Covishield’s green pass approval by EMA to be discussed on G20 sidelines
The approval of Serum Institute of India (SII)’s Covishield vaccine by the European Medicines Agency (EMA) is expected to be taken up by the Indian side with the European Union on the margins of the G20 foreign ministers’ meeting in Italy on June 29, said people familiar with developments.
SII chief executive officer Adar Poonawalla also said on Monday that he has taken up the matter “at the highest level” to ensure Indians don’t face any travel restrictions.
“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,” Poonawalla tweeted.
People familiar with the matter said on condition of anonymity that SII would apply to EMA for certification.
External affairs minister S Jaishankar and his team are currently in Italy for a meeting of the foreign and development ministers of the G20, which includes 19 countries and the EU. The agenda for the meeting at Matera includes a swift international response to the Covid-19 pandemic and equitable worldwide access to diagnostics and vaccines.
The people cited above said the issue of EMA approval is expected to figure in discussions between Indian and EU officials on the margins of the G20 meeting.
Travellers vaccinated with Covishield, the version of the AstraZeneca vaccine manufactured in India, are currently ineligible for the EU Digital Covid certificate or “green pass” – an immunity document set to be in place by July 1 to ease travel within and to the 27-member bloc – as EMA has approved only four Covid-19 vaccines that have received EU-wide marketing authorisation.
The position taken by EMA is perplexing because Covishield and Vaxzevria, the AstraZeneca vaccine approved by the European agency, are qualitatively similar in nature, the people said.
The Indian side has also reached out to EU authorities and key members of the bloc for greater understanding about the green pass and other national health regulations. The understanding on the Indian side is that the green pass is currently applicable only for intra-EU travel, though there could be a wider rollout at a later stage, and it will initially be available only to citizens of the 27 member states and EU citizens based outside the bloc.
The people cited above also said EMA approval was more about processes involving the manufacturer of a vaccine and less about government-to-government understandings. The government can help facilitate the process but it is the responsibility of the manufacturer to seek approval from EMA.
“There is still some time, and a solution will likely come soon as the matter is being taken up at different levels,” another government official aware of the matter said on condition of anonymity.
The EMA’s current list of approved vaccines includes Vaxzervria, the AstraZeneca shot produced in the UK and other sites around Europe, Comirnaty or the Pfizer-BioNTech vaccine, the Moderna shot and Johnson & Johnson’s Janssen vaccine.
The European Parliament voted overwhelmingly for the EU Digital Covid certificate on April 29 in response to demands from tourism-dependent countries such as Spain and Greece but questions remain about varying vaccination and testing rules in the 27 member states.
Diplomats told Reuters in April that national differences on recognising negative antibody tests on top of PCR tests, technical difficulties in creating a single EU gateway, worries about discrimination against those who have not been vaccinated, and privacy issues meant that finding common ground across the EU might be tricky.
The green pass, which was originally known as the “digital green certificate”, will contain information about vaccination, tests and recovery from Covid-19. Reports have said EU citizens will be able to obtain the green pass if they have any one of the three elements.