Adverse events following quadrivalent meningococcal CRM-conjugate vaccine (Menveo®) reported to the Vaccine Adverse Event Reporting system (VAERS), 2010–2015

Abstract

Background Limited data are available describing the post-licensure safety of meningococcal vaccines, including Menveo®. We reviewed reports of adverse events (AEs) to the Vaccine Adverse Event Reporting System (VAERS) to assess safety in all age groups. Methods VAERS is a national spontaneous vaccine safety surveillance system co-administered by the Centers for Disease Control and Prevention and the US Food and Drug Administration. We searched the VAERS database for US reports of adverse events in persons who received Menveo from 1 January 2010 through 31 December 2015. We clinically reviewed reports and available medical records for serious AEs, selected pre-specified outcomes, and vaccination during pregnancy. We used empirical Bayesian data mining to identify AEs that were disproportionately reported after receipt of Menveo. Results During the study period, VAERS received 2614 US reports after receipt of Menveo. Of these, 67 were classified as serious, including 1 report of death. Adolescents (aged 11–18 years) accounted for 74% of reports. Most of the reported AEs were non-serious and described AEs consistent with data from pre-licensure studies. Anaphylaxis and syncope were the two most common events in the serious reports. We did not identify any new safety concerns after review of AEs that exceeded the data mining threshold, although we did observe disproportionate reporting for terms that were not associated with an adverse event (e.g., “incorrect drug dosage form administered”, “wrong technique in drug usage process”). Although reports were limited, we did not find any evidence for concern regarding the use of Menveo during pregnancy. Conclusions In our review of VAERS reports, findings of AEs were consistent with the data from pre-licensure studies. Vaccine providers should continue to emphasize and adhere to proper administration of the vaccine.

Safety of the 9-Valent Human Papillomavirus Vaccine

“…The safety profile observed for 9vHPV is consistent with data from the vaccine's prelicensure clinical trials and is similar to postlicensure safety monitoring data for 4vHPV and bivalent HPV vaccine and for other vaccines administered in this age group (eg, tetanus, diphtheria, and acellular pertussis; meningococcal conjugate; and influenza vaccines). 7,[36][37][38][39] For 9vHPV, 97.4% of reports to the VAERS were classified as nonserious (versus 94.2% for 4vHPV); crude AE reporting rates for all reports and serious reports were 259 and 7 reports per million doses distributed, respectively (versus 327 and 19 reports per million, respectively, for 4vHPV); and the most frequently reported AEs (dizziness, syncope, headache, nausea, and injection site reactions) were similar to those observed for 4vHPV. 7 VAERS is a critical early warning system to detect possible safety problems in US-licensed vaccines and is a key component of the US vaccine safety monitoring infrastructure.…”

Meningococcal Vaccination: Recommendations of the Advisory Committee on Immunization Practices, United States, 2020

“…One study observed an increased risk for Bell's palsy among adolescents after MenACWY-CRM vaccination, although this was based on a small number of cases and the importance of this finding is uncertain (138). No additional safety concerns have been identified in postlicensure surveillance, although administration errors appear more common than with other vaccines, predominantly because of the need to reconstitute the vaccine using lyophilized and liquid components (139,140).…”

Post-marketing surveillance of adverse events following measles, mumps, rubella and varicella (MMRV) vaccine: retrospecive study in apulia region (ITALY), 2009-2017

“…Performing the Causality Assessment, the relation was "consistent causal association to immunization". 35…”