WHO to take decision on Covaxin's EUL listing in August first week

The World Health Organisation (WHO) is likely to take a decision on the Emergency Use Listing (EUL) of Bharat Biotech's Covaxin in the first week of August. 

WHO's Emergency Use Listing is important for the vaccine company to supply vaccines for global facilities such as Covax or international procurement.

WHO's Chief Scientist Soumya Swaminathan, while speaking at a webinar organised by the Centre for Science and Environment (CSE) on July 9, 2021 said that WHO is reviewing Covaxin as its manufacturer Bharat Biotech is now uploading its entire data on the health body's portal.

What all is required for WHO's EUL Listing?

• A vaccine company has to follow a certain process to get WHO's EUL listing such as completing phase 3 trials and submitting the whole data to WHO's regulatory department, which will then be examined by an expert advisory group.

• The data includes safety and efficacy for the vaccine and also the manufacturing quality and standard. 

• As per WHO guidelines, Emergency Use Listing is a procedure to streamline the process by which new or unlicensed products can be used during public health emergencies.

• Bharat Biotech has already submitted the required data and WHO is expected to announce the decision on its inclusion in 4-6 weeks. 

Covaxin 

• India's indigenous COVID-19 vaccine, Covaxin has showed 63.6 percent efficacy against the Delta variant of Covid-19, which is currently spreading cross the world. 

• It has demonstrated 93.4 percent efficacy against severe symptomatic Covid-19 and 63.6 percent against asymptomatic Covid-19.

• The trial was conducted on 25,800 participants and the data submitted to the Subject Expert Committee (SEC) showed the vaccine was "well-tolerated."