Green pass not precondition to travel, says EU official
The European Union (EU)’s so-called “green pass” is not a precondition to travel and individual states have the option to accept vaccines approved by the WHO such as Covishield, an EU official said on Tuesday.
The EU offered the clarification against the backdrop of speculation on the possible impact of the “EU Digital Covid Certificate” or green pass on Indian nationals as the regime doesn’t include any of the vaccines currently being administered in India. The green pass system is expected to be in place from July 1.
As of Monday, the Serum Institute of India (SII) had not applied to the European Medicines Agency (EMA) for approval of Covishield, the EU official said. The EMA has so far approved only four vaccines – Comirnaty, Johnson & Johnson’s Janssen vaccine, Spikevax or the Moderna vaccine and Vaxzevria or the AstraZeneca vaccine.
“For the purpose of the Digital Covid Certificate, individual [EU] member states will have the option to also accept vaccinations that have been authorised by the World Health Organization (WHO), such as Covishield,” the EU official said.
The Digital Covid Certificate is meant to “facilitate safe free movement during the Covid-19 pandemic within the EU”, and it will serve as “proof that a person was vaccinated against Covid-19, received a negative test result or recovered from Covid-19”, the official added.
“The aim of the EU Digital Covid Certificate is to facilitate free movement inside the EU. It is not a precondition to travel,” the official said.
Referring to the possible EMA authorisation for Covishield, the official said, “As of yesterday [Monday], the EMA stated that it had not received a request for approval. It will examine any such request when received, as per its procedures.”
The EU further clarified that EMA “does not investigate new drugs on its own, unless it is asked by the relevant companies”.
The official noted that temporary restrictions on non-essential travel to the EU were currently in place for many non-EU countries, including India, due to the pandemic. “EU member states shall gradually lift these temporary travel restrictions at the external borders, based on developments of the health situation,” the official said.
The issue of a “fair travel regime” figured in talks between external affairs minister S Jaishankar and the EU commissioner for international partnerships, Jutta Urpilainen, when they met in Italy on Monday ahead of a meeting of G20 foreign ministers.
Jaishankar tweeted that he had a “good conversation” with Urpilainen, adding: “Discussed the Covid challenge, our Connectivity Partnership and development cooperation. Underlined the importance of equitable vaccine access and a fair travel regime.”
India has linked the issue of so-called “vaccine passports” to equitable access to doses around the world. External affairs ministry spokesperson Arindam Bagchi had said on June 17 that many developing countries had not yet been able to vaccinate a large percentage of their population.
“We would favour discussions on the subject of vaccine passport with greater focus on vaccine equity,” he had said, hinting that India had no plans to issue vaccine passports.
The EMA had said on Monday that is only responsible for the scientific evaluation of medicines and vaccines in connection with their marketing authorisation in the EU, and that it is not responsible for travelling conditions associated with Covid-19 vaccination, such as the Digital Covid Certificate.
The agency further said the only Covid-19 vaccine from AstraZeneca that had been authorised in the EU was Vaxzevria and that Covishield did not currently have marketing authorisation.
“Even though it may use an analogous production technology to Vaxzevria...Covishield as such is not currently approved under EU rules. 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,” an EMA spokesperson 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 spokesperson added.