Sanjeev Kumar Patro

News Highlights

  • As EMA and FDA have their own set of stringent regulations to give approval to a vaccine for EUA, Indian manufacturers have to apply so separately. Though the normal approval time-period is 250 days,since the vaccines are against the pandemic like Covid-19, the granting of EUA to other vaccines manufacturers will take only 150 days (5-months).

Little over a fortnight ago, the former civil servant and BJD Rajya Sabha MP Amar Patnaik had stirred a political storm when he blamed the BJP -led Central Government for imposing country's first indigenous vaccine Covaxin on people and , thereby, jeopardising the future of students who go abroad for studies or work.

Taking a strong exception, the State BJP then had hit back deploring the BJD leader's statement on the indigenously manufactured Covaxin. The party spokesperson had then even demanded expulsion of Patnaik from BJD.

Days later, the Bhubaneswar Municipal Corporation (BMC) has launched a special vaccination drive for foreign bound students. Hundreds of them were given Covishield at designated centres.

The sparks of political jab flew over the fact that when Covishield has been granted EUA (Emergency Use Athorisation) by WHO, the same has not been granted to Covaxin. The process of granting EUA to Covaxin has been under process, a WHO note said.

However, come July 1, people vaccinated with 2-doses of Covishield cannot visit any of the European Union countries. Because, the European Union's green pass to the vaccinated individuals has not included Covishield vaccines despite being manufactured in technological collaboration with AstraZeneca and Oxford University.

But the political reactions in Odisha are not forthcoming and muted this time.

"European Union is set to make available its COVID-19 passport (Digital COVID Vaccine Certificate) for all EU citizens and residents, as well as for specific categories of travellers from third countries, by July 1.The EU will facilitate safe free movement of citizens in the EU during the COVID-19 pandemic," said a statement.

What Is an EU COVID-19 Vaccine Passport?

The EU COVID Vaccination Passport will be issued to all those who have been fully vaccinated against the Coronavirus.

The Twist In The Tale

Significantly, the twist here is the EU has made it crystal clear that one will be issued a vaccine passport, provided h/she had the shots of the four vaccines approved by only the European Medicine Agency (EMA), which are:

•    Comirnaty (BioNTech, Pfizer)

•    Moderna

•    Vaxzevria (previously COVID-19 Vaccine AstraZeneca, Oxford)

•    Janssen (Johnson & Johnson)  (see the image below).

Covishield No Passport To Europe?


The fact of concern is despite the Covishield having granted EUA by WHO, the EMA has not approved the vaccine yet. As a consequence, none from India can travel to any EU countries for the simple reason that none of the vaccines approved by EMA are available in India.

Will It Impact Travel To US?

Though US government has gone on record to say that there is no plan to implement national vaccination passport in USA. As per US embassy notification, the United States does not require a COVID-19 vaccination certificate for entry into the United States. Therefore, vaccinated with Indian vaccines or even not vaccinated has not been a bar to travel US.

Though there is no blanket bar in travelling to US, however, the Biden administration has left it to the jurisdiction of respective states. 

For instance, New York State has issued  Excelsior Passes to residents who have been vaccinated or tested negative for Covid so they can gain admittance to certain venues and events. And the passes will be issued to those who have taken the shots approved by US-FDA (Food and Drug Administration).

So, in New York State, the excelsior passes required to go to certain venues and event will not be granted to travellers (or students) from India. The approved vaccine list of FDA doesn't include any Indian-made vaccine. Unlike EU, the impact on travelers from India will be bery limited. 

The vaccines approved by FDA are:

•    Pfizer-BioNTech Vaccine

•    Moderna Covid-19 vaccine

•    Janssen Covid-19 vaccine

The Solution  

As EMA and FDA have their own set of stringent regulations to give approval to a vaccine for EUA, Indian manufacturers have to apply so separtely. Though the normal approval time-period is 250 days,since the vaccines are against the pandemic like Covid-19, the granting of EUA to other vaccines manufacturers will take only 150 days (5-months).

FDA has recently didn't grant EUA to Covaxin, and sought additional data. Bharat Biotech statement post rejection mentioned that the company will go for full approval, not EUA, in US soon.

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