World Health Organisation (WHO) Chief Scientist Soumya Swaminathan on July 9 said the body may decide on the emergency use listing (EUL) status of Covaxin in the next 4 to 6 weeks, Mint reported.
Covaxin is the indigenously developed COVID-19 vaccine by Bharat Biotech. The company has submitted “almost complete” papers to WHO for EUL.
The approval is significant as it will likely lead to more international acceptance of the vaccine. It will also boost prospects of international travel for the many Indians who have taken Covaxin but are currently excluded from the list of globally accepted vaccines.
“It is mandatory to supply a complete dossier listing safety, efficacy and manufacturing conditions of the vaccine to WHO. I understand that Bharat Biotech is in this process and I think a decision on their case is likely in the next four to six weeks," Swaminathan said.
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The stamp will also allow Covaxin to join the WHO’s COVAX vaccine alliance which is ensuring supply for other countries. So far, only six vaccines have EUL from the apex global health body – AstraZeneca-Oxford, Moderna, Johnson & Johnson, Pfizer-BioNTech, Sinopharm and Sinovac.
Last week, Bharat Biotech released its Phase 3 trial results and claimed vaccine efficacy of 78.8 percent against COVID-19. It tweeted: “COVAXIN Proven SAFE in India's Largest Efficacy Trial,” the company tweeted on July 3."
Phase III data has found Covaxin to be 78 percent effective against mild, moderate, and severe COVID-19; 93 percent effective against severe COVID-19 – reducing hospitalisations, and 63 percent effective against asymptomatic COVID-19 transmission.
It was also found to be 65 percent effective against the B.1.617.2 COVID-19 strain or Delta variant of the coronavirus disease and the company said Covaxin has been “well-tolerated” among participants and showed “minimal adverse effects post-immunisation”
As per data available on covid19.trackvaccines.org, less than 10 nations have officially approved the Covaxin. Most countries only recognise Oxford-AstraZeneca’s Covishield, manufactured by the Serum Institute of India (SII), as the required vaccine for passengers coming from India.For full coverage on the coronavirus pandemic click here