Euro Roundup: COVID vaccines drive 93% jump in EudraVigilance reports

| 21 April 2022 | By Nick Paul Taylor 

The number of authorized product suspected adverse reactions sent to EudraVigilance jumped 93% last year because of a surge in reports related to COVID-19 vaccines. Almost half of the record 3.5 million individual case safety reports (ICSRs) uploaded to the database related to vaccines against the pathogen.
With member states seeking to quickly vaccinate hundreds of millions of people with newly authorized products, the European Medicines Agency (EMA) was braced for a rise in adverse event reports in 2021. The 2021 annual report on EudraVigilance, the system EMA uses for managing and analyzing information on suspected adverse reactions, shows the expected jump in ICSRs came to pass.
In 2020, EMA processed 1.8 million adverse event reports in total. Last year, EMA processed 1.7 million adverse event reports related to COVID-19 vaccines. The ICSRs for COVID-19 vaccines, which accounted for 48% of all adverse event reports last year, drove the total up 93% year on year to 3.5 million.
“The high number of suspected adverse reactions reported after the use of COVID-19 vaccines is not unexpected considering that over 700 million doses of vaccines were administered in the EU in 2021. This represented the largest vaccination campaign ever conducted, and also the fact that citizens and healthcare professionals were highly aware of the importance of reporting possible side effects. 2021 demonstrated EudraVigilance’s ability to deal with increased submissions,” EMA wrote.
The emergence of COVID-19 vaccines as a major contributor to all EudraVigilance reports drove a shift in the nature of reporting. EMA tracked a 114% increase in the number of reports submitted from within the European Economic Area (EEA), as well as a 156% jump in non-serious reporting. Two-thirds of the COVID-19 reports originated in the EEA, and 72% were non-serious.
Almost 90% of the COVID-19 vaccine reports were submitted by European patients through the national competent authorities and marketing authorization holders. To put that figure in context, patients filed 13% of the reports for all other types of products. The number of adverse event reports submitted by European patients and consumers increased by 443%.
One concern going into the campaign was whether regulators would have the capacity to make sense of the wave of data. EMA’s signal management team reviewed the information on 2,477 potential signals in detail in 2021, up from 1,888 the prior year. As 992 of the signals reviewed in 2021 related to COVID-19 vaccines, the number of reviewed signals related to other products actually fell around 20% year on year.
Annual Report
EMA shares advice on managing ‘manifold’ effects of Ukraine war on clinical trials
EMA’s Biostatistics Working Party has published points to consider about the impact of the war in Ukraine on methodological aspects of ongoing clinical trials. The working party is advising sponsors to focus on the interests of patients already enrolled in trials, even if it means unblinding individuals.
Shortly after Russia invaded Ukraine, EMA and other agencies advised sponsors to refer to the points to consider about COVID-19 for advice on how to handle the impact of the war on their clinical trials. That advice remains valid, but EMA has now followed up with a points to consider document that is specific to the situation in Ukraine. EMA has put study participants at the heart of the document.
“Most importantly, safety of study participants is the absolute priority and must be at the heart of every decision taken, regardless of any potential consequences for an ongoing trial,” EMA wrote. “Secondly, whenever feasible and in the interest of their continuing care, patients should be offered to continue receiving treatment (even if this might require unblinding at individual patient level) and supported to stay in the trial as long as this does not imply a safety risk.”
The rest of the document covers the R&D and regulatory implications of following those principles. EMA is advising sponsors that need to make substantial changes to their trials to appropriately document the revisions and get ethics committee approvals. The exception is if sponsors “need to assure the safety of participants and personnel involved.” In such circumstances, sponsors can act without prior notification but need to provide adequate information on the situation and their responses without undue delay.
When assessing data submitted for marketing authorization, EMA will “thoroughly” reflect on the impact of the war on trial design elements, recruitment, data collection, analysis and interpretation of results.
EMA Document
MHRA finds fault with references to J&J depression drug on hospital website
The UK Medicines & Healthcare products Regulatory Agency (MHRA) has found a private mental health hospital likely breached advertising regulations by referencing a Johnson & Johnson depression drug on its website.
According to MHRA, Nightingale Hospital London’s website referenced J&J’s prescription-only medicine Spravato. The site featured a photograph of a named healthcare professional pictured with a box of the J&J drug captioned that the individual was “proudly pictured with Spravato”. Other webpages made references to the medicine being “safe”.
MHRA found the references to the medicine being safe “were not consistent with the quality standards required because all medicines have the potential to cause side-effects and no medicine is risk-free.” The agency also considered that the website likely promoted a specific prescription medicine and may lead a member of the public to request Spravato. The hospital agreed to amend the website.
Details of the case emerged alongside reports of other MHRA investigations, including the upholding of a complaint regarding potentially misleading promotions of an ibuprofen product on TV and social media.
MHRA Notice, More
UK approves Valneva COVID-19 vaccine, label expansion for Moderna’s Spikevax
MHRA has approved Valneva’s COVID-19 vaccine and expanded the label of Moderna’s Spikevax to cover use in children aged 6 to 11 years.
The approval makes Valneva the first company to bring a whole-virus inactivated COVID-19 vaccine to market in the UK. Valneva’s vaccine can be stored at normal refrigeration temperatures, potentially making it a useful option in countries with limited cold chain capacity, but as the sixth product approved by MHRA, its impact on the highly vaccinated UK may be limited.
MHRA took EMA’s decision to expand the label for Spikevax into account when making its own ruling on the Moderna vaccine. The approach reflects the fact the original Spikevax license in Great Britain relied on the EU decision.
Press Release, More
PRAC updates strategy on measuring impact of pharmacovigilance activities
EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has updated its strategy on measuring the impact of pharmacovigilance activities in light of progress over the past five years.
PRAC established the strategy to address the risk that unintended consequences may occur if regulatory actions are inadequately implemented or fail to achieve their intended objectives. By systematically measuring the health outcomes associated with regulatory interventions, PRAC sought to shift focus to impactful activities and regulatory tools.
The second revision integrates the achievements of the first phase in four activity areas: effectiveness evaluation of risk minimization measures, effectiveness of pharmacovigilance processes, enablers of effective pharmacovigilance and stakeholder engagement and analytical methods for impact research.
PRAC Strategy
Other News:
EMA has published an overview of the comments on International Council for Harmonisation guideline Q9 (R1) on quality risk management. Public Feedback


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