Faced with new product rollouts of unprecedented scale, the EMA adopted a safety monitoring plan for COVID-19 vaccines late last year. The plan mandated the submission of monthly safety reporting summaries, known by the abbreviation MSSRs, in addition to regular periodic safety update reports (PSURs).
In July, the EMA followed up with a document that reminded manufacturers of COVID-19 vaccines that MSSRs “are not meant to replace the PSURs” and explained what information it wants to receive in the periodic reports.
“All relevant information (safety signals evaluations, regulatory requests…) in scope of the reporting period should be provided in the PSURs. However, all those safety evaluations or regulatory requests that have been closed during the reporting period in the context of another regulatory procedure should provide a cross reference to the corresponding procedure,” wrote EMA.
The rest of the guidance discusses the additional requirements specific to COVID-19 vaccines that apply to different parts of the PSUR. No additional requirements apply to some sections.
Use of COVID-19 vaccines during pregnancy
Many of the additional requirements relate to the PSUR section on the evaluation of risks and new information. The EMA is placing additional requirements on the reporting of information related to the use of COVID-19 vaccines in pregnancy, while breastfeeding, in immunocompromised patients, in people with autoimmune or inflammatory disorders, and in frail patients with comorbidities.
For example, the EMA expects manufacturers to separate prospective and retrospective reports of data on the use of vaccines in pregnancy “to decrease the recall bias.” Manufacturers should classify outcomes by trimester of exposure and further describe any reported congenital anomalies.
Elsewhere in the PSUR section on the evaluation of risks and new information, the EMA wants vaccine manufacturers to address reports of lack of efficacy. The guidance features definitions of confirmed and suspected vaccination failure, as well as details of the factors to consider when ruling if a vaccine has failed to prevent disease.
Vaccine effectiveness is covered in other parts of the PSUR. The EMA is asking manufacturers to use the PSUR section about newly identified information on efficacy and effectiveness to share details of data from any source that relates to how well the vaccine works against circulating strains, antibody waning, the need for booster shots and the impact of mixed-dose schedules on outcomes.
PSURs are submitted at six-month intervals in the first two years after a product comes to market in the European Union. The interval length means PSURs for COVID-19 vaccines authorized early in the year are now due.
