Euro Roundup: UK says local plasma is acceptably safe in immunoglobulin medicines

RoundupsRoundups | 29 April 2021 |  By 

Plasma obtained from UK patients is “acceptably safe” for use in immunoglobulin products, if certain risk mitigation measures are implemented, according to the UK Commission on Human Medicines.
Manufacturers have been unable to use UK plasma to make immunoglobulin medicines since 1999, when it was its use banned due to the potential for iatrogenic transmission of the prions that cause variant Creutzfeldt–Jakob disease (vCJD). Since then, plasma for immunoglobulin and similar products has been imported, mostly from the US.
“Due to limitations in the supply of immunoglobulin products caused by the need to import plasma in the UK, long-term measures had to be implemented in the NHS to prioritize supply of these products to patients with the highest clinical need. The COVID-19 pandemic is placing further pressures on supply,” the UK Medicines and Healthcare products Regulatory Agency (MHRA) wrote.
MHRA considered lifting the ban for COVID-19 convalescent plasma last year. CHM, which advises the government on medicinal products, recommended waiting until more information was available, leading MHRA to do a deep dive into the evidence and present its findings to the commission.
The evidence has persuaded CHM that the UK can lift the ban without causing more than a minimal risk of vCJD. CHM’s acceptance of the safety of UK plasma is predicated on the application of measures already used to mitigate the risk of blood components for transfusion to the immunoglobulin supply chain, and on manufacturers performing product-specific risk assessments.
MHRA Report
EDQM posts guidance on recombinant protein, viral vector COVID vaccines
The European Directorate for the Quality of Medicines (EDQM) has published guidelines on the batch release testing of recombinant spike protein and non-replicating adenovirus-vectored COVID-19 vaccines. 
Guidelines covering vaccines developed by AstraZeneca and Johnson & Johnson were published in late 2020. The new document combines and updates those texts into a guideline that describes the tests that control laboratories need to run and the protocol that manufacturers must file. In creating the guideline, EDQM has reduced the number of containers that need testing in each lot.
The other guideline, which applies to protein vaccines such as those in development at Novavax and Sanofi, is at an earlier stage of its development. EDQM expects control laboratories to perform batch release on at least 2 ml of each non-absorbed bulk and 15 dose containers of each final lot.
Control laboratories will test the bulk for purity and the final lot for appearance, identity and purity. The guidelines on adenovirus and mRNA vaccines only require final lot testing. Based on the process for those types of vaccines, EDQM is likely to publish a revised version of the recombinant protein guideline in the coming months.
The introduction of the protein guideline precedes the anticipated introduction of a third type of COVID-19 vaccine. Novavax has generated Phase 3 data in the UK and is set to seek approval this quarter, while Sanofi expects to start a pivotal trial of its GlaxoSmithKline-partnered prospect by the midpoint of the year.
EDQM Notice
EU risk committee finalizes opinion on breast implant-lymphoma link
The Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) has finalized its opinion on the safety of textured breast implants in relation to anaplastic large cell lymphoma (ALCL), upholding its draft conclusion that there is moderate evidence of a causal relationship. 
SCHEER analyzed evidence of a link between breast implants and ALCL at the request of the European Commission and published its preliminary findings last year. The final opinion retains the preliminary findings but adds more nuance to its conclusions.
“Overall SCHEER considers that there is a moderate weight of evidence for a causal relationship between textured breast implants and ALCL, particularly in relation to implants with an intermediate to high surface roughness,” SCHEER wrote in the final opinion.
The draft opinion lacked the line about the risks of implants with an intermediate to high surface roughness. Respondents including a representative of the Dutch National Institute for Public Health and the Environment said the draft opinion needed rewording “to provide an honest and complete picture of current knowledge,” specifically about the current inability to stratify “between the relative risks of various types of textures.”
Elsewhere, SCHEER added a paragraph discussing the numbers of ALCL cases associated with different types of implant. SCHEER has only seen one case in a recipient of a smooth implant and there are differences in rates associated with textured devices.
Final Opinion, Consultation Responses, Commission Statement
France’s ANSM forms group to assess thrombotic events in vaccine recipients
The French National Agency for Medicines and Health Products Safety (ANSM) has formed an expert committee that will meet weekly to analyze rare and unusual thrombotic events in recipients of COVID-19 vaccines. 
France is administering COVID-19 vaccines developed by AstraZeneca and Johnson & Johnson, which use similar technology and have been linked to thrombotic events, to protect people aged 55 years and older.
Scientists, clinicians and other stakeholders will sit on the temporary committee, adding to the expertise already available to ANSM through its pharmacovigilance committee. The committee will interview other experts on an ad-hoc basis if specialized skills are required.
ANSM has appointed 15 people to the committee for three months.
ANSM Notice (French)
EMA seeks feedback on concept paper disrupted by move to Amsterdam
EMA is seeking feedback on plans to reduce the risk of resistance to certain antiparasitic drugs. The draft concept paper was originally released for consultation in 2017 but work stopped when EMA moved its headquarters to Amsterdam.
The Efficacy Working Party identified the need to revise the Summary of Product Characteristics (SPC) for anthelmintics, a group of antiparasitic drugs, in 2017. After gathering feedback on its plans, it took the working party three years to come up with a revised concept paper because it stopped its work during EMA’s move from London to Amsterdam.
In restarting the process, the working party has expanded the scope of its proposals to cover other types of antiparasitic veterinary medicinal products. The plan is to create a guideline that covers all species of parasites and animals other than the ruminants and horses addressed by the current text.
EMA is accepting feedback on the draft concept paper until 31 May. The agency aims to have a draft guideline ready for consultation in July and finalized by the end of the year.
Draft Paper
Other news
EDQM is seeking feedback on plans to delete the test for heavy metals in monographs on substances for veterinary use only. EDQM Notice


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