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EU-Covishield Row: Serum Institute Applies for Emergency Use Authorization With EMA


EU-Covishield Row: Serum Institute Applies for Emergency Use Authorization With EMA
SHARES

India-based vaccine and pharma manufacturer Serum Institute of India (SII) said that the company has applied for an emergency use authorization (EUA) with the European Medicines Agency (EMA) for its coronavirus vaccine known as Covishield after reports revealed that individuals who had taken their jabs faced trouble entering the European Union (EU). 

“I realize that a lot of Indians who have taken Covishield are facing issues with travel to the EU. I assure everyone I have taken this up at the highest levels and hope to resolve this matter soon, both with the regulators and at a diplomatic level with countries,” the CEO of SII, Adar Poonawalla said on Twitter. 

https://twitter.com/adarpoonawalla/status/1409382675748515841 

A person familiar with the matter was quoted by Livemint saying that SII has applied for a EUA with the EMA, and that clearance is expected not too long from now. 

ReadWar Of Words Erupts On Twitter Over Efficacy Of Covishield Vs Covaxin

The timing of Poonawalla’s Twitter statement also coincides with reports of Covishield being left out of the European digital vaccination certificate, otherwise known as a “vaccine passport” that would allow residents to move more freely within the EU.

European health guidelines state that only people who have received either of the EMA approved vaccines will be considered vaccinated against COVID-19. Currently, the Pfizer, Moderna, Johnson & Johnson, and Vaxzevria vaccines have been approved by the EU. 

What’s confusing about this is the fact that the EU vaccine passport recognizes the AstraZeneca COVID-19 vaccine (Vaxzevria), while Serum Institute’s version of the same vaccine isn’t on the list. 

However, SII is confident that Covishield will make it to the EMA’s list of approved vaccines, though the timeline is currently unclear. 

Although Bharat Biotech’s Covaxin has received emergency use authorization from the Drugs Controller General of India (DCGI), it hasn’t been approved by the World Health Organization (WHO). Similarly, Russia’s Sputnik V COVID-19 vaccine hasn’t received the requisite emergency use approvals from the WHO either.

Also readNMMC To Conduct Special Vaccination Drive For Covishield Second Dose

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