Politics, Policy & Law
Europe prepares for COVID-19 variants with HERA Incubator
While Europe continues to grapple with a slower than hoped for rollout of COVID-19 vaccines, the EU bloc is trying to get ahead of the curve on SARS-CoV-2 variants with the launch of the HERA Incubator. The biodefense preparedness plan is targeting improved variant surveillance coupled with incentives to develop and rapidly approve new vaccines.
The incubator is the first step in the European initiative to establish the Health Emergency Preparedness and Response Authority (HERA), a new EU level agency that would coordinate pandemic surveillance and response across Europe.
Its launch comes as both academic and industry groups have begun work on the best ways to respond to and predict new COVID-19 variants.
The incubator will provide at least €75 million ($90.3 million) in new funding to support the development of tests to detect COVID-19 variants and a surveillance effort to sequence 5% of all positive tests across Europe to better identify and monitor the spread of new variants. Research on new variants will see at least €150 million in support from HERA.
The European Commission also said the new plan will adapt the EMA flu vaccine approval model to expedite the review of adapted COVID-19 vaccines targeting new variants. The EC said this would allow for the rolling review and rapid approval of new versions of COVID-19 vaccines based on a smaller set of additional data.
EMA plans to publish guidance shortly for vaccine developers on what level of data would be required for addressing COVID-19 variants.
The HERA Incubator will also investigate the potential for creating a new emergency authorization pathway for vaccines at the EU level. Current vaccines have had to go through the existing conditional marketing authorization process at EMA.
The third aim of the incubator is to ramp up manufacturing capacity in the EU for both the existing and future COVID-19 vaccines.
While the EC didn’t provide any capacity targets, it said the plans may include facilitating certification of repurposed manufacturing facilities via early regulatory engagement; working with manufacturers to monitor supply chains and address any production bottlenecks; and developing a voluntary licensing mechanism to facilitate technology transfer.
The EU has advanced purchase agreements for up to 2.6 billion doses of COVID-19 vaccines. But the EC has faced criticism as some EU countries have seen slow uptake in vaccines or experienced delays in delivery.