15 European Countries Recognize India’s Covishield Vaccine for EU Travel Pass; Only 10 Adopt All WHO-Approved Jabs European Medicines Agency 08/07/2021 • Svĕt Lustig Vijay & Elaine Ruth Fletcher Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to email this to a friend (Opens in new window)Click to print (Opens in new window) The European Medicines Agency (EMA) does not recognize Covishield – the India-produced AstraZeneca vaccine Nearly half of the 31 European nations using the European Union’s new digital COVID travel certificate have recognized the India-made version of the AstraZeneca vaccine, Covishield, alongside its European-made counterpart, Vaxzevria, an analysis by Health Policy Watch has revealed. But other major countries, including France, Poland, and Italy, seem to be holding out, authorizing only those vaccines recognized by the European Medicines Agency (EMA). The 15 countries that have adoped more progressive policies include: Austria, Bulgaria, Finland, Germany, Greece, Hungary, Ireland, Latvia, the Netherlands, Slovenia, Spain, Sweden. Belgium also announced Wednesday that it would recognize the Covishield vaccine – good news for vaccine advocates in the Democratic Republic of Congo – which has been one of the most vaccine-hesitant countries to date. Iceland and Switzerland, among the four members of the European Free Trade Association (EFTA) that align with EU policies, also are accepting Covishield vaccines for travel. La #Belgique a annoncé hier qu’elle reconnaît le Covishield (AstraZeneca) qui est distribué à travers l’initiative #COVAX et qui a exactement la même efficacité et les mêmes propriétés que le vaccin AstraZeneca qui est utilisé massivement dans l’UE. ⬇️⬇️⬇️ https://t.co/SpCQU3CDHx — Belgique en RDCongo (@BelgiqueRDCongo) July 8, 2021 But only 10 out of the 31 EU/EFTA countries have fully followed World Health Assembly recommendations, recognizing all eight vaccines that have been granted a WHO Emergency Use Listing, as valid for the entry of non-European visitors on “non-essential” visits, the Health Policy Watch analysis also found. They include: Finland, Germany, Latvia, Netherlands, Hungary, Spain, Sweden – as well as Iceland and Switzerland, according to a country-by-country analysis of the latest travel policies. Rather than a unified response, the EU COVID pass has thus triggered a cacophony of different policies, by country. In the case of “vaccination with a vaccine that does not correspond to one centrally authorised in the EU, each Member State has the option to recognise it,” EU spokesperson Stefan de Keersmaecker told Health Policy Watch, in remarks last week. Asked whether the EU might at sometime in the future consider a region-wide policy for Covishield, or the other 3 WHO-approved vaccines, the spokesperson declined to comment. Only fifteen EU/EFTA nations have recognized Covishield, the India-made version of the AstraZeneca vaccine as of 8 July, 2021. Legend: green – approved; purple – unapproved (HPW/Svet Lustig Vijay). Lack of Recognition Spurred Diplomatic Uproar Health Policy Watch inventoried all 27 EU country policies, as well as those of the four EFTA countries, via online sites or direct emails, to examine European responses to the new travel pass systems. This followed a wave of protest across South Asia and Africa late last month over the lack of EU recognition for the Covishield vaccine, as part of the new EU-wide COVID digital pass, which is being adopted by the 27-member bloc of countries, along with its four EFTA neighbors. The protests began after France and other European embassies in Africa posted guidance for would-be travelers about the new COVID digital pass, launched 1 July. That information failed to include Covishield – the jab most widely distributed by the WHO-supported COVAX global vaccine facility – as a valid vaccine for the travel certificates. In comments to Health Policy Watch last week, European Union officials said that the AstraZeneca vaccine produced by the Serum Institute of India could not be automatically included in the COVID digital certificate because the Indian version had never been formally approved by the European Medicines Agency (EMA). “Unlike Vaxzevria [the EU-produced AstraZeneca vaccine], Covishield never received European Medicines Agency marketing approval since it is not being manufactured on the European continent,” EU spokesperson Stefan de Keersmaecker told Health Policy Watch. Rather than taking a EU-wide approach, Keersmaecker said that it would be left up to each “individual country” to determine whether to recognize Covishield – as well as three other vaccines that were approved for Emergency use by the WHO but not by the EMA. Those three other WHO-approved vaccines include yet another AstraZeneca jab, produced by SK Bio in the Republic of Korea and two vaccines manufactured by China’s Sinopharm and Sinovac. Vaccines recognized by the EMA, as well as