People With Covaxin Jab Might Have to Delay International Travel Plans as WHO, FDA Rejects Listing of Vaccine

As several countries, especially in Europe have thrown open their borders for vaccinated foreign travellers, and many are getting ready to reopen their borders, Indians who have received Bharat Biotech’s Covid-19 vaccine Covaxin jabs may not qualify for travelling abroad. United States’ Food and Drug Administration (FDA) recently turned down Bharat Biotech’s proposal for an emergency use authorisation (EUA) of covaxin, delaying the company’s vaccine launch in that country.

On the other hand, Covaxin is not yet on the World Health Organisation’s (WHO) Emergency Use Listing (EUL) as well. The latest WHO guidance document shows that Bharat Biotech has submitted its Expression of Interest (EoI) but “more information is required".

Not just that, many other countries are yet to approve the vaccine and put it on the list of approved vaccine for international travellers. On the other hand, almost every nation in the world currently accept Serum Institute of India’s (SII) Covishield vaccine developed by AstraZeneca, to enter their country.

As per reports, Covaxin is accepted in only in nine nations. According to a report by Mint, Ocugen, the US partner of Bharat Biotech, on Thursday said the company will now be seeking a full approval of Covaxin.

“The FDA provided feedback to Ocugen regarding the Master File the Company had previously submitted and recommended that Ocugen pursue a BLA submission instead of an EUA application for its vaccine candidate and requested additional information and data," said a statement from Ocugen to NYSE.

“While this will extend our timelines, we are committed to bringing Covaxin to the US," Shankar Musuniri, chief executive of Ocugen was quoted in Mint.

The phase 3 data is crucial for the company, as only with those results can the company seek emergency approval from the World Health Organisation. An emergency approval from the WHO will allow the company to export its vaccines, besides granting the much-needed validation that is required for the vaccine to be considered as part of a “vaccine passport".

Vaccine passport or immunity passports are becoming a reality as countries open their borders for non-essential travel to fully vaccinated individuals.

With inputs from agencies.

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