Euro Roundup: EMA supports blended approach for COVID-19 vaccine courses and recalls

The European Medicines Agency (EMA) has supported the use of a mixed approach for initial COVID-19 vaccine courses and booster injections, for example two injections of AstraZeneca followed by a booster dose of the vaccine Pfizer-BioNTech.

Many countries in the European Union and beyond already allow people to receive two different COVID-19 vaccines for their first and second doses and, in particular, boosters that differ from their initial treatment. Heterologous primary vaccination and booster regimens are supported by a growing body of evidence for the safety, tolerability and immunogenicity of different vaccine mixtures.

The EMA reviewed studies in collaboration with the European Center for Disease Prevention and Control and other experts, emerging with evidence that using mRNA vaccines to stimulate viral vector jabs may have benefits through compared to counterpart regimes.

“Evidence from heterologous vaccination studies 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 T cell response higher than the use of the same vaccine (homologous vaccination) whether as part of a primary or booster vaccination schedule. Heterologous treatment regimens were generally well tolerated, ”the review found.

The EMA plans to publish a detailed review of the literature to support its guidance in the future. The agency’s view on using mRNA injections to boost viral vector vaccines is consistent with the findings of an article published in The Lancet which was published shortly before the regulator released its recommendations.

There are currently not enough data to fully answer some questions, such as the duration of immunity induced by treatment regimens and the effect of using a jab viral vector to stimulate an initial course of d ‘an mRNA vaccine. Despite this, the EMA sees enough evidence to support the use of a range of combinations, including a viral vector booster if there is an issue with the availability of mRNA vaccines.

The EMA encourages Marketing Authorization Holders to submit changes to add details about the use of their vaccines in heterologous treatment regimens to the product information.

EMA statement

EMA publishes 421 pages of comments on recommendations for drug-device combination

The EMA has published a 421-page overview of the comments it received on a draft guideline on quality requirements for drug-device combinations. The agency finalized the guidelines, which will take effect on January 1, in July, but only released the detailed comments it received this week.

The comments date back to a consultation the agency held in 2019. The EMA made significant changes to the draft which it released for consultation, but the role industry feedback played in the changes was not clear. Through the full overview of the comments on the draft directive, the EMA details its responses to the comments and the changes they precipitated.

For example, the EMA accepted Medicines for Europe’s request for clarification that the directive does not apply when referring to a general group of medical devices, such as “using a syringe ”Or“ an infusion line ”. Likewise, the EMA removed the term ‘drug-device combination’ from the directive after the EFPIA and other business groups called for a clear legal definition.

The finalized document gives developers of medicinal products used with a medical device an overview of the information they must present in the quality part of the marketing authorization dossier.

Consultation comments, final guideline

The EDQM seeks comments on two draft texts of the European Pediatric Formulary

The European Directorate for the Quality of Medicines (EDQM) has published two draft texts for public consultation with a view to their inclusion in the European Pediatric Formulary. The texts are entitled “Simple syrup (without preservative)” and “Oral phosphate solution 60 mg / mL”.

The EDQM selected the simple syrup monograph to “provide users with a standardized vehicle for oral fluids which could be referenced in other monographs of the European pediatric formulary”. The syrup can be used as a standardized vehicle for suspending or dissolving solid dosage forms just prior to administration.

When developing the monograph, the EDQM identified the concentration of simple syrup most commonly used in Europe, 64%, and took into account the existing test methods and the limitations present in the monographs. The EDQM experimentally verified the production steps and the test methods.

The Phosphate Project is the first monograph of the European Pediatric Formulary to be revised. The EDQM is organizing the consultation to gather comments on an appendix that will list all the authorized options available to pharmacists and prescribers.

“Licensed products remain the gold standard and the aim is to draw attention to medicines that might be suitable for use and that are authorized in at least one European country. Annexing this valuable information to the monograph makes it easily accessible to clinicians and pharmacists across Europe and improves the usefulness of the form, ”the EDQM wrote.

EDQM opinion

Irish HPRA imposes new condition on authorization of parallel imports

The Irish Health Products Regulatory Authority (HPRA) has imposed a new condition on the authorization of parallel imports of medicines for human use.

The HPRA last defined the conditions for the parallel marketing authorization (APP) in 2017. The guide stated that HPRA would only grant an AEP if the product had a marketing authorization. complete and pending in Ireland or had been withdrawn for commercial reasons, and whether the parallel marketing authorization – the imported product had the same active substance and pharmaceutical form as the product on the Irish market.

When updating the guide, the HPRA added a third authorization condition for parallel import products. ‘The parallel importer must demonstrate how the objectives of any additional risk minimization measures imposed on the product from the Irish market, for example a patient alert card or a supply through a controlled distribution system, will be achieved for the product being imported at the same time. . The parallel importer should get in touch with the Irish Market MAH and / or HPRA to discuss these requirements when they apply, ”the guide says.

HPRA added the condition as part of a larger document update. Other changes are limited to small changes to the wording of existing sentences and adding references to other guides.

HPRA guidelines

EMA begins continuous review of Valneva’s COVID-19 vaccine and supports use of RoActemra

The EMA has started an ongoing review of the Valneva VLA2001 COVID-19 vaccine. The agency revealed the start of the review shortly before it became the latest regulator to recommend approval of Roche’s Actemra, known in Europe as RoActemra, for use in adults with COVID- 19 severe.

Valneva’s efforts 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 supply agreement obligations. However, Valneva, who “categorically” denied breaking the contract, then released Phase 3 data and launched an ongoing review in the UK.

The EMA has now joined the list of regulators reviewing data from Valneva. Valneva expects to receive regulatory approvals for its whole virus, inactivated and adjuvanted vaccine candidate during the first quarter of next year.

Separately, the EMA has recommended the use of RoActemra in adults with severe COVID-19. The EMA made the decision after reviewing data from a study of 4,116 hospitalized adults with severe COVID-19 who required supplemental oxygen or mechanical ventilation and had elevated 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, Plus

© 2021 Society of Regulatory Affairs Professionals.

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