Role of the Hospital Pharmacist in the Evaluation of the Anti- COVID-19 Vaccine Safety Profile in the Post-Marketing Phase

ABSTRACT

Introduction: The European Medicines Agency, following positive evaluation regarding the safety, quality, and efficacy of anti-COVID- 19 vaccines, granted conditional marketing authorization (CMA) for these drugs on the condition that the developers would continuously provide additional data on their safety and efficacy even after marketing authorization in order to confirm the risk-benefit ratio. Following the start of the vaccination campaign in December 2020, special attention was paid to the occurrence of possible adverse reactions (ADRs). The pharmacist staff of Pugliese-Ciaccio Hospital, in order to monitor the safety of the new vaccine and to promptly report suspected vaccine ADRs, prepared a short questionnaire to be administered to the employees of the hospital at the time of administration of the second dose of vaccine. Objective(s) Monitoring vaccine safety & promptly reporting side effects. Method(s) The survey was conducted between January and April 2021. All employees were administered mRNA vaccine and, at the time of the administration of the second dose, were asked to answer the above questionnaire specifying the following information biographical data, gender, date of administration of the two doses of vaccine, occurrence of any ADRs resulting from the first dose of vaccine, type of resolution, presence of concomitant diseases and related medication intake in the days before/following the vaccination. Result(s) The questionnaire was administered to 1,656 health care workers and all of them answered the questions comprehensively. Among them, 51.6 percent experienced adverse reactions after administration of the first dose of vaccine, and the predominantly noted symptoms included systemic diseases and conditions related to the site of administration, musculoskeletal and connective tissue disorders, nervous system disorders and gastrointestinal disorders. The frequency of reporting was higher among the young than the elderly population (58% vs. 38.67%). ADRs occurred approximately 1,7 times more frequently among women than men. Conclusion(s) The intense pharmacovigilance activity carried out by the Hospital Pharmacist was a pivotal moment during the pandemic emergency, as it allowed the safety profile of anti-COVID-19 vaccines to be readily confirmed with real-life data. Infact, it was found that the main symptoms detected were in line with what was reported in the safety data from the pre-registration studies [1], from which it was also found that the frequency of ADRs was higher among the young than the elderly, a finding that was also confirmed by our study. So, the questionnaire survey was able to substantiate the safety of vaccines, confirming that the benefits of vaccination outweigh the risks.