Euro Roundup: EDQM posts batch control guidelines for COVID vaccines

RoundupsRoundups | 19 November 2020 |  By 

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has released guidelines on the tests that laboratories need to perform as part of the independent control of COVID-19 vaccines.
Official Medicines Control Laboratories (OMCLs) will test the potency and other characteristics of COVID-19 vaccines distributed in the European Union and review batch release protocols from the manufacturers. The work, which the laboratories will undertake as part of Official Control Authority Batch Release, will enable the OMCLs to review batch release quality control data from the vaccine manufacturers and ensure only compliant products reach the public.
EDQM has created three guidelines to support the work of the OMCLs. The guidelines cover the tests that need to be run on the three types of vaccines EDQM expects to be the first available in the EU: non-replicating chimpanzee adenovirus-vectored vaccines, non-replicating human adenovirus-vectored vaccines and mRNA vaccines.
Each guideline states OMCLs need at least 30 single or multi-dose containers of each final lot. All of the guidelines call for the OMCLs to assess the appearance, identity and potency of the vaccines. For viral-vectored vaccines, potency may serve as an identity test. Vaccines based on mRNA technology need to undergo integrity tests, too.
The guidelines lack information beyond the numbers of vaccine containers the OMCLs need and the one-word descriptions of the tests the laboratories will run. EDQM will review and update the texts once marketing authorizations have been approved, for example by adding the model protocol for a manufacturer’s data submission.
EDQM made the guidelines available in their current, early forms to give OMCLs and manufacturers time to prepare for batch release control. The directorate aims to prevent delays to vaccine availability while ensuring the quality and safety of the products.
The guidelines cover the mRNA vaccines from Pfizer and Moderna that delivered Phase 3 data earlier this month. The guidelines on viral-vectored vaccines apply to candidates in development at AstraZeneca and Johnson & Johnson. EDQM is still developing guidelines for other vaccine technologies that are further from market, such as the recombinant protein-based approach being developed by Sanofi and GlaxoSmithKline.
EDQM Notice
EMA seeks feedback on updated anticancer clinical trial guideline
The European Medicines Agency (EMA) has released draft guidelines on the clinical evaluation of anticancer therapies for consultation. EMA is updating the guideline to address the emergence of master protocols and tumor-agnostic medicines.
The current version of the guideline took effect in 2018. However, the pace of change in cancer R&D meant EMA released a consultation paper setting out its thoughts on the need for an update within months of the guideline coming into force. The concept paper addressed the rising use of biomarkers to stratify patients, as well as the trend’s effect on the use of basket and umbrella trial designs. 
Now, EMA is seeking feedback on the changes it plans to make to the guidance. The draft features an expanded, completely rewritten section on biomarkers, in which EMA addresses topics including the steps sponsors need to take to ensure a representative study population and when biomarkers can be used as surrogate endpoints. Only biomarkers with a “comprehensively established” link to a treatment effect in the clinical endpoint can be used as surrogates in confirmatory trials.
EMA has also added a new section on “specific designs for special situations.” The section provides an overview of basket and umbrella trials, which respectively study one drug in multiple diseases and the effect of multiple drugs on one disease, and specifics of when and how to use each study design. The rise of biomarker-targeted medicines has increased interest in basket trials.
The new section also addresses studies in very rare cancers. The current guidance covers such trials but EMA has rewritten and expanded the text in the draft to provide more detail on when it will permit non-randomized trials and what sponsors can do to establish efficacy in the absence of a control arm.
EMA is accepting feedback on the draft until 15 February.
Draft Guideline
European Commission posts recommendations on use of COVID-19 antigen tests
The European Commission has issued recommendations about the use of COVID-19 antigen tests. Officials are advising EU member states to limit use to tests with at least 80% sensitivity and 97% specificity and certain settings.
Antigen tests are faster and cheaper than PCR but typically carry a higher risk of false positives and negatives. Those strengths and weaknesses inform the recommendations made by the Commission.
The Commission recommends the use of antigen kits when more than 10% of tests are coming back positive, thereby reducing the risk of getting more false results than true ones. Member states can also consider using antigen tests when people are admitted to healthcare facilities. The Commission is adding antigen kit information to the COVID-19 test database.
Press Release, Commission Recommendations
EMA shares concept paper on reporting veterinary antimicrobial sales
EMA has released a concept paper on reporting veterinary antimicrobial sales at an EU level. The draft paper is the precursor to a guideline intended to establish denominators and indicators of EU antimicrobial consumption.
A European Surveillance of Veterinary Antimicrobial Consumption methodology for reporting data on microbial sales already exists. However, countries participating in the initiative have asked for EMA to revisit the sales denominator. The draft concept paper is the start of that process.
EMA ultimately wants to draft a guideline that recommends denominators and indicators that should be used for reporting on sales. The goal is to adopt the final guideline in December 2021. EMA is accepting feedback on the draft concept paper until the end of January.
Concept Paper
Ireland’s HPRA revises guide to trading tissues and cells outside EU
Ireland’s Health Products Regulatory Authority (HPRA) has updated its guide to imports and exports of tissues and cells for human application involving countries outside the EU.
The revised guide addresses the impact of an EU directive on the import and export of tissues and cells. As a result of the directive, HPRA has changed the terminology it uses to describe imports that only happen once for any given recipient. Such transactions are now known as “one-off,” whereas the term “non-routine” was previously used by HPRA.
Importation of tissues and cells must be carried out by an authorized establishment that can trace the materials from donor to recipient and ensure they meet quality and safety standards equivalent to those set out in the EU directive.
HPRA Guide
Other News:
The Danish Medicines Agency (DKMA) has officially opened its Data Analytics Center (DAC). DKMA set up the center to extract new knowledge about medicines and medical devices from existing data. The official opening follows around one year of work to establish the capabilities of DAC. DKMA plans to collaborate with other agencies through DAC. DKMA Notice
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has warned of increased risk of birth defects when sleep disorder drug modafinil is taken during pregnancy. MHRA issued the notice after reviewing the findings of a US study that linked the narcolepsy drug, which Teva sells as Provigil, to congenital malformations. MHRA Notice


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