Three doses of BNT162b2 vaccine confer neutralising antibody capacity against the SARS-CoV-2 Omicron variant

Ariën, Kevin K.; Heyndríckx, Leo; Míchiels, Johan; Vereecken, Katleen; Lent, Kurt Van; Coppens, Sandra; Willems, Betty; Pannus, Pieter; Martens, Guy; Esbroeck, Marjan Van; Goossens, Maria E.; Marchant, Arnaud; Bartholomeeusen, Koen; Desombere, Isabelle

doi:10.1038/s41541-022-00459-z

Cited by 39 publications

(26 citation statements)

References 14 publications

(14 reference statements)

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“…In line with the results from the general populations 1 , 2 , hemodialysis patients show a clearly decreased humoral and cellular immune response against Omicron compared with SARS-CoV-2 wild-type after four doses of vaccination. Of interest, Omicron-specific Nab titer was significantly lower as compared to Delta-specific Nab explaining the more efficient evasion of Omicron from neutralizing antibodies 3 and its efficient spread in vaccinated individuals 4 .…”

supporting

confidence: 87%

Inferior cellular and humoral immunity against Omicron and Delta variants of concern compared with SARS-CoV-2 wild type in hemodialysis patients immunized with 4 SARS-CoV-2 vaccine doses

Anft

Blázquez-Navarro

Frahnert

et al. 2022

Kidney International

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supporting

confidence: 87%

Inferior cellular and humoral immunity against Omicron and Delta variants of concern compared with SARS-CoV-2 wild type in hemodialysis patients immunized with 4 SARS-CoV-2 vaccine doses

Anft

Blázquez-Navarro

Frahnert

et al. 2022

Kidney International

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“…More than half of the world's population has received two doses of vaccine, and booster mRNA vaccines can reduce SARS‐CoV‐2 transmission and infection 15 . It is evident that two doses of mRNA vaccine provide limited protection against BA.1 which could be enhanced by a booster dose 16,17 . We evaluated the effectiveness of three doses of recombinant spike protein vaccines against D614G and the VOCs (Alpha, Beta, Gamma, Delta, BA.1, and BA.2) (Figure 3A).…”

Section: Resultsmentioning

confidence: 99%

“…15 It is evident that two doses of mRNA vaccine provide limited protection against BA.1 which could be enhanced by a booster dose. 16,17 We evaluated the effectiveness of three doses of recombinant spike protein vaccines against D614G and the VOCs (Alpha, Beta, Gamma, Delta, BA.1, and BA.2) (Figure 3A). Among these groups, higher anti-D614G spike IgG compared to anti-BA.1 spike IgG was observed in all of them except for the threedose BA.1 group which showed comparable anti-D614G spike IgG and anti-BA.1 spike IgG (Figure 3B).…”

Section: Broad Immunity Induced By D614g Spike Protein Combined With ...mentioning

confidence: 99%

A bivalent vaccine containing D614G and BA.1 spike trimer proteins or a BA.1 spike trimer protein booster shows broad neutralizing immunity

Xiong

Tang

et al. 2022

Journal of Medical Virology

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The newly emerged severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Omicron variant, sublineages BA.1 and BA.2, recently became the dominant variants of concern (VOCs) with significantly higher transmissibility than any other variant appeared and markedly greater resistance to neutralization antibodies and original ancestral WA1 spike-matched vaccine. Therefore, it is urgent to develop vaccines against VOCs like Omicron. Unlike the new booming messenger RNA (mRNA) vaccine, protein vaccines have been used for decades to protect people from various kinds of viral infections and have advantages with their inexpensive production protocols and their relative stability in comparison to the mRNA vaccine. Here, we show that sera from BA.1 spike protein vaccinated mice mainly elicited neutralizing antibodies against BA.1 itself. However, a booster with BA.1 spike protein or a bivalent vaccine composed of D614G and BA.1 spike protein-induced not only potent neutralizing antibody response against D614G and BA.1 pseudovirus, but also against BA.2, other four SARS-CoV-2 VOCs (Alpha, Beta, Gamma, and Delta) and SARS-CoV-2-related coronaviruses (pangolin CoV GD-1 and bat CoV RsSHC014). The two recombinant spike protein vaccines method described here lay a foundation for future vaccine development for broad protection against pan-sarbecovirus.

