Vakcīnu pieejamības nodrošināšana
Drošas un iedarbīgas vakcīnas pret Covid-19 ir labākais veids, kā pārvarēt pandēmiju. Komisija un dalībvalstis ir pieņēmušas vienotu ES pieeju, lai nodrošinātu vakcīnu piegādi un atvieglotu to izplatīšanu.
Noslēdzot pirkuma priekšlīgumus ar dažiem vakcīnu ražotājiem, Komisija nodrošināja tiesības noteiktā laikposmā iegādāties noteiktu skaitu vakcīnu devu par konkrētu cenu. No savas puses Komisija no Ārkārtas atbalsta instrumenta budžeta finansēja daļu no sākotnējām 2,7 miljardus eiro lielajām izmaksām, kuras radās vakcīnu ražotājiem. Šis finansējums bija sākotnējā iemaksa par vakcīnām, ko dalībvalstis iegādājas.
2020. gada 17. jūnijā Eiropas Komisija nāca klajā ar ES vakcīnu stratēģiju, kuras mērķis ir paātrināt Covid-19 vakcīnu izstrādi, ražošanu un ieviešanu.
Ar vakcīnu stratēģiju Komisija atbalstīja centienus procesu padarīt efektīvāku. Līdz ar to vairumu vakcīnu izdevās izstrādāt ātrāk nekā gada laikā.
ES vakcīnu stratēģijas mērķi:
- nodrošināt vakcīnu kvalitāti, drošumu un iedarbīgumu;
- nodrošināt dalībvalstīm un to iedzīvotājiem laicīgu piekļuvi vakcīnām, vienlaikus vadot globālos solidaritātes centienus;
- pēc iespējas ātrāk visiem ES nodrošināt taisnīgu piekļuvi vakcīnai par pieņemamu cenu;
- gādāt, lai ES valstīs tiktu veikti sagatavošanās darbi drošu un iedarbīgu vakcīnu ieviešanai, atrisināti ar transportēšanu un izvēršanu saistīti jautājumi un noteikts, kuras grupas ir prioritāras.
Vakcīnu stratēģija būtu jāizmanto par atsauces punktu dalībvalstīm, kad tās formulē savas nacionālās vakcinācijas stratēģijas.
Drošas un iedarbīgas vakcīnas Eiropas Savienībā sāka izplatīt 2020. gada beigās, ievērojot stingras atļauju piešķiršanas procedūras un visaugstākos drošuma standartus.
To date, five safe and effective vaccines against COVID-19 have been authorised by the Commission for use in the EU following positive scientific recommendations by the European Medicines Agency
On 21 December 2020, the Commission granted a conditional marketing authorisation for the COVID‑19 vaccine developed by BioNTech and Pfizer, making it the first COVID-19 vaccine authorised in the EU. This followed a positive scientific recommendation by the European Medicines Agency.
The Advance Purchase Agreement with BioNTech-Pfizer provided for the initial purchase of 200 million doses on behalf of all EU Member States, plus an option to purchase up to a further 100 million doses. On 15 December 2020, the Commission decided to purchase these 100 million additional doses.
On 8 January 2021, the Commission proposed to Member States to purchase an additional 200 million BioNTech-Pfizer vaccine doses, with the option to acquire another 100 million doses.
On 10 March 2021, the European Commission reached an agreement with BioNTech-Pfizer for the supply of 4 million additional doses of COVID-19 vaccines to tackle coronavirus hotspots and to facilitate free movement across borders.
On 20 May 2021, the European Commission signed a third contract with BioNTech-Pfizer. It reserves an additional 1.8 billion doses on behalf of all EU Member States, between the end of 2021 and 2023. It will allow for the purchase of 900 million doses of the current vaccine and of a vaccine adapted to variants (if necessary and if approved), with the option to purchase an additional 900 million doses.
On 19 December 2021, the Commission agreed with BioNTech-Pfizer to accelerate deliveries of 20 million vaccine doses in Member States during the first quarter of 2022 (5 million in January, 5 million in February and 10 million in March), bringing the total number of deliveries for this period to 215 million.
The Commission and Member States have also activated a first option to order over 200 million doses under the third contract with BioNTech-Pfizer. These doses come on top of the 450 million doses already planned to be delivered in 2022 based on the agreement already signed. This will bring the total number of deliveries by BioNTech-Pfizer to 650 million doses in 2022.
