Euro Regulatory Roundup: EMA completes COVID-19 vaccine monitoring infrastructure

RoundupsRoundups | 23 July 2020 |  By 

The European Medicines Agency (EMA) has finalized a third contract to complete the build out of its infrastructure for monitoring the safety and efficacy of COVID-19 vaccines and medicines in the real world.
Through the latest agreement EMA has tasked Utrecht University and the University Medical Center Utrecht with coordinating an initiative to collect data on the effect of COVID-19 in pregnancy. The program, called the CONSIGN project, will analyze electronic health records and hospital data while tracking cohorts of people to reveal how COVID-19 and treatments for it affect women and babies at different trimesters of pregnancy.
EMA said the real-world data will inform decisions about vaccine indications, immunization policies and treatment options for pregnant women. ConcePTION, an existing project funded by the industry collaboration the Innovative Medicines Initiative, is working with EMA on the CONSIGN project.
The CONSIGN project comes weeks after EMA contracted IQVIA to work on a framework for running multicenter cohort studies of COVID-19 medicines. EMA disclosed the IQVIA contract in a brief update on its COVID-19 page last month, but only provided a fuller picture of the project this week.
Working with IQVIA and the European Health Data & Evidence Network, EMA will identify large national cohorts of COVID-19 patients and suitable comparator groups. The project also will seek to develop a study protocol template for multinational clinical trials and create a framework to support collaborations between researchers.
The CONSIGN project and IQVIA collaboration followed EMA’s first COVID-19 vaccine monitoring project, which also involves Utrecht University. The new COVID-19-specific infrastructure will complement EMA’s broader, established postmarketing abilities.
EMA has established the capabilities ahead of the introduction of fast-tracked products that could be used across entire populations. The capabilities could enable EMA to quickly identify any effects of COVID-19 drugs and vaccines that were not apparent in the clinical trial data.
EMA Notice
Brexit drives down MHRA income, raises 'significant implications’ for funding
The Medicines and Healthcare products Regulatory Agency’s (MHRA) revenue from EMA fell 71% last year, causing its trading income to decline despite additional support from the government.
MHRA played a major role in pan-European Union authorizations and inspections before the United Kingdom voted for Brexit. The work provided a significant source of income for MHRA. In the 2016 to 2017 financial year, almost 10% of MHRA’s trading income came from its work with EMA. The income stream shrunk by 29% over the next two years but was still worth £10.2 million ($13.0 million) in the 2018 to 2019 financial year.
Now, MHRA has suffered its biggest drop in EMA income. In the 2019 to 2020 financial year, income from EMA slumped 71% to below £3 million. The loss of the EMA business, coupled to a fall in sales related to decentralised marketing authorizations, caused MHRA’s income from fee-generating work to fall 10% last year.
The drop in fee-generating work was partly offset by £12.6 million in government support intended to help MHRA prepare for Brexit. However, it is unclear if the government will continue to provide extra support.
Sir Michael Rawlins, the outgoing chairman of MHRA, said Brexit “has significant implications for the future direction of the Agency and its funding model.” MHRA will need to manage those changes at the same time as addressing several other issues identified in the report, including COVID-19 and the criticisms levelled at the regulator in the recent Cumberlege Review.
Annual Report
UK orders destruction of face masks after complaints about flaky foam strips
The UK has ordered the destruction of around 80 lots of Cardinal Health masks due to problems with the foam strips. The masks were from an old batch that was cleared for use after shelf-life extension testing.
In late May, the PPE Dedicated Supply Channel set up to meet rising demand for personal protective equipment (PPE) sent an email about complaints from users of Cardinal Type IIR face masks. The next month, the manufacturer put seven lots through additional testing. Six of the lots failed a material inspection of the foam strip, validating complaints that it can flake off and enter the wearer’s mouth.
This week, MHRA responded to the situation with a notice ordering the destruction of the affected face masks, some of which also suffer from a fault that causes stitching to detach. The issue appears to be localized to the UK.
MHRA said the masks have passed their original expiry date. Shelf-life extension testing carried out by the manufacturer more than five years ago supported the revision of the original expiry date. The MHRA comments support a Sky News report that the masks were part of a stockpile created at the time of the 2009 influenza pandemic, but only deployed as the coronavirus hit the UK.
MHRA Notice, Sky News, More
NICE clears Astellas’ Xospata for routine NHS use
The National Institute for Health and Care Excellence (NICE) has recommended Astellas’ Xospata for use in relapsed or refractory FLT3-mutation-positive acute myeloid leukaemia patients.
NICE rejected Xospata in a draft recommendation at the start of the year amid uncertainty about its effect on long-term survival. Faced with the uncertainty, NICE ruled Xospata was unlikely to meet the threshold for cost effectiveness. NICE strengthened the wording about the uncertainty of Xospata’s long-term benefits in its final appraisal but reached a different conclusion regarding its value.
The decision follows a debate about when it is plausible to assume patients are cured. At first, Astellas assumed patients who were alive after three years were cured. Astellas changed to a two-year cure point during NICE’s original assessment of Xospata. In NICE’s view, Astellas failed to provide evidence or a clear rationale for the change.
After getting the initial rejection, Astellas provided NICE with information to support its use of the two-year cure point, including evidence that curves flatten between 18 and 24 months. NICE remains unconvinced that two years is the right cut off, pointing to three deaths in a Xospata trial after that time, but now thinks a cure point closer to two years than three years is plausible. 
The changes and other revisions to the model brought NICE’s assessment of the cost of Xospata per quality-of-life-year gained below its £50,000 threshold. In the original analysis, NICE put the figure at £54,844, leading it to recommend against the use of the drug.
Astellas also provided new evidence from patients who restarted Xospata after stem cell transplant. However, the evidence failed to sway NICE, which recommended against the use of the Astellas drug as a maintenance therapy after stem cell transplant.
NICE Appraisal
Other News:
MHRA has issued a notice about missing information on the patient information leaflets of some brands of ibuprofen sold in the UK. Products from Aspar Pharmaceuticals lack information about the need for patients to immediately seek medical attention if they take too many tablets and the risk of severe skin reaction. The products are sold under the brands of multiple supermarkets, pharmacies and other organizations. MHRA Notice


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