PMID- 33324721
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20240330
IS  - 2328-8957 (Print)
IS  - 2328-8957 (Electronic)
IS  - 2328-8957 (Linking)
VI  - 7
IP  - 12
DP  - 2020 Dec
TI  - Safety Surveillance of Bivalent Meningococcal Group B Vaccine, Vaccine Adverse 
      Event Reporting System, 2014-2018.
PG  - ofaa516
LID - 10.1093/ofid/ofaa516 [doi]
LID - ofaa516
AB  - BACKGROUND: In October 2014, MenB-FHbp (Trumenba, Pfizer) became the first 
      meningococcal group B vaccine licensed in the United States. It is approved for 
      use in individuals aged 10-25 years. Our objective was to evaluate the safety of 
      MenB-FHbp postlicensure. METHODS: The Vaccine Adverse Event Reporting System 
      (VAERS) is a national passive vaccine safety surveillance system. We analyzed US 
      VAERS reports for MenB-FHbp received from the date of licensure in October 2014 
      through December 2018. We described the characteristics of the persons and 
      adverse events (AEs) reported and calculated reporting rates using the number of 
      doses distributed. We used empirical Bayesian data mining to identify AEs 
      reported at least twice as often as expected compared with all other vaccines. 
      RESULTS: VAERS received 2106 reports involving MenB-FHbp, representing 698 
      reports per million doses distributed. The median age of vaccinees was 17 years, 
      and 55% were female. MenB-FHbp was given simultaneously with other vaccines in 
      37% of reports. Most reports (57%) described AEs that started on the day of or 
      day after vaccination. The most common AEs reported were pyrexia (27%), headache 
      (25%), and pain (16%). There were 44 serious reports (2% of all reports), among 
      which 42 reported a hospitalization. Data mining identified disproportional 
      reporting of headache, pyrexia, chills, and myalgia. CONCLUSIONS: The AEs most 
      commonly or disproportionately reported following MenB-FHbp were consistent with 
      those identified in clinical trials as described in the US package insert. We did 
      not identify any new safety issues.
CI  - Published by Oxford University Press on behalf of Infectious Diseases Society of 
      America 2020.
FAU - Duffy, Jonathan
AU  - Duffy J
AUID- ORCID: 0000-0002-8060-0940
AD  - Immunization Safety Office, Centers for Disease Control and Prevention, Atlanta, 
      Georgia, USA.
FAU - Marquez, Paige
AU  - Marquez P
AD  - Immunization Safety Office, Centers for Disease Control and Prevention, Atlanta, 
      Georgia, USA.
FAU - Dores, Graca M
AU  - Dores GM
AD  - Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and 
      Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
FAU - Ng, Carmen
AU  - Ng C
AD  - Immunization Safety Office, Centers for Disease Control and Prevention, Atlanta, 
      Georgia, USA.
FAU - Su, John
AU  - Su J
AD  - Immunization Safety Office, Centers for Disease Control and Prevention, Atlanta, 
      Georgia, USA.
FAU - Cano, Maria
AU  - Cano M
AD  - Immunization Safety Office, Centers for Disease Control and Prevention, Atlanta, 
      Georgia, USA.
FAU - Perez-Vilar, Silvia
AU  - Perez-Vilar S
AD  - Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and 
      Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
LA  - eng
PT  - Journal Article
DEP - 20201027
PL  - United States
TA  - Open Forum Infect Dis
JT  - Open forum infectious diseases
JID - 101637045
PMC - PMC7724509
OTO - NOTNLM
OT  - meningococcal vaccines
OT  - neisseria meningitidis serogroup B
OT  - pharmacovigilance
EDAT- 2020/12/17 06:00
MHDA- 2020/12/17 06:01
PMCR- 2020/10/27
CRDT- 2020/12/16 05:38
PHST- 2019/12/16 00:00 [received]
PHST- 2020/10/26 00:00 [accepted]
PHST- 2020/12/16 05:38 [entrez]
PHST- 2020/12/17 06:00 [pubmed]
PHST- 2020/12/17 06:01 [medline]
PHST- 2020/10/27 00:00 [pmc-release]
AID - ofaa516 [pii]
AID - 10.1093/ofid/ofaa516 [doi]
PST - epublish
SO  - Open Forum Infect Dis. 2020 Oct 27;7(12):ofaa516. doi: 10.1093/ofid/ofaa516. 
      eCollection 2020 Dec.