ABSTRACT
Introduction: Rare or serious Adverse Events (AEs) in the reproductive sphere have been reported following the administration of the COVID-19 vaccine, especially mRNA vaccines. Although several fertility Societies have announced that COVID-19 mRNA vaccines are unlikely to affect fertility, pregnancy, or breastfeeding, there is no denying that the current evidence is very limited [1]. Objective(s): Aim of this study was a post-marketing assessment of the safety profile of COVID-19 vaccines, through the analysis of the Individual Case Safety Reports (ICSRs) collected in EudraVigilance in 2021 year, by focusing on reproductive disorders. Method(s): We analyzed all ICSRs that contained at least one COVID- 19 vaccine as suspected and at least one AE belonging to the Standardized MedDRA Query (SMQ) level 1 ''Fertility disorders'' or ''Pregnancy and neonatal conditions''. We performed a descriptive analysis and all AEs have been coded as Preferred Term (PT) according to MedDRA. Finally, we used the Reporting Odds Ratio (ROR) with a 95% of Confidence Interval (95% CI) to investigate disproportional reporting of AEs belonging to the SMQs of interest among the vaccines included in the analysis. Result(s): During the study period, 27,089 ICSR were collected and the total number of AEs was found to be 31,337;of these, 62.8% were referred to Comirnaty-, 20.8% to Spikevax-, 12.7% to Vaxzevria-, and 3.7% to Janssen-. For each of the four COVID-19 vaccines, 96.4% were related to female patients, aged between 18-64 years (88.1%), 71.5% were not serious, 46.0% were not resolved yet and 82.3% were reported by non-healthcare professionals. Regardless of the type of vaccine, the most reported PTs were amenorrhea, irregular menstruation, and delayed menstruation. The ROR showed that the probability to report an AE belonging to the SMQ ''Fertility disorders'' is greater for Comirnaty (ROR: 4.20, 95% CI 4.08-4.32) while no statistically significant difference was observed to the SMQ ''Pregnancy and neonatal conditions''. Conclusion(s): In this study, no potential signs of reproductive system safety were found regarding fertility, pregnancy or breastfeeding. Most of the reported events were related to changes in the menstrual cycle, although these disorders are temporary and normally common in the female population. At the time, the EMA's PRAC concluded that the evidence did not support a causal link between these vaccines and menstrual disorders, however, it decided to further studies collecting data from real life contexts are strongly needed to assess their safety profile in relation to reproductive function.
ABSTRACT
Introduction: As part of post-authorization safety surveillance, the European Medicines Agency (EMA) has identified a potential safety concern for Guillain-Barre syndrome (GBS) following COronaVIrusDisease 2019 (COVID-19) vaccines [1,2]. Objective(s): To assess reports of GBS reported in the Vaccine Adverse Event Reporting System (VAERS) following COVID-19 vaccination and to evaluate if a COVID-19 vaccine has a lower/higher probability of reporting Individual Case Safety Reports (ICSRs) with GBS in a direct comparison with all other COVID-19 vaccines. Method(s): After selecting all ICRSs of GBS following vaccination reported in VAERS from 1 January 2021 to 31 December 2021, we assessed them through the case definition and classification of the Brighton Collaboration (BC). We performed a descriptive analysis. Finally, we used the Reporting Odds Ratio with a 95% of Confidence Interval to investigate disproportional reporting of GBS among the vaccines included in the analysis. Result(s): 774 ICSRs of GBS have been reported in VAERS, and 279 of them met the BC Case Definition: 30 (10.7%) have been evaluated as Definitive, 56 (20.0%) as Probable, and 193 (69.3%) as Possible. COVID-19 Vaccine Pfizer-BioNTech was the most commonly vaccine reported (N = 118;42.3%) followed by COVID-19 Vaccine Moderna (N = 82;29.4%) and COVID-19 Vaccine Janssen (N = 79;28.3%). GBS was more commonly reported for male subjects (N = 143;51.3%) aged between 12 and 20 years (N = 59;21.1%). GBS mainly occurred between the 1st and 12th day following the first dose administration of mRNA vaccines and between the 4th and the 15th day following COVID-19 Vaccine Janssen. COVID-19 Vaccine Janssen was significantly associated with increased risks for Guillan- Barre syndrome (ROR 3.47, CI 95% = 2.58-4.65) compared to COVID-19 Vaccine Pfizer-BioNTech and COVID-19 Vaccine Moderna. Conclusion(s): GBS is an adverse event of special interest for all COVID-19 vaccines requiring specific safety monitoring. GBS is very rare, and the benefit-risk balance of the vaccine remains unchanged.
