Investigation of Foreign Particles in Moderna COVID-19 Vaccine Article Swipe
Hiroko Shibata
,
Yusuke Nomura
,
Tsuyoshi Kawakami
,
Eiichi Yamamoto
,
Daisuke Ando
,
Nahoko Uchiyama
,
Hiroko Tokumoto
,
Tatsuo Koide
,
Hideyuki Sakoda
,
Hiroyuki Yoshida
,
Yasuhiro Abe
,
Takashi Hakamatsuka
,
Yoshiaki Ikarashi
,
Yuji Haishima
,
Akiko Ishii‐Watabe
,
Ken‐ichi Izutsu
,
Masamitsu Honma
,
Yukihiro Goda
·
YOU?
·
· 2022
· Open Access
·
· DOI: https://doi.org/10.1248/yakushi.22-00067
YOU?
·
· 2022
· Open Access
·
· DOI: https://doi.org/10.1248/yakushi.22-00067
Particular batches of Moderna mRNA Coronavirus Disease 2019 (COVID-19) vaccine were recalled after foreign particles were found in some vaccine vials at the vaccination site in Japan in August 2021. We investigated the foreign particles at the request of the Ministry of Health, Labour and Welfare. Energy dispersive X-ray spectroscopy analysis suggested that the foreign particles found in the vials recalled from the vaccination sites were from stainless steel SUS 316L, which was in line with the findings of the root cause investigation by the manufacturer. The sizes of the observed particles ranged from <50 μm to 548 μm in the major axis. Similar foreign particles were also detected in 2 of the 5 vaccine vials of the same lot stored by the manufacturer, indicating that the foreign particles have already been administered to some people via vaccine. Observation of the vials of the same lot by digital microscope found smaller particles those were not detected by visual inspection, suggesting that more vials were affected. Contrarily, visual inspection and subvisible particulate matter test indicated no foreign particles in the vials of normal lots. Possible root cause and strategies to prevent such a deviation were discussed from technical and regulatory aspects.
Related Topics
Concepts
Vial
Vaccination
Christian ministry
Coronavirus disease 2019 (COVID-19)
Virology
Materials science
Medicine
Chemistry
Chromatography
Pathology
Disease
Infectious disease (medical specialty)
Theology
Philosophy
Metadata
- Type
- article
- Language
- en
- Landing Page
- https://doi.org/10.1248/yakushi.22-00067
- https://www.jstage.jst.go.jp/article/yakushi/142/8/142_22-00067/_pdf
- OA Status
- diamond
- Cited By
- 1
- Related Works
- 10
- OpenAlex ID
- https://openalex.org/W4289076386
All OpenAlex metadata
Raw OpenAlex JSON
- OpenAlex ID
-
https://openalex.org/W4289076386Canonical identifier for this work in OpenAlex
- DOI
-
https://doi.org/10.1248/yakushi.22-00067Digital Object Identifier
- Title
-
Investigation of Foreign Particles in Moderna COVID-19 VaccineWork title
- Type
-
articleOpenAlex work type
- Language
-
enPrimary language
- Publication year
-
2022Year of publication
- Publication date
-
2022-07-31Full publication date if available
- Authors
-
Hiroko Shibata, Yusuke Nomura, Tsuyoshi Kawakami, Eiichi Yamamoto, Daisuke Ando, Nahoko Uchiyama, Hiroko Tokumoto, Tatsuo Koide, Hideyuki Sakoda, Hiroyuki Yoshida, Yasuhiro Abe, Takashi Hakamatsuka, Yoshiaki Ikarashi, Yuji Haishima, Akiko Ishii‐Watabe, Ken‐ichi Izutsu, Masamitsu Honma, Yukihiro GodaList of authors in order
- Landing page
-
https://doi.org/10.1248/yakushi.22-00067Publisher landing page
- PDF URL
-
https://www.jstage.jst.go.jp/article/yakushi/142/8/142_22-00067/_pdfDirect link to full text PDF
- Open access
-
YesWhether a free full text is available
- OA status
-
diamondOpen access status per OpenAlex
- OA URL
-
https://www.jstage.jst.go.jp/article/yakushi/142/8/142_22-00067/_pdfDirect OA link when available
- Concepts
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Vial, Vaccination, Christian ministry, Coronavirus disease 2019 (COVID-19), Virology, Materials science, Medicine, Chemistry, Chromatography, Pathology, Disease, Infectious disease (medical specialty), Theology, PhilosophyTop concepts (fields/topics) attached by OpenAlex
- Cited by
-
1Total citation count in OpenAlex
- Citations by year (recent)
-
2023: 1Per-year citation counts (last 5 years)
- Related works (count)
-
10Other works algorithmically related by OpenAlex
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