World News

Explainer: COVID-19 vaccination in the EU

Published

2 years ago

December 25, 2020

The Pfizer-BioNTech COVID-19 vaccine is the first vaccine to be made readily available in some parts of the world. BioNTech

With which companies have you concluded COVID-19 vaccine agreements?

The Commission is negotiating intensely to build a diversified portfolio of vaccines for EU citizens at fair prices. Contracts have been concluded with AstraZeneca (400 million doses), Sanofi-GSK (300 million doses), Johnson and Johnson (400 million doses ), BioNTech-Pfizer 300 million doses, CureVac (405 million doses) and Moderna (160 million doses). The Commission has concluded exploratory talks with the pharmaceutical company Novavax with a view to purchasing up to 200 million doses.

This means that the Commission has secured a portfolio of more than 2 billion doses. For the Commission it was important from the beginning to build a diversified portfolio of vaccines based on different technologies, to increase the chances that one or more of the vaccine candidates are approved by EMA. Should all vaccines candidates turn out to be safe and effective, Member States have the possibility to donate part of their doses to lower and middle income countries.

Which vaccine is now authorised?

The Commission has given on 21 December the conditional marketing authorisation for the vaccine developed by BioNTech and Pfizer, following EMA positive assessment of its safety and efficacy. It is now waiting for EMA’s opinion on the possible conditional marketing authorisation for the vaccine by Moderna, which should be provided by 6 January at the latest.

No other vaccine producer has formally applied for a marketing authorisation to EMA. In order to accelerate the process, EMA has started rolling reviews on the vaccines produced by Johnson and Johnson and AstraZeneca.

How will vaccines be monitored post authorisation under the Conditional Marketing Authorisation (CMA)?

The monitoring of the safety and effectiveness of vaccines after authorisation is a requirement under EU law and a cornerstone of the EU’s pharmacovigilance system relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem. The system is exactly the same than for a normal market authorisation.

The safety and effectiveness of vaccines which have received conditional marketing authorisations are rigorously monitored, as for all medicines, through the EU’s established medicines monitoring system.

In addition, special measures are in place to quickly collect and evaluate new information. For example, manufacturers must usually send a safety report to the European Medicines Agency every six months. For COVID-19 vaccines, safety reports must be sent every month.

The European Medicines Agency will set up additional large-scale safety monitoring given the exceptionally high numbers of people expected to receive the vaccines.

Once authorised, when will vaccines be available in the EU?

In line with the EU vaccine strategy agreed with Member States, once authorised and produced, each vaccine will be available to Member States at the same time and at the same conditions.

The distribution will start progressively. This means that in the first few months, there will not be enough doses available to vaccinate all adults. The first doses will go to the priority groups identified by Member States (e.g. healthcare professionals, persons over 60 years of age). Supplies will increase over time, and all adults should be able to get vaccinated during the course of 2021.

For most contracts concluded, the majority of delivery is foreseen to be completed in 2021. Under some contracts, first deliveries are expected to already start in the first quarter of 2021.

First deliveries of the BioNTech and Pfizer vaccine are expected within days of authorisation and first vaccinations would take place in the context of the EU vaccination days of 27-29 December.

The Commission has been asking national authorities to prepare as early as possible for organising the fast and accessible deployment of vaccines, according to national vaccination plans and has issued guidance on the large-scale vaccination deployment.

The Commission is following the developments of national vaccination plans very closely and provides support notably by organising joint procurement for vaccination supplies, such as syringes and needles, and running a stress test of the national vaccination plans ahead of deployment together with the ECDC.

Will the EU have enough capacity to manufacture the COVID vaccines?

There is already substantial vaccine production capacity in the EU – and the Commission is working intensively to increase it. In addition, and in order to ensure that vaccine developers have the necessary capacity to scale up the production of COVID-19 vaccines as soon as they have been approved by the EMA, the Commission supports the necessary investment in the development of such production capacities.

How will logistics work? How will vaccines be distributed?

Logistics and transportation is a key aspect on which all Member States have to work, as emphasised in the Communication on preparedness for COVID-19 vaccination strategies and vaccine deployment of 15 October.

