PMID- 32474825
OWN - NLM
STAT- MEDLINE
DCOM- 20201014
LR  - 20201014
IS  - 1179-1918 (Electronic)
IS  - 1173-2563 (Linking)
VI  - 40
IP  - 8
DP  - 2020 Aug
TI  - Post-approval Safety Monitoring of Quadrivalent and Bivalent Human Papillomavirus 
      Vaccines Based on Real-world Data from the Korea Adverse Events Reporting System 
      (KAERS).
PG  - 727-735
LID - 10.1007/s40261-020-00930-6 [doi]
AB  - BACKGROUND AND OBJECTIVES: The vaccine adjuvant, AS04, present in bivalent human 
      papilloma virus (bHPV) vaccines, induces greater local immune responses than the 
      aluminum adjuvant in quadrivalent HPV (qHPV) vaccines. These distinctions might 
      also result in disparities in immunogenicity and responsiveness, possibly 
      contributing to differences in adverse events (AEs) between these vaccines. Here 
      we comparatively analyzed AEs between qHPV and bHPV vaccines based on 10-year 
      real-world AE data. METHODS: We evaluated the Korea Adverse Events Reporting 
      System (KAERS), a nationwide drug database including vaccines from January 2007 
      to December 2016, analyzing AEs reported for qHPV and bHPV vaccines. Vaccine-AE 
      pairs were generated, and the characteristics of all reported AEs were analyzed. 
      Signals were derived using the disproportionality method of signal detection 
      algorithms (reporting odds ratios and information component). RESULTS: Of the 
      total 2566 HPV vaccine-associated AE reports, 2686 and 1994 were vaccine-AE pairs 
      for qHPV and bHPV, respectively. Application site disorders were the most 
      frequent AEs for both vaccines but were more frequently reported with the bHPV 
      vaccine. The characteristics of non-application site AEs between the two vaccines 
      were generally similar, but systemic AEs such as fever and fatigue were more 
      common with the bHPV vaccine. Tremor, rash, eye pain, myopathy and circulatory 
      failure were identified as signals in both qHPV and bHPV vaccines. CONCLUSIONS: 
      Both application site disorders and systemic AEs were somewhat more frequent with 
      the bHPV vaccine than with the qHPV vaccine. This might be caused by an immune 
      response induced by adjuvants contained within the vaccines.
FAU - Kim, MoonJung
AU  - Kim M
AD  - School of Pharmacy, Sungkyunkwan University, 2066, Seobu-ro, Jangan-gu, Suwon, 
      Gyeonggi-do, 16419, South Korea.
FAU - Kim, SangHee
AU  - Kim S
AD  - School of Pharmacy, Sungkyunkwan University, 2066, Seobu-ro, Jangan-gu, Suwon, 
      Gyeonggi-do, 16419, South Korea.
FAU - Shin, Ju-Young
AU  - Shin JY
AUID- ORCID: 0000-0003-1010-7525
AD  - School of Pharmacy, Sungkyunkwan University, 2066, Seobu-ro, Jangan-gu, Suwon, 
      Gyeonggi-do, 16419, South Korea. shin.jy@skku.edu.
LA  - eng
GR  - HG18C0068/Government-wide R&D Fund for Infectious Disease Research (GFID)/
PT  - Journal Article
PL  - New Zealand
TA  - Clin Drug Investig
JT  - Clinical drug investigation
JID - 9504817
RN  - 0 (Papillomavirus Vaccines)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Algorithms
MH  - *Drug Approval
MH  - Female
MH  - Humans
MH  - Papillomavirus Infections/*prevention & control
MH  - Papillomavirus Vaccines/adverse effects/immunology/*therapeutic use
MH  - *Product Surveillance, Postmarketing
MH  - Republic of Korea
EDAT- 2020/06/01 06:00
MHDA- 2020/10/21 06:00
CRDT- 2020/06/01 06:00
PHST- 2020/06/01 06:00 [pubmed]
PHST- 2020/10/21 06:00 [medline]
PHST- 2020/06/01 06:00 [entrez]
AID - 10.1007/s40261-020-00930-6 [pii]
AID - 10.1007/s40261-020-00930-6 [doi]
PST - ppublish
SO  - Clin Drug Investig. 2020 Aug;40(8):727-735. doi: 10.1007/s40261-020-00930-6.