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“…The cytopathic effect caused by viral growth was scored microscopically. The Reed-Muench method was used to calculate the neutralizing Ab titer that reduced the number of infected wells by 50% (NT50), which was used as a proxy for the neutralizing Ab concentration in the sample (1–3).…”

Section: S2 Appendix: Supplementary Methodsmentioning

confidence: 99%

Safety and immunogenicity of a reduced dose of the BNT162b2 mRNA COVID-19 vaccine (REDU-VAC): a single blind, randomized, non-inferiority trial

Pannus

Depickère

Kemlin

et al. 2022

Preprint

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Background The use of fractional dose regimens of COVID-19 vaccines has the potential to accelerate vaccination rates in low-income countries. Dose-finding studies of the mRNA vaccine BNT162b2 (Pfizer-BioNTech) have suggested that a fractional dose induces comparable antibody responses to the full, licensed dose in people below 55 years old. Here, we report the safety and immunogenicity of a fractional dose regimen of the BNT162b2 vaccine. Methods REDU-VAC is a participant-blinded, randomised, phase 4, multicentre, non-inferiority study investigating safety, reactogenicity and immunogenicity of BNT162b2. Adults aged between 18 and 55 years, without uncontrolled co-morbidities, either previously infected or infection naive, were eligible and recruited at five sites across Belgium. Participants were randomly assigned to receive 20ug/20ug (fractional dose) or 30ug/30ug (full dose) of BNT162b2, administered intra-muscularly at a three-week interval. The primary endpoint was the geometric mean ratio (GMR) of serum SARS-CoV-2 anti-RBD IgG titres at 28 days post second dose between the reduced and the full dose regimens. The reduced dose was considered non-inferior to the full dose if the lower limit of the two-sided 95% CI of the GMR was greater than 0.67. The primary analysis was done on the per-protocol population, including infection naive participants only. Findings Between April 19 and April 23, 2021, 145 participants were enrolled in the study and randomized, of whom 141 were vaccinated and reached the primary endpoint. Participants were mostly female (69.5%), of European origin (95%), with a mean age of 40.4 years (SD 7.9). At 28 days post second dose, the geometric mean titre (GMT) of SARS-CoV-2 anti-RBD IgG of the reduced dose regimen (1,705 BAU/mL) was not non-inferior to the full dose regimen (2,387 BAU/mL), with a GMR of 0.714 (two-sided 95% CI 0.540-0.944). No serious adverse events occurred. Conclusions While non-inferiority of the reduced dose regimen was not demonstrated, the SARS-CoV-2 anti-RBD IgG titre was only moderately lower than that of the full dose regimen and, importantly, still markedly higher than the reported antibody response to the licensed adenoviral vector vaccines. These data suggest that reduced doses of the BNT162b2 mRNA vaccine may offer additional benefit as compared to the vaccines currently in use in most low and middle-income countries, warranting larger immunogenicity and effectiveness trials. The trial is registered at ClinicalTrials.gov (NCT04852861).

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Three doses of BNT162b2 vaccine confer neutralising antibody capacity against the SARS-CoV-2 Omicron variant

Cited by 39 publications

References 14 publications

Inferior cellular and humoral immunity against Omicron and Delta variants of concern compared with SARS-CoV-2 wild type in hemodialysis patients immunized with 4 SARS-CoV-2 vaccine doses

Inferior cellular and humoral immunity against Omicron and Delta variants of concern compared with SARS-CoV-2 wild type in hemodialysis patients immunized with 4 SARS-CoV-2 vaccine doses

A bivalent vaccine containing D614G and BA.1 spike trimer proteins or a BA.1 spike trimer protein booster shows broad neutralizing immunity

Safety and immunogenicity of a reduced dose of the BNT162b2 mRNA COVID-19 vaccine (REDU-VAC): a single blind, randomized, non-inferiority trial

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