Delivery to national distribution hub(s) will be ensured by the manufacturers.

Further distribution to vaccination centres will be ensured by Member States, who will also be responsible for the vaccination of their population.

Who should be vaccinated first?

All Member States will have access to COVID-19 vaccines at the same time on the basis of the size of their population. The overall number of vaccine doses will however be limited during the initial stages of deployment and before production can be ramped up. The Commission has therefore provided examples of unranked priority groups to be considered by countries once COVID-19 vaccines become available.

Most countries have defined priority groups and are further refining who should get priority in these priority groups e.g. older person over 80 years of age. The ECDC published an overview of where EU/EEA countries and the UK are with the development of their vaccination plans/strategies. ECDC is also working on a modelling exercise on prioritisation to support Member States. This report should be published before Christmas.

Will citizens know which vaccine they will be getting?

Yes.

When vaccines receive conditional marketing authorisation, the package leaflet with details on the specific vaccine will be translated into all languages and published in electronic form by the Commission.

All health care professionals and all patients would therefore have access to a leaflet in electronic form in their own languages.

The vaccine companies are responsible for putting in place the necessary mechanisms to ensure that each patient receives the package leaflet in print form in his/her language upon request without burdening healthcare professionals administering the vaccine.

What labelling and packaging information will citizens and health care professionals get with the COVID-19 vaccines?

In order to allow for a rapid deployment of COVID-19 vaccines at large scale, the Commission has developed, with Member States and the European Medicines Agency, labelling and packaging flexibilities for a temporary period. Flexibility in the labelling and packaging requirements is expected to reduce transport costs and storage space, improving the distribution of the doses between Member States and limit possible impact on the production of other routine vaccines. Despite these flexibilities, anyone vaccinated and health care professionals will have access to all the information on the vaccine used.

An example of such flexibilities is the fact that the outer and immediate packaging may only be printed in English. Also, the package leaflet does not have to be included inside the package of the medicinal product, but will be provided separately by the vaccine company, who will be responsible for the distribution of the printed package leaflet locally in the national language(s).

Some Member States do not require the package leaflet to be printed in their national language(s). The leaflet may be printed in English only, but the information contained in the leaflet should still be available in the national language(s), for instance via a QR code printed in the package leaflet and also available in the EMA website in all languages.

How will the Commission support Member States in the rolling-out of vaccines?

The Commission stands ready to support Member States to ensure the smooth deployment of COVID-19 vaccines. A number of EU instruments in the programming period 2021-2027 can offer financial support in this regard.

For instance, investments to support health reforms and resilient, effective and accessible health systems are eligible under the Recovery and Resilience Facility (RRF), and can be included in the national Recovery and Resilience Plans. Furthermore, the Cohesion Policy funds (European Regional Development Fund – ERDF and European Social Fund Plus – ESF+) as well as the REACT-EU programme can provide financing to Member States and their regions to strengthen their health systems, both in terms of managing and recovering from the current health crisis and as well as ensuring their resilience in the longer term.

Collectively, these programmes can support a range of investment needs, for example, in health infrastructure, training of health professionals, health promotion, disease prevention, integrated care models, digital transformation of healthcare, and equipment, including critical medical products and supplies to strengthen the resilience of health systems.

In this context, investments to prepare health systems for the roll out COVID-19 vaccines are eligible under these programme, especially given the direct link to the resilience of health systems, the availability of critical medical products and disease prevention. However, it will be up to each Member State to decide on the priorities and content of their Recovery and Resilience Plan and also their Programmes for the Cohesion Policy funds.

How will vaccination certificates work?

A common approach to pharmacovigilance, and to trusted, reliable and verifiable vaccination certificates across the EU could reinforce the success of vaccination programmes in Member States and the trust of citizens.

Registering data on vaccination is important both at individual and population levels. For an individual, it is a means to know and demonstrate their vaccination status. Proof of vaccination should be available from the moment vaccination starts. Vaccination certificates could for example be useful in the context of travel, showing that a person has been vaccinated and therefore may not need testing and quarantine upon arrival in another country.

