Covaxin: Government reviews process to get WHO approval

Covaxin: Government reviews process to get WHO approval

90% of paperwork submitted by Bharat Biotech, say sources

The government on Monday “took stock” of Bharat Biotech’s application process with the World Health Organisation (WHO) for regulatory clearances for the Covaxin vaccine, as an inter-ministerial group led by Foreign Secretary Harsh Shringla met with company representatives in Delhi.

The meeting, that included senior officials from the Ministry of External Affairs, Ministry of Health, and Department of Biotechnology, with Bharat Biotech International Limited (BBIL) Managing Director Dr. Krishna Mohan, went over the paperwork submitted in April for the WHO’s Emergency Use Listing (EUL), amidst concerns that Indians who have taken Covaxin doses will face travel restrictions without global regulatory approval.

“On the issue of WHO’s authorisation for Emergency Use Listing (EUL), BBIL noted that they had submitted 90% of the documentation required for EUL to WHO. The remaining is expected to be submitted in June 2021. BBIL is confident about obtaining WHO EUL subsequently, given its experience of getting its other vaccines pre-qualified by WHO,” sources present at the meeting said.

Bharat Biotech is yet to publish results in any peer-reviewed journal, of its Phase-3 trials and has so far only announced interim clinical results claiming 81% efficacy. Indian Council of Medical Research (ICMR) chief Dr Balram Bhargava has also said that the publication is likely in June.

ICMR and Bharat Biotech are partners in developing the vaccine as well as the clinical trials.

When asked, MEA officials said the meeting was an “internal discussion” that had been convened with a view to “assessing” whether BBIL required any assistance in pushing through its application. However, they declined to comment on just what the role of the government would be in the WHO’s technical processes, which do not involve diplomats or political inputs.

According to the sources, government and BBIL representatives also discussed their forays into other markets, which include 11 countries that have granted Covaxin regulatory approval and “11 companies in 7 countries” that have expressed an interest in technology transfer and production of Covaxin. In addition, BBIL said it is in the “final stages of submission” for Covaxin’s regulatory approvals in Brazil and Hungary, and in negotiations with the American Food and Drug Administration (US-FDA) to conduct Phase-III clinical trials in the US as well.

While officials conceded that it was a long shot to expect that the U.S. or European countries would themselves promote the Indian-made vaccine as a part of the bouquet of vaccines gaining global approval, they said it was important that Covaxin be included in the discussions as countries decide on opening up international entry policies based on vaccinations.

Prime Minister Narendra Modi, members of the cabinet and many senior government officials have all received Covaxin shots, and could be amongst those affected if travel restrictions are actually placed in the future on the basis of WHO-approved vaccines.

The sources said it was important to note that despite reports and fears in India over the prospect, no country has yet made “vaccine passports” mandatory, and in most cases, negative RT-PCR reports and quarantine requirements are the measures instituted to screen travellers.

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