Evaluation of mRNA-1273 Vaccine in Children 6 Months to 5 Years of Age

Anderson, Evan J.; Creech, C. Buddy; Berthaud, Vladimir; Piramzadian, Arin; Johnson, Kimball A.; Zervos, Marcus J.; Garner, Fredric; Griffin, Carl; Palanpurwala, Khozema; Turner, Mark; Gerber, Jeffrey S.; Bennett, Richard L.; Ali, Kashif; Ampajwala, Madhavi; Berman, Gary; Nayak, Jennifer L.; Chronis, Carey; Rizzardi, Barbara; Muller, William J.; Smith, Christopher A.; Fuchs, George J.; Hsia, Daniel S.; Tomassini, Joanne E.; DeLucia, Dianne; Reuter, Caroline; Kuter, Barbara J.; Zhao, Xiaoping; Deng, Weiping; Zhou, Honghong; Schrempp, Daniela Ramirez; Hautzinger, Kelly; Girard, Bethany; Slobod, Karen; McPhee, Roderick; Pajón, Rolando; Aunins, Anne; Das, Rituparna; Miller, Jacqueline M.; Ghamloush, Sabine Schnyder

doi:10.1056/nejmoa2209367

Cited by 94 publications

(89 citation statements)

References 22 publications

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“…To our knowledge there are only 6 published Phase 2/3 studies of authorized COVID-19 vaccines in pediatric population for primary immunization – 2 mRNA vaccines [21-24], 1 receptor binding domain vaccine [45] and 1 nonrandomized study of an inactivated vaccine [46]. Our study is the first published data in pediatric age group for the spike protein vaccine and adds to the existing evidence that COVID-19 vaccines work well in pediatric population.…”

Section: Discussionmentioning

confidence: 87%

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A Phase 2/3 observer-blind, randomized, controlled study to determine the safety and immunogenicity of SARS-CoV-2 recombinant spike protein vaccine in Indian children and adolescents aged 2 to 17 years

Gunale

Kapse

Kar

et al. 2023

Preprint

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Background: A recombinant, adjuvanted COVID-19 vaccine, SII-NVX-CoV2373 was manufactured in India and evaluated in Indian children and adolescents to assess safety and immunogenicity. Methods: This was a Phase 2/3 observer-blind, randomized, controlled study in children and adolescents aged 2 to 17 years. Participants were randomly assigned in 3:1 ratio to receive two doses of SII-NVX-CoV2373 or placebo on day 1 and day 22. Solicited adverse events (AEs) were collected for 7 days after each vaccination. Unsolicited AEs were collected for 35 days following first dose and serious AEs (SAEs) and adverse events of special interest (AESI) were collected throughout the study. Anti S IgG and neutralizing antibodies against the SARS-CoV-2 were measured at baseline, day 22, day 36 and day 180. Variant immune responses were assessed in a subset of participants at baseline, day 36 and day 180. Primary objectives were to demonstrate non-inferiority of SII-NVX-CoV2373 in each pediatric age group (12 to 17 years and 2 to 11 years, separately) to that in adults in terms of ratio of titers of both anti-S IgG and neutralizing antibodies 14 days after the second dose (day 36). Non-inferiority was to be concluded if the lower bound of 95% CI of the ratio was >0.67. Results: A total of 920 children and adolescents (460 in each age cohort; 12 to 17 years and 2 to 11 years) were randomized and vaccinated. The demographic and baseline characteristics between the two groups were comparable in both age groups. After the second dose, there were more than 100-fold rise in anti-S IgG GMEUs and more than 84-fold rise in neutralizing antibodies GMTs from baseline in the participants who received SII-NVX-CoV2373. The GMTs in both age groups were non-inferior to those observed in Indian adults. The seroconversion rate was ≥ 98% (anti-S IgG) and ≥ 97.9% (neutralizing antibodies) in both age groups, respectively. Similar findings were seen in the baseline seronegative participants. SII-NVX-CoV2373 also showed robust responses against various variants of concern. Injection site pain, tenderness, swelling, erythema and fever, headache, malaise, fatigue, myalgia, arthralgia, nausea and vomiting were the common solicited adverse events which were transient and resolved without any sequelae. Throughout the study, only two causally unrelated SAEs and no AESI were reported. Conclusion: SII-NVX-CoV2373 has been found safe and well tolerated in children and adolescents of 2 to 17 years. The vaccine was highly immunogenic and the immune response was non-inferior to that in adults.

