Comparing immunogenicity and efficacy of two different mRNA-based COVID-19 vaccines as a fourth dose; six-month follow-up, Israel, 27 December 2021 to 24 July 2022

Barda, Noam; Canetti, Michal; Gilboa, Mayan; Indenboim, Victoria; Asraf, Keren; Weiss-Ottolenghi, Yael; Amit, Sharon; Zibly, Daniel; Doolman, Ram; Mendelson, Ella; Harats, Dror; Freedman, Laurence S.; Kreiss, Yitshak; Lustig, Yaniv; Regev‐Yochay, Gili

doi:10.2807/1560-7917.es.2022.27.39.2200701

Cited by 7 publications

(15 citation statements)

References 13 publications

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“…Additionally, the fourth dose of the mRNA vaccine correlated with a notable decrease in hospitalisation, symptomatic infection, and severe outcomes during the Omicron predominance period, distinguishing patients from control participants who did not receive a fourth dose 33,37 . These results underscore the effectiveness of both vaccines in elevating IgG levels after the fourth dose and mitigating the risk of Omicron infection and severe disease 32–34,37,38 . Nevertheless, when comparing the monovalent mRNA vaccine (mRNA‐1273 booster) with the bivalent mRNA vaccine (mRNA‐1273.214) after 28 days of the fourth dose, mRNA‐1273.214, as a second booster, exhibited significantly greater neutralising antibody titres against Omicron BA.1 and other variants (BA.4/5, alpha, beta, gamma, and delta), maintaining a safety and reactogenicity profile akin to that of the monovalent vaccine 38 .…”

Section: Discussionmentioning

confidence: 93%

“…The characteristics of the included studies are summarised in Table 1 32–71 . This systematic review included seven clinical trials, incorporating both randomized and nonrandomised designs; the remaining studies were observational, encompassing cohort, case‒control (test‐negative), and case series studies 32–71 . The most studied vaccines are monovalent messenger RNA (mRNA) vaccines, which include BioNTech nucleoside‐modified messenger RNA (BNT162b2; Pfizer‐BioNTech COVID‐19 vaccine) and Spikevax mRNA‐1273 (Moderna COVID‐19 vaccine).…”

Section: Study Characteristicsmentioning

confidence: 99%

“…One study reported that both vaccines were effective at preventing symptomatic and severe disease, with hazard ratios of 0.28 for mRNA-1273 and 0.51 for mRNA-1273. The study concluded that both mRNA-based COVID-19 vaccines provided similar immunogenicity and efficacy against the risk of omissions associated with infection and substantial disease outcomes as did a fourth dose 34. In a phase III clinical trial byMéndez et al, the effect of a second booster of the CoronaVac COVID-19 vaccine, an inactivated vaccine administered 6 months after the first booster, on the neutralisation of SARS-CoV-2 was evaluated.…”

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confidence: 99%

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Immunogenicity, clinical efficacy and safety of additional second COVID‐19 booster vaccines against Omicron and its subvariants: A systematic review

Chenchula,

Chandra,

Adusumilli

et al. 2024

Reviews in Medical Virology

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The Omicron variant of severe acute respiratory syndrome coronavirus 2 is a new variant of concern (VOC) and an emerging subvariant that exhibits heightened infectivity, transmissibility, and immune evasion, escalating the incidence of moderate to severe coronavirus disease 2019 (COVID‐19). It resists monoclonal antibodies and diminishes vaccine efficacy. Notably, new sublineages have outpaced earlier predominant sublineages. Although the primary vaccination series and initial boosters were robust against previous VOCs, their efficacy waned against Omicron and its subvariants. In this systematic review, we assessed real‐world evidence on the immunogenicity, clinical efficacy, and safety of a second booster or fourth COVID‐19 vaccine dose against the Omicron VOC and its subvariants. A comprehensive literature search was conducted in Medline/PubMed, Google Scholar, bioRxiv, and medRxiv, and relevant studies published between 2022 and 30 May 2023 were reviewed. We found a total of 40 relevant articles focusing on a second booster dose for COVID‐19, including clinical trials and observational studies, involving 3,972,856 patients. The results consistently revealed that an additional second booster dose restored and prolonged waning immunity, activating both humoral and cellular responses against Omicron and its subvariants. A second booster treatment correlated with enduring protection against COVID‐19, notably preventing substantial symptomatic disease and mortality associated with severe Omicron infection. Both monovalent messenger RNA (mRNA) and nonmRNA vaccines demonstrated similar efficacy and safety, with bivalent mRNA vaccines exhibiting broader protection against emerging subvariants of Omicron. The safety profiles of second booster were favourable with only mild systemic and local symptoms reported in some recipients. In conclusion, this systematic review underscores the additional COVID‐19 vaccine boosters, particularly with bivalent or multivalent mRNA vaccines, for countering the highly infectious emerging subvariants of Omicron.

