What Next For SII And Covishield Recipients As The Vaccine Is Not Included In EU Green Pass?

In a setback to millions of Indians and those around the world who had taken the Covishield COVID-19 vaccine, manufactured and marketed by the Serum Institute of India in Pune, it was left out of the EU Pass list.

The European Medicines Agency (EMA) has approved four vaccines Comirnaty of Pfizer/BioNTech, Moderna, Vaxzervria by AstraZeneca-Oxford and, Johnson & Johnson's Janssen.

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Only those inoculated with these vaccines will be given vaccination passports and allowed to travel within the EU during the pandemic.

Vaxzervria in, Covishield out!

However, the made-in-India version of the AstraZeneca-Oxford vaccine, Covishield was left out.

This has left many, including students and those who had to travel to Europe for business purposes in the lurch.

In India, those wanting to go abroad for study and work purposes were given Covishield preference as the other vaccine approved in the country, COVAXIN is yet to be cleared by the WHO for emergency use.

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What happened?

According to reports, the Covishield was left out while Vaxzervria (which are essentially the same) was approved because the SII had not applied for e a marketing authorisation" of the Covishield vaccine in Europe.

"The only COVID-19 vaccine from AstraZeneca for which a marketing authorisation application was submitted to and evaluated by EMA, leading to its authorisation in the EU, is Vaxzevria," Alessandro Faia, a spokesperson of the EMA said.

"In the EU, the vaccine called Covishield does not currently have a marketing authorisation. Even though it may use an analogous production technology to Vaxzevria, Covishield as such is not currently approved under EU rules," the official said.

Reuters

Explaining the reason, the official said even tiny differences in the manufacturing conditions can result in differences in the final product.

"This is because vaccines are biological products. Even tiny differences in the manufacturing conditions can result in differences in the final product, and EU law, therefore, requires the manufacturing sites and production process to be assessed and approved as part of the authorisation process," the spokesperson said.

What next?

He, however, said that if the SII files an application, that will be considered.

"Should we receive a marketing authorisation application for Covishield or should any change to the approved manufacturing sites for Vaxzevria be approved, we would communicate about it," he said.

Twitter/@adarpoonawalla

What is SII doing?

SII CEO Adar Poonawalla also confirmed that his company is making efforts to resolve the matter soon.

"I realise 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 regulators and at a diplomatic level with countries," he said in a tweet.

I realise 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 and hope to resolve this matter soon, both with regulators and at a diplomatic level with countries.

¡ª Adar Poonawalla (@adarpoonawalla) June 28, 2021

According to PTI, SII has urged the government to take up the issue with the European Union and other countries.

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"India has a large population. However, not including Covishield in the EU COVID-19 Vaccination Passport will not allow Covishield vaccinated people to travel to European countries and this will affect students, business travellers back and forth, and cause severe disruptions to our economy and to the global economy," Poonawalla wrote in a letter to External Affairs Minister S Jaishankar.

Poonawalla, in his letter, is learnt to have mentioned that nearly 30 crore people have already been vaccinated with Covishield in India and it is expected that more than 50 per cent of Indian population will be protected with this vaccine finally.