Europe – EMA, MHRA update on COVID vaccine pharmacovigilance

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…