With several countries planning to reopen their borders for fully vaccinated travellers, concerns have been raised that Indians who have received Bharat Biotech’s Covaxin jabs may not qualify. This is due to the vaccine not being approved for World Health Organization’s (WHO) Emergency Use Listing (EUL) yet.
Places including the US, Canada, Australia, Ireland, and the European Union do not recognise Covaxin as an approved vaccine for now.
What does the Emergency Use Listing mean? How does it affect international travel? When will Covaxin get approval? Here’s what we know until now.
The WHO’s Emergency Use Listing procedure assesses, approves, and lists unlicensed vaccines for use during a public health emergency. They help determine the acceptability of vaccines based on available quality, safety, efficacy, and performance data, according to WHO.
Top universities across the globe are only allowing those who have received vaccines approved by their countries or the WHO. Countries like Canada, the United States, and other European nations are also likely to follow suit.
This puts Indians who have taken Covaxin at a disadvantage, since it is not yet approved.
Bharat Biotech, addressing the concerns, said that “90 percent of the documentation required” for WHO’s authorisation for Emergency Use Listing, has been submitted.
“The remaining is expected to be submitted in June,” it said, adding that it is “confident of getting clearance subsequently.”
Bharat Biotech has further added that regulatory approvals are expected by July – September 2021.
The WHO has said that it needs more documents to complete the process. Their Guidance Document says that while the EOI (Expression of Interest) has been submitted, there is still “more information required.”
The following vaccines have been approved by the WHO:
According to Bharat Biotech, Covaxin has obtained EULs from 13 countries.
Bharat Biotech has also said that it in the final stages of submission of required documents for regulatory approvals for Covaxin in Brazil and Hungary. Regulatory approvals are in process in over 60 countries.
Additionally, Bharat Biotech added that it is in the final stages of negotiations with the United States’ Food and Drug Administration (FDA) for conducting small-scale phase-III clinical trials of Covaxin in the USA, reported PTI.