According to the European Commission, the swift development and global deployment of safe and effective vaccines against COVID-19 is key to resolving the current public health crisis. In this context, the European Commission is working to ensure Europe-wide access to safe vaccines and encouraging a coordinated vaccination strategy.
In the same vein, laboratories worldwide are working against the clock to develop a successful vaccine as soon as possible. To this end, the European Union is leading the way in mobilising resources to advance research and accelerate the development, manufacture and distribution of COVID-19 vaccines.(1)
On 17 June 2020 the European Union published the Communication from the Commission to the European Parliament, the European Council, the Council and the European Investment Bank EU Strategy for COVID-19 Vaccines, which sets out a number of strategic objectives based primarily on:
- ensuring the sufficient production of vaccines in the European Union for distribution to all member states, guaranteeing quality, safety and efficacy;
- adapting the EU regulatory framework in light of the urgent need for such vaccines in order to accelerate their development, authorisation and availability, ensuring that quality and efficacy standards are met (eg, by introducing EU Regulation 2020/1043 on the conduct of multicentre clinical trials (for further details please see "Latest EU measures relating to COVID-19 pandemic – multicentre clinical trials")).
- securing timely access to vaccines for member states and their populations; and
- ensuring equitable access to an affordable vaccine as soon as possible for everyone in the European Union.
To support the production of vaccines in the European Union, work is underway to agree a common approach to efficiency and solidarity in the European single market that will allow for the free movement of both goods and people. As no individual member state has the capacity to effectively develop vaccines, joint action is the safest and most effective way to achieve the common goal of halting the spread of the pandemic through the supply of effective vaccines.
Advance purchase agreements have also been put in place through the Emergency Support Instrument. In this regard, Point 2.2 of the abovementioned communication states as follows:
In order to support companies in the swift development and production of a vaccine, the Commission will enter into agreements with individual vaccine producers on behalf of Member States. In return for the right to buy a specified number of vaccine doses in a given timeframe and at a given price, part of the upfront costs faced by vaccines producers will be financed from the ESI. This will be done in the form of advance purchase agreements (APAs).
Therefore, if any vaccine developed in any member state is successful, all other member states will have the right to acquire said vaccine directly from the laboratory producing it. However, purchasing member states will be responsible for distributing the vaccine.
Criteria for the selection of vaccine candidates is being established (ie, the European Commission intends to enter into negotiations with laboratories undertaking advanced clinical trials in order to compile a list of candidates, which will be updated as new information is acquired).
Additional support will be made available to research laboratories through loans from the European Investment Bank (EIB). The European Commission is providing guarantees to the EIB under its financial instruments, such as:
- Horizon 2020 InnovFin;(2)
- the European Fund for Strategic Investment (ESF);(3) and
- the forthcoming InvestEU.(4)
This allows the EIB to offer attractive conditions for financial products offered for vaccine development and related manufacturing activities.
Finally, a flexible and robust regulatory process must be respected, the objectives of which include the following:
- commitment to the European Medicines Agency (EMA) and international cooperation – the EMA has created a working group (COVID-ETF) to interact with COVID-19 vaccine developers and provide scientific support from the early stages of development;
- accelerated licensing procedure – in a pandemic situation, clinical trials must be conducted within a significantly shortened period, which limits the data available to review marketing authorisation applications. The EU regulatory system is designed to accommodate this situation by providing a system of conditional approval;
- flexibility in labelling and packaging – under normal circumstances, the packaging and labelling of authorised medicines, including vaccines, should be provided in all EU languages. However, requirements relating to labelling and packaging may delay the rapid deployment of COVID-19 vaccines, so flexibility has been promoted in this respect;
- genetically modified organism (GMO) legislation – there is considerable variation among member states with respect to national requirements and procedures implementing the GMO directives that are used to assess the environmental risks of clinical trials of medicines containing or consisting of GMOs. This is likely to result in significant delays, particularly for multicentre clinical trials carried out in several member states.
In recent times, the European Union has also focused on assisting pharmaceutical laboratories in vaccine development and research by financially supporting projects to improve preparedness and response to new virus outbreaks.
In addition, Communication published on 15 October 2020 (Communication from the Commission to the European Parliament and the Council Preparedness for COVID-19 Vaccination Strategies and Vaccine Deployment) complements all of the information provided in the abovementioned communication of 17 June 2020 and sets out the key steps that EU member states must take to be fully prepared in the development of the vaccines.
In this latest communication, all EU member states are encouraged to continue the strategy outlined in June 2020. In relation with this strategy, to date there have been various developments regarding contracts that allow the purchase of a vaccine once its safety has been demonstrated:
- AstraZeneca: on 27 August 2020, the first contract that the EU Commission negotiated on behalf of EU member states with a pharmaceutical company entered into force following the formal signature between AstraZeneca and the commission. AstraZeneca's vaccine candidate has already entered large-scale Phase II or III clinical trials after achieving promising Phase I or II results in safety and immunogenicity.
