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?
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.
COVAX and World Bank to Accelerate Vaccine Access for Developing Countries
COVAX and the World Bank will accelerate COVID-19 vaccine supply for developing countries through a new financing mechanism that builds on Gavi’s newly designed AMC cost-sharing arrangement. This allows AMC countries to purchase doses beyond the fully donor-subsidized doses they are already receiving from COVAX.
COVAX will now be able to make advance purchases from vaccine manufacturers based on aggregated demand across countries, using financing from the World Bank and other multilateral development banks. Participating developing countries will have greater visibility of available vaccines, quantities available, and future delivery schedules, enabling them to secure doses earlier, and prepare and implement vaccination plans more effectively.
“This important and timely financing mechanism, made possible now by the World Bank and Gavi teaming up on the AMC cost-sharing arrangement, will allow COVAX to unlock additional doses for low- and middle-income countries,” said Dr. Seth Berkley, CEO, Gavi, the Vaccine Alliance. “As we move beyond initial targets and work to support countries’ efforts to protect increasingly large portions of their populations, World Bank financing will help us advance further towards our goal of bringing COVID-19 under control.”
The scalable mechanism brings together COVAX’s ability to negotiate advance purchase agreements with vaccine manufacturers with the World Bank’s ability to provide predictable financing to countries for vaccine purchase, deployment and broader health systems investments. The new mechanism will mitigate risks and uncertainties in country demand and financing ability.
“Accessing vaccines remains the single greatest challenge that developing countries face in protecting their people from the health, social, and economic impacts of the COVID-19 pandemic,” said World Bank Group President David Malpass. “This mechanism will enable new supplies and allow countries to speed up the purchase of vaccines. It will also provide transparency about vaccine availability, prices, and delivery schedules. This is crucial information as governments implement their vaccination plans.”
Countries with approved World Bank vaccine projects that confirm the purchase of additional doses through COVAX will agree with COVAX on the number of doses of a specific vaccine as well as related windows of delivery. On receiving a request from the country, the World Bank will provide COVAX a payment confirmation, allowing COVAX to make advance purchases of large amounts of vaccine doses with manufacturers at competitive prices.
Under the cost-sharing arrangement for AMC countries (92 low- and middle-income countries), COVAX plans to make available up to 430 million additional doses, or enough to fully vaccinate 250 million people, for delivery between late 2021 and mid-2022. There will be several supply offerings where countries will have the opportunity to select and commit to procuring specific vaccines that align with their preferences.
COVAX is co-led by the Coalition for Epidemic Preparedness Innovations (CEPI), Gavi, the Vaccine Alliance and the World Health Organization (WHO). The World Bank and COVAX will work in partnership with UNICEF and the PAHO Revolving Fund as key implementing partners to ensure safe vaccine delivery and supply of materials such as syringes, safety boxes and other items essential for vaccination campaigns.
Study Finds That India Might Have Half Of All Covid-19 Deaths Worldwide
On July 20th, an analysis that was published of India’s “excess mortality estimates from three different data sources from the pandemic’s start through June 2021 … yields an estimate of 4.9 million excess deaths.” As-of July 20th, the total number of deaths that had been officially reported worldwide from Covid-19 was 4,115,391, and only 414,513 (10%) of those were in India. If this new study is correct, then the possibility exists that around half of all deaths that have occurred, thus far, from Covid-19, could be in India, not merely the currently existing 10% that’s shown in the official figures.
This study doesn’t discuss why the actual number of deaths in India from Covid-19 might be around ten times higher than the official Indian figures, but one reason might be a false attribution of India’s greatly increased death-rate from the Covid-19 epidemic not to Covid-19 but to other causes, such as to Covid-19-related illnesses.
The new study is titled “Three New Estimates of India’s All-Cause Excess Mortality during the COVID-19 Pandemic”, and the detailed version of it can be downloaded here. The study was funded by U.S.-and-allied billionaires and their foundations and corporations, and by governments that those billionaires also might control. However, this doesn’t necessarily mean that its methodology is in any way unscientific or otherwise dubious. The study raises serious questions — it does not, in and of itself, answer any. It’s a serious scientific study.
On 1 August 2020, I headlined “India and Brazil Are Now the Global Worst Coronavirus Nations”, and reported that, “India and Brazil have now overtaken the United States as the world’s worst performers at controlling the cononavirus-19 plague. The chart of the numbers of daily new cases in India shows the daily count soaring more than in any other country except Brazil, whereas in the United States, the daily number of new cases has plateaued ever since it hit 72,278 on July 10th, three weeks ago.” At that time, there was great pressure upon India’s Government to stop the alarming acceleration in the daily numbers of people who were officially counted as being patients (active cases) from the disease, and of dying from it. One way that a government can deal with such pressures is by mis-classifying cases, and deaths, from a disease, as being due to other causes, instead.
Sharp rise in Africa COVID-19 deaths
COVID-19 deaths in Africa have risen sharply in recent weeks, amid the fastest surge in cases the continent has seen so far in the pandemic, the regional office for the World Health Organization (WHO) said on Thursday.
Fatalities are rising as hospital admissions increase rapidly as countries face shortages in oxygen and intensive care beds.
COVID-19 deaths rose by more than 40 per cent last week, reaching 6,273, or nearly 1,900 more than the previous week.
The number is just shy of the 6,294 peak, recorded in January.
Reaching ‘breaking point’
“Deaths have climbed steeply for the past five weeks. This is a clear warning sign that hospitals in the most impacted countries are reaching a breaking point,” said Dr Matshidiso Moeti, WHO Regional Director for Africa.
“Under-resourced health systems in countries are facing dire shortages of the health workers, supplies, equipment and infrastructure needed to provide care to severely ill COVID-19 patients.”
Africa’s case fatality rate, which is the proportion of deaths among confirmed cases, stands at 2.6 per cent compared to the global average of 2.2 per cent.
Most of the recent deaths, or 83 per cent, occurred in Namibia, South Africa, Tunisia, Uganda and Zambia.
Six million cases
COVID-19 cases on the continent have risen for eight consecutive weeks, topping six million on Tuesday, WHO reported.
An additional one million cases were recorded over the past month, marking the shortest time to reach this grim milestone. Comparatively, it took roughly three months for cases to jump from four million to five million.
Delta, variants drive surge
The surge is being driven by public fatigue with key health measures and an increased spread of virus variants.
The Delta variant, the most transmissible, has been detected in 21 countries, while the Alpha and Beta variants have been found in more than 30 countries each.
Globally, there are four COVID-19 virus variants of concern. On Wednesday, a WHO emergency committee meeting in Geneva warned of the “strong likelihood” of new and possibly more dangerous variants emerging and spreading.
Delivering effective treatment
WHO is working with African countries to improve COVID-19 treatment and critical care capacities.
The UN agency and partners are also delivering oxygen cylinders and other essential medical supplies, and have supported the manufacture and repair of oxygen production plants.
“The number one priority for African countries is boosting oxygen production to give critically ill patients a fighting chance,” Dr Moeti said. “Effective treatment is the last line of defence against COVID-19 and it must not crumble.”
The rising caseload comes amid inadequate vaccine supplies. So far, 52 million people in Africa have been inoculated, which is just 1.6 per cent of total COVID-19 vaccinations worldwide.
Meanwhile, roughly 1.5 per cent of the continent’s population, or 18 million people, are fully vaccinated, compared with over 50 per cent in some high-income countries.
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