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SII says working on Covishield EU pass

Indian officials said it was “perplexing” that the list includes Vaxzevria, the AstraZeneca vaccine produced and marketed in the UK and other sites around Europe, but not Covishield, the version manufactured and distributed in India, though they are similar if not identical.
By HT Correspondent, Hindustan Times, New Delhi
UPDATED ON JUN 29, 2021 04:41 AM IST
The Covishield vaccine “does not currently have a marketing authorisation” in Europe and the matter would be considered when an application is received for it, the EMA said.(AFP )

The Serum Institute of India (SII) is approaching the European Medicines Agency (EMA) for approval to its Covid-19 vaccine, Covishield, for the European Union’s Green Pass, a document that will ease travel within and to the bloc, people aware of the matter said on Monday.

EMA currently recognises only four Covid-19 vaccines that have received EU-wide marketing authorisation so far.

Indian officials said it was “perplexing” that the list includes Vaxzevria, the AstraZeneca vaccine produced and marketed in the UK and other sites around Europe, but not Covishield, the version manufactured and distributed in India, though they are similar if not identical.

The issue of Covishield’s approval by EMA is also expected to be taken up by the Indian side with European Union (EU) officials on the margins of the G20 foreign ministers’ meeting in Italy on June 29, said people familiar with developments, even as SII’s CEO Adar Poonawalla said on Monday that he has taken up the matter at the highest level to ensure Indians don’t face any travel restrictions.

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“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 tweeted.

“SII has applied for EMA certification,” said a person familiar with the development, on condition of anonymity.

The Covishield vaccine “does not currently have a marketing authorisation” in Europe and the matter would be considered when an application is received for it, the European Medicines Agency said. “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,” the agency added.

Almost 88% of the 323million doses of vaccines administered in India thus far are of Covishield.

The other three vaccines that EMA has approved for use by the EU member states to issue the certificates are Comirnaty (Pfizer/BioNTech), Moderna, and Janssen (Johnson & Johnson).

The Green Pass is likely to be available for use by July 1, 2021.

“The position taken by EMA is perplexing because Covishield and Vaxzevria, the AstraZeneca vaccine approved by the European agency, are qualitatively similar in nature,” said a senior government official who spoke on condition of anonymity.

EMA’s position is that Covishield has not been approved for use in Europe. The agency’s approval is also site-specific. It wasn’t immediately clear why Covishield, approved by WHO (through an emergency-use listing), and also the mainstay of Gavi and WHO’s Covax programme, did not apply for marketing authorisation.

Bharat Biotech’s Covaxin does not have a WHO emergency-use listing yet.

“There is still some time, and a solution will likely come soon as the matter is being taken up at different levels,” a second government official said on condition of anonymity.

External affairs minister S Jaishankar and other officials from the foreign ministry are currently in Italy for the meeting of the foreign and development ministers of the G20, which includes 19 countries and the EU. The agenda for the meeting includes a swift international response to the Covid-19 pandemic and equitable worldwide access to diagnostics and vaccines.

According to PTI, SII has, in a letter to Jaishankar, requested him to take up the matter of the inclusion of Covishield vaccine in the EU Covid-19 vaccination passport with the European Union and other countries, citing that this will affect students and business travellers and cause severe disruptions to the Indian and global economy.

A third government official said it is always the responsibility of the manufacturer, in this case SII, to apply for approval from EMA. “The government can only facilitate the process, it is not something done at government to government level.”

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