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Safety and immunogenicity of the Pfizer/BioNTech SARS-CoV-2 mRNA third booster vaccine dose against the BA.1 and BA.2 Omicron variants.
Seki, Yohei; Yoshihara, Yasuo; Nojima, Kiyoko; Momose, Haruka; Fukushi, Shuetsu; Moriyama, Saya; Wagatsuma, Ayumi; Numata, Narumi; Sasaki, Kyohei; Kuzuoka, Tomoyo; Yato, Yoshiyuki; Takahashi, Yoshimasa; Maeda, Ken; Suzuki, Tadaki; Mizukami, Takuo; Hamaguchi, Isao.
  • Seki Y; Department of Safety Research on Blood and Biological Products, National Institute of Infectious Diseases, Tokyo 208-0011, Japan.
  • Yoshihara Y; National Hospital Organization Murayama Medical Center, Tokyo 208-0011, Japan.
  • Nojima K; Department of Safety Research on Blood and Biological Products, National Institute of Infectious Diseases, Tokyo 208-0011, Japan.
  • Momose H; Department of Safety Research on Blood and Biological Products, National Institute of Infectious Diseases, Tokyo 208-0011, Japan.
  • Fukushi S; Department of Virology 1, National Institute of Infectious Diseases, Tokyo 162-8640, Japan.
  • Moriyama S; Research Center for Drug and Vaccine Development, National Institute of Infectious Diseases, Tokyo 162-8640, Japan.
  • Wagatsuma A; National Hospital Organization Murayama Medical Center, Tokyo 208-0011, Japan.
  • Numata N; National Hospital Organization Murayama Medical Center, Tokyo 208-0011, Japan.
  • Sasaki K; National Hospital Organization Murayama Medical Center, Tokyo 208-0011, Japan.
  • Kuzuoka T; National Hospital Organization Murayama Medical Center, Tokyo 208-0011, Japan.
  • Yato Y; National Hospital Organization Murayama Medical Center, Tokyo 208-0011, Japan.
  • Takahashi Y; Research Center for Drug and Vaccine Development, National Institute of Infectious Diseases, Tokyo 162-8640, Japan.
  • Maeda K; Department of Veterinary Science, National Institute of Infectious Diseases, Tokyo 162-8640, Japan.
  • Suzuki T; Department of Pathology, National Institute of Infectious Diseases, Tokyo 162-8640, Japan.
  • Mizukami T; Department of Safety Research on Blood and Biological Products, National Institute of Infectious Diseases, Tokyo 208-0011, Japan. Electronic address: tmiz@nih.go.jp.
  • Hamaguchi I; Department of Safety Research on Blood and Biological Products, National Institute of Infectious Diseases, Tokyo 208-0011, Japan.
Med (N Y) ; 3(6): 406-421.e4, 2022 06 10.
Article in English | MEDLINE | ID: covidwho-1926779
ABSTRACT

BACKGROUND:

The Omicron variant of severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) was identified in Japan in November 2021. This variant contains up to 36 mutations in the spike protein, the target of neutralizing antibodies, and can escape vaccine-induced immunity. A booster vaccination campaign began with healthcare workers and high-risk groups. The safety and immunogenicity of the three-dose vaccination against Omicron remain unknown.

METHODS:

A total of 272 healthcare workers were initially evaluated for long-term vaccine safety and immunogenicity. We further established a vaccinee panel to evaluate the safety and immunogenicity against variants of concern (VOCs), including the Omicron variants, using a live virus microneutralization assay.

FINDINGS:

Two-dose vaccination induced robust anti-spike antibodies and neutralization titers (NTs) against the ancestral strain WK-521, whereas NTs against VOCs were significantly lower. Within 93-247 days of the second vaccine dose, NTs against Omicron were completely abolished in up to 80% of individuals in the vaccinee panel. Booster dose induced a robust increase in anti-spike antibodies and NTs against the WK-521, Delta, and Omicron variants. There were no significant differences in the neutralization ability of sera from boosted individuals among the Omicron subvariants BA.1, BA.1.1, and BA.2. Boosting increased the breadth of humoral immunity and cross-reactivity with Omicron without changes in cytokine signatures and adverse event rate.

CONCLUSIONS:

The third vaccination dose is safe and increases neutralization against Omicron variants.

FUNDING:

This study was supported by grants from AMED (grants JP21fk0108104 and JP21mk0102146).
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Immunization, Secondary / Immunogenicity, Vaccine / COVID-19 / BNT162 Vaccine / Antibodies, Viral Type of study: Experimental Studies / Prognostic study / Randomized controlled trials Topics: Vaccines / Variants Limits: Humans Language: English Journal: Med (N Y) Year: 2022 Document Type: Article Affiliation country: J.medj.2022.04.013

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Immunization, Secondary / Immunogenicity, Vaccine / COVID-19 / BNT162 Vaccine / Antibodies, Viral Type of study: Experimental Studies / Prognostic study / Randomized controlled trials Topics: Vaccines / Variants Limits: Humans Language: English Journal: Med (N Y) Year: 2022 Document Type: Article Affiliation country: J.medj.2022.04.013