On 13 May 2022, the European Commission and BioNTech-Pfizer reached an agreement to better address Member States’ needs for COVID-19 vaccines. This agreement ensures that Member States have access to the vaccines when they need them – including future variant-adapted vaccines if authorised, so that they can quickly respond to any epidemiological developments and continue to supporting partner countries globally.
With the agreement of BioNTech-Pfizer, the redacted Advance Purchase Agreement is available. The Purchase Agreement is also available
On 6 January 2021, the European Commission granted a conditional marketing authorisation for the vaccine developed by Moderna, making it the second vaccine authorised for use in the EU. This followed a positive scientific recommendation by the European Medicines Agency.
The Advance Purchase Agreement with Moderna provides for the initial purchase of 80 million doses on behalf of all EU Member States, plus an option to request up to a further 80 million doses. On 15 December 2020, the Commission decided to purchase these 80 million additional doses.
On 17 February 2021, the European Commission approved a second contract with Moderna, which provided for an additional purchase of 300 million doses (150 million in 2021 and an option to purchase an additional 150 million in 2022). On 22 June 2021, the Commission approved an amendment to the second contract for the activation of the 150 million optional additional doses in 2022.
With the agreement of Moderna, the redacted Advance Purchase Agreement and the redacted Purchase Agreement are available.
On 16 December 2021, the Commission reached an agreement with Moderna to further accelerate the delivery of its vaccine to Member States who have a short-term need, particularly Germany. 10 million doses were delivered in December 2021, to be followed by 25 million extra doses in the first quarter of 2022.
On 2 June 2022,the Commission reached an agreement with Moderna to ensure the delivery of vaccines is adapted to the needs of Member States. The agreement postpones the delivery of some doses planned for the second quarter of 2022. In addition, should an adapted vaccine receive an EU marketing authorisation following the assessment of the European Medicines Agency, a part of the doses scheduled for April, May and June might be delivered as booster vaccines adapted to the current COVID-19 variants from September 2022.
On 9 August 2022, the Commission and Moderna reached an agreement to better address Member States' needs for COVID-19 vaccines for the late summer and winter period. Doses originally scheduled for delivery in the summer will now be delivered in September, and during the autumn and winter period 2022, when Member States will more likely need additional stocks of vaccines for national campaigns and meeting their international solidarity commitments. Additionally, at the request of some Member States, the agreement also secures 15 million additional doses of Omicron-containing vaccine booster candidates from Moderna, subject to marketing authorisation within timelines that would allow the use of these doses for their vaccination campaigns.
On 29 January 2021, the European Commission granted a conditional marketing authorisation for the vaccine against COVID-19 developed by AstraZeneca, making it the third vaccine authorised for use in the EU. This authorisation follows a positive scientific recommendation by the European Medicines Agency.
With the agreement of AstraZeneca, the Commission has made the redacted Advance Purchase Agreement public.
On 18 June 2021, the Court of First Instance of Brussels ordered AstraZeneca to deliver vaccine doses to the EU.
On 11 March 2021, the European Commission granted a conditional marketing authorisation for the COVID‑19 vaccine developed by Janssen Pharmaceutica NV, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, making it the fourth vaccine authorised for use in the EU. This authorisation follows a positive scientific recommendation by the European Medicines Agency.
With the conditional market authorisation, Janssen will be able to deliver 200 million of their single dose COVID-19 vaccine to the EU starting in the second quarter of 2021. The contract, that was closed on 7 October 2020, allows Member States to purchase an additional 200 million doses.
With the agreement of Johnson & Johnson, the Commission has made the redacted Advance Purchase Agreement public.
On 17 December 2020, the Commission concluded exploratory talks with the pharmaceutical company Novavax, with a view to purchasing its potential vaccine against COVID-19.
The Novavax vaccine is a protein subunit product already in phase 3 clinical trial stage. The envisaged contract would provide for the possibility of EU Member States to initially purchase 100 million doses, followed by 100 million additional ones.
On 21 December 2021, the Commission granted a conditional marketing authorisation (CMA) for the COVID 19 vaccine Nuvaxovid, developed by Novavax, the fifth COVID-19 vaccine authorised in the EU. This authorisation follows a positive scientific recommendation based on a thorough assessment of the safety, effectiveness and quality of the vaccine by the European Medicines Agency and is endorsed by the Member States. The first doses are expected to arrive in the first months of 2022 and for this first quarter, Member States have ordered around 27 million doses.
On 20 July 2022, the Commission approved an amendment to the original advance purchase agreement with Valneva for the purchase its vaccine against COVID-19. The joint agreement enables participating Member States to purchase a total amount of 1,250,000 vaccine doses.