The Commission and Member States, together with WHO, are working on vaccination certificates. This work includes a minimum dataset, including a unique identifier, for each individual vaccination which will ease the issuance of certificates and vaccination monitoring on a Europe-wide basis from the moment that the COVID-19 vaccines are authorised.

The development of the common specifications framework will take account of and contribute to the work of WHO. EU funds, such as RRF, ERDF, InvestEU can support the setting up of the Immunisation Information Systems (IIS), Electronic Health Records and secondary use of health data on immunisation.

How much does the vaccine cost? What is the price of the vaccine?

The Commission negotiated advantageous deals with vaccine manufacturers to secure access to almost 2 billion doses so far.

At this stage the specific pricing per dose is covered by confidentiality obligations. However, a significant part of the overall costs are funded by a contribution from the overall EU funding for vaccines.

Will the vaccine be free in all EU Member States?

While this is a Member State responsibility, the large majority of the Member States intend to offer vaccination free of charge.

Are the contracts with the companies publicly available?

The focus for the Commission is the protection of public health and securing the best possible agreements with companies so that vaccines are affordable, safe and efficacious.

Contracts are protected for confidentiality reasons, which is warranted by the highly competitive nature of this global market. This is in order to protect sensitive negotiations as well as business related information, such as financial information and development and production plans.

Disclosing sensitive business information would also undermine the tendering process and have potentially far-reaching consequences for the ability of the Commission to carry out its tasks as set out in the legal instruments that form the basis of the negotiations. All companies require that such sensitive business information remains confidential between the signatories of the contract. The Commission therefore has to respect the contracts it concludes with the companies.

When will the vaccine allow the control of the pandemic?

For some known communicable diseases, it is understood that herd immunity allowing to control a pandemic and eventually eradicate a disease requires around 70% of the population to have protection either from vaccination or previous infection.

Depending on the pace of vaccination and natural infections, the pandemic might be controlled by the end 2021 in Europe.

Can we still spread the disease once vaccinated?

We do not yet know. Additional evaluations will be needed to assess the effect of the vaccine in preventing asymptomatic infection, including data from clinical trials and from the vaccine’s use post-authorization.

Therefore, and for the time being, even vaccinated people will need to wear masks, avoid indoor crowds, and respect social distance, so on. Other factors, including how many people get vaccinated and how the virus is spreading in communities may also prompt revision of this guidance.

If I have already had COVID-19 and recovered, do I still need to get the vaccine?

There is not enough information currently available to say if or for how long after infection someone is protected from getting COVID-19 again; this is called natural immunity. Early evidence suggests natural immunity from COVID-19 may not last very long, but more studies are needed to better understand this.

World News

EU joins efforts to address the global water crisis and ensure water security for all by 2050

Published

15 hours ago

March 21, 2023

Newsroom

From tomorrow, at the United Nations Water Conference in New York from 22 to 24 March, the EU will be confirming its strong engagement for global water security by announcing 33 commitments for action starting now. These commitments will underpin the EU vision that by 2050, the world should be resilient to increasing water stress, providing water security for all.

The world is currently facing a water crisis driven by overdemand, mismanagement and the impacts of the triple crisis of climate change, biodiversity loss and pollution. 40% of the world’s population live in areas affected by water stress. Water resilience is key to prevent and address the current and future health, food and energy crises.

The UN 2023 Water Conference is the first of its kind in almost 50 years, aiming to mobilise global action for water resilience and security. The EU delegation, led by Commission Vice-President Dubravka Šuica, will be presenting the EU voluntary commitments to the Water Action Agenda – a platform to accelerate global progress on the water-related sustainable development goals. The EU priorities for the conference include:

Ensuring access to safe drinking water and sanitation as a human right;
Protecting and restoring aquatic ecosystems for sustainable development, climate mitigation and adaptation;
Promoting a more integrated approach to the management of water resources across sectors;
Promoting circularity in the use of water for industry, energy and agriculture by increasing water efficiency and water reuse;
Promoting transboundary water cooperation, as a catalyst for peace and security; and
Mobilising public and private finance, research and innovation, and knowledge sharing.

