EU vaccination strategy

EU Vaccination Strategy

On 17 June, the European Commission presented a European vaccines strategy to accelerate the development, manufacturing and deployment of vaccines against COVID-19. A safe and effective vaccine is our best bet to overcome the pandemic.

Questions and answers on the EU Vaccination strategy.

Vaccine development is a complex and lengthy process, which normally takes around 10 years. With the vaccines strategy, the Commission supports efforts and accelerate the development and availability of safe and effective vaccines in a timeframe between 12 and 18 months, if not earlier. At the same time strict and robust authorisation procedures and safety standards will be respected at all times. This requires running clinical trials in parallel with investing in production capacity to be able to produce millions, or even billions, of doses of a successful vaccine.

Europe needs a broad portfolio of vaccine candidates based on different technological approaches to maximise the chances of quickly developing, manufacturing and deploying a vaccine for all Europeans.

Under its vaccines strategy, the Commission has forged agreements with individual vaccine producers on behalf of EU countries. Once available, proven safe and effective, and authorised at EU level, all Member States will have access to COVID-19 vaccines at the same time and the distribution will be done on a per capita basis to ensure fair access.

The Commission will put in place a common reporting framework and a platform to monitor the effectiveness of national vaccine strategies. To share best practices, the conclusions of the first review on national vaccination plans will be presented in the second half of December 2020.

The agreements are financed with the Emergency Support Instrument. The Commission has taken a decision to support these vaccine based on a sound scientific assessment, the technology used, and its production capacity in Europe to supply the whole of the EU.

To date, 4 safe and effective vaccines against COVID-19 have been authorised for use in the EU following positive scientific recommendations by the European Medicines Agency:

BioNTech-Pfizer

On 21 December 2020, the European 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 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.

On 11 November 2020, the European Commission approved the contract with a pharmaceutical company, BioNTech-Pfizer, which provides 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, to be supplied once a vaccine has proven to be safe and effective against COVID-19. On 15 December 2020, the Commission decided to purchase these 100 million additional doses. In addition, 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 Member States can decide to donate the vaccine to lower and middle-income countries or to re-direct it to other European countries.

On 10 March 2021, the European Commission reached an agreement with BioNTech-Pfizer for the supply of 4 million more doses of COVID-19 vaccines for Member States to tackle coronavirus hotspots and to facilitate free movement across borders. These doses come on top of the schedule of deliveries currently agreed between Member States and BioNTech-Pfizer.

Moderna

On 6 January 2021, the European Commission granted a conditional marketing authorisation for the vaccine against COVID-19 developed by Moderna, making it the second vaccine authorised for use 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.

On 25 November 2020, the European Commission approved contract with Moderna to purchase a potential vaccine against COVID-19. The contract 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, to be supplied once a vaccine has proven to be safe and effective against COVID-19. On 15 December 2020, the Commission decided to purchase 80 million additional doses.

On 17 February, the Commission approved a second contract with Moderna, which provides for an additional purchase 300 million doses (150 million in 2021 and an option to purchase an additional 150 million in 2022) on behalf of all EU Member States.

The contract would provide for the possibility for all EU Member States to purchase the vaccine, as well as to donate to lower and middle income countries or re-direct to European countries.

AstraZeneca

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 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. With the agreement of AstraZeneca, the redacted Advance Purchase Agreement is available.

On 14 August 2020, the European Commission reached a first agreement with the pharmaceutical company AstraZeneca to purchase a potential coronavirus vaccine, as well as to donate or re-direct vaccines to other European or other lower and middle-income countries. On 27 August, the first contract that the Commission negotiated on behalf of the EU Member States with a pharmaceutical company entered into force following the formal signature between AstraZeneca and the Commission.

Johnson & Johnson

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 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. 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.

2 contracts have been concluded that allow the purchase of a vaccine once proven safe and effective:

Sanofi-GSK

On 18 September, a second contract between Sanofi-GSK and the European Commission entered into force. Once Sanofi-GSK vaccine has proven to be safe and effective against COVID-19, the contract will allow all EU Member States to purchase up to 300 million doses of the vaccine. Moreover, Member States may donate reserved doses to lower – and middle-income countries. The contract was preceded by exploratory talks between Sanofi-GSK and the Commission.

The companies started a Phase I / II study in September, followed by a Phase III study by the end of 2020. If successful, and subject to regulatory considerations, the companies aim to have the vaccine available by the second half of 2021.

Sanofi and GSK will also endeavour to provide a significant portion of their vaccine supply through a collaboration with the COVID-19 Vaccines Global Access facility (COVAX) – the vaccine pillar of the Access to COVID-19 Tools Accelerator for lower and middle income countries – in a timely manner. With the agreement of Sanofi-GSK, the redacted Advance Purchase Agreement is available.

CureVac

On 19 November, the European Commission approved a fifth contract with the pharmaceutical company CureVac. 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, to be supplied once a vaccine has proven to be safe and effective against COVID-19. Member States can also decide to donate the vaccine to lower and middle-income countries or to re-direct it to other European countries. CureVac, a European company based in Germany, signed a €75 million loan agreement with the European Investment Bank on 6 July for the development and large-scale production of vaccines, including CureVac’s vaccine candidate against COVID-19. With the agreement of CureVac, the redacted Advance Purchase Agreement is is available.

Exploratory talks

Novavax

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 all EU Member States to initially purchase 100 million doses, followed up by 100 million additional ones.

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. The envisaged contract with Valneva would provide for the possibility for all EU Member States to purchase 30 million doses, and they could further purchase up to 30 million more doses.

The Commission, with the support of EU Member States, has decided to support these vaccines based on sound scientific assessments, the technologies used, the companies experience in vaccine development and their production capacities to supply all EU Member States.

The 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

EU Vaccine portfolio / COVID-19 vaccine tracker

Article is from:
https://ec.europa.eu/info/live-work-travel-eu/coronavirus-response/public-health/coronavirus-vaccines-strategy_en

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