute of Medical Sciences, Nagpur with two doses administered in an interval of 28 days. The vaccine has overall efficacy of 77.8% against COVID and 65.2 per cent protection against the new Delta variant.

According to sources, the SEC found out that Covaxin's trials were compatible with safety protocols. It further found that the vaccine results were similar between children and adults on both safety and immunogenicity. Results of the three-phase trials of children aged 2-6 yrs, 6-12 yrs and 12-18 yrs were examined by the SEC separately.