EU commitments

The EU brings together a range of commitments to the Water Action Agenda. They draw on a number of policy actions and EU laws, leading water technologies, as well as extensive support to partner countries on water and sanitation. The EU contributions include:

Supporting the improved access to water and sanitation for 70 million people worldwide;
Securing safe drinking water in the EU and enhancing the availability of tap water in public spaces;
Contributing to the reduction of water use in the EU by setting water-saving standards for products, and developing non-conventional supplies, such as reuse of treated water for agricultural irrigation or desalinisation;
Tackling the pollution of our rivers and oceans, by 50% reduction of pesticides, nutrients, antimicrobials and plastic litter at sea as well as 30% reduction in microplastics;
Increasing research and innovation, citizen engagement and blue investments: the EU as a whole and the EU Member States have committed over € 1.4 billion from 2021-2024 and additional commitments are expected until 2027;

Increasing the restoration of rivers in the EU;
Increasing the resilience of society to floods, droughts and sea level rise, by improving risk management, preparedness, and response;

Reducing greenhouse gas emissions in water management, among others by reducing energy needs of urban wastewater treatment plants;
Improving transboundary water cooperation, supported by Global Gateway investments: EU and Member States have committed over €1.1 billion for transboundary water management in Africa and Central Asia covering 47 countries and 18 major transboundary water basins.

The full list of commitments can be found here.

Background

Safe water is a precondition for human and environment health, and a human right. Water is an indispensable resource for the economy and plays a fundamental role in the fight against climate change.

Yet this vital natural resource is being depleted, polluted and mismanaged. 2.2 billion people still lack access to safe drinking water worldwide, and more than half of the global population does not have access to safe sanitation. 80% of the world’s wastewater is discharged untreated directly into the environment. Pressure on both quality and quantity of water is mounting. Across the globe, extended periods of severe drought and massive flooding affect the availability of water for human consumption as well as productivity in agriculture, industry and the energy sector. Water stress contributes to the increasing risk of conflicts and instability.

In the EU, access to safe drinking water and sanitation is high, and water quality is improving overall. At the same time, with the increasing frequency and intensity of droughts and floods the EU is confronted with many water challenges, which require new solutions. The progress in reducing water pollution from agriculture is stalling and most European water bodies are not yet in good status. The conference offers the opportunity to look for common solutions and best practises.

At the conference, the EU will participate in the five interactive dialogues. Together with China, the EU will co-chair the inter-active dialogue “Water for sustainable development”.

World News

Global Times: Xi’s visit to Russia conveys great significance, injects certainty and positive energy

Published

19 hours ago

March 21, 2023

Newsroom

Photo: Sergei Karpukhin, TASS

Chinese President Xi Jinping’s state visit to Moscow is expected to attract global attention as the visit – the first overseas visit of the Chinese top leader in 2023 following the two sessions – is a trip of friendship, cooperation and peace, writes ‘Global Times’.

However, the US and its allies are viewing the upcoming visit through “tinted glasses” by distorting the nature of China-Russia relations, smearing China’s possible role as a mediator in the Ukraine crisis and rejecting its calls for a ceasefire in the conflict.

Some Chinese and Russian observers believe that the question is whether the US and the West want a mediator now or they just want the Ukraine crisis to prolong as long as possible, using Ukraine as a pawn to weaken Russia and control Europe while maintaining its hegemony in the world.

Not only is the US worried about the deepening China-Russia relations, it also constantly smears China and rejects China’s proposal for peace talks, which shows that Washington does not want peace as it only wants to continue using Ukraine as a tool of weakening Russia and using the Ukraine crisis to engage in bloc-led confrontation, Zhang Hong, an associate research fellow at the Institute of Russian, Eastern European & Central Asian Studies of the Chinese Academy of Social Sciences, told the Global Times.

Although the US and some of its allies are skeptical about China’s role and show “growing concerns” over the deepening China-Russia relations, some European countries such as France and Germany, which have been under the shadow of the crisis over the past year, are expecting China to play a bigger role in mediating the conflict, some experts said.

The China-Russia comprehensive strategic partnership of coordination for a new era is based on independent foreign policy, and the regular reciprocal visits of heads of states of Russia and China have been a tradition since mid-1990s said some Chinese and Russian experts.