- The EMA's scientific committee for human medicines has initiated the first 'rolling review' of a COVID-19 vaccine, which is being developed by AstraZeneca in collaboration with Oxford University.(5)
- Sanofi-GSK: the contract between Sanofi-GSK and the European Commission entered into force on 18 September 2020, following the contract's formal signature.
- Johnson & Johnson: the European Commission approved a third contract with Janssen Pharmaceutica NV on 21 October 2020, one of the Janssen Pharmaceutical Companies of Johnson & Johnson. In this case, the EMA's scientific committee for human medicines has also begun a rolling review of Ad26.COV2.S, a COVID-19 vaccine from Janssen-Cilag International NV.
- BioNTech-Pfizer: on 11 November 2020, the European Commission approved the fourth contract with a pharmaceutical company, BioNTech-Pfizer. The EMA has received a conditional marketing authorisation (CMA) application for BNT162b2, a COVID-19 mRNA vaccine developed by BioNTech and Pfizer.(6) The evaluation of BNT162b2 will be conducted under an accelerated schedule and a marketing authorisation assessment could be issued in a few weeks, depending on whether the data submitted are robust and complete enough to demonstrate the quality, safety and efficacy of the vaccine.
- CureVac: the European Commission approved the fifth contract with the pharmaceutical company CureVac on 19 November 2020.
- Moderna: lastly, on 25 November 2020, the European Commission approved the sixth contract with Moderna to purchase a potential vaccine against COVID-19. As well as the BioNTech-Pfizer application, the EMA has also received a conditional marketing authorisation application for a COVID-19 mRNA vaccine. The evaluation of the vaccine known as the Modern Covid-19 vaccine (also known as mRNA1273) will be conducted in an accelerated timeframe as well and a marketing authorisation opinion could also be issued in a few weeks.
In short, it must be emphasised from the above that, on 1 December 2020 the European Agency of Medicines received applications from BioNTech-Pfizer and Moderna for conditional marketing authorisations of the vaccines that these companies developed against COVID-19. In the next weeks, the EMA will carry out independent scientific evaluations of the quality, safety and efficacy of each vaccine.
Moreover, it is important to mention that these approved contracts include provisions whereby member states may donate or resell vaccine doses to third countries for the sole purpose of achieving global collaboration. At present, it is unknown which potential vaccine, if any, will successfully complete the long process of development and licensing that is being made more flexible, so the European Union must acquire a large portfolio of vaccine candidates to maximise the potential for an effective vaccine.
For this reason, it is essential that EU member states share their experiences and research findings with each other and coordinate their efforts in response to the pandemic. Thus, when effective and safe vaccines against COVID-19 become available, the immediate stages of supply will depend on available production capacities. EU member states will need to decide which groups should have priority access to COVID-19 vaccines to save the most lives. These decisions must be based on two criteria:
- protecting the most vulnerable groups and individuals; and
- stopping the spread of the disease.
The specific epidemiological situations of each country at the time of vaccine distribution, among other factors, will significantly influence decision making at the national level. Therefore, the methods of vaccination and the objectives set should be adjusted accordingly to meet the needs of each state.
In addition, the communication proposes a series of actions for the consideration of each member state as to their current and future cooperation, including:
- defining a flexible priority list for vaccination and identifying and targeting key population groups;
- developing and conducting modelling exercises to share experiences at the EU level;
- periodically reviewing critical factors, such as the epidemiological situation at the national and subnational level and any new data on the virus and its impact on human health; and
- exchanging knowledge and experiences regarding the development and implementation of vaccination strategies, especially with respect to priority groups.
The communication emphasises that unity among EU member states must be maintained in order to reduce the spread of COVID-19 as quickly and effectively as possible. In this regard, member states must continue to work as a team in order to achieve their shared goals of:
- reducing mortality rates;
- reducing the pressure on health systems; and
- improving member states' shared capability to deal with future pandemics.
(1) For further information on EU measures relating to COVID-19 please see "Latest EU measures relating to COVID-19 pandemic – multicentre clinical trials" and "Short-term health preparedness for COVID-19 outbreaks".
(3) The ESF is the central component of the Investment Plan for Europe. It aims to address the lack of confidence and investment resulting from the financial crisis and to make use of the liquidity maintained by financial institutions, companies and individuals at a time of scarce public resources.
(4) The InvestEU programme will bring together under one roof the multitude of EU financial instruments available to support investment in the European Union, making EU funding for investment projects in Europe simpler, more efficient and more flexible.
(5) A rolling review is one of the regulatory tools that the EMA uses to speed up the assessment of a promising medicine or vaccine during a public health emergency. Normally, all data on a medicine's effectiveness, safety and quality and all required documents must be submitted at the start of the evaluation in a formal application for marketing authorisation.
(6) In the European Union, CMAs allow for the authorisation of medicines that fulfil an unmet medical need on the basis of less complete data than normally required. This happens if the benefit of a medicine or vaccine's immediate availability to patients outweighs the risk inherent in the fact that not all the data are yet available.