Travellers Vaccinated with Covishield ‘Should’ be Allowed into European Union – but Member States Have Final Say Health Equity 30/06/2021 • Kerry Cullinan 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 print (Opens in new window) AstraZeneca’s Covishield is not recognised by the EU COVID vaccine certificate although its European equivalent, Vaxzevria, is. Travellers who are fully vaccinated with vaccines authorised in the European Union (EU) “should” be allowed entry for non-essential travel – even if these vaccines were not “produced in facilities covered by the marketing authorisation in the EU”, a European Commission spokesperson for health, food safety and transport told Health Policy Watch on Wednesday. At the same time, it remains up to individual EU member states to decide if they wish to interpret that European Council policy recommendation, adopted by EU member states on 20 May, so as to authorize entry to vaccinated recipients of the Indian-made Covishield vaccine, said the EC spokesperson, Stefan de Keersmaecker. Covishield, the AstraZeneca vaccine produced by the Serum Institute of India, has the same biological composition as the European vaccine branded Vaxzevria. However, unlike Vaxzevria, Covishield never received European Medicines Agency marketing approval since it is not being manufactured on the European continent. The EC spokesperson was speaking in response to Health Policy Watch’s recent report that the Indian-made “Covishield” vaccine would not be recognised by the EU digital COVID vaccination certificate, which launched on Thursday, 1 July. “As set out in the Council Recommendation on the temporary restriction on non-essential travel to the EU, adopted by Member States on 20 May, entry into the EU should be allowed to people fully vaccinated with one of the vaccines authorised in the EU. This does not mean that the vaccines has to be produced in facilities covered by the marketing authorisation in the EU,” Keersmaecker stated, adding that, “Member States could also allow entry for people vaccinated with vaccines having completed the WHO Emergency Use Listing process. Specifically with respect to Covishield, while it is “not authorised for placing on the market in the EU…. it has completed the WHO Emergency Use Listing process.,” he added. “On the basis of the relevant Council Recommendation on the temporary restriction on non-essential travel to the EU, Member States may allow travellers (without an essential reason) fully vaccinated with this vaccine to enter the EU.” At the same time, he cautioned that while member states might take various approaches to recognizing vaccines administered, or vaccine certificates issued, outside of the EU, they are not required to do so as part of the new EU digital COIVD pass policies: “Member States are, however, not required to issue certificates for a vaccine that is not authorised on their territory, ” he stated. Clarification Comes After Week of Growing Protest In LMICs over EU Vaccine Pass Policies The EU clarification comes after it emerged last week that Covishield, the only vaccine available in most African countries, would not be recognised by the EU digital COVID vaccination certificate as the European Medicines Agency had only authorised Vaxzevria – and not the Covidshield counterpart. The new certificate aims to enable safe and free movement of people by providing proof that travellers have had COVID vaccinations, received a negative test result or recovered from the virus. Earlier in the week, the African Union Commission and the Africa Centres for Disease Control and Prevention (Africa CDC) urged the EU Commission to include “vaccines deemed suitable for global rollout through the EU-supported COVAX facility”. “The current applicability guidelines put at risk the equitable treatment of persons having received their vaccines in countries profiting from the EU-supported COVAX Facility, including the majority of the African Union (AU) member states,” they noted. News of the EU’s exclusion of Covishield has also sparked concerns in various African countries that the Indian version of the vaccine is sub-standard, prompting vaccine hesitancy at a critical moment when the continent faces a major new wave of the virus – and scarce vaccines remain precious resources. Member States Could Allow Vaccines with WHO Emergency Use Listing In his responses, De Keersmaecker acknowledged that while “Covishield is not authorised for placing on the market in the EU”, it had been given Emergency Use Lising (EUL) by the World Health Organization (WHO) – which grants it a certain status. “Member states could also allow entry for people vaccinated with vaccines having completed the WHO Emergency Use Listing process,” he noted. He added that an EU Digital COVID certificate also is not an absolute prerequisite for non-essential EU travel – but rather “a practical tool that can facilitate travel in those cases where restrictions are lifted.” In fact, EU member states have gradually been lifting their overall restrictions on non-essential travel at a varying pace – and with respect to a diversity of approaches to visitors from non-EU countries. Those also may include recognition of certificates of COVID recovery alongside vaccines, as well as requirements for PCR tests, as conditions for entry. While the new EU digital pass attempts to set out a more standardized system, that does not preclude recognizing certificates from other countries, should member states choose to do so, Keersmaecker said: “Member states are free to accept the documentation issued in third countries for vaccination. These should contain information that at least allows [the country] to identify the person, the type of vaccine and the date of the administration of the vaccine,” he added. Travellers from abroad who were fully vaccinated with an EU-authorised vaccine also could be issued with certificates “on a case by case basis”. Over the coming weeks and months, the European Commission may also opt to adopt, on a country by country basis, “an equivalence decision for a third country COVID-19 certificate, which will then be considered as equivalent to EU Digital COVID certificates issued by member states”, said De Keersmaecker. “This is only possible when a third country’s certificates are interoperable with the digital COVID certificate technical standards,” he stressed. He did not elaborate on which countries’ certificates had already been recognized as equivalent. The European Council and European Parliament adopted the COVID digital certificate policy on 20 May, with the issuance of certificates on a systematic, EU-wide basis beginning this week. Countries have six weeks to phase in the system. Some 15 EU member states have already done so. They include Austria, Belgium, Bulgaria, Croatia, Czech Republic, Denmark, Estonia, Germany, Greece, Latvia, Lithuania, Luxembourg, Poland, Portugal and Spain. They are joined by Iceland, one of the four European Economic Area member states also eligible for the scheme. . The certificates are available as a smartphone app, or on paper. For EU/EEA residents, the certificate includes a QR code with the necessary data showing vaccination, PCR test, or recovery status, as well as a digital signature. Along with that, citizens or residents of third countries that have been vaccinated with one of the four EMA-approved vaccines, can use the vaccine cerficates to make non-essential trips to EU countries, according to the new EU-wide policies. The EMA approved vaccines include: Pfizer/BioNTech, Moderna, Johnson & Johnson, along with AstraZeneca’s Vaxzevria version. In contrast, WHO has granted emergency use listing to four other vaccines that are not on the EMA list. Those include AstraZeneca’s Covishield and SK-Bio versions, produced in India and the Republic of Korea respectively, along with the Chinese made, Sinopharm and Sinovac vaccines. -Updated 1 July, 2021 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 print (Opens in new window) Combat the infodemic in health information and support health policy reporting from the global South. Our growing network of journalists in Africa, Asia, Geneva and New York connect the dots between regional realities and the big global debates, with evidence-based, open access news and analysis. To make a personal or organisational contribution click here on PayPal.