Interim safety and immunogenicity of COVID-19 omicron BA.1 variant-containing vaccine in children in the USA: an open-label non-randomised phase 3 trial

Article

Author: Muller, William ; Ohnmacht, Richard ; Padhye, Amruta ; Miller, Jacqueline M ; Schnyder Ghamloush, Sabine ; Lavery, William ; Turner, Mark ; Poston, Rosanne ; Atz, Andrew ; Dunn, Michael ; Hernandez, John M. ; Deng, Weiping ; Zhou, Wen ; Waits, John ; Johnson, Kimball ; Palanpurwala, Khozema ; Fuchs, George ; Yeakey, Anne ; Hautzinger, Kelly ; Kuter, Barbara J ; Berman, Gary ; Warfield, Peter ; Griffin, Carl ; Jeanfreau, Robert ; Eder, Frank ; Slobod, Karen ; Girard, Bethany ; Ali, Kashif ; Ampajwala, Madhavi ; Priddy, Frances ; Vasko, Todd ; Clifford, Robert A ; Meyer, Jay ; Clifford, Robert ; Dixit, Avika ; Rodrigue, Carina ; Bennett, Richard ; Das, Rituparna ; Zhou, Honghong

BACKGROUNDVariant-containing mRNA vaccines for COVID-19 to broaden protection against SARS-CoV-2 variants are recommended based on findings in adults. We report interim safety and immunogenicity of an omicron BA.1 variant-containing (mRNA-1273.214) primary vaccination series and booster dose in paediatric populations.METHODSThis open-label, two-part, non-randomised phase 3 trial enrolled participants aged 6 months to 5 years at 24 US study sites. Eligible participants were generally healthy or had stable chronic conditions, without known SARS-CoV-2 infection in the previous 90 days. Individuals who were acutely ill or febrile 1 day before or at the screening visit or those who previously received other COVID-19 vaccines (except mRNA-1273 for part 2) were excluded. In part 1, SARS-CoV-2-vaccine-naive participants received two-dose mRNA-1273.214 (25 μg; omicron BA.1 and ancestral Wuhan-Hu-1 mRNA) primary series. In part 2, participants who previously completed the two-dose mRNA-1273 (25 μg) primary series in KidCOVE (NCT04796896) received a mRNA-1273.214 (10 μg) booster dose. Primary study outcomes were safety and reactogenicity of the mRNA-1273.214 primary series (part 1) or booster dose (part 2) as well as the inferred effectiveness of mRNA-1273.214 based on immune responses against ancestral SARS-CoV-2 (D614G) and omicron BA.1 variant at 28 days post-primary series (part 1) or post-booster dose (part 2). The safety set included participants who received at least one dose of the study vaccine; the immunogenicity set included those who provided immunogenicity samples. Interim safety and immunogenicity are summarised in this analysis as of the data cutoff date (Dec 5, 2022). This trial is registered with ClinicalTrials.gov, NCT05436834.FINDINGSBetween June 21, 2022, and Dec 5, 2022, 179 participants received one or more doses of mRNA-1273.214 primary series (part 1) and 539 received a mRNA-1273.214 booster dose (part 2). The safety profile within 28 days after either dose of the mRNA-1273.214 primary series and the booster dose was consistent with that of the mRNA-1273 primary series in this age group, with no new safety concerns or vaccine-related serious adverse events observed. At 28 days after primary series dose 2 and the booster dose, both mRNA-1273.214 primary series (day 57, including all participants with or without evidence of prior SARS-CoV-2 infection at baseline) and booster (day 29, including participants without evidence of prior SARS-CoV-2 infection at baseline) elicited responses that were superior against omicron-BA.1 (geometric mean ratio part 1: 25·4 [95% CI 20·1-32·1] and part 2: 12·5 [11·0-14·3]) and non-inferior against D614G (part 1: 0·8 [0·7-1·0] and part 2: 3·1 [2·8-3·5]), compared with neutralising antibody responses induced by the mRNA-1273 primary series (in a historical comparator group).INTERPRETATIONmRNA-1273.214 was immunogenic against BA.1 and D614G in children aged 6 months to 5 years, with a comparable safety profile to mRNA-1273, when given as a two-dose primary series or a booster dose. These results are aligned with the US Centers for Disease Control and Prevention recommendations for the use of variant-containing vaccines for continued protection against the emerging variants of SARS-CoV-2.FUNDINGModerna.

