EMA, MHRA update on COVID vaccine pharmacovigilance

Regulatory NewsRegulatory News | 08 February 2021 |  By 

Regulators in Europe are beginning to give safety readouts from global experiences with vaccines against COVID-19, while the United Kingdom has issued a report delineating its multi-pronged safety surveillance approach.
The European Medicines Agency’s safety committee met at the end of January to review data from clinical use of the COVID-19 messenger RNA (mRNA) vaccine co-developed by Moderna and the US National Institutes of Health.
Following a 28 January meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) that investigated reports of a cluster of cases of anaphylaxis following receipt of the Moderna vaccine in San Diego, the European Medicines Agency (EMA) reported that it has “no new safety concern” regarding the Moderna vaccine.
“PRAC requested the marketing authorization holder to continue reviewing all anaphylaxis cases for further assessment by the committee as part of the assessment of the company’s upcoming first Summary Monthly Safety Report,” according to the EMA report.
The US investigation into the reported cluster did not reveal quality problems with the vaccine, and US regulators permitted vaccinations to continue from the vaccine lot in question. PRAC concurred with the US Centers for Disease Control and Prevention (CDC), which calculated an anaphylaxis rate of 2.5 individuals per million vaccine doses administered for the Moderna vaccine.
Previously, EMA had published a 28 January safety update for the COVID-19 vaccine co-developed by Pfizer and BioNTech, called Comirnaty in the EU. “Reports of suspected severe allergic reaction have not identified new aspects regarding the nature of this known side effect. No specific safety concern has been identified for vaccine use in frail elderly individuals,” wrote EMA in that report, which specifically investigated reports of a cluster of deaths of frail elderly individuals in a Norwegian nursing home following Comirnaty vaccination.
Separately, the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) issued a 5 February working group report on COVID-19 vaccine safety surveillance. The report delineates a “four-stranded approach to vigilance” in safety monitoring for vaccines against COVID-19.
First, MHRA plans to use their Yellow Card vaccine adverse event reporting mechanism to conduct enhanced passive surveillance, looking for signals of observed events that rise above what the agency’s scientists expect to see. Through reports on the Yellow Card app, the standard Yellow Card site and MHRA’s dedicated COVID-19 Yellow Card site, the regulator hopes to see early signals for common problems as well as “the rarest of side effects.” Bayesian analysis of incoming data will facilitate early detection.
Additionally, MHRA will use its Clinical Practice Research Datalink (CPRD) Aurum database to perform rapid cycle analysis on a weekly basis to hunt for pre-defined events. This database currently includes about one in five general practitioner practices in the UK, encompassing 13 million patients. The Aurum database will also be used for ecological analyses to monitor trends in pre-defined events to see if they are climbing among those vaccinated. “This approach is most useful when we see high vaccine uptake and is another way to quickly detect a potential safety signal,” noted MHRA.
Third, MHRA plans “targeted active monitoring” of some vaccine recipients with a focus on groups that may have been under-represented in or excluded from vaccine trials. An extension of the Yellow Card system, called the Yellow Card Vaccine Monitor, will be used to randomly enroll members of these cohorts to be contacted at set intervals after vaccination. “The objective of this is not necessarily to detect very rare risks… but to compare the frequency and severity of side effects to groups that were included in trials to allow further characterization of the safety profile,” according to the report.
Finally, formal epidemiological studies will augment MHRA’s other tools. This final strand will enable scientists and clinicians to know with more certainty whether an adverse event is truly causally related to receipt of the vaccination. “A formal epidemiological study, designed and powered specifically to test a given hypothesis in an unbiased way, is usually necessary to confirm and quantify a suspected rare side effect,” wrote MHRA. Such studies will be driven by data generated by the regulator’s other pharmacovigilance activities and may make use of a variety of data sources available in the UK.


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Tags: coronavirus, EMA, EU, MHRA, UK

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