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Section: Discussionmentioning

confidence: 93%

Section: Study Characteristicsmentioning

confidence: 99%

mentioning

confidence: 99%

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Immunogenicity, clinical efficacy and safety of additional second COVID‐19 booster vaccines against Omicron and its subvariants: A systematic review

Chenchula,

Chandra,

Adusumilli

et al. 2024

Reviews in Medical Virology

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“…In addition, a study in Israel showed that a fourth dose with mRNA1273 caused higher NAbs and anti-RBD levels over time than BNT162b2 [18]. This finding coincided with a slightly higher vaccine efficacy against infection and symptomatic disease with mRNA1273 than BNT162b2 [18,19].…”

Section: Discussionmentioning

confidence: 94%

Humoral Response after a Fourth Dose with mRNA-1273 in Healthcare Workers with and without a History of SARS-CoV-2 Infection and Previously Vaccinated with Two Doses of BBIBP-CorV Plus BNT162b2 Vaccine

Torre¹,

Hueda-Zavaleta

Cáceres-DelAguila³

et al. 2023

Vaccines

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There is limited information on the kinetics of the humoral response elicited by a fourth dose with a heterologous mRNA1273 booster in patients who previously received a third dose with BNT162b2 and two doses of BBIBP-CorV as the primary regimen. We conducted a prospective cohort study to assess the humoral response using Elecsys® anti-SARS-CoV-2 S (anti-S-RBD) of 452 healthcare workers (HCWs) in a private laboratory in Lima, Peru at 21, 120, 210, and 300 days after a third dose with a BNT162b2 heterologous booster in HCW previously immunized with two doses of BBIBP-CorV, depending on whether or not they received a fourth dose with the mRNA1273 heterologous vaccine and on the history of previous SARS infection -CoV-2. Of the 452 HCWs, 204 (45.13%) were previously infected (PI) with SARS-CoV-2, and 215 (47.57%) received a fourth dose with a heterologous mRNA-1273 booster. A total of 100% of HCWs presented positive anti-S-RBD 300 days after the third dose. In HCWs receiving a fourth dose, GMTs 2.3 and 1.6 times higher than controls were observed 30 and 120 days after the fourth dose. No statistically significant differences in anti-S-RBD titers were observed in those HCWs PI and NPI during the follow-up period. We observed that HCWs who received a fourth dose with the mRNA1273 and those previously infected after the third dose with BNT162b2 (during the Omicron wave) presented higher anti-S-RBD titers (5734 and 3428 U/mL, respectively). Further studies are required to determine whether patients infected after the third dose need a fourth dose.

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“… 34 Subsequent studies that were performed in periods when a mix of BA.1, BA.2, BA.4, and BA.5 viruses circulated have reported low effectiveness of a second booster against infection, but higher effectiveness against more severe disease. 18 , 19 , 35 , 36 Waning protection after monovalent boosters and the emergence of antigenically distinct sublineages support the need for bivalent mRNA boosters containing spike protein mRNA of both the original SARS‐CoV‐2 virus and Omicron variant, which are now available in the United States and other countries.…”

Section: Discussionmentioning

confidence: 99%

Effectiveness of first and second COVID‐19 mRNA vaccine monovalent booster doses during a period of circulation of Omicron variant sublineages: December 2021–July 2022

Petrie

King

McClure

et al. 2023

Influenza Resp Viruses

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Background US recommendations for COVID‐19 vaccine boosters have expanded in terms of age groups covered and numbers of doses recommended, whereas evolution of Omicron sublineages raises questions about ongoing vaccine effectiveness. Methods We estimated effectiveness of monovalent COVID‐19 mRNA booster vaccination versus two‐dose primary series during a period of Omicron variant virus circulation in a community cohort with active illness surveillance. Hazard ratios comparing SARS‐CoV‐2 infection between booster versus primary series vaccinated individuals were estimated using Cox proportional hazards models with time‐varying booster status. Models were adjusted for age and prior SARS‐CoV‐2 infection. The effectiveness of a second booster among adults ≥50 years of age was similarly estimated. Results The analysis included 883 participants ranging in age, from 5 to >90 years. Relative effectiveness was 51% (95% CI: 34%, 64%) favoring the booster compared with primary series vaccination and did not vary by prior infection status. Relative effectiveness was 74% (95% CI: 57%, 84%) at 15 to 90 days after booster receipt, but declined to 42% (95% CI: 16%, 61%) after 91 to 180 days, and to 36% (95% CI: 3%, 58%) after 180 days. The relative effectiveness of a second booster compared to a single booster was 24% (95% CI: −40% to 61%). Conclusions An mRNA vaccine booster dose added significant protection against SARS‐CoV‐2 infection, but protection decreased over time. A second booster did not add significant protection for adults ≥50 years of age. Uptake of recommended bivalent boosters should be encouraged to increase protection against Omicron BA.4/BA.5 sublineages.

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Comparing immunogenicity and efficacy of two different mRNA-based COVID-19 vaccines as a fourth dose; six-month follow-up, Israel, 27 December 2021 to 24 July 2022

Cited by 7 publications

References 13 publications

Immunogenicity, clinical efficacy and safety of additional second COVID‐19 booster vaccines against Omicron and its subvariants: A systematic review

Immunogenicity, clinical efficacy and safety of additional second COVID‐19 booster vaccines against Omicron and its subvariants: A systematic review

Humoral Response after a Fourth Dose with mRNA-1273 in Healthcare Workers with and without a History of SARS-CoV-2 Infection and Previously Vaccinated with Two Doses of BBIBP-CorV Plus BNT162b2 Vaccine

Effectiveness of first and second COVID‐19 mRNA vaccine monovalent booster doses during a period of circulation of Omicron variant sublineages: December 2021–July 2022

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