On 23 June 2022, the European Medicines Agency recommended granting a marketing authorisation for the vaccine against COVID-19 by Valneva.
On 12 January 2021, the Commission concluded exploratory talks with the pharmaceutical company Valneva with a view to purchasing its potential vaccine against COVID-19.
On 10 November 2021, the European Commission approved a contract with Valneva, providing for the possibility for all EU Member States to purchase around 27 million doses in 2022, once the vaccine is proven safe and effective. The contract also includes the possibility to adapt the vaccine to new variant strains, and for Member States to make a further order of up to 33 million additional vaccines in 2023.
On 11 November 2022, the European Commission granted a marketing authorisation for VidPrevtyn Beta, the protein-based COVID 19 vaccine developed by Sanofi and GSK, as a booster dose. The authorisation follows a positive scientific recommendation from the European Medicines Agency based on a thorough assessment of the safety, effectiveness, and quality of the vaccine, and is endorsed by the Member States. On 18 September 2020, the Advance Purchase Agreement negotiated on behalf of the EU Member States- between Sanofi-GSK and the European Commission entered into force . It allows EU Member States to purchase up to 300 million doses of the vaccine. With the agreement of Sanofi-GSK, the redacted Advance Purchase Agreement is available.
On 19 November 2020, contract negotiated on behalf of the EU Member States- between CureVac and the European Commission entered into force.
Once the vaccine is proven safe and effective, the contract provides for the initial purchase of 225 million doses on behalf of all EU Member States, plus an option to request up to a further 180 million doses.
CureVac, a European company based in Germany, signed a €75 million loan agreement with the European Investment Bank on 6 July 2020 for the development and large-scale production of vaccines.
With the agreement of CureVac, the Commission has made the redacted Advance Purchase Agreement public.
On 11 October 2021, CureVac informed the European Medicines Agency that it is withdrawing its COVID-19 vaccine from the rolling review process.
On 2 August 2022, the European Commission signed a joint procurement framework contract with the company HIPRA HUMAN HEALTH for the supply of their protein COVID-19 vaccine.
The COVID-19 vaccine from HIPRA is currently under rolling review by the European Medicines Agency. If the vaccine receives a marketing authorisation participating countries will be able to purchase the vaccine through the framework contract in place.
On 1 September 2022, based on the recommendation of the European Medicines Agency, the Commission authorised the adapted omicron vaccines from BioNTech-Pfizer and Moderna in the EU.
Measures that should be taken in view of new and adapted COVID-19 vaccines becoming available include:
- Developing national vaccination strategies clarifying which vaccines, including the new and adapted vaccines, should be administered to which population groups in view of the possible emergence of new variants. This should be based on the guidance which his to be issued shortly by the European Medicines Agency and the European Centre for Disease Prevention and Control.
Ensuring sufficient logistical capacity to administer the vaccines as soon as new and adapted vaccines are delivered.
Exploratory talks are intended to result in an Advance Purchase Agreement to be financed through the Emergency Support Instrument, which has funds dedicated to the creation of a portfolio of potential vaccines produced by different companies.
Companies with a promising vaccine candidate, already in or close to starting clinical trials, are invited to contact the Commission at EC-VACCINES@ec.europa.eu
On 15 October 2020, the European Commission published a Communication on preparedness for COVID-19 vaccination that included key elements to be considered for national vaccination strategies.
In the beginning, the focus was on decreasing the rate of fatalities and the burden on essential services. Consideration was given to priority groups such as the elderly, healthcare workers and persons whose state of health means they are particularly at risk.
Speeding up vaccine production
On 19 January 2021, the European Commission adopted a Communication calling on Member States to speed up the rollout of vaccines across the EU.
By mid-July, Europe had enough vaccine doses to vaccinate 70% of the EU adult population.
Vaccination progress in Europe can be followed at the website of the European Centre for Disease Prevention and Control (ECDC).
Ramping up industrial vaccine production in the EU
On 4 February 2021, the European Commission set up a Task Force under the authority of the Commissioner for the Internal Market, Thierry Breton, in cooperation with the Commissioner for Health and Food Safety, Stella Kyriakides. The Task Force aims to ramp up production capacity for vaccines in the EU, acting as a one-stop-shop for manufacturers in need of support, and to identify and address bottlenecks in production capacity and supply chains.
The regular contacts of the Task Force with industry and Member States allow the Commission to have a good understanding of vaccine production capacities in the EU. The Task Force is also regularly updating a mapping of vaccine production capacities in the EU, including the related EU supply chain.
