EU plan to tackle COVID variants features flu vaccine-like pathway

Regulatory NewsRegulatory News
| 17 February 2021 | By Michael Mezher 

The European Union’s plan to take on new and emerging COVID-19 variants came into focus Wednesday with the European Commission’s announcement of a new incubator tasked with scanning for and assessing variants, speeding regulatory approvals and boosting EU production of vaccines.
The incubator is said to lay the groundwork for the recently proposed European Health Emergency Preparedness and Response Authority (HERA), which the Commission has billed as a “central element for strengthening the European Health Union” against future health threats. (RELATED: EC seeks input on health emergency authority, Regulatory Focus 4 February 2021).
“Taking action now is important as new variants continue to emerge and challenges with scaling up vaccine production are arising. The HERA Incubator will also serve as a blueprint for the EU's long‑term preparedness for health emergencies,” the Commission said, noting the variants’ potential to disrupt efforts to overcome the virus.
Several variants of the SARS-CoV-2 virus, including those first identified in the United Kingdom (B.1.1.7), South Africa (B.1.351) and Brazil (B.1.1.28), have raised international concern as they appear to be more transmissible and may impact the efficacy of certain treatments and vaccines.
Key tenets of the incubator include support for the development of tests for new variants, research and data exchange, genome sequencing and the launch of a COVID-19 clinical trial network dubbed VACCELERATE that includes 16 EU member states and five other countries. The plan also aims to ramp up production of COVID-19 vaccines through new or updated purchase agreements that feature EU-based manufacturing and seeks to develop a voluntary dedicated licensing mechanism to facilitate technology transfer between manufacturers.
One of the main objectives of the HERA Incubator is to speed the authorization of adapted vaccines targeting COVID-19 variants. As such, the plan calls for the European Medicines Agency (EMA) to amend its regulatory procedures to mirror those in place for human influenza vaccines. “This will enable the approval of an adapted vaccine with a smaller set of additional data submitted to EMA on a rolling basis, also using the rolling review concept for post-authorisation changes,” the Commission said.
The plan acknowledges EMA’s effort to develop guidance detailing its expectations for adapting existing COVID-19 vaccines to protect against new and future variants of the virus and tasks EMA with overseeing the possibility for vaccine development in children and adolescents. (RELATED: EMA plans guidance on adapting vaccines for COVID variants, Regulatory Focus 10 February 2021).
The plan also foresees the early involvement of regulators in certifying new or repurposed production lines as critical to the speedy rollout of adapted vaccines. “The early and rapid development of the necessary process control, validation and stability data by companies is key in order to enable the review by EMA on a rolling basis and rapid authorisation of the new production facilities,” the Commission said.
Additionally, the Commission said it is ready to propose a targeted amendment to pharmaceutical legislation to enable EU-level emergency authorization of vaccines with shared liability among member states. The admission marks a potential shift from the EU’s current approach for regulating COVID-19 vaccines, which has seen three vaccines granted conditional marketing authorizations. As other regulators began authorization COVID-19 vaccines under temporary and emergency procedures, such as the US Food and Drug Administration’s emergency use authorization (EUA) pathway, top EU officials including EMA Executive Director Emer Cooke and European Health Commissioner Stella Kyriakides touted the conditional pathway as more robust than the emergency authorizations issued by other regulators. (RELATED: MHRA authorizes Pfizer-BioNTech COVID vaccine as FDA, EMA set more conservative timeline, Regulatory Focus 2 December 2020; EMA chief says Pfizer, Moderna data ‘very robust,’ defends vaccine review approach, Regulatory Focus 10 December 2020).
European Commission, Statement


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