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No application received yet for Covishield approval, European health regulator says

While SII says it has applied for the approval through its partner, AstraZeneca, the EMA says it it is yet to receive any formal request for the evaluation of Covishield.

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New Delhi: The approval of Covishield vaccine by the European Medicines Agency (EMA) will help fully vaccinated Indians travel to European Union countries without any ban. But Europe’s health regulator said Thursday it is yet to receive any formal request for the evaluation and marketing authorisation of Covishield.

In a tweet posted on its official handle, the EMA clarified its position: “For the #COVID19vaccine Covishield to be evaluated for use in the EU, the developer needs to submit a formal marketing authorisation application to EMA, which to date has not been received.”

In an emailed response to ThePrint on 8 July, the EMA confirmed that it has “not received” an application for the evaluation of Covishield yet.

“Should we receive a marketing authorisation application for any vaccine not currently approved in the EU, we will communicate about it on our website,” it said.

With Europe issuing a new vaccine passport programme on 1 July  — it recognised a few Covid-19 vaccines to enable people to travel in and out of Europe with fewer roadblocks — the spotlight has been on vaccines that had not yet been “approved” by the regulator.

Covishield is one of them. The AstraZeneca-Oxford vaccine made in India has been manufactured by the Serum Institute of India (SII). The SII, had, however, claimed that it has applied for the approval through its partner, AstraZeneca, and would get it within a month.

Claims, counter-claims

SII CEO Adar Poonawalla had said there was “no controversy” and that he was expecting to receive approval from the EMA for Covishield in a month.

“We are quite confident that in a month EMA will approve Covishield,” he had stated in various statements to the press.

An SII official, requesting anonymity, however, told The Print Friday, that “we have applied through AstraZeneca and we are confident”. The company is expected to release an official statement on the matter soon.

Four vaccines are under evaluation but not Covishield

To date, EMA has approved four vaccines — Comirnaty (Pfizer/BioNTech), Moderna, Vaxzevria (AstraZeneca) and Janssen (Johnson & Johnson). While the AstraZeneca vaccine, Vaxzevria, has been endorsed, Covishield awaits approval.

“Information on the four vaccines currently approved in the EU and the vaccines currently under evaluation (under rolling review) is available on our website,” EMA’s press office added.

The vaccines, according to the website, under evaluation are products by CureVac (CVnCoV), Novavax (NVX-CoV2373), Sputnik V and Sinopharm.

The section of “marketing authorisation application submitted” on the website is blank and shows no entry which also seems to confirm the EMA position.

EMA ‘not responsible’ for decisions on travelling

The health watchdog also told The Print in its email that EMA is “not responsible,” per se, for any decision regarding travelling to the European Union. “It might be helpful to also clarify what is the European Medicines Agency’s role. EMA is in charge of the scientific evaluation of medicines/vaccines in view of their marketing authorisation in the EU, which is a basis of their use in vaccination campaigns in the EU member states.”

“However, EMA is not responsible for any decision regarding travelling into the EU and travelling conditions associated with Covid-19 vaccination, such as the EU Digital COVID Certificate. This is a matter for the European Commission and for individual member States,” it added.

(Edited by Paramita Ghosh)

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