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EMA finds AstraZeneca vaccine has no specific risks linked to age or gender

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Emer cooke, executive director, European medicines agency

EMA’s safety committee has concluded today (7 April) that unusual blood clots with low blood platelets should be listed as very rare side effects of Vaxzevria - AstraZeneca vaccine.

The European Medicines Executive Director, Emer Cooke, said: "The safey committee, after an in-depth analysis, has concluded that the reported cases of unusual blood clots following vaccination with AstraZeneca vaccine should be listed as possible side effects of the vaccine.” In reaching its conclusion, the committee took into consideration all currently available evidence. However, Cooke was at pains to underline that the benefits of the AstraZeneca vaccine in preventing Covid far outweigh the risks of side effects.

The safety Committee (PRAC) have concluded, based on current evidence, that there are no specific risk factors, such as age, gender, or previous medical history of clotting disorders linked to the AstraZeneca vaccine. However, the agency encouraged people to continue to come forward and to report any symptoms that they believe may be linked to their vaccination. 

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At the same time as EMA reported its findings, the UK’s regulator reported that it would be recommending a different vaccine for under 30s - a group that is not yet broadly eligible for vaccination. Based on the 20.2 million doses of the AstraZeneca vaccine the UK has administered, it estimates that the overall risk of blood clots is approximately 4 people in a million who receive the vaccine.

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COVID-19

EU and US propose target of 70% of world vaccinated by next year

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Today (18 October) the European Commission President Ursula von der Leyen announced that together with the Biden administration will propose a target of 70% vaccination for the world. 

Von der Leyen said the EU will do its part, on top of its expertise the EU will donate at least  500 million doses of vaccines to the most vulnerable countries. She said that other countries had to set up and that she would work with Prime Minister Draghi and President Biden to rally G20 leaders to commit to this target. 

One billion vaccines exported from the EU

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Von der Leyen said the EU had reached an important milestone in exporting more than 1 billion COVID-19 vaccines to the rest of the world: “Vaccines from the European Union have been shipped to more than 150 countries, just to name a few to Japan, to Turkey to the UK to New Zealand, to South Africa to Brazil.”

“We delivered around 87 million doses to the low- and middle-income countries through COVAX. So we made good on our promise, we have always shared our vaccine nation production capacity fairly with the rest of the world. We've said that at least every second dose is produced in the European Union will go abroad.”

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Von der Leyen added that this hadn’t stopped the EU from reaching its target of more than 75% of the adult population fully vaccinated. She pointed to the fact that the EU managed to do this even when vaccines were scarce.

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EU vaccinates 70% of its adult population

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Today (31 August) the EU has reached a target of 70% of the adult population fully vaccinated. More than 256 million adults in the EU have now received a full vaccine course. 

The Commission already announced that it had met its target to deliver enough vaccines to vaccinate this proportion of the population at the end of July; today’s announcement confirms that these vaccines have been administered. European Commission President Ursula von der Leyen said: “The full vaccination of 70% of adults in the EU already in August is a great achievement. The EU's strategy of moving forward together is paying off and is putting Europe at the vanguard of the global fight against COVID-19.”

Given the prevalence of the more virulent Delta variant, von der Leyen is urging EU countries and its partners to continue vaccinating at a pace. 

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Health Commissioner Stella Kyriakides said: “I am very pleased that as of today we have reached our goal to vaccinate 70% of EU adults before the end of the summer. This is a collective achievement of the EU and its member states that shows what is possible when we work together with solidarity and in co-ordination. Our efforts to further increase vaccinations across the EU will continue unabated. We will continue to support in particular those states that are continuing to face challenges.”

The picture across the EU varies enormously; the good news hides significant differences between EU members, with Romania (26%) and Bulgaria (17%) having very low rates of vaccination. Ireland, which has a very high rate of vaccination, has been able to purchase vaccines from Romania, despite its low rate of vaccination. 

Council removes 5 countries and one entity/territorial authority travel restrictions list 

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The Council has updated the list of countries, special administrative regions and other entities and territorial authorities for which travel restrictions should be lifted. In particular, Israel, Kosovo, Lebanon, Montenegro, the Republic of North Macedonia and the United States of America were removed from the list.

Non-essential travel to the EU from countries or entities is subject to temporary travel restriction. Member states can lift the temporary restriction on non-essential travel to the EU for fully vaccinated travellers.

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Ensuring smooth air travel while checking EU Digital COVID Certificates: New guidelines for member states

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Following the launch of the EU Digital COVID Certificate on 1 July, the European Commission has issued guidelines for EU member states on the best ways to check them before travel, ensuring the smoothest possible experience for air passengers and staff alike. The non-mandatory EU Digital COVID Certificate provides either proof of vaccination, shows if a person holds a negative SARS-COV-2 test result, or has recovered from COVID-19. Therefore, the EU Digital COVID Certificate is essential to support the re-opening of safe travel.

As passenger numbers will rise over the summer, an increased number of Certificates will need to be checked. The airline sector is particularly concerned by this since, in July for example, air traffic is expected to reach more than 60% of 2019 levels, and will rise thereafter. Currently, how and how often passenger's Certificates are checked, depends on the holder's departure, transit and arrival points.

A better-coordinated approach would help avoid congestion at airports and unnecessary stress for passengers and staff. Transport CommissionerAdina Vălean said: “Reaping the full benefits of the EU Digital COVID Certificate requires the harmonization of the verification protocol. Cooperating for a ‘one-stop' system to check the certificates makes for a seamless travel experience for the passengers across the Union.”

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To avoid duplication, i.e. checks by more than one actor (airline operators, public authorities etc.), the Commission recommends a ‘one-stop' verification process prior to departure, involving co-ordination between authorities, airports and airlines. Moreover, EU member states should ensure that the verification is carried out as early as possible and preferably before the passenger arrives at the departure airport. This should ensure smoother travel and less burden for all involved.

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