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EU clears vaccine sites to boost inoculation drive

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The European Medicines Agency (EMA) has approved two factories for the production of COVID-19 vaccines, with the European Union banking on them to boost deliveries in the second quarter and accelerate the slow pace of inoculations in the bloc, write Philip Blenkinsop and Joan Faus.

The EMA said in statement it had cleared the Halix production site in the Netherlands that makes the AstraZeneca vaccine and a facility in Marburg in Germany producing BioNTech/Pfizer shots.

The European Union has blamed massive shortfalls of AstraZeneca doses for the slow roll-out of vaccines across the bloc, while BioNTech/Pfizer has plans to sharply increase its deliveries in the second quarter.

European Internal Markets Commissioner Thierry Breton said vaccines produced by AstraZeneca within the bloc would stay there until the company returns to fulfilling its delivery commitments.

His comments echoed those of Commission President Ursula von der Leyen after a video conference summit of EU leaders on Thursday. Of 300 million doses due to be delivered to EU countries by the end of June, AstraZeneca aims to deliver only 100 million.

AstraZeneca’s request to the EMA for authorisation of its Dutch plant run by subcontractor Halix was only confirmed on Wednesday by EU Health Commissioner Stella Kyriakides.

It is not clear why the request only came now despite Halix being listed as a supplier in the company’s contract with the European Union in August. AstraZeneca has declined to comment on the timing, but said Halix is a relatively small part of its vaccine supply chain. Halix says its monthly production is about 5 million doses.

Kyriakides said she expected vaccines from this plant to be delivered to EU countries in the coming days as part of AstraZeneca’s commitment to EU citizens.

It is also unclear whether the approval of Halix will allow the distribution of 16 million doses of AstraZeneca vaccines seized this week by the Italian authorities, and which AstraZeneca said were waiting approval before being shipped to EU countries. AstraZeneca declined to comment on this.

If the doses seized in Italy were manufactured at Halix, as European Union sources had suspected, the green light for the site would mean the batch is cleared for use.

Under an AstraZeneca internal schedule dated March 10 and seen by Reuters, the company expected to deliver to the EU nearly 10 million doses of vaccines next week, a third of its entire supply to the EU so far.

The supply forecast hinged on the approval of the Halix site, the document said.

MAJOR PFIZER-BIONTECH RAMP-UP

Italian Prime Minister Mario Draghi reiterated on Friday his threat to put export blocks on companies that failed to honour vaccine delivery commitments, and ruled out getting into trade disputes with countries such as Britain over supplies.

“I don’t want to go into details and without naming names, but one has the impression that some companies deliberately sold the doses two or three times,” he said with a laugh, and without elaborating.

Draghi said he expected at least 4 million more vaccine doses to get to Italy before the end of the month, with production slowly being ramped up in various sites.

Underscoring the growing output capacity, the EU’s drugs regulator also granted German biotech firm BioNTech approval for the use of COVID-19 vaccines produced at its new site in Marburg.

BioNTech launched production in February at the site, which it purchased from Novartis last year. The firm said on Friday the Marburg site had an annual capacity of 1 billion doses, up from 750 million doses flagged previously.

That makes it a key element of BioNTech and partner Pfizer’s global delivery plans of 2.3 billion to 2.4 billion doses this year.

The first batches of vaccines manufactured at the Marburg site are expected to be delivered in the second half of April.

Kyriakides called the approval “very good news” that should enable the expected acceleration of production and deliveries.

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Vaccinating the world: ‘Team Europe' to share more than 200 million doses of COVID-19 vaccines with low and middle-income countries by the end of 2021

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Ensuring access to safe and affordable COVID-19 vaccines around the world, and notably for low and middle-income countries, is a priority for the European Union.

At the Global Health Summit in Rome, on 21 May 2021, President von der Leyen announced that ‘Team Europe' would share with low and middle-income countries at least 100 million doses by the end of 2021, mainly via COVAX, our partner in vaccinating the world.

Team Europe (the EU, its institutions and all 27 member states) is on track to exceed this initial goal, with 200 million doses of COVID-19 vaccines foreseen to be shared with the countries that need them most, by the end of 2021.

President von der Leyen said: “Team Europe takes its responsibility in helping the world fight the virus, everywhere. Vaccination is key – that's why it is essential to ensure access to COVID-19 vaccines to countries worldwide. We will be sharing more than 200 million doses of COVID-19 vaccines with low and middle-income countries by the end of this year.”

The more than 200 million doses of COVID-19 vaccines that have been committed by Team Europe will reach their destination countries, mainly through COVAX, by the end of this year.

COVAX has so far delivered 122 million doses to 136 countries.

In parallel, Team Europe has launched an initiative on manufacturing and access to vaccines, medicines and health technologies in Africa.

The initiative will help create the right conditions for local vaccine manufacturing in Africa, backed by €1 billion from the EU budget and the European development finance institutions such as the European Investment Bank (EIB).

On 9 July, Team Europe agreed to support large-scale investment in vaccine production by the Institut Pasteur in Dakar, alongside other support measures. The new manufacturing plant will reduce Africa's 99% dependence on vaccine imports and strengthen future pandemic resilience in the continent.

Background

The EU has been the driving force behind the Coronavirus Global Response and the creation of the ACT-Accelerator, the world's facility for access to COVID-19 vaccines, diagnostics and treatments.

As most low and middle-income countries need time and investments to build their own manufacturing capacities, the immediate and most effective response still is vaccine sharing.

The Global Health Summit was convened by President von der Leyen and the Prime Minister of Italy Mario Draghi on 21 May 2021. This very first G20 summit on health marked the beginning of a new chapter in global health policy.

World leaders committed to multilateralism, global cooperation in health and to ramping up vaccine manufacturing capacities worldwide, to make this pandemic the last pandemic.

More information

Coronavirus Global Response

Global Health Summit

Africa initiative

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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.”

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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Coronavirus: Commission steps up research funding with €120 million for 11 new projects to tackle the virus and its variants

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The Commission has short-listed 11 new projects worth €120 million from Horizon Europe, the biggest European research and innovation programme (2021-2027), for supporting and enabling urgent research into the coronavirus and its variants. This funding is part of a wide range of research and innovation actions taken to fight the coronavirus and contributes to the Commission's overall action to prevent, mitigate and respond to the impact of the virus and its variants, in line with the new European bio-defence preparedness plan HERA Incubator. The 11 short-listed projects involve 312 research teams from 40 countries, including 38 participants from 23 countries outside of the EU.

Innovation, Research, Culture, Education and Youth Commissioner Mariya Gabriel said: “The European Union has been taking strong action to fight the coronavirus crisis. Today we are stepping up our research efforts to meet the challenges and threats that coronavirus variants present. By supporting these new research projects and reinforcing and opening relevant research infrastructures, we continue to fight this pandemic as well as prepare for future threats.”

Most of the projects will support clinical trials for new treatments and vaccines, as well as the development of large scale, coronavirus cohorts and networks beyond Europe's borders, forging links with European initiatives. The Commission has been at the forefront of supporting research and innovation and coordinating European and global research efforts, including preparedness for pandemics. It pledged €1.4 billion to the Coronavirus Global Response, of which €1bn comes from Horizon 2020, the previous EU research and innovation programme (2014-2020). The new projects will complement those previously funded under Horizon 2020 to fight the pandemic. More information is available in a press release.

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