WHO approval for Bharat Biotech’s Covaxin likely this week: Report
- After receiving Bharat Biotech’s documentation WHO chief scientist Dr Soumya Swaminathan had said on July 9 that the final approval will be granted in four to six weeks.
The World Health Organization (WHO) is likely to grant approval to India’s indigenously manufactured Covid-19 vaccine, Covaxin, for an emergency use listing (EUL), this week, sources told news agency ANI on Monday.
Covaxin, which is manufactured by Hyderabad-based Bharat Biotech and the Indian Council of Medical Research (ICMR), has been on the pipeline for approval since July, after the manufacturer submitted all of the documentation needed for WHO's EUL on July 9.
“All documents required for EUL of Covaxin have been submitted to WHO as of July 9. 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, had said on Twitter.
Suchitra Ella, Bharat Biotech's co-founder and joint managing director, had said in early July that the UN health body’s approval is not expected to be a "long-drawn process".
After receiving Bharat Biotech’s documentation WHO chief scientist Dr Soumya Swaminathan had said that the final approval will be granted in four to six weeks.
“There is a process to be followed for approval. Companies have to submit their safety data, complete trial data, and even manufacturing quality data for approval. Bharat Biotech has already started submitting the data and the dossier is being assessed. It is the next vaccine to be reviewed by our committee. There will be a decision on inclusion in the next four to six weeks,” Swaminathan said during a webinar on July 9.
Covaxin was found to be nearly 77.8% effective against symptomatic Covid-19 cases in final phase 3 trials, according to Bharat Biotech. As per the data submitted by the manufacturer, the vaccine was found to be 63% effective against asymptomatic cases, and 65% effective in countering the Delta variant. Swaminathan had remarked that the third phase trial results of Covaxin “looks good” and meets the safety profile of the international public health agency so far.
An EUL approval will bring relief to Indians who have travelled or will be travelling abroad and to citizens of at least 12 other countries where the vaccine was administered.