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Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age.
Muñoz, Flor M; Sher, Lawrence D; Sabharwal, Charu; Gurtman, Alejandra; Xu, Xia; Kitchin, Nicholas; Lockhart, Stephen; Riesenberg, Robert; Sexter, Joanna M; Czajka, Hanna; Paulsen, Grant C; Maldonado, Yvonne; Walter, Emmanuel B; Talaat, Kawsar R; Englund, Janet A; Sarwar, Uzma N; Hansen, Caitlin; Iwamoto, Martha; Webber, Chris; Cunliffe, Luke; Ukkonen, Benita; Martínez, Silvina N; Pahud, Barbara A; Munjal, Iona; Domachowske, Joseph B; Swanson, Kena A; Ma, Hua; Koury, Kenneth; Mather, Susan; Lu, Claire; Zou, Jing; Xie, Xuping; Shi, Pei-Yong; Cooper, David; Türeci, Özlem; Sahin, Ugur; Jansen, Kathrin U; Gruber, William C.
  • Muñoz FM; From Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.); Peninsula Research Associates, Rolling Hills Estates (L.D.S.), and Stanford University School of Medicine, Palo Alto (Y.M.) - both in Californi
  • Sher LD; From Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.); Peninsula Research Associates, Rolling Hills Estates (L.D.S.), and Stanford University School of Medicine, Palo Alto (Y.M.) - both in Californi
  • Sabharwal C; From Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.); Peninsula Research Associates, Rolling Hills Estates (L.D.S.), and Stanford University School of Medicine, Palo Alto (Y.M.) - both in Californi
  • Gurtman A; From Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.); Peninsula Research Associates, Rolling Hills Estates (L.D.S.), and Stanford University School of Medicine, Palo Alto (Y.M.) - both in Californi
  • Xu X; From Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.); Peninsula Research Associates, Rolling Hills Estates (L.D.S.), and Stanford University School of Medicine, Palo Alto (Y.M.) - both in Californi
  • Kitchin N; From Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.); Peninsula Research Associates, Rolling Hills Estates (L.D.S.), and Stanford University School of Medicine, Palo Alto (Y.M.) - both in Californi
  • Lockhart S; From Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.); Peninsula Research Associates, Rolling Hills Estates (L.D.S.), and Stanford University School of Medicine, Palo Alto (Y.M.) - both in Californi
  • Riesenberg R; From Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.); Peninsula Research Associates, Rolling Hills Estates (L.D.S.), and Stanford University School of Medicine, Palo Alto (Y.M.) - both in Californi
  • Sexter JM; From Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.); Peninsula Research Associates, Rolling Hills Estates (L.D.S.), and Stanford University School of Medicine, Palo Alto (Y.M.) - both in Californi
  • Czajka H; From Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.); Peninsula Research Associates, Rolling Hills Estates (L.D.S.), and Stanford University School of Medicine, Palo Alto (Y.M.) - both in Californi
  • Paulsen GC; From Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.); Peninsula Research Associates, Rolling Hills Estates (L.D.S.), and Stanford University School of Medicine, Palo Alto (Y.M.) - both in Californi
  • Maldonado Y; From Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.); Peninsula Research Associates, Rolling Hills Estates (L.D.S.), and Stanford University School of Medicine, Palo Alto (Y.M.) - both in Californi
  • Walter EB; From Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.); Peninsula Research Associates, Rolling Hills Estates (L.D.S.), and Stanford University School of Medicine, Palo Alto (Y.M.) - both in Californi
  • Talaat KR; From Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.); Peninsula Research Associates, Rolling Hills Estates (L.D.S.), and Stanford University School of Medicine, Palo Alto (Y.M.) - both in Californi
  • Englund JA; From Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.); Peninsula Research Associates, Rolling Hills Estates (L.D.S.), and Stanford University School of Medicine, Palo Alto (Y.M.) - both in Californi
  • Sarwar UN; From Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.); Peninsula Research Associates, Rolling Hills Estates (L.D.S.), and Stanford University School of Medicine, Palo Alto (Y.M.) - both in Californi
  • Hansen C; From Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.); Peninsula Research Associates, Rolling Hills Estates (L.D.S.), and Stanford University School of Medicine, Palo Alto (Y.M.) - both in Californi
  • Iwamoto M; From Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.); Peninsula Research Associates, Rolling Hills Estates (L.D.S.), and Stanford University School of Medicine, Palo Alto (Y.M.) - both in Californi
