The European Medicines Agency (EMA) on Monday clarified the exclusion of Covishield manufactured by the Serum Institute of India (SII) from the list of approved vaccines for the “Green Pass” and stated that the vaccine is currently not approved for the market in the European Union has (EU).
“The vaccine called Covishield currently has no marketing approval in the EU. Although it may use an analog production technology such as Vaxzevria (Astra Zeneca’s EU-approved COVID-19 vaccine),” EMA spokeswoman Zala Grudnik told India Today TV in response to an email request.
The EMA said tiny differences in manufacturing conditions can lead to differences in the end product. “That’s because vaccines are biological products,” it said.
Also read: Covishield has yet to be listed by the EMA for EU Covid ‘Green Pass’ eligibility
EU law requires an assessment of the production facilities and the production process. This is absolutely necessary for the approval.
“The only Covid-19 vaccine from AstraZeneca for which an application for approval has been submitted to and assessed by the EMA, which led to its approval in the EU, is Vaxzevria (formerly AstraZeneca COVID-19 vaccine),” said the EMA With.
The agency said it has so far approved the Green Pass for four vaccines – Comirnaty (Pfizer), Covid-19 vaccine Janssen, Spikevax (formerly Covid-19 vaccine Moderna) and AstraZenecas Vaxzevria.
The EMA also said they would consider the application if a marketing authorization application was received from the vaccine’s developers.
“Should we receive an application for approval for Covishield or should a change in the approved production facilities for Vaxzevria be approved, we would communicate it,” said Grudnik.
The EMA also said it would communicate about a possible change to the approved manufacturing facilities for Vaxzevria.
In India, Adar Poonawala, CEO of the Serum Institute of India said: the matter is being dealt with at the highest level in the hope of resolving this matter soon.
“I realize that many Indians who have taken COVISHIELD have problems traveling to the EU, I assure everyone, I have addressed this at the highest level and I hope to resolve this matter soon, both with regulators and diplomatically . ” with countries, “Poonawala tweeted.
WHAT IS GREEN PASS?
Individuals vaccinated with Covishield, manufactured by AstraZeneca and manufactured by SII, are unlikely to be eligible for the European Union (EU) Green Pass because the vaccine has not yet been approved by the European Medical Agency (EMA).
The “Green Pass” is introduced to enable problem-free travel within and between EU countries. However, only those who have been vaccinated with EMA-approved vaccines can claim this “digital passport”.
ALSO READ: The Covishield Rut: Indians traveling abroad don’t really have a choice for a Covid vaccine
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