Euro Roundup: EMA lists critical monkeypox medicines, shares opinion on intradermal vaccine

RoundupsRoundups | 25 August 2022 |  By 

An antiviral and a vaccine comprise the European Medicines Agency (EMA) list of critical medicines for the monkeypox public health emergency (PHE); the list was created as part of EMA’s new role monitoring and mitigating potential drug shortages.
Once a PHE is declared, EMA’s Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) must adopt a list of medicinal products that it deems to be critical for the emergency.
The list currently includes Siga Technologies’ tecovirimat, an antiviral, and Bavarian Nordic’s Imvanex, a vaccine. Both are authorized in the EU for monkeypox and smallpox. The steering group will also continue to evaluate which products are critical to the monkeypox emergency and add to the list as needed.
Market authorization holders of PHE-critical products must provide regular updates on potential and existing shortages, including details of available stocks and forecasts of supply and demand. National competent authorities also will provide regular reports on estimated demand in their jurisdictions.

EMA also shared details of the Emergency Task Force (ETF) review of the data on intradermal administration of Imvanex. While the vaccine currently is authorized for subcutaneous injection, some studies indicate efficacy when a smaller dose is administered intradermally.
Based on the review of a  clinical trial of over 500 adults where antibody levels were similar in those who received the standard 0.5 ml subcutaneous shot and a 0.1 ml intradermal dose, EFT concluded that national authorities may decide to temporarily employ intradermal doses to stretch their supplies, although that green light came with cautions and caveats.
Members of the task force warned that intradermal injections have a higher risk of local reactions and noted the lack of information on how many 0.1 ml doses can be drawn from the 0.5 ml suspension bottle. The ETF recommends using low-dead volume syringes to maximize the number of doses that can be drawn.
EMA Notice, More
NICE grants early access to AI, digital technology advisory service site ahead of 2023 launch
The UK National Institute for Health and Care Excellence (NICE) has opened its multi-agency advisory service (MAAS) for artificial intelligence (AI) and digital technologies in health and care for early access.
NICE is working with the UK Care Quality Commission, Health Research Authority, and Medicines and Healthcare products Regulatory Agency to create the site to enable the development and widespread adoption of new technologies and to improve outcomes across the healthcare system. The service brings together four organizations involved in regulating or evaluating digital technologies.
The collaboration now is making the MAAS available for private beta testing to gather feedback and inform further development.
The private beta program will run through October. NICE plans to launch the online service next year.
EMA schedules extraordinary meeting to discuss Moderna and Pfizer’s Omicron vaccines
EMA has scheduled an extraordinary meeting for 1 September to discuss the evaluation of applications for Omicron-specific COVID-19 vaccines from Moderna and Pfizer/BioNTech. The agency aims to conclude the evaluation of the applications at the meeting.
Rolling reviews of bivalent forms of Moderna’s Spikevax and Pfizer/BioNTech’s Comirnaty started in Europe in June and have now advanced to the point that EMA is near a decision. The next step is to gather the Committee for Medicinal Products for Human Use in early September to discuss the evaluation of the applications.
Both applications cover vaccines designed to induce protection against wild-type SARS-CoV-2 and the Omicron BA.1 subvariant. The European Centre for Disease Prevention and Control now lists BA.1 as “de-escalated,” reflecting the fact that, like forms of the virus such as delta, it is now “detected at extremely low levels in the EU/EEA.”
In the US, officials and manufacturers are racing to bring vaccines against the more prevalent BA.4 and BA.5 subvariants to market based on preclinical data, plus clinical data on their BA.1 vaccines. However, EMA wants to see clinical data on vaccines tailored to BA.4 and BA.5 before authorizing their use.
EMA Notice
EDQM seeks feedback on replacing plasticizer used in intravenous infusion containers
The European Directorate for the Quality of Medicines & HealthCare (EDQM) is running a consultation into alternative plasticizers to DEHP for use in containers for aqueous solutions for intravenous infusion.
EDQM took the step due to a November 2021 change to the REACH Regulation. In recent years, European authorities have imposed restrictions on DEHP and other phthalate plasticizers considering potential links to human birth defects.
The directorate has requested information on containers made from materials based on plasticized PVC used for licensed medicinal products in Europe and contain a plasticizer other than DEHP. EDQM also asked if respondents know of ongoing regulatory submissions or tests concerning the replacement of DEHP in plasticized PVC bags for intravenous infusions, and if they are willing to share their data.
EDQM Notice
Ireland’s HPRA invites experts in a range of therapeutic areas to join new external panel
Ireland’s Health Products Regulatory Authority (HPRA) is setting up a new external expert panel to offer input on activities such as clinical studies and scientific advice for new products under development.
HPRA has called for applications from experts in oncology/hematology, infectious diseases, ophthalmology, clinical pharmacology, and diagnostic and therapeutic radiopharmaceuticals. Applicants should be healthcare professionals who are recognized experts in their chosen field. Advisory experience is desirable.
The panel will advise HPRA when it is the lead Member State reviewing an EMA marketing authorization application and when it has a lead role in advising on the development of novel medicines. HPRA foresees asking the experts to contextualize the current treatment landscape and discuss the clinical importance and relevance of clinical trial endpoints.
HPRA is accepting expressions of interest until 30 September. “Any clinical expert involvement would be contingent on an expert’s availability, with no expectation or defined minimum commitment,” according to the authority.
HPRA Notice, More


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