08 Feb 2024·Hong Kong Medical Journal

The Omicron variant of COVID-19 and its association with croup in children: a single-centre study in Hong Kong

Article

Author: Lam, D S Y ; Lam, M C Y

INTRODUCTIONThe fifth wave of the coronavirus disease 2019 (COVID-19) pandemic in Hong Kong was dominated by the Omicron variant, which may cause more upper airway involvement in children. This study was performed to identify any associations between the Omicron variant of COVID-19 and croup in children.METHODSThis retrospective study reviewed the electronic medical records of patients admitted to Tuen Mun Hospital in Hong Kong from 1 January 2018 to 31 March 2022 under the diagnostic code for croup (J05.0 in the International Classification of Diseases 10th Edition). Patients were categorised into three groups according to their admission periods, namely, non-COVID-19, COVID-19-pre-Omicron, and COVID-19-Omicron groups. Disease associations and severity were compared according to incidence, Westley Croup Score, length of hospital stay, medication use, respiratory support, and intensive care unit admissions.RESULTSThe COVID-19 incidence among patients with croup was significantly higher in the COVID-19-Omicron group than in the COVID-19-pre-Omicron group (90.0% vs 2.0%; P<0.001). Compared with patients in the COVID-19-pre-Omicron and non-COVID-19 groups, patients in the COVID-19-Omicron group also had a higher Westley score (moderate and severe disease in the COVID-19-Omicron group: 56.7%; COVID-19-pre-Omicron group: 22.0%, P=0.004; non-COVID-19 group: 24.8%, P<0.001), longer median hospital stay (COVID-19-Omicron group: 3.00 days; COVID-19-pre-Omicron group: 2.00 days, P<0.001; non-COVID-19 group: 2.00 days, P=0.034), and higher mean dexamethasone requirement (COVID-19-Omicron group: 0.78 mg/kg; COVID-19-pre-Omicron group: 0.49 mg/kg, P<0.001; non-COVID-19 group: 0.58 mg/kg, P=0.001).CONCLUSIONThe Omicron variant of COVID-19 is associated with croup and can cause more severe disease in Hong Kong children.

02 Jan 2023·Human Vaccines & Immunotherapeutics

Effectiveness of the pre-Omicron COVID-19 vaccines against Omicron in reducing infection, hospitalization, severity, and mortality compared to Delta and other variants: A systematic review

Review

Author: Almasri, Muna ; Al-Ali, Dana ; Paul, Pradipta ; Sinha, Pratyaksha ; Chamseddine, Reem ; Burney, Zain ; Shree, Thanu ; Pillai, Krishnadev V. ; Khalil, Omar ; Salameh, Mohammad A. ; Khanjar, Bushra ; AlAnni, Jamal ; Mhaimeed, Omar ; Abdelati, Ali A. ; Mhaimeed, Nada ; Laswi, Ibrahim ; Alroobi, Hasan ; Zakaria, Dalia ; Elshafeey, Abdallah ; D’Souza, Ashton ; Bshesh, Khalifa ; Yagan, Lina ; Aly, Ahmed ; Bhatti, Mohammad ; Hamad, Omar ; El-Naas, Ahmed ; Mhaimeed, Narjis

Despite widespread mass rollout programs, the rapid spread of the SARS-CoV-2 Omicron variant called into question the effectiveness of the existing vaccines against infection, hospitalization, severity, and mortality compared to previous variants. This systematic review summarizes and compares the effectiveness of the COVID-19 vaccines, with respect to the above outcomes in adults, children, and adolescents. A comprehensive literature search was undertaken on several databases. Only 51 studies met our inclusion criteria, revealing that the protection from primary vaccination against Omicron infection is inferior to protection against Delta and Alpha infections and wanes faster over time. However, mRNA vaccine boosters were reported to reestablish effectiveness, although to a lower extent against Omicron. Nonetheless, primary vaccination was shown to preserve strong protection against Omicron-associated hospitalization, severity, and death, even months after last dose. However, boosters provide more robust and longer-lasting protection against hospitalizations due to Omicron as compared to only primary series.

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Indication	Highest Phase	Country/Location	Organization	Date
Coronavirus Infections	IND Application	CN	RinuaGene Biotechnology Co., Ltd.	01 Nov 2024

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