The mapping exercise is based on data gained through the Task Force activities, from the Commission-organised matchmaking event in March 2021 with companies that have consented to have their name made public, publicly available information and on information shared by Member States. This data will be complemented and updated as further information becomes available.
The Task Force categorised the companies based on their main area of activity, thus companies can have more capacities that may not be reflected in the map. The data in the mapping exercise is aggregated in five main categories for visualisation purposes as follows:
- Supply (production/supply of raw materials, consumables, disposables, equipment)
- Production (manufacturing and formulation, CDMO/CMO)
- Fill & Finish, Packaging
- Storage & Shipment
- Other (process development of vaccines, CROs, R&D, clinical trial management services)
On 12 July 2021, the Task Force organised a second matchmaking event, this time on COVID-19 therapeutics, to foster industrial collaborations to accelerate the development and production of new or repurposed medicines to treat COVID-19.
Transparency and authorisation mechanism for exports of vaccines
On 29 January 2021, the European Commission put a measure in place requiring COVID-19 vaccine exports to be authorised by Member States. This is to ensure timely access to vaccines for all EU citizens and transparency of vaccine exports outside the EU.
However, the EU will not extend the COVID-19 vaccines export transparency and authorisation mechanism, which expires on 31 December 2021. As of 1 January 2022, this mechanism will be replaced by a new monitoring tool, which will mean vaccine producers no longer have to request an authorisation for the export of vaccines outside the EU. Transparency of exports will continue to be ensured through this new tool, providing the Commission with timely, company-specific export data.
The Commission has invested large amounts of funding in the development of the production capacity of vaccine developers in the EU, and continues to monitor the epidemiological situation in order to adopt appropriate measures if necessary.
On 18 September 2020, the European Commission confirmed its participation in the COVAX Facility for equitable access to affordable COVID-19 vaccines.
COVAX’s global supply forecast
COVAX is part of the Access to COVID-19 Tools (ACT) Accelerator, a global collaboration to accelerate the development, production, and equitable access to COVID-19 tests, treatments, and vaccines.
On 12 November 2020, the European Union announced it will contribute an additional €100 million in grant funding to support the COVAX Facility to secure access to the future COVID-19 vaccine in low and middle-income countries. The funds will complement the €400 million in guarantees the EU already committed for COVAX, making the Union one of the leading donors.
On 19 February 2021, the President of the European Commission announced an additional €500 million for the COVAX Facility. The new package consists of a €300 million EU grant and €200 million in guarantees by the European Fund for Sustainable Development plus (EFSD+) that will back a loan by the European Investment Bank.
With this new contribution, the EU is further stepping up investment in support of the global recovery with a total of €1 billion. Team Europe (EU and Member States) are a lead contributor to the COVAX Facility with close to €3 billion pledged to date.
ACT brings together governments, scientists, businesses, civil society, philanthropists and global health organizations such as
- the Bill & Melinda Gates Foundation
- The Global Fund
- the WHO
- the World Bank
- Global Financing Facility
In its Communication of 19 January 2021, the Commission announced that it will set up an EU vaccine sharing mechanism to structure the provision of vaccines shared by Member States with partner countries through a Team Europe approach, paying special attention to the Western Balkans, the Eastern and Southern neighbourhood, and Africa.
On 21 May 2021, at the G20 Global Health Summit in Rome, the President announced a Team Europe initiative on manufacturing and access to vaccines, medicines and health technologies in Africa. The initiative will help create an enabling environment for local manufacturing in Africa and tackle barriers on both supply and demand sides. It will be backed by €1 billion from the EU budget and the European development finance institutions such as the European Investment Bank (EIB). This amount will be further enhanced by contributions from EU Member States.
On 22 July 2021, the President announced the firm commitment that Team Europe will deliver at least 200 million doses to low and middle-income countries by the end of the year. A majority of these doses will be delivered through COVAX.
On 11 October 2021, the European Commission proposed to amend the EU Budget for 2021. It will provide an additional €450 million to reach the €1.3 billion which are needed to secure an additional 200 million doses of vaccines against COVID-19 for low and middle-income countries through COVAX, as announced by President von der Leyen in her State of the Union speech.
On 29 November 2021, on the occasion of the second-ever special session of the World Health Assembly of the World Health Organization, the President of the European Commission confirmed that the EU aims to share at least 700 million vaccine doses by mid-2022 with low and middle-income countries. This comes on top of the €3 billion in financing already provided to help create the ACT-Accelerator.
Redacted Framework Contracts for Supplies
Redacted Advance Purchase Agreements
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