The Chinese envoy to Russia also viewed such close interactions and exchange of views between the heads of state of the two countries as “the compass and anchor” of the development of bilateral relations.

“President Xi’s state visit to Russia this time is a milestone for China-Russia relations in the new era. It will inject a strong impetus into bilateral relations and lead the sustained development of bilateral ties at a high level,” Chinese Ambassador to Russia Zhang Hanhui told the Global Times in a recent interview.

Ten years ago, Xi’s first overseas visit after being elected as the President was to Russia and during that visit, he elaborated for the first time on building a community of shared future for mankind, Wang Yiwei, director of the Institute of International Affairs at the Renmin University of China, told the Global Times on Sunday. “Ten years later, Xi’s first visit after being elected as president will be to Russia, which also fully underscored how much importance China attaches to China-Russia relations in the new era,” Wang said, noting that the visit will convey milestone significance, setting an example for a new type of international relations.

“As two permanent members of the UN Security Council, China and Russia are responsible for advancing the course of a multipolar world, rejecting unilateralism and hegemony,” Wang said, noting that it’s important to enhance strategic coordination with Russia and remain vigilant on Washington to reproduce the Ukraine crisis in Asia, writes ‘Global Times’.

World News

The American Thinker: “A prestige and perceptions of US power have dramatically crashed”

Published

2 days ago

March 20, 2023

Newsroom

The shocking announcement that China had brought together bitter rivals Shiite Iran and Sunni Saudi Arabia to resume diplomatic relations in a deal negotiated in Beijing is a stunning defeat for America, threatening the basis of our Middle Eastern and world diplomatic power, writes Thomas Lifson at “The American Thinker”.

If, as it appears, Saudi Arabia is no longer a reliable ally that can be counted upon to keep the Armageddon-mongering mullahs in Iran at bay while warming up to Israel, then the entire power calculus of the Middle East is shattered.

At a minimum, American prestige and perceptions of our power have dramatically crashed, though our propaganda media are doing their best to prevent the domestic public from understanding this.

The Chinese triumph in the Middle East, pushing aside America as the significant other, is one of the principal, if not the worst, signs of the disaster that the Biden presidency has unleashed. This is very bad news for us, our European and Japanese/Korean/Taiwanese allies dependent on Middle Eastern oil, and Israel.

In trying to comprehend how a catastrophe of this magnitude could have unfolded, I have been searching for explanatory factors. One that, perhaps strangely, didn’t occur to me, was the Nordstream pipeline sabotage. Now I strongly suspect, notes Thomas Lifson, that the U.S. or its proxies are responsible for blowing up the pipeline, which (despite our media virtually ignoring this) ranks as the greatest man-made release of CO2 in history, and which has crippled the economy of Germany, our ostensible ally (for now).

One of America’s most powerful international weapons is its overwhelming control over the global news ecosystem, and a complete blanket of media silence was soon enforced, causing that huge event to quickly fade from public consciousness.

When someone such as Prof. Jeffrey Sachs mentioned what had probably happened on Bloomberg TV, he was quickly yanked off the air. The information that Sachs imparts and that yank-off moment speaks volumes about the propagandistic “global news ecosystem” and is worth viewing.

Unlike the American public, world leaders and their populations are not prisoners of the “news ecosystem,” and, as Sachs points out, many if not most believe that America is not above selling out its own allies. In private, well informed American journalists and others agree.

The suspicion of such perfidy is likely to have weighed heavily on the Saudis, though it was not the sole factor in them turning to China.

There are obviously many long-term factors behind this apparent diplomatic revolution, notably including China’s economic rise and its position as the leading purchaser of Middle Eastern oil.

However, I think that the colossal arrogance of our own country, and the extent to which we have increasingly abused and victimized our own allies and vassals over the years must surely have been a huge contributing factor.

One problem with relying too heavily upon the power of your dishonest propaganda is that you may continue to believe in it yourself even after most of the intended targets of your deception have stopped doing so.

A fundamental distrust of our government and the propaganda lines enforced by our media is the only prudent way to approach understanding the realities of the world historical global power competition underway. We know that we are being lied to, but we don’t fully understand what the lies are, – stresses Thomas Lifson at “The American Thinker”.