‘Expect WHO nod to Covaxin in July-Sept’

New Delhi, May 25: As countries prep to gradually restart travel and tourism after prolonged Covid restrictions, there is nervousness among students about the World Health Organisation and many countries not listing Bharat Biotech’s Covaxin among approved vaccines.
The US, Canada, Australia, Ireland and the EU are among those do not have Covaxin on their approved list of vaccines for now. And top universities are reportedly allowing those who have received vaccines approved by the countries or WHO. “Covaxin is not on the approved list, which means students may not be exempt from mandatory hotel quarantine. To stay in a hotel for 14 days will be very expensive,” said Soumya Pandey, Country Advisor, University of Limerick. The WHO has Pfizer, Moderna and Covishield on its approved list but for Covaxin, it says “more information required”. Bharat Biotech, at a meeting today with the government on the status of its application before the WHO, reportedly said the company was on track and had submitted “90 per cent of the documentation required” for WHO’s authorization.
“The remaining is expected to be submitted in June,” the company said according to government sources. It also reportedly assured that it is confident of getting clearance subsequently, “given its experience of getting its other vaccines pre-qualified by WHO”.
Academic sessions are set to begin by August-September in foreign universities.
Government sources say Bharat Biotech informed that it was in the final stages of submitting documents for Covaxin’s regulatory approvals in Brazil and Hungary after “extensive bilateral consultations”. “BBIL is also in the final stages of negotiations with the FDA of US for conducting small-scale phase-III clinical trials in the US,” the company reportedly told the Centre.
Bharat Biotech, sources say, told the government it is in regular touch with regulatory authorities in these countries and was confident about the robustness of its dossier with data for much longer duration – for anti-body persistence after six months as well as eight months. Also, Bharat Biotech was among the few companies that had published papers on all four Covid virus variants, according to sources.
Covaxin has received regulatory approvals from 11 countries, it was pointed out, and 11 companies in seven countries have shown interest towards the technology transfer and production of the Covid shot.
“It is important to note that no country has instituted a vaccine passport. Countries have their own requirements for approval, which in most cases involves travel by carrying a negative RT-PCR report,” Bharat Biotech reportedly said.
Covaxin and Serum Institute of India’s Covishield are the two vaccines being used to inoculate people in the country. Russia’s Sputnik will become the third. Covaxin was approved for emergency use in January without full clinical data, which caused a lot of controversy and was linked to vaccine hesitancy in the initial stages of the nationwide vaccine drive.
In April, Bharat Biotech and the government’s top medical body ICMR claimed that Covaxin had shown overall interim effectiveness of 78 per cent and was 100 per cent effective against severe Covid.

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