Tuesday, October 12 2021

The European Medicines Agency (EMA) on Monday clarified the exclusion of the Serum Institute of India (SII) manufactured by Covishield from the list of vaccines approved for the ‘Green Pass’, saying the vaccine currently has no marketing authorization in the European Union. (EU).

“In the EU, the vaccine called Covishield does not currently have a marketing authorization. Although it may use production technology similar to Vaxzevria (the COVID-19 Astra Zeneca vaccine authorized in the EU ) “, Zala Grudnik, EMA press officer, told India. Today Television in response to an email request.

The EMA said that tiny differences in manufacturing conditions can lead to differences in the final product. “It’s because vaccines are biologics,” he said.

Also read: Covishield Not Yet Listed by EMA for EU Covid ‘Green Pass’ Eligibility

EU law requires manufacturing sites and the production process to be assessed. This is mandatory for customs clearance.

“The only AstraZeneca Covid-19 vaccine for which a marketing authorization application has been submitted and assessed by the EMA, leading to its authorization in the EU, is Vaxzevria (formerly COVID-19 AstraZeneca vaccine ) “, said the EMA.

The body said it had authorized the Green Pass for four vaccines so far – Comirnaty (Pfizer), Covid-19 Vaccine Janssen, Spikevax (formerly Covid-19 Vaccine Moderna) and Vaxzevria from AstraZeneca.

The EMA also said that if an application for marketing authorization is received from the developers of the vaccine, they will consider the application.

“If we received a marketing authorization application for Covishield or if a change to the approved manufacturing sites for Vaxzevria were approved, we would notify,” said Grudnik.

The EMA also said it will communicate on a possible change in the approved manufacturing sites for Vaxzevria.

In India, Serum Institute of India CEO Adar Poonawala said the issue is being addressed at the highest levels, hoping to resolve this issue quickly.

“I realize that a lot of Indians who have taken COVISHIELD are facing travel issues in the EU, I assure everyone, I have taken this to the highest level and hope to resolve this issue soon. , both with regulators and at the diplomatic level with countries, ”Poonawala tweeted.


People inoculated with Covishield, manufactured by AstraZeneca and manufactured by SII, may not be eligible for the European Union (EU) Green Pass because the vaccine has not yet been recognized by the European Medical Agency. (EMA).

The “Green Pass” is launched to allow hassle-free travel to and between EU countries. However, only those inoculated with vaccines recognized by the EMA will be able to claim this “digital passport”.

READ ALSO: The Covishield Rut: Indians traveling abroad do not really have a choice of the Covid vaccine

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