Covaxin has received regulatory approvals from 11 countries (File)
New Delhi:
As countries prep to gradually restart travel and tourism after prolonged Covid restrictions, there is nervousness among students with the World Health Organisation not approving Bharat Biotech’s Covaxin.
Nations like the US, Canada, Australia, Ireland and the EU do not recognize Covaxin on their approved list of vaccines for now. Top universities are only allowing those who have received vaccines approved by their countries or the WHO.
“Covaxin is not on the approved list, which means students will not be exempt from mandatory hotel quarantine which is very expensive – to stay in a hotel for 14 days,” 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, in a detailed statement today addressing the concerns, said the company was on track to get approvals and had submitted “90 per cent of the documentation required” for WHO’s authorization for Emergency Use Listing.
“The remaining is expected to be submitted in June,” said the company, adding 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.
Bharat Biotech also said it was in the final stages of submitting documents for Covaxin’s regulatory approvals in Brazil and Hungary after “extensive bilateral consultations” with both countries. “BBIL is also in the final stages of negotiations with FDA of the USA for conducting small-scale phase-III clinical trials in the US,” the company said.
Bharat Biotech released the statement after a meeting with the government on the status of its application before the WHO.
Covaxin has received regulatory approvals from 11 countries 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 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.