Along with other tried and tested public health measures, the head of the World Health Organization (WHO) told journalists on Monday that “there is now real hope” that vaccines will play an essential part in helping end the COVID pandemic.
“With the latest positive news from vaccine trials, the light at the end of this long, dark tunnel is growing brighter”, said Director-General Tedros Adhanom Ghebreyesus. “The significance of this scientific achievement cannot be overstated”.
Setting new standards
Noting that no vaccine in history has been developed as rapidly, the WHO chief remarked that the scientific community had set “a new standard for vaccine development” and now the international community must set “a new standard for access”.
“The urgency with which vaccines have been developed must be matched by the same urgency to distribute them fairly”, he spelled out, warning of a real risk that the poorest, and most vulnerable will be “trampled in the stampede” to get innoculated.
“The ACT Accelerator has supported the fastest, most coordinated and successful global effort in history to develop vaccines, diagnostics and therapeutics”, he attested.
He said that currently 50 diagnostics are under evaluation; rapid antigen diagnostics are now available for low and middle income countries; while life-saving treatments are being rolled out and new medicines tested.
Moreover, 187 countries are taking part in the COVAX facility, to collaborate on the procurement and rollout of vaccines, “ensuring the best possible prices, volumes and timing for all countries”, he said.
Despite the excellent progress, Tedros said that “only a fundamental change in funding and approach will realize the full promise of the ACT Accelerator”.
He revealed that $4.3 billion is still needed to support mass procurement and delivery, tests and treatments this year and another $23.8 billion would will be required in 2021.
“This isn’t charity, it’s the fastest and smartest way to end the pandemic and drive the global economic recovery”, he stressed.
According to the International Monetary Fund (IMF), if medical solutions can be made available faster and more widely, they could lead to a cumulative increase in global income of almost $9 trillion by the end of 2025.
“The real question is not whether the world can afford to share vaccines and other tools; it’s whether it can afford not to”, stated the WHO chief.
WHO: Step up surveillance of emerging coronavirus variants
Efforts should be stepped up to quickly identify and study emerging variants of the COVID-19-causing SARS-CoV-2 virus, UN World Health Organization (WHO) scientists said on Tuesday.
Alongside monitoring, virus and serum samples should be shared via globally agreed mechanisms so that critical research can be promptly initiated each time, according to the agency.
“Our collective goal is to get ahead of the game and have a global mechanism to quickly identify and study variants of concern and understand their implications for disease control efforts,” said Ana Maria Henao Restrepo, Head of WHO’s R&D Blueprint.
She was speaking at a virtual meeting of scientists from around the globe, convened by the UN health agency, attended by over 1,750 experts from 124 countries.
Participants noted the importance of research to detect and understand early on the potential impact of emerging variants on diagnostics, treatments and vaccines, and highlighted the importance of integrating new SARS-CoV-2 variants research into the global research and innovation agenda, according to WHO.
Normal for viruses to mutate
It is normal for viruses to mutate, but the more the SARS-CoV-2 virus spreads, the more opportunities it has to change. High levels of transmission mean emergence of more variants should be expected, according to WHO.
Of the significant variants reported so far, some are associated with increases in transmissibility but not disease severity. Research is ongoing to address whether the changes impact public health tools and measures.
“So far an astounding 350,000 sequences have been publicly shared, but most come from just a handful of countries. Improving the geographic coverage of sequencing is critical for the world to have eyes and ears on changes to the virus,” said Maria Van Kerkhove, WHO Technical Lead on COVID-19.
New variants of the coronavirus have been detected in the UK, South Africa and Japan, which appear to be more transmissible, although health officials have said that there is no evidence it is more deadly, or that it would not respond in the same way to the vaccines cleared for emergency use.
Information sharing critical
Genomic sequencing has been critical in identifying and responding to new variants, and increasing sequencing capacity across the world is a priority research area for WHO.
Better surveillance and laboratory capacity to monitor strains of concern needs to be accompanied by prompt sharing of virus and serum samples via globally agreed mechanisms so that critical research can be promptly initiated each time, the agency added.
UN agencies and partners establish global Ebola vaccine stockpile
In a major milestone in the fight against deadly diseases, United Nations agencies and humanitarian partners announced on Tuesday, the establishment of a global Ebola vaccine stockpile, to help control future epidemics by ensuring timely access to vaccines for populations at risk, during outbreaks.
Ebola virus disease is a severe and often fatal illness, with fatality rates varying from 25 per cent to 90 per cent. Thousands of people have lost their lives to the disease, since the virus was first discovered in 1976.
“Ebola vaccines have made one of the most feared diseases on earth preventable. This new stockpile is an excellent example of solidarity, science and cooperation between international organizations and the private sector to save lives.”
The International Coordinating Group on Vaccine Provision (ICG), which includes WHO, UN Children’s Fund (UNICEF), the International Federation of Red Cross and Red Crescent Societies (IFRC), and Médecins Sans Frontières (MSF), led efforts to establish the stockpile, with financial support from Gavi, the Vaccine Alliance.
The stockpile is stored in Switzerland, and vaccines are ready to be shipped to countries for emergency response.
Preparedness is key
Henrietta Fore, Executive Director of UNICEF, said that when it comes to combatting disease outbreaks, “preparedness is key.”
“This Ebola vaccine stockpile is a remarkable achievement – one that will allow us to deliver vaccines to those who need them the most as quickly as possible,” she added.
UNICEF, on behalf of ICG will manage the stockpile, and as with stockpiles of cholera, meningitis and yellow fever vaccines, will be the decision-making body for its allocation and release.
As Ebola outbreaks are relatively rare and unpredictable, there is no natural market for the vaccine, and doses are only secured through the establishment of stockpiles and are available in limited quantities.
According to the UN agencies, an initial 6,890 doses are available for outbreak response and quantities will be added over the coming months to take the emergency stockpile to 500,000 doses, the amount recommended by health experts.
Important and positive milestone
Partners MSF and IFRC, which have worked tirelessly to stop Ebola outbreaks, also hailed the stockpile establishment.
IFRC Secretary General, Jagan Chapagain recalled the devastating impact of Ebola on communities in West and Central Africa, adding “through each outbreak, our volunteers have risked their lives to save lives. With this stockpile, it is my hope that the impact of this terrible disease will be dramatically reduced.”
Natalie Roberts, Programme Manager at MSF Foundation, said that the Ebola vaccine stockpile “can increase transparency in the management of existing global stocks and the timely deployment of the vaccine where it’s most needed.”
According to the UN agencies, the injectable single-dose Ebola vaccine (rVSV∆G-ZEBOV-GP, live) is manufactured by Merck, Sharp & Dohme (MSD) Corp. and developed with financial support from the US Government. The European Medicines Agency licensed the Ebola vaccine in November 2019, and the vaccine is now prequalified by WHO, and licensed by the US Food and Drug Administration (FDA) as well as in eight African countries.
Before achieving licensure, the vaccine was administered to more than 350,000 people in Guinea and in the 2018-2020 Ebola outbreaks in the Democratic Republic of the Congo (DRC) under a protocol for “compassionate use”.
The vaccine, which is recommended by the Strategic Advisory Group of Experts (SAGE) on Immunization for use in Ebola outbreaks as part of a broader set of Ebola outbreak response tools, protects against the Zaire ebolavirus species which is most commonly known to cause outbreaks.
Explainer: COVID-19 vaccination in the EU
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.
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