Euro Roundup: EMA backs mix-and-match approach to COVID-19 vaccine courses and boosters

RoundupsRoundups | 09 December 2021 |  By 

The European Medicines Agency (EMA) has backed the use of a mix-and-match approach to COVID-19 vaccine initial courses and booster shots, for example two AstraZeneca jabs followed by a booster dose of the Pfizer-BioNTech vaccine.
Many countries in the European Union and beyond are already allowing people to receive two different COVID-19 vaccines for their first and second doses and, in particular, booster shots that differ from their initial course. The heterologous primary vaccination and boosting regimens are supported by a growing body of evidence of the safety, tolerability and immunogenicity of different mixes of vaccines.
EMA reviewed the studies in collaboration with the European Centre for Disease Prevention and Control and other experts, emerging with evidence that using mRNA vaccines to boost viral vector jabs may have advantages over homologous regimens.
“Evidence from studies on heterologous vaccination suggests that the combination of viral vector vaccines and mRNA vaccines produces good levels of antibodies against the COVID-19 virus (SARS-CoV-2) and a higher T-cell response than using the same vaccine (homologous vaccination) whether in a primary or booster regimen. The heterologous regimens were generally well tolerated,” the review found.
EMA is planning to publish a detailed review of the literature supporting its advice in the future. The agency’s view on using mRNA shots to boost viral vector vaccines is in line with the findings of a paper in The Lancet that was published shortly before the regulator released its recommendations.
There is currently insufficient data to fully answer some questions, such as the duration of immunity induced by the regimens and the effect of using a viral vector jab to boost an initial course of an mRNA vaccine. Even so, EMA sees enough evidence to support the use of a range of combinations, including a viral vector booster if there is a problem with availability of mRNA vaccines.
EMA is encouraging marketing authorization holders to submit variations to add details about the use of their vaccines in heterologous regimens to the product information.
EMA Statement
EMA publishes 421 pages of comments on drug-device combination guidance
EMA has released a 421-page overview of the comments it received about a draft guideline on quality requirements for drug-device combinations. The agency finalized the guidance, which will take effect on 1 January, in July but only released the extensive comments it received this week.
The comments date back to a consultation the agency held in 2019. EMA made extensive changes to the draft it released for consultation, but the role that industry feedback played in the changes was unclear. Across the extensive overview of feedback on the draft guideline, EMA details its responses to comments and the changes they precipitated.
For example, EMA agreed with Medicines for Europe’s request for a clarification that the guideline does not apply where reference is made to a general group of medical devices, such as “using a syringe” or “an infusion line.” Similarly, EMA removed the term “drug-device combination” from the guideline after EFPIA and other trade groups called for a clear legal definition.
The finalized document gives developers of medicinal products that are used with a medical device an overview of the information they should present in the quality section of the marketing authorization dossier.
Consultation Feedback, Final Guideline
EDQM seeks feedback on two draft European Paediatric Formulary texts
The European Directorate for the Quality of Medicines (EDQM) has released two draft texts for public consultation ahead of their inclusion in the European Paediatric Formulary. The texts are titled “Simple syrup (preservative-free)” and “Phosphate 60 mg/mL Oral solution.”
EDQM selected the simple syrup monograph to “provide users with a standardized vehicle for oral liquids that could be cross-referenced in other European Paediatric Formulary monographs.” The syrup can be used as a standardized vehicle for suspending or dissolving solid dosage forms just before administration.
In developing the monograph, EDQM identified the most commonly used simple syrup concentration in Europe, 64%, and took into account existing test methods and limits present in monographs. EDQM has verified the production steps and test methods experimentally.
The phosphate draft is the first European Paediatric Formulary monograph to be revised. EDQM is holding the consultation to gather feedback on an annex that will list all the licensed options available to pharmacists and prescribers.
“Licensed products remain the gold standard and the aim is to draw attention to medicines that could be suitable for use and that are licensed in at least one European country. Annexing such valuable information to the monograph makes it readily available to clinicians and pharmacists throughout Europe, and enhances the usefulness of the formulary,” EDQM wrote.
EDQM Notice
Ireland’s HPRA imposes new condition on the authorization of parallel imports
Ireland’s Health Products Regulatory Authority (HPRA) has imposed a new condition on the authorization of parallel imports of human medicines.
HPRA last set out the conditions of parallel product authorization (PPA) in 2017. The guide stated that HPRA would only grant a PPA if the product had a current, full marketing authorization in Ireland or had been withdrawn for commercial reasons, and if the parallel-imported product had the same active substance and pharmaceutical form as the product on the Irish market.
In updating the guide, HPRA has added a third condition of authorization for parallel-imported products. “The parallel importer must demonstrate how the aims of any additional risk minimization measures imposed on the Irish market product, e.g. a patient alert card or supply through a controlled distribution system, will be achieved for the parallel imported product. The parallel importer should liaise with the Irish market MAH and/or the HPRA to discuss these requirements where they apply,” the guide states.
HPRA added the condition as part of a broader update to the document. The other changes are limited to small changes to the wording of existing sentences and the addition of references to other guides.
HPRA Guidance
EMA starts rolling review of Valneva’s COVID-19 vaccine, backs use of RoActemra
EMA has begun a rolling review of Valneva’s COVID-19 vaccine VLA2001. The agency revealed the start of the review shortly before it became the latest regulator to recommend the approval of Roche’s Actemra, known in Europe as RoActemra, for use in adults with severe COVID-19. 
Valneva’s effort to become a player in the COVID-19 vaccine market took a hit in September when the UK government canceled its contract with the company over an alleged breach of the obligations of the supply agreement. However, Valneva, which “strenuously” denied it breached the contract, went on to report Phase 3 data and start a rolling review in the UK.
EMA has now joined the list of regulators reviewing Valneva’s data. Valneva expects to receive regulatory approvals for its whole virus, inactivated, adjuvanted vaccine candidate in the first quarter of next year.
Separately, EMA recommended the use of RoActemra in adults with severe COVID-19. EMA reached the decision after reviewing data from a study of 4,116 hospitalized adults with severe COVID-19 who required extra oxygen or mechanical ventilation and had high levels of C-reactive protein in the blood. In the RoActemra arm, 31% of patients died, compared to 35% of people in the control group.
EMA Notice, More


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