17 Jul 2021: EU body says it didn't receive application for Covishield approval
The European Medicines Agency (EMA) said it has not received any application for the authorization of the coronavirus vaccine Covishield. The statement came nearly two weeks after the European Union (EU) introduced a digital certificate for easier travel. An approval from the said agency allows unrestricted travel within all the EU member countries for business and tourism purposes.
Fact: 'Developer needs to submit a formal authorization application'
"For the COVID-19 vaccine Covishield to be evaluated for use in the EU, the developer needs to submit a formal marketing authorization application to EMA, which to date has not been received," the EMA said at a press briefing on July 15.
Implication: What does this mean for Indians?
Covishield's exclusion from the EU pass implies that Indians or other nationals who have been vaccinated with this jab would not be eligible for restriction-free travel in European countries. They would be subject to strict rules concerning quarantine and testing as enforced by each country they travel to. However, EU member countries are free to individually include other vaccines in the list.
Vaccines: Which vaccines have been approved by the EMA?
The EMA has listed four vaccines - Vaxzevria (developed by Oxford-AstraZeneca), Comirnaty (Pfizer-BioNTech), Spikevax (Moderna), and Janssen (Johnson & Johnson). Both Covishield and Vaxzevria are notably the same jab developed by the Oxford University and the UK-based AstraZeneca. While Covishield is manufactured in India by the Serum Institute of India (Pune), Vaxzevria is manufactured in the UK and other locations across Europe.
Fact: 'Tiny manufacturing differences can affect the final product'
However, the EMA had earlier said that even tiny differences in the manufacturing process could lead to differences in the final product. "This is because vaccines are biological products," EMA press officer Zala Grudnik had said.
Statement: Serum CEO Poonawalla had assured resolution soon
Last month, Serum Institute CEO Adar Poonawalla said he had taken up the matter and hoped it would be resolved soon. "I realize that a lot of Indians who have taken COVISHIELD are facing issues with travel to the E.U., I assure everyone, I have taken this up at the highest levels...both with regulators and at a diplomatic level with countries," Poonawalla had tweeted.
Other details: Several European countries independently approve Covishield
However, several European countries, including Germany and Spain, have independently allowed those vaccinated with Covishield to travel there without restrictions. Other nations that have approved the shot are Ireland, Austria, Greece, Iceland, and Slovenia. Covishield is India's most prevalent COVID-19 vaccine and one of the few jabs to have received the emergency use listing from the World Health Organization (WHO).
The news article, EU body says it didn't receive application for Covishield approval appeared first on NewsBytes.
Also see: Seven EU nations, Switzerland approve India-made Covishield for 'Green Pass'
'Not received Covishield approval request,' says EU body amid concerns
India takes up Covishield's exclusion from the EU's 'Green Pass'
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