Euro Roundup: EC seeks input on health emergency authority

RoundupsRoundups | 04 February 2021 |  By 

The European Commission is seeking feedback on plans to create a Health Emergency Preparedness and Response Authority (HERA) to address shortcomings exposed by the COVID-19 pandemic.
EU efforts to coordinate the response to the pandemic at times have been in tension with member states’ desires to protect their own populations. Late last year the Commission published plans to strengthen the European Medicines Agency’s (EMA) ability to coordinate the development and supply of drugs, vaccines and medical devices.
Now, they have gone a step further by proposing to set up a dedicated health emergency authority. HERA’s main goal would be to enable an “EU level countermeasure management system” that supports “rapid and equal access, availability, development and deployment of the most advanced medical countermeasures in the event of a health emergency.”
The Commission said HERA would identify and address “market and regulatory challenges/failures” and “regulatory pathways and marketing authorizations.” The end goal of those activities would be to “overcome industry development challenges to ensure that there are final public returns on prioritized policy areas in the field of medical countermeasures.”
The Commission is accepting feedback on the proposals until 24 February and will use the comments to support “further development and fine tuning of the initiative.”
Commission Consultation
Swissmedic demands additional Phase 3 data on AstraZeneca’s COVID vaccine
The Swiss Agency for Therapeutic Products (Swissmedic) has told AstraZeneca its COVID-19 vaccine cannot be approved on the strength of the available data. Swissmedic wants to see results from a Phase 3 clinical trial underway in the US and other parts of the Americas before deciding.
Other European regulators have approved the vaccine but questions about the strength of the data generated by the University of Oxford group that originated the vaccine have swirled since the Phase 3 results were shared last year. Compared to studies run by Moderna and Pfizer, the Oxford late-phase trial was relatively small and enrolled fewer older participants. “The data currently available do not point to a positive decision regarding benefits and risks,” according to Swissmedic.
AstraZeneca is already running a 30,000-subject Phase 3 study with sites across the US trial that could address the gaps in the data.
Swissmedic Notice
MHRA clarifies guidance on qualified person responsible for pharmacovigilance
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has updated its guidance on the qualified person responsible for pharmacovigilance (QPPV) in response to feedback.
In the new document, the original version of which was published at the end of last year, MHRA says there is no requirement to appoint a deputy to the UK pharmacovigilance contact. However, if the contact is absent for more than one month, the marketing authorization holder should assign another person to the role and share their details with MHRA within two weeks of the change.
Further, the guidance states that the pharmacovigilance system master file (PSMF) must be accessible electronically from an address in the UK. If an address outside the UK is used, the PSMF number will be invalidated and not accepted on filings to MHRA.
The updated guidance also clarifies MHRA will send the UK PSMF to the email address of the QPPV, as well as the address nominated on the request form. Companies that do not receive a confirmation email within three hours of submitting the form should contact MHRA by email.
MHRA Guidance
EMA starts rolling review of Regeneron’s COVID antibody cocktail
EMA has started a rolling review of REGN-COV2, the anti-SARS-CoV-2 antibody cocktail from Regeneron and partner Roche, moving it  a step closer to its use in the EU to treat and prevent COVID-19.
Regeneron received emergency use authorization for REGN-COV2 in the US last year but progress in the EU has lagged. The EMA rolling review is based on preliminary evidence REGN-COV2 reduces levels of the coronavirus in the nose and throat of non-hospitalized COVID-19 patients.
However, there are now concerns that antibodies will be less effective against the variants first seen in Brazil, South Africa and the UK. Regeneron included two antibodies in REGN-COV2, rather than the one used in Eli Lilly’s comparable product, in part due to the risk of viral escape.
EMA Notice
EMA shares draft concept papers on veterinary vaccine master files
EMA has published two draft veterinary concept papers on the data requirements for vaccine platform and antigen master files. EMA is holding the consultation as part of a push to flesh out concepts introduced in veterinary medicine regulations.
Through an annex that is still in development, the EC is set to introduce Vaccine Platform Technology Master Files (PTMF) into veterinary regulations for the first time. The concept of Vaccine Antigen Master Files (VAMF) has a longer history in veterinary medicine, but it is yet to be addressed in scientific guidelines or procedural guidance.
EMA uses the term “platform technology” to describe approaches such as mRNA-based vaccination that can be modified to generate protection against a different antigen or set of antigens. Companies with such platforms will be able to submit PTMFs alongside their first filings to share data that will remain the same regardless of the target antigen.
Having an approved PTMF will spare companies from the need to resubmit certain information in subsequent submissions based on the platform. To support that process, EMA wants to create guidance that details the content of PTMFs and how they will reduce data requirements.
The VAMF concept paper covers a stand-alone part of the marketing authorization application dossier that companies can voluntarily use to share information on the quality of active substances. Once a VAMF is in place, applicants can use it to support submissions for vaccines featuring the same antigens.
Annex II of the new veterinary medicine directive addresses VAMFs. However, EMA has heard that more detailed guidance may be needed “to give the necessary predictability for the submission of a VAMF.” EMA wants to know if developers of veterinary vaccines agree that additional technical guidance is needed and, if so, gather feedback on the topics that need clarifying.
EMA is accepting feedback on the drafts until the end of March. After discussing the feedback, EMA plans to prepare draft guidance for consultation by July. EMA is aiming to adopt final guidance in January 2022.
Platform Paper, Antigen Paper


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