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Explainer | EU ‘Green Pass’ hitch for Covishield

The COVISHIELD and COVAXIN vaccine vials. File   | Photo Credit: MURALI KUMAR K

The story so far: The European Union COVID Digital Green Pass which was launched on July 1 has one problem for Indian travellers to the EU — it does not recognise Covishield, the AstraZeneca vaccine manufactured by the Serum Institute of India (SII), as yet. Adar Poonawalla, CEO of the SII, tweeted that he has taken it up “at the highest levels” and hoped to resolve the matter soon. At the moment, the EU pass recognises only the Vaxzevria version of the Oxford-AstraZeneca vaccine, manufactured in the U.K. and other places in Europe and approved by the European Medicines Agency (EMA).

What does the Green Pass permit?

The EU COVID Digital Green Pass is the popular form of the EU Digital COVID Certificate or EUDCC which is a digital (or paper) certificate that will enable a person to travel within and to the EU region covering 27 member-states. The certificate will act as proof of the fact that the person concerned has been vaccinated or has recovered from COVID-19 or has a negative certificate on a COVID-19 test done 24 hours prior to travelling. EU’s ambassador to India Ugo Astuto said the Green Pass is for travel within the EU region.

Explainer | EU ‘Green Pass’ hitch for Covishield
 

Member-states of the EU are expected not to impose additional travel restrictions on bearers of the Green Pass. In case a member-country of the EU stops a person carrying the Green Pass, then the government will have to justify its action by proving that the person has a virus variant that can prove to be a risk to the greater public.

EU’s health authorities have argued that the digital certificate will streamline the process of clearance of passengers entering the region as member-countries were earlier (in some cases even now) using national certificates that were creating barriers for region-wide travel. The EU member-states argue that the move is necessary to deal with countries that are said to have “virus variants”.

Can unvaccinated people travel to the EU?

The EUDCC is applicable under three groups. It allows those who have been vaccinated as well as those who have recovered from COVID-19 and also those who have tested negative in the last 24 hours to enter the EU states. In principle, unvaccinated travellers can reach EU using the options in the green pass.

What is the controversy around the Covishield vaccine?

From July 1, travellers to EU countries are being allowed entry into EU region only if they have taken vaccines cleared by the EMA. Its list of certified vaccines includes Pfizer/BioNTech’s Comirnaty, Moderna’s Spikevax, Oxford-AstraZeneca Vaxzevria and Johnson & Johnson’s Janssen. The European Commission says of the 27 member-states, 16 have already started using the EUDCC through the EMA’s approved list of vaccines. Though the EMA has cleared Oxford-AstraZeneca’s Vaxzevria which is the European variant of the AstraZeneca doses, it has not cleared the Covishield injections which are manufactured by the SII under licence from Oxford-AstraZeneca as it did not have an application for market authorisation from Covishield.

Why has not the EMA cleared Covishield?

In response to questions from The Hindu, the EMA has informed that it is solely in charge of the scientific evaluation of medicines/vaccines in order to grant the items “marketing authorisation” in the EU and “the only COVID-19 vaccine from AstraZeneca for which marketing authorisation was submitted to and evaluated by EMA, leading to its authorisation in the EU, is Vaxzevria (previously COVID-19 Vaccine AstraZeneca).

“Even though it may use an analogous production technology to Vaxzevria (the COVID-19 AstraZeneca vaccine authorised in the EU), 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,” the EMA told The Hindu. The EMA’s answer clearly indicates that there is no “automatic” system for vaccine clearance. That means Covishield which is based on the AstraZeneca formula will not get automatic clearance because a version of the AstraZeneca vaccine (Vaxzevria) was cleared earlier. “The EMA does not investigate new drugs on its own, unless it is asked by the relevant companies,” EU authorities said.

What does it mean for Indian travellers?

Travellers who wish to reach EU using Covishield are likely to find themselves in two kinds of situations. Firstly, they will face difficulty for non-authorisation of Covishield by the EMA. Secondly, they may find it possible to enter countries that have decided to recognise Covishield as “valid proof of vaccination against COVID-19”. European authorities, however, maintain that they are not yet opening travelling from India as it is a country with a specific “virus variant”. As a result, even essential travelling like those by university students and businesspersons are unlikely to get clearance as of now. “As to travel to the EU from India, temporary restriction on non-essential travel to the EU are currently in place from many non-EU countries, including India, due to COVID,” EU authorities said. As of Friday, at least 10 European countries have recognised Covishield as a valid proof of vaccination against COVID-19 . The list includes — Austria, Germany, Slovenia, Greece, Iceland, Ireland, Spain, Switzerland, Estonia and the Netherlands. However, the recognition helps in increasing credibility of Covishield vaccine but it does not yet clarify whether Indians with Covishield doses can travel from one country to another within the EU region just on the basis of “national” recognition of the Indian vaccine, without getting EMA’s clearance.

When will EU allow Indians to travel to the region?

The final status on this issue will be clear only after there is communication between the SII and the EU. As of now EU authorities have said, “EU member-states shall gradually lift these temporary travel restrictions at the external borders based on developments of the health situation.” However, the EU has also said that the “Green Pass” is not a “pre-condition to travel”. This has given some hope to Covishield recipients as it allows space to EU member-states the option to allow vaccines that have been authorised by the World Health Organization. Covishield is WHO-certified and a “national solution” by individual EU states may help resolve the situation in case Indian travellers are stuck in airports in the region.

What is the SII saying?

Sources from the SII said the company has applied to the EMA for clearance of the vaccine. But EU authorities in a statement issued on Tuesday said it had not received a request for approval as of Monday. The SII will have to clarify the exact status of the vaccine with the EMA as without it travel hurdles for Indians with Covishield certificates cannot be ruled out. External Affairs Minister S. Jaishankar has raised the Green Pass for Covishield issue with the EU.

Will Indians face difficulties in all countries in Europe?

As of now non-essential travel to EU member-countries is temporarily halted. But Serbia which is yet to become a member of the EU remains open to Indian visitors. However, reaching Serbia from India remains difficult. “Pre-approved cases” handed out by embassies of Austria, Estonia, Hungary, Iceland, Ireland are likely to enable Indians to travel in case restrictions are lifted in the coming days. Switzerland may join this list too.

Covishield was also distributed to many low and middle-income countries such as Nepal, Bangladesh in the neighbourhood as well as African countries such as Kenya, Mauritania and others under the WHO-co-sponsored COVAX initiative. Passengers from these countries are expected to face the same difficulties like Indian travellers till the EMA grants recognition to Covishield manufactured by the SII.


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Printable version | Dec 3, 2021 4:39:38 PM | https://www.thehindu.com/news/national/explainer-eu-green-pass-hitch-for-covishield/article35094396.ece

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