The Indian pharma company Bharat Biotech got a further set back on Monday with respect to its hopes of being granted an emergency-use listing by the World Health Organization for the Covid-19 vaccine developed by it called Covxin as the world health body aid it expected the company to provide it with more data and information on its vaccine.
The two-dose Covaxin is already being used extensively throughout India.
But if the vaccine does not get a green signal from the WHO, it is unlikely that the vaccine would be accepted in other countries around the world as a valid Covid-19 vaccine.
It has been several months now that the WHO has been approached by Bharat Biotech for granting its vaccine an emergency-use listing. The company has been submiting data on a rolling basis since July.
“We are aware that many people are waiting for WHO’s recommendation for (Bharat Biotech’s) Covaxin to be included in the #COVID19 Emergency Use Listing, but we cannot cut corners,” WHO said on Twitter.
There were no comments on the issue available from Bharat Biotech.
The Indian government and regulator have already granted emergency usage status to Covaxin, along with two other Covid-19 vaccines to be used in the adult vaccination campaign in the country.
Only about 30 per cent of the approximately 944 million eligible adults in the country have so far been fully vaccinated and Covxin doses accounted for more than 112 shots.
“Bharat Biotech … has been submitting data to WHO on a rolling basis and WHO experts have reviewed these data. WHO is expecting one additional piece of information from the company today,” the global health agency said on Twitter.
The WHO’s technical advisory group will meet on Oct. 26 to consider the listing for Covaxin, said WHO’s chief scientist Soumya Swaminathan on Sunday.
“WHO has been working closely with Bharat Biotech to complete the dossier. Our goal is to have a broad portfolio of vaccines approved for emergency use & to expand access to populations everywhere,” Swaminathan said in a tweet.
After providing data on a rolling basis to the WHO, Bharat Biotech also submitted additional data on September 27 on the vaccine following the WHO seeking more data.
Previously, a meeting was held on October 6 by the Strategic Advisory Group of Experts on Immunization (SAGE) of the WHO when it had said that it would decide on the granting EUL status to Covaxin in a week.
Clinical information from Covaxin’s Phase 1, 2, 3 and post-marketing studies on the vaccine’s safety, immunogenicity, efficacy, and effectiveness was presented by the company to the SAGE in a meeting held on October 5.
The Subject Expert Committee of India’s regulatory authority, the Central Drugs Standard Control Organisation (CDSCO) was earlier presented with data by the Hyderabad-based Bharat Biotech in June about its Phase-3 clinical trials data which showed that the vaccine was 77.8% was effective against the coronavirus.
(Adapted from Reuters.com)