  • Webber C; From Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.); Peninsula Research Associates, Rolling Hills Estates (L.D.S.), and Stanford University School of Medicine, Palo Alto (Y.M.) - both in Californi
  • Cunliffe L; From Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.); Peninsula Research Associates, Rolling Hills Estates (L.D.S.), and Stanford University School of Medicine, Palo Alto (Y.M.) - both in Californi
  • Ukkonen B; From Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.); Peninsula Research Associates, Rolling Hills Estates (L.D.S.), and Stanford University School of Medicine, Palo Alto (Y.M.) - both in Californi
  • Martínez SN; From Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.); Peninsula Research Associates, Rolling Hills Estates (L.D.S.), and Stanford University School of Medicine, Palo Alto (Y.M.) - both in Californi
  • Pahud BA; From Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.); Peninsula Research Associates, Rolling Hills Estates (L.D.S.), and Stanford University School of Medicine, Palo Alto (Y.M.) - both in Californi
  • Munjal I; From Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.); Peninsula Research Associates, Rolling Hills Estates (L.D.S.), and Stanford University School of Medicine, Palo Alto (Y.M.) - both in Californi
  • Domachowske JB; From Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.); Peninsula Research Associates, Rolling Hills Estates (L.D.S.), and Stanford University School of Medicine, Palo Alto (Y.M.) - both in Californi
  • Swanson KA; From Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.); Peninsula Research Associates, Rolling Hills Estates (L.D.S.), and Stanford University School of Medicine, Palo Alto (Y.M.) - both in Californi
  • Ma H; From Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.); Peninsula Research Associates, Rolling Hills Estates (L.D.S.), and Stanford University School of Medicine, Palo Alto (Y.M.) - both in Californi
  • Koury K; From Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.); Peninsula Research Associates, Rolling Hills Estates (L.D.S.), and Stanford University School of Medicine, Palo Alto (Y.M.) - both in Californi
  • Mather S; From Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.); Peninsula Research Associates, Rolling Hills Estates (L.D.S.), and Stanford University School of Medicine, Palo Alto (Y.M.) - both in Californi
  • Lu C; From Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.); Peninsula Research Associates, Rolling Hills Estates (L.D.S.), and Stanford University School of Medicine, Palo Alto (Y.M.) - both in Californi
  • Zou J; From Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.); Peninsula Research Associates, Rolling Hills Estates (L.D.S.), and Stanford University School of Medicine, Palo Alto (Y.M.) - both in Californi
  • Xie X; From Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.); Peninsula Research Associates, Rolling Hills Estates (L.D.S.), and Stanford University School of Medicine, Palo Alto (Y.M.) - both in Californi
  • Shi PY; From Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.); Peninsula Research Associates, Rolling Hills Estates (L.D.S.), and Stanford University School of Medicine, Palo Alto (Y.M.) - both in Californi
  • Cooper D; From Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.); Peninsula Research Associates, Rolling Hills Estates (L.D.S.), and Stanford University School of Medicine, Palo Alto (Y.M.) - both in Californi
  • Türeci Ö; From Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.); Peninsula Research Associates, Rolling Hills Estates (L.D.S.), and Stanford University School of Medicine, Palo Alto (Y.M.) - both in Californi
  • Sahin U; From Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.); Peninsula Research Associates, Rolling Hills Estates (L.D.S.), and Stanford University School of Medicine, Palo Alto (Y.M.) - both in Californi
  • Jansen KU; From Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.); Peninsula Research Associates, Rolling Hills Estates (L.D.S.), and Stanford University School of Medicine, Palo Alto (Y.M.) - both in Californi
  • Gruber WC; From Texas Children's Hospital, Baylor College of Medicine, Houston (F.M.M.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.); Peninsula Research Associates, Rolling Hills Estates (L.D.S.), and Stanford University School of Medicine, Palo Alto (Y.M.) - both in Californi
N Engl J Med ; 388(7): 621-634, 2023 02 16.
Статья в английский | MEDLINE | ID: covidwho-2243580
ABSTRACT

