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[Investigation of Foreign Particles in Moderna COVID-19 Vaccine]

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 Goda
Source :
Yakugaku zasshi : Journal of the Pharmaceutical Society of Japan. 142(8)
Publication Year :
2022

Abstract

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 from50 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.

Details

ISSN :
13475231
Volume :
142
Issue :
8
Database :
OpenAIRE
Journal :
Yakugaku zasshi : Journal of the Pharmaceutical Society of Japan
Accession number :
edsair.doi.dedup.....2ca9d49a927e465e22486c2edfec5f09