HOPE TO RESOLVE COVISHIELD, EU TRAVEL ISSUES SOON: SII CEO

External affairs ministry also planning to take up issue of Covishield’s non-inclusion in list of approved vaccines by the European Union

Amid reports that people who have taken the Serum Institute of India (Sii)-manufactured Astrazeneca vaccine Covishield will face challenges in travelling to Europe, SII Chief Executive Officer Adar Poonawalla said on Monday that he has taken it up at the ‘highest levels’.

In a tweet from his official handle, Poonawalla said: “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.”

He added that he hopes to resolve the issue soon.

Speaking to a television channel, Poonawalla said that he has already applied to the European Medicines Agency (EMA) for approval of Covishield in the European markets. He further noted that he is taking up the issue with the EMA diplomatically.

“Covishield is already cleared by the World Health Organization (WHO) and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (UKMHRA), so I hope the EMA clearance will also come on over the next few weeks,” he added.

Meanwhile, reports also suggest that India plans to take the matter of noninclusion of Covishield in the list of approved vaccines for Eurpean Union (EU) ‘Green Pass’, up with the EU.

This pass, which will be launched from July 1, is required for easy travel to and within the EU.

The Ministry of External Affairs has reportedly taken this issue up with the European Medicines Agency (EMA), the EU drug regulator.

While Covishield has not been included in the list of vaccines for Green Pass, the Astrazeneca manufactured vaccine Vaxzevria has been approved by the EMA. People who have got a Vaxzevria shot can enter the EU.

The EU had said sometime back that member states could issue certificates for vaccines that have received a nod from the EMA.

At present, four vaccines have been approved by the EMA — Comirnaty (Pfizer/biontech), Moderna, Vaxzervria (Astrazeneca-oxford), and Janssen (Johnson & Johnson).

The move is surprising, given that Covishield features in the World Health Organization (WHO)’S Emergency Use List (EUL) and is also supplied by the vaccine alliance Covax. The vaccine has been administered largely to Indians and people in low- and middle-income countries (LMICS), who have received it through the Who-led Covax initiative.

WHO has listed eight vaccines under its EUL, which includes Covishield.

According to reports, EU countries have the options to accept other vaccine certificates too for travelers apart from those approved by the EMA.

Iceland will allow entry to individuals who have been vaccinated by vaccines authorized by either the EMA or the WHO. France, on the other hand, has indicated that it will approve vaccines approved by the EMA only.

This would rule out Indian, Chinese, Russian vaccines.

ADAR POONAWALLA,

CEO, Serum Institute of India

“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”