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Section: Discussionmentioning

confidence: 87%

“…The vaccine efficacy was already demonstrated in adults and therefore, we used adult results as a control so as to immuno-bridge the vaccine in children. This is the approach used in other COVID-19 vaccine studies [21][22][23][24].…”

Section: Discussionmentioning

confidence: 99%

A Phase 2/3 observer-blind, randomized, controlled study to determine the safety and immunogenicity of SARS-CoV-2 recombinant spike protein vaccine in Indian children and adolescents aged 2 to 17 years

Gunale

Kapse

Kar

et al. 2023

Preprint

View full text Add to dashboard Cite

show abstract

“…Los resultados del ensayo clínico de Spikevax® de fase II/III ( 8 , 11 , 12 ), aleatorizado, doble ciego y controlado con placebo (6388 participantes), mostraron que esta vacuna es segura. La mayoría de las reacciones adversas locales (66,1%) fueron de grado 1-2 y tuvieron una duración de 1 a 3 días.…”

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Vacunación frente a la COVID-19 a partir de los 6 meses de edad. Completando el círculo de la prevención en pediatría

Llop¹

2023

Vacunas

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“…Given the risk of COVID-19 infection in children, vaccines against COVID-19 have been approved for use in children aged 6 months and older, and have been shown to be effective in preventing complications and hospitalization from COVID-19 infection. [16][17][18][19] Congenital heart disease (CHD) is prevalent in 1% of the population. [20] These children are at increased risk for complications from respiratory viral infections, including in uenza and respiratory syncytial virus (RSV) [21,22], but there are only limited data on complications associated with COVID-19 infection among children with CHD.…”

mentioning

confidence: 99%

Impact of congenital heart disease on outcomes among pediatric patients hospitalized for COVID-19 infection

Ghimire

Chou

Aljohani

et al. 2023

Preprint

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Background COVID-19 infection is generally regarded as an acute self-limiting illness in children, but it can cause significant morbidity and mortality in both healthy and high-risk children. There are limited data on the outcomes of children with congenital heart disease (CHD) and COVID-19. This study aimed to examine the risks of mortality, in-hospital cardiovascular and non-cardiovascular complications in this patient population. Methods We analyzed data from hospitalized pediatric patients from 2020 using the nationally representative National Inpatient Sample (NIS). Children hospitalized for COVID-19 were included, and weighted data were used to compare in-hospital mortality and morbidities between children with and without CHD. Results Out of 33,220 children admitted with a diagnosis of COVID-19 infection(ICD-10 code:U07.1) during calendar year 2020, 875 (2.6%) had CHD. Compared to children without CHD, children with CHD had similar in-hospital mortality (1.2% vs 0.8%, p = 0.63), with adjusted OR (aOR) of 2.0 (95% CI: 0.5–8.3). Tachyarrhythmias and heart block were more likely in CHD children with an aOR of 4.9 (95% CI: 1.9–12.4) and aOR of 4.4 (95% CI: 2.0-9.7), respectively. Similarly, respiratory failure [aOR = 1.8 (1.2–2.9)], respiratory failure requiring non-invasive mechanical ventilation [aOR = 3.1 (1.5–6.2)] and invasive mechanical ventilation [aOR = 2.2 (1.2-4.0)], and acute kidney injury [aOR = 3.0 (1.8–4.9)] were all significantly higher among patients with CHD. Median length of hospital stay in children with CHD was longer than those without CHD [5 days (IQR: 2-9.3) vs. 3 days (IQR: 2–5), p = < 0.001]. Conclusions Children with CHD hospitalized with COVID-19 infection were at increased risk of serious cardiovascular and non-cardiovascular adverse clinical outcomes. They were not at increased risk for death when compared to children without CHD but had increased length of hospital stay and utilization of healthcare resources.

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Evaluation of mRNA-1273 Vaccine in Children 6 Months to 5 Years of Age

Cited by 94 publications

References 22 publications

A Phase 2/3 observer-blind, randomized, controlled study to determine the safety and immunogenicity of SARS-CoV-2 recombinant spike protein vaccine in Indian children and adolescents aged 2 to 17 years

A Phase 2/3 observer-blind, randomized, controlled study to determine the safety and immunogenicity of SARS-CoV-2 recombinant spike protein vaccine in Indian children and adolescents aged 2 to 17 years

Vacunación frente a la COVID-19 a partir de los 6 meses de edad. Completando el círculo de la prevención en pediatría

Impact of congenital heart disease on outcomes among pediatric patients hospitalized for COVID-19 infection

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