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Commission strengthens transparency and authorization mechanism for exports of COVID-19 vaccines

EU Reporter Correspondent

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The European Commission has introduced the principles of reciprocity and proportionality as new criteria to be considered for authorising exports under the transparency and authorisation mechanism for COVID-19 vaccine exports. This system has significantly improved the transparency of exports. Nevertheless, the objective to ensure timely access to COVID-19 vaccines for EU citizens is still not met. Related media

European Commission President Ursula von der Leyen said: “The EU is proud to be the home of vaccine producers who not only deliver to EU citizens but export across the globe. While our Member States are facing the third wave of the pandemic and not every company is delivering on its contract, the EU is the only major OECD producer that continues to export vaccines at large scale to dozens of countries. But open roads should run in both directions. This is why the European Commission will introduce the principles of reciprocity and proportionality into the EU's existing authorisation mechanism. The EU has an excellent portfolio of different vaccines and we have secured more than enough doses for the entire population. But we have to ensure timely and sufficient vaccine deliveries to EU citizens. Every day counts.”

Towards increased transparency, reciprocity and proportionality

The new regulation introduces two changes to the existing mechanism. First, in addition to the impact of a planned export to the fulfilment of the EU's Advance Purchase Agreements (APAs) with vaccine manufacturers, member states and the Commission should also consider:

  • Reciprocity – Does the destination country restrict its own exports of vaccines or their raw materials, either by law or other means?
  • Proportionality – Are the conditions prevailing in the destination country better or worse than the EU's, in particular its epidemiological situation, its vaccination rate and its access to vaccines.

Member states and the Commission should assess whether the requested exports do not pose a threat to the security of supply of vaccines and their components in the Union.

Second, to gain a full picture of vaccine trade, the new act includes 17 countries previously exempted in the scope of the regulation.*

The EU remains committed to international solidarity and will therefore continue to exclude from this scheme vaccine supplies for humanitarian aid or destined to the 92 low and middle income countries under the COVAX Advance Market Commitment list.

The export authorization scheme

This implementing act is targeted, proportionate, transparent and temporary. It is fully consistent with the EU's international commitment under the World Trade Organization and the G20, and in line with what the EU has proposed in the context of the WTO's trade and health initiative. Member states decide on the requests for authorization in accordance with the Commission's opinion.

Since the start of this mechanism, 380 export requests to 33 different destinations have been granted for a total of around 43 million doses. Only one export request was not granted. The main export destinations include the United Kingdom (with approximately 10.9 million doses), Canada (6.6 million), Japan (5.4 million), Mexico (4.4 million), Saudi Arabia (1.5 million), Singapore (1.5 million), Chile (1.5 million), Hong Kong (1.3 million), Korea (1.0 million) and Australia (1.0 million).

About the EU's vaccine strategy

The European Commission presented on 17 June 2020 a European strategy to accelerate the development, manufacturing and deployment of effective and safe vaccines against COVID-19. In return for the right to buy a specified number of vaccine doses in a given timeframe, the Commission finances part of the upfront costs faced by vaccines producers in the form of Advance Purchase Agreements (APAs). Funding provided is considered as a down-payment on the vaccines that are actually purchased by member states. The APA is therefore a de-risk investment upfront against a binding commitment from the company to pre-produce, even before it gets marketing authorisation. This should allow for a quick and steady delivery as soon as the authorization has been granted.

The Commission has so far signed APAs with six companies (AstraZeneca, Sanofi-GSK, Janssen Pharmaceutica NV, BioNTech-Pfizer, CureVac, and Moderna), securing access to up to 2.6 billion doses. Negotiations are advanced with two additional companies. The four contracts with the companies whose vaccines have been granted conditional marketing authorization amount to more than 1.6 billion doses.

More information

Commission Implementing Regulation

Press release on the extension of the measure (11 March 2021)

Frequently asked questions

*List of countries included: Albania, Armenia, Azerbaijan, Belarus, Bosnia and Herzegovina, Georgia, Israel, Jordan, Iceland, Lebanon, Libya, Liechtenstein, Montenegro, Norway, North Macedonia, Serbia and Switzerland.

