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Explainer: COVID-19 vaccination in the EU

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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 600 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 the conditional marketing authorisation for the vaccines developed by BioNTech and Pfizer on 21 December, and Moderna on 6 January following EMA positive assessment of its safety and efficacy. 

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 occurred within days of authorisation and most of the first vaccinations took 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.

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Clarity still needed on effectiveness of COVID-19 vaccine passports

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Being vaccinated against COVID-19 may not prevent transmission and vaccination passports may not be an “effective strategy” for restarting travel, the World Health Organization (WHO) cautioned on Tuesday.

“At this stage, we would not like to see vaccination passports as a requirement for entry or exit because we are not sure at this stage that the vaccine prevents transmissions,” said WHO spokesperson Dr Margaret Harris, just ahead of World Health Day on 7 April 2021.

Supply and demand

Dr. Harris added that vaccine passports may not be an effective strategy as “not everyone has access to vaccines and there are groups in society who are excluded…We are still waiting on adequate supplies to provide the vaccines to all the countries that need them.”

Highlighting how COVID-19 has impacted some people more than others, Dr. Harris said that the virus “has really exposed the stark inequities in access to and coverage of health services…Groups who already faced discrimination, poverty, social exclusion, difficult living and working conditions were the hardest hit by the pandemic”.

World Health Day plea

For this year’s World Health Day, the UN agency has urged countries to build a fairer, healthier world post-COVID-19. Dr. Harris called for action to “put in place policies and allocate resources so the most vulnerable groups can see their condition improve faster”.

This means “improving living conditions for all”, tackling “poverty and health inequities”, building sustainable societies and strong economies, and promoting “a more equitable sharing of resources, ensuring food security and nutrition” and turning “the tide on climate change”.  There is so much work to do”, she said.

Latest WHO data from Tuesday 6 March at the time of posting, indicates that there have been 131,309,792 confirmed cases of COVID-19, including 2,854,276 deaths globally, reported to WHO.

By the end of 5 April, a total of 604,032,357 vaccine doses have been administered.

Regionally, infections and deaths remain highest in the Americas, with 56,880,123 million confirmed cases, followed by Europe (46,085,310 million), South-East Asia (15,438,907), Eastern Mediterranean (7,785,717), Africa (3,126,037) and Western Pacific (1,992,953).

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How a Digital Algorithm is Helping Doctors Treat COVID-19 Patients

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Moscow’s backup hospitals and inpatient clinics for treatment of the coronavirus infection have started using a new solution as part of the unified digital healthcare platform. The News2 app, which is integrated into the Unified Medical Information and Analysis System (EMIAS), helps physicians assess the severity of a patient’s COVID-19 symptoms and risks of deterioration, and suggests adjustments to treatment tactics where necessary.

The system is operated on tablets with specialized software. These allow medics to read the QR codes on a patient’s hospital identification bracelet or on an identification sheet in an inpatient clinic and enter data on their condition: heart rate, blood oxygen saturation level, blood pressure, body temperature, and respiration rate. The system then calculates the result and assigns the patient to a risk group, highlighting the relevant category with a specific color.

The patient’s risk score is entered in their electronic medical record. Physicians can then review both the patient’s current integrated risk score on the international NEWS2 scale and any changes to it at any time, together with the baseline data used to generate the information. Use of this clinical scale significantly improves patient safety, ensuring that examinations are conducted at predetermined time intervals and that specific indicators are measured, resulting in timely and optimal adjustments to patient therapy.

The benefits of the system for physicians are obvious: when the risk score increases from 3 to 5, for instance, the clinician can simply decide whether more treatment is necessary or, conversely, satisfy himself that the treatment is effective if the score subsequently falls.

The NEWS2 scale is used around the world to assess the severity of a patient’s condition by interpreting results based on a sum of scores. These are used to generate a final score for assigning the patient to a specific risk group.

Digital solutions in Moscow’s healthcare sector are being implemented jointly by the city’s Department of Health and Department of Information Technology.

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COVID-19 origins report inconclusive: We must ‘leave no stone unturned’

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The report from a team of international scientists assembled by the World Health Organization (WHO) to examine how COVID-19 first spread to humans was published on Tuesday, and was described by the UN health agency’s chief as a welcome start, but far from conclusive.

“This report is a very important beginning, but it is not the end”, said WHO Director-General, Tedros Adhanom Ghebreyesus. “We have not yet found the source of the virus, and we must continue to follow the science and leave no stone unturned as we do.”

He welcomed the findings of the 34-member team, which in January, visited the Chinese city of Wuhan where the first cases of the then new coronavirus came to light at the end of 2019.

But the WHO chief was clear that overall, it raises “further questions that will need to be addressed by further studies, as the team itself notes in the report.”

He noted that although much data had been provided, to fully understand the earliest cases, they would need access from Chinese authorities “to data including biological samples from at least September” 2019.

“In my discussions with the team, they expressed the difficulties they encountered in accessing raw data. I expect future collaborative studies to include more timely and comprehensive data sharing.”

Animal markets’ role, ‘still unclear’

Tedros welcomed the recommendations for further studies to understand the earliest human cases and clusters, and to trace animals sold at markets in and around Wuhan, but “the role of animal markets is still unclear.”

The team confirmed there had been widespread contamination in the large market of Huanan but could not determine the source of this contamination.

“Again, I welcome the recommendations for further research, including a full analysis of the trade in animals and products in markets across Wuhan, particularly those linked to early human cases”, he said.

He agreed that farmers, suppliers and their contacts should be interviewed, and that more study was needed to identify what role “farmed wild animals may have played in introducing the virus to markets in Wuhan and beyond.”

Lab leak theory not ruled out

The team also visited several laboratories in Wuhan and considered the possibility that the virus had entered the human population as a result of a laboratory incident, noted Tedros.

“However, I do not believe that this assessment was extensive enough. Further data and studies will be needed to reach more robust conclusions”, he said.

“Although the team has concluded that a laboratory leak is the least likely hypothesis, this requires further investigation, potentially with additional missions involving specialist experts, which I am ready to deploy.”

As far as WHO is concerned “all hypotheses remain on the table”, he told the Member State briefing on the report in Geneva.

“Finding the origin of a virus takes time and we owe it to the world to find the source so we can collectively take steps to reduce the risk of this happening again. No single research trip can provide all the answers.”

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