On Wednesday 17 February, the European Commission unveiled its ‘HERA Incubator’ plan to further arm the European Union against the increased threat of Covid-19 variants.
With this initiative, the institution intends to take a proactive approach.
“New variants of the virus are emerging fast, and we must adapt our response even faster”, said Commission President Ursula von der Leyen.
According to the Commissioner for Health and Food Safety, Stella Kyriakides, this plan thus represents “an exercise in foresight, anticipation and united response”, in order to “stay ahead of the threat of new coronavirus variants”.
Aimed at building “bridges” between research, industry and regulators, the Commission’s new plan has three main objectives: – detect, analyse and evaluate variants; – expedite regulatory approval of vaccines adapted to variants, in case some of them are less responsive to existing vaccines; and – increase the production of Covid-19 vaccines as well as the production of new vaccines (or the adaptation of existing vaccines) to combat variants.
Develop specialised tests
Under the first objective, the Commission wants to develop specialised tests for new variants and support genome sequencing in the Member States. European funding of at least €75 million will be dedicated to this task.
A further €150 million will be used to step up research and data exchange on variants within the framework of Horizon Europe.
Furthermore, the Commission announced the launch of the ‘VACCELERATE COVID-19’ clinical trial network, which brings together 16 EU Member States and five associated countries, including Switzerland and Israel, to exchange data and gradually include children and young adults in the trials.
Accelerate vaccine approvals
In order to speed up the regulatory procedure for approving adapted versions of existing vaccines, the Commission will pursue a new category of EU-wide emergency vaccine authorisations, with responsibility shared between Member States.
Basing its approach on the model of the annual influenza vaccine, it also intends to adapt the regulatory framework so that a suitable vaccine can be approved on the basis of a more limited set of additional data submitted to the European Medicines Agency (EMA), while facilitating the certification of new or converted manufacturing sites.
The EMA will also be responsible for providing guidance to vaccine developers on data requirements so that the requirements relevant to variants are known ahead of time.
Asked about the risk that an acceleration of vaccine control procedures could lead to an increase in the population’s mistrust, especially if the Russian Sputnik V vaccine were to be authorised, Ms von der Leyen was reassuring.
The Commission’s intention, she explained, is to examine where it is possible to “better synchronise” certain steps in the process, “without losing content”.
She continued, “With the view on the variants, you do not need the whole approval process anymore, if you have an updated vaccine, because now there is a baseline knowledge on, for example, the mRNA technology. You only need to look at what the incremental improvement is or what change occurred and that it is still effective and that it is safe”.
She also pointed out that the EMA would need all the data to authorise Sputnik V, while expressing her surprise that Russia was offering millions of doses instead of prioritising the vaccination of its own population.
Increasing production
Regarding the last objective of the HERA Incubator scheme, the Commission plans to resume the use of advance purchase contracts to support the development or adaptation of vaccines with EU funding.
This time, however, these contracts will have to be accompanied by a “detailed and credible plan showing capability to produce vaccines in the EU on a reliable timescale”, the institution specified. This is a precondition for any new or updated agreement, reflecting the Commission’s determination not to repeat the same mistakes in the delivery of vaccine orders (see EUROPE 12655/1).
The Commission will also ensure the implementation of the ‘EU Fab’ project. This project aims to set up a network of European vaccine and drug production capacities, in order to consolidate manufacturing capacity on European soil and thus be better able to respond to health emergencies at EU level. Questioned on this subject, the Commissioner for the Internal Market, Thierry Breton, considered that Europe “will be undoubtedly one of the first continents in terms of making vaccines”, “if everything runs smoothly”.
While the Commission has set up a working group to speed up vaccine production by working with the industrial sector, ‘HERA Incubator’ will also aim to strengthen this collaboration to help manufacturers monitor supply chains and address bottlenecks in production chains (see EUROPE 12657/11).
“With this increased cooperation, we will ensure that the industrial phase of vaccine production allows manufacturers to meet their commitments while anticipating our future needs and adjusting vaccine production to future variants”, Mr Breton said.
300 million additional doses
Finally, Ms von der Leyen also announced the approval of a second contract with Moderna. This provides for the purchase of 300 million additional doses of the Covid-19 vaccine developed by the US pharmaceutical company (150 million in 2021 and an option to purchase a further 150 million in 2022) and includes the possibility of donating doses to low- and middle-income countries or redirecting them to other European countries.
“The contract is important not only for the short term needs of the EU, but also for our future work to limit the rapid spread of new variants”, Ms Kyriakides stressed in this regard.
With this new contract, the EU has secured a total portfolio of 2.6 billion doses of six different vaccines: three that have already been authorised (BioNTech/Pfizer, Moderna and AstraZeneca) and three that have yet to prove their safety and efficacy to the EMA (Sanofi-GSK, Janssen Pharmaceutica NV, CureVac).
Of these 2.6 billion doses, 33 million of the three authorised vaccines have so far been delivered to EU countries, Ms von der Leyen said.
According to her, “22 million people received at least one dose, of which 7 million received a second dose”. (Original version in French by Damien Genicot and Agathe Cherki)