the WHO, include those by Pfizer/BioNTech, Moderna, Johnson & Johnson, and Vaxzevria, the EU-manufactured version of the AstraZeneca vaccine. Only 10 EU/EFTA nations have recognized all eight vaccines that have been granted WHO Emergency Use Listing. Legend: red – EMA-approved vaccines only; blue – WHO-approved vaccines (HPW/Svet Lustig Vijay). EU Is “Utterly Irresponsible” “I think it is utterly irresponsible for the EU not to accept Covishield in its Green Pass system, and leave decisions to a patchwork of different European countries,” Lawrence Gostin, Director of the O’Neill Institute for National and Global Health Law, told Health Policy Watch. “Covishield is a safe and effective vaccine, and has been authorized by a number of rigorous regulatory agencies. It is a highly discriminatory decision, given that Covishield is a major vaccine used by COVAX. It will mean that many people in lower-income countries will be discriminated against,” added Gostin, who is also the Director of the WHO Collaborating Center on National and Global Health Law. Covishield represents 90% of the 89 million vaccines distributed to Africa by the global COVAX facility and 80% of the 350 million jabs administered so far in India. The vaccine also has been sold or distributed in a range of other SouthEast Asian and Latin American countries. Some Covishield vaccines also have been donated to UN peacekeepers in Africa and elsewhere. The WHO-approved Sinovac and Sinopharm vaccines – which also lack wide EU recognition – have meanwhile been widely deployed Latin America and South East Asia. The European digital green passport France, Italy, Poland – Denying Covishield Recognition The protests, including by WHO and other lead agencies of the COVAX initiative, as well as the Indian government, have so far left a number of EU countries unmoved. France, Poland, and Italy, continue to be among those EU/ EFTA countries that consider travelers as “unvaccinated” unless they have received one of the four EMA-approved jabs, the Health Policy Watch review of their official travel guidance found. As a result, tens of millions of vaccinated people in Africa, Asia and Latin America, along with the five million Brits who received Covishield as as part of the UK’s national vaccination drive, still may face quarantine or test requirements upon their arrival to the more than dozen EU countries that don’t recognize the Covishield vaccine – if they are allowed to travel to those countries at all. That’s in comparison to vaccinated peers in countries like the United States or Canada, who received EMA-approved jabs. To date, the EMA has approved AstraZeneca manufacturing sites in the EU, the UK, the US, and China. In contrast, AstraZeneca’s production sites in India (Serum Institute), Korea (SK Bioscience), and Thailand (Siam Bioscience), were never submitted to the EMA for approval. India Warns of Potential Retaliation If Covishield Not Approved By EMA Should the EU fail to greenlight Covishield, India has warned that it will retaliate by mandating quarantines to EU citizens upon their arrival to India, irrespective of their vaccination status. But Serum Institute’s CEO Adar Poonawalla has said that is unlikely to happen; in a recent tweet he predicted that the EMA would approve Covishield region-wide by the end of July. 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. — Adar Poonawalla (@adarpoonawalla) June 28, 2021 “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,” said Poonawalla. “In a month we are confident the EMA will approve Covishield,” Poonawall also told the Times of India last week. “There is no reason not to, as it is based on AstraZeneca data and our product is identical to AstraZeneca more or less.” Adding more to the confusion, four EU countries, including Greece, Cyprus, Hungary, and Slovenia, have also recognized the Russian-made Sputnik V vaccine as valid for entry by tourists and other non-essential travelers – even though that vaccine has yet to get any WHO approval at all. The WHO review process stalled recently after reports of contamination issues identified at a Russian vaccine “fill and finish” manufacturing plant. Says Gostin, “it is clear” that more harmonization between the WHO, EU and EMA is urgently needed to streamline global travel and ensure travel policies are fair. “I do think the EU will ultimately accept Covishield,” predicted Gostin. But he warns that delaying such a decision “will lower confidence in that vaccine to the detriment of the global vaccination campaign.” – Surabhi Agarwal contributed to the creation of Tableau charts. Image Credits: Azhar Khan, Algorithm Watch. Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to email this to a friend (Opens in new window)Click to print (Opens in new window) Combat the infodemic in health information and support health policy reporting from the global South. 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