ABSTRACT
Introduction: Rare or serious Adverse Events (AEs) in the reproductive sphere have been reported following the administration of the COVID-19 vaccine, especially mRNA vaccines. Although several fertility Societies have announced that COVID-19 mRNA vaccines are unlikely to affect fertility, pregnancy, or breastfeeding, there is no denying that the current evidence is very limited [1]. Objective: Aim of this study was a post-marketing assessment of the safety profile of COVID-19 vaccines, through the analysis of the Individual Case Safety Reports (ICSRs) collected in EudraVigilance in 2021 year, by focusing on reproductive disorders. Methods: We analyzed all ICSRs that contained at least one COVID-19 vaccine as suspected and at least one AE belonging to the Standardized MedDRA Query (SMQ) level 1 "Fertility disorders" or "Pregnancy and neonatal conditions". We performed a descriptive analysis and all AEs have been coded as Preferred Term (PT) according to MedDRA. Finally, we used the Reporting Odds Ratio (ROR) with a 95% of Confidence Interval (95% CI) to investigate disproportional reporting of AEs belonging to the SMQs of interest among the vaccines included in the analysis. Results: During the study period, 27,089 ICSR were collected and the total number of AEs was found to be 31,337;of these, 62.8% were referred to Comirnaty®, 20.8% to Spikevax®, 12.7% to Vaxzevria®, and 3.7% to Janssen®. For each of the four COVID-19 vaccines, 96.4% were related to female patients, aged between 18-64 years (88.1%), 71.5% were not serious, 46.0% were not resolved yet and 82.3% were reported by non-healthcare professionals. Regardless of the type of vaccine, the most reported PTs were amenorrhea, irregular menstruation, and delayed menstruation. The ROR showed that the probability to report an AE belonging to the SMQ "Fertility disorders" is greater for Comirnaty® (ROR: 4.20, 95% CI 4.08-4.32) while no statistically significant difference was observed to the SMQ "Pregnancy and neonatal conditions". Conclusion: In this study, no potential signs of reproductive system safety were found regarding fertility, pregnancy or breastfeeding. Most of the reported events were related to changes in the menstrual cycle, although these disorders are temporary and normally common in the female population. At the time, the EMA's PRAC concluded that the evidence did not support a causal link between these vaccines and menstrual disorders, however, it decided to further studies collecting data from real life contexts are strongly needed to assess their safety profile in relation to reproductive function.
ABSTRACT
Introduction: As part of post-authorization safety surveillance, the European Medicines Agency (EMA) has identified a potential safety concern for Guillain-Barre syndrome (GBS) following COronaVIrusDisease 2019 (COVID-19) vaccines [1,2]. Objective: To assess reports of GBS reported in the Vaccine Adverse Event Reporting System (VAERS) following COVID-19 vaccination and to evaluate if a COVID-19 vaccine has a lower/higher probability of reporting Individual Case Safety Reports (ICSRs) with GBS in a direct comparison with all other COVID-19 vaccines. Methods: After selecting all ICRSs of GBS following vaccination reported in VAERS from 1 January 2021 to 31 December 2021, we assessed them through the case definition and classification of the Brighton Collaboration (BC). We performed a descriptive analysis. Finally, we used the Reporting Odds Ratio with a 95% of Confidence Interval to investigate disproportional reporting of GBS among the vaccines included in the analysis. Results: 774 ICSRs of GBS have been reported in VAERS, and 279 of them met the BC Case Definition: 30 (10.7%) have been evaluated as Definitive, 56 (20.0%) as Probable, and 193 (69.3%) as Possible. COVID-19 Vaccine Pfizer-BioNTech was the most commonly vaccine reported (N = 118;42.3%) followed by COVID-19 Vaccine Moderna (N = 82;29.4%) and COVID-19 Vaccine Janssen (N = 79;28.3%). GBS was more commonly reported for male subjects (N = 143;51.3%) aged between 12 and 20 years (N = 59;21.1%). GBS mainly occurred between the 1st and 12th day following the first dose administration of mRNA vaccines and between the 4th and the 15th day following COVID-19 Vaccine Janssen. COVID-19 Vaccine Janssen was significantly associated with increased risks for GuillanBarre syndrome (ROR 3.47, CI 95% = 2.58-4.65) compared to COVID-19 Vaccine Pfizer-BioNTech and COVID-19 Vaccine Moderna. Conclusion: GBS is an adverse event of special interest for all COVID-19 vaccines requiring specific safety monitoring. GBS is very rare, and the benefit-risk balance of the vaccine remains unchanged.