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Showing 1 to 12 of 25 entries
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Evaluation of the BNT162b2 Covid-19 Vaccine in Children 5 to 11 Years of Age.

The New England journal of medicine

Walter EB, Talaat KR, Sabharwal C, Gurtman A, Lockhart S, Paulsen GC, Barnett ED, Muñoz FM, Maldonado Y, Pahud BA, Domachowske JB, Simões EAF, Sarwar UN, Kitchin N, Cunliffe L, Rojo P, Kuchar E