BACKGROUND:

Safe and effective vaccines against coronavirus disease 2019 (Covid-19) are urgently needed in young children.

METHODS:

We conducted a phase 1 dose-finding study and are conducting an ongoing phase 2-3 safety, immunogenicity, and efficacy trial of the BNT162b2 vaccine in healthy children 6 months to 11 years of age. We present results for children 6 months to less than 2 years of age and those 2 to 4 years of age through the data-cutoff dates (April 29, 2022, for safety and immunogenicity and June 17, 2022, for efficacy). In the phase 2-3 trial, participants were randomly assigned (in a 21 ratio) to receive two 3-µg doses of BNT162b2 or placebo. On the basis of preliminary immunogenicity results, a third 3-µg dose (≥8 weeks after dose 2) was administered starting in January 2022, which coincided with the emergence of the B.1.1.529 (omicron) variant. Immune responses at 1 month after doses 2 and 3 in children 6 months to less than 2 years of age and those 2 to 4 years of age were immunologically bridged to responses after dose 2 in persons 16 to 25 years of age who received 30 µg of BNT162b2 in the pivotal trial.

RESULTS:

During the phase 1 dose-finding study, two doses of BNT162b2 were administered 21 days apart to 16 children 6 months to less than 2 years of age (3-µg dose) and 48 children 2 to 4 years of age (3-µg or 10-µg dose). The 3-µg dose level was selected for the phase 2-3 trial; 1178 children 6 months to less than 2 years of age and 1835 children 2 to 4 years of age received BNT162b2, and 598 and 915, respectively, received placebo. Immunobridging success criteria for the geometric mean ratio and seroresponse at 1 month after dose 3 were met in both age groups. BNT162b2 reactogenicity events were mostly mild to moderate, with no grade 4 events. Low, similar incidences of fever were reported after receipt of BNT162b2 (7% among children 6 months to <2 years of age and 5% among those 2 to 4 years of age) and placebo (6 to 7% among children 6 months to <2 years of age and 4 to 5% among those 2 to 4 years of age). The observed overall vaccine efficacy against symptomatic Covid-19 in children 6 months to 4 years of age was 73.2% (95% confidence interval, 43.8 to 87.6) from 7 days after dose 3 (on the basis of 34 cases).

CONCLUSIONS:

A three-dose primary series of 3-µg BNT162b2 was safe, immunogenic, and efficacious in children 6 months to 4 years of age. (Funded by BioNTech and Pfizer; ClinicalTrials.gov number, NCT04816643.).
Тема - темы

Полный текст: Имеется в наличии Коллекция: Международные базы данных база данных: MEDLINE Основная тема: COVID-19 / BNT162 Vaccine Тип исследования: Экспериментальные исследования / Наблюдательное исследование / Прогностическое исследование / Рандомизированные контролируемые испытания Темы: Вакцина / Варианты Пределы темы: Подростки / Взрослые / Дети / Детский дошкольный / Люди / Грудные дети / Молодой взрослый Язык: английский Журнал: N Engl J Med Год: 2023 Тип: Статья

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Полный текст: Имеется в наличии Коллекция: Международные базы данных база данных: MEDLINE Основная тема: COVID-19 / BNT162 Vaccine Тип исследования: Экспериментальные исследования / Наблюдательное исследование / Прогностическое исследование / Рандомизированные контролируемые испытания Темы: Вакцина / Варианты Пределы темы: Подростки / Взрослые / Дети / Детский дошкольный / Люди / Грудные дети / Молодой взрослый Язык: английский Журнал: N Engl J Med Год: 2023 Тип: Статья