Bharat Biotech submits all documents to WHO for Covaxin's emergency use listing assessment

On Monday, the Hyderabad-based pharmaceutical firm Bharat Biotech announced that it has submitted all the documents required for Emergency Use Listing (EUL) of India's homegrown COVID-19 jab Covaxin on July 9 to the World Health Organization (WHO). "All documents required for EUL of Covaxin have been submitted to WHO as of July 9th. The review process has now commenced with the expectation that we will receive EUL from WHO at the earliest," Dr. Krishna Ella, chairman and managing director of Bharat Biotech, said in a statement. 

This comes just days after Bharat Biotech officially released Covaxin's phase-3 trial data. Suchitra Ella, Bharat Biotech's co-founder, and joint managing director had told a press conference earlier that Covaxin's approval process with the WHO would not be lengthy, challenging, or time-consuming. Many other vaccines manufactured by India's well-known pharma company have been authorized for emergency use by the global health body in the past.

"We are working closely with the World Health Organization for the inclusion of Covaxin in its Emergency Use Listing. Approval from WHO is not expected to be a long-drawn process as the cell line and majority of our facilities have already been audited and approved by WHO for our other vaccines in the past," Suchitra Ella tweeted.

Covaxin shows 93.4 percent efficacy against coronavirus 

Additionally, the results from the clinical trials turned back promising as the vaccine showed 93.4 percent efficacy against severe COVID-19 symptomatic cases, 78 percent against mild or moderate cases, and 63 percent against the asymptomatic cases. Close to 65.2 percent efficacy was shown by the Indian jab in neutralizing the highly contagious Delta variant of SARS-CoV-2 lineage. Volunteers showed extremely well tolerance to the vaccine with no clinically or statistically significant differences in serious adverse events (SAEs). 

"It is good that these results have finally been published and this will help to get Covaxin the WHO emergency use listing. People who have been administered Covaxin in India will be able to travel without restrictions", Dr. NK Arora, the chief of the National Technical Advisory Group on Immunisation (NTAGI) said in an interview with ANI.

"Covaxin is effective against the Delta variant which is a big relief. We feel very comfortable that both the vaccines which are currently in use in India under COVID Immunisation Programme is effective and safe", he added.