The European Commission has launched a new bio-defence preparedness plan designed to bolster Europe’s preparedness against the looming threat of new coronavirus strains, which includes moves to fast-track future variant vaccines.
The plan, known as the “HERA incubator”, was unveiled by the Commission on Wednesday (17 February). It will work with researchers, biotech companies, manufacturers and public authorities in the EU and globally to detect and prevent the spread of new variants.
In a multi-pronged approach, the HERA incubator works to provide incentives to develop new and adapted vaccines, speed up the approval process for these vaccines and ensure scaling up of manufacturing capacities.
“With our new bio-defence preparedness plan, we are tackling parallel or subsequent series of pandemics deriving from the variants,” said Margaritis Schinas, vice-president of the European Commission, adding that this is “the way to get out from the crisis, ready to adapt to new circumstances and united in action, ensuring solidarity across the EU and the world.”
The incubator, also designed to serve as a blueprint for the EU’s long‑term preparedness for health emergencies, comes as new variants continue to emerge, amid challenges with scaling up vaccine production.
Stressing the importance of adapting responses to “stay ahead of the curve” at a press conference marking the unveiling of the programme, European Commission President Ursula von der Leyen warned that we are seeing “more and more cases of COVID-19 linked to variants,” with new variants of the virus still emerging fast in Europe and around the world.
Health Commissioner Stella Kyriakides added that the EU needs to “act decisively, we need to act collectively,” calling the incubator the EU’s “targeted response”.
No compromise on safety
One of the incubator’s main aims is to speed up the regulatory approval of novel varieties of vaccines which have been altered to tackle COVID variants, and the Commission will look to alter the regulatory framework of the European Medicines Agency (EMA) in order to achieve this.
“We don’t need the whole approval process anymore if you have an updated vaccine because there is already a bottom-line knowledge, for example on the mRNA technology,” von der Leyen said.
The news raised questions as to how this can be achieved without compromising on safety.
Stressing that this would not be the case, the Comission president said this would involve synchronising steps in the process rather than losing content.
“The point is that if we have an incremental change of the vaccine that is targeted, and that only needs reduced additional information or data, then of course you can reduce the time while being thorough,” she said, adding that safety is of “utmost importance”.
Kyriakides said that amending the regulatory procedure may mean that the approval of an adapted vaccine requires a smaller set of additional data submitted to the EMA.
Thierry Breton, Commissioner for the internal market, told the same press conference that with the incubator, the EU is focusing efforts on helping companies to scale up their production, stressing that the EU is well-placed to do this.
“We’ve done all the groundwork. So this objective can be met, it will be met,” he said, stressing the importance of having a forward-looking approach to this.
“Our ambition is to look to the future as well,” he said, adding that this will also contribute to a higher level of autonomy in the area of health in the near future for the EU.
“When you look at what happened over the last few years, we need to have health sovereignty in the EU. We need to be capable to react quickly if there’s a new crisis,” Breton said.
Comparing apples with pears
There is also a strong emphasis on the detection of new variants, including genomic sequencing of variants, for which the Commission has pledged to offer at least €75 million to member states.
The Commission will also offer €150 million in funding to step up research and data exchange on variants, while a new clinical trial network, ‘Vaccelerate’, is envisaged to enable data exchange and expand clinical trials.
This will create a standardised quality approach to data collection which ensures that “apples are not being compared with pears”.
“What we saw in the data was a variety of quality,” von der Leyen said, specifying the need to establish the different specifics of patients included in trials.