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Coronavirus variants: Commission calls for limiting essential travel from India

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The Commission calls on EU member states to take co-ordinated action to further restrict travel from India on a temporary basis, with a view to limiting the spread of the B.1.617.2 variant first detected in India. This follows a proposal of the World Health Organization on 10 May 2021 to change the classification of that variant from “variant of interest” to “variant of concern”. It is important to limit to the strict minimum the categories of travellers that can travel from India for essential reasons and to subject those who may still travel from India to strict testing and quarantine arrangements.

To ensure a fully co-ordinated and efficient response to this variant and taking into account the deteriorating health situation in India, the Commission proposes that member states apply an ‘emergency brake' on non-essential travel from India. On 3 May, the Commission had proposed to add an ‘emergency brake mechanism' to the Council recommendation on restrictions to non-essential travel.

Limited exemptions for those travelling for compelling reasons, subject to strict safeguards

The restrictions should not affect those travelling for compelling reasons such as for imperative family reasons or persons in need of international protection or for other humanitarian reasons. EU citizens and long-term residents, as well as their family members, should still be able to travel to Europe.

For those travellers, the Commission calls on member states to apply additional health-related measures such as strict testing and quarantine arrangements. These measures should apply regardless of whether the travellers have been vaccinated.

Next steps

Any restrictions on essential travel from India should be temporary and regularly reviewed. member states should assess their effectiveness in containing the new variant. When triggering the ‘emergency brake' mechanism to further restrict travel from a non-EU country, the member states meeting within the Council structures should review the situation together in a coordinated manner and in close co-operation with the Commission.

Background

A temporary restriction on non-essential travel to the EU is currently in place from many non-EU countries, including from India, based on a recommendation agreed by the Council.

Following a proposal by the Commission, the Council agreed on 2 February 2021 additional safeguards and restrictions for international travellers into the EU, aimed at ensuring that essential travel to the EU continues safely in the context of the emergence of new coronavirus variants and the volatile health situation worldwide.

On 3 May, the Commission proposed that member states ease the current restrictions on non-essential travel into the EU to take into account the progress of vaccination campaigns and developments in the epidemiological situation worldwide while putting in place a new ‘emergency brake mechanism', to address coronavirus variants. The ‘emergency brake mechanism' is a coordination mechanism intended to limit the risk of variants of interest and variants of concern entering the EU. It allows member states to act quickly and in a coordinated manner to temporarily limit to a strict minimum all travel from a non-EU country where the epidemiological situation worsens quickly and in particular where a variant of concern or interest is detected.

Variants of interest and variants of concern are assessed as such by the World Health Organisation (WHO) and for the EU by the European Centre for Disease Prevention and Control (ECDC) based on key properties of the virus such as transmission, severity and ability to escape immune response.

The European Centre for Disease Prevention and Control has assessed the B.1.617.2 variant first detected in India as a variant of interest and keeps this assessment under constant review. Variants of interest are variants that show increased transmissibility and severity. On 10 May 2021, the World Health Organization proposed to change the classification of the B.1.617.2 variant from “variant of interest” to “variant of concern”.

Under the current Council Recommendation on the temporary restriction on non-essential travel into the EU, member states can temporarily limit the categories of essential travellers that can travel to the EU where the epidemiological situation worsens quickly and where a high incidence of variants of concern of the virus is detected. 

The Council recommendation covers all member states (except Ireland), as well as the four non-EU states that have joined the Schengen area: Iceland, Liechtenstein, Norway and Switzerland. For the purpose of the travel restriction, these countries are covered in a similar way as the member states.

The latest information on the rules applying to entry from non-EU countries as communicated by member states are available on the Re-open EU website.

More information

Press release: Coronavirus: Commission proposes to ease restrictions on non-essential travel to the EU while addressing variants through new ‘emergency brake' mechanism, 3 May 2021

European Centre for Disease Prevention and Control threat assessment brief: Emergence of SARS-CoV-2 B.1.617 variants in India and situation in the EU/EEA, 11 May 2021

Travel during the coronavirus pandemic

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'I'm finally here': Greece formally opens to tourists

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Tourists eat at the Monastiraki district, as the country's tourism season officially opens, in Athens, Greece May 15, 2021. REUTERS/Costas Baltas
Tourists visit the ancient temple of Hephaestus, as the country's tourism season officially opens, in Athens, Greece May 15, 2021. REUTERS/Costas Baltas

Greece formally opened to visitors on Saturday (15 May), kicking off a summer season it hopes will resurrect its vital tourism industry battered by the coronavirus pandemic.

After months of lockdown restrictions, Greece also opened its museums this week, including the Acropolis museum, home to renowned sculptures from Greek antiquity.

"I feel really alive and good because it has been such a hard and long year because of COVID," said Victoria Sanchez, a 22-year-old student on holiday from the Czech Republic.

"I feel again alive," she said, as she strolled near the Roman Agora in downtown Athens.

As of Saturday, foreign tourists will be allowed in Greece if they have been vaccinated or can show negative COVID-19 test results. Travel between regions, including to the islands, will also be allowed for those with negative tests or vaccinations.

"Greece is offering what people need," Tourism Minister Harry Theoharis tweeted. "Calm and care-free moments on the road towards normality."

Tourists in Athens were elated.

"I'm finally here," said Rebecca, a tourist in Athens from Florida, who declined to give her last name. "I've been waiting two years - two years with the COVID."

Greece has been rolling out vaccines to its islands and hopes to vaccinate most of them by the end of June. The government says vaccines and rapid testing, as well as warmer weather allowing outdoor activities, mean visitors can travel safely.

As the pandemic brought international travel to a halt in 2020, Greece suffered its worst year for tourism on record, with 7 million visitors compared with a record 33 million in 2019. Tourist revenues tumbled to 4 billion euros ($4.9 billion) from 18 billion euros.

This year, it is aiming for 40% of 2019 levels.

On the island of Mykonos, one flight was given a water salute upon landing. Four islands in the south Aegean, including Mykonos, received 32 international flights on Saturday from countries including Sweden, Germany and Qatar.

Corfu, in the Ionian sea, welcomed visitors from Germany and France.

"We are so happy. I'm happy to be here," said Pierre-Olivier Garcia, soon after arriving on the island.

Greeks also welcomed the lifting of lockdown measures, with scores of people leaving for the islands or holiday homes on the mainland on Saturday.

"The first weekend of freedom," Alpha TV proclaimed during a broadcast from the busy port of Piraeus.

Greece fared better than much of Europe during the first wave of the pandemic, but rising infections later in 2020 forced it to impose several lockdowns to protect its struggling health system.

A country of 11 million, it has recorded 373,881 infections and 11,322 deaths.

($1 = 0.8237 euros)

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Italian study shows COVID-19 infections, deaths plummeting after jabs

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COVID-19 infections in adults of all ages fell by 80% five weeks after a first dose of Pfizer (PFE.N), Moderna (MRNA.O) or AstraZeneca (AZN.L) vaccine, according to Italian research published on Saturday (15 May).

The first such study by a European Union country on the real-world impact of its immunisation campaign was carried out by Italy's National Institute of Health (ISS) and the Ministry of Health on 13.7 million people vaccinated nationwide.

Scientists started studying data from the day Italy's vaccination campaign began, on Dec. 27 2020, until May 3 2021.

The analysis showed that the risk of SARS-CoV-2 infection, hospitalisation, and death decreased progressively after the first two weeks following the initial vaccination.

"As of 35 days after the first dose, there is an 80% reduction in infections, 90% reduction in hospitalisations, and 95% reduction in deaths," the ISS said, adding that the same pattern was seen in both men and women regardless of age.

"This data confirms the effectiveness of the vaccination campaign and the need to achieve high coverage across the population quickly to end the emergency," ISS president Silvio Brusaferro said in the statement.

Among the nearly 14 million people included in the Italian study, 95% of those who had taken Pfizer and Moderna had completed the vaccine cycle, while none of those given AstraZeneca had received a second dose.

Up until now, Italy has been following the makers' recommendations, giving a second dose of Pfizer three weeks after the first, a second dose of Moderna after a four week gap and a second dose of AstraZeneca after a 12 week gap.

As of Saturday morning, some 8.3 million Italians, or 14% of the population, were completely vaccinated, while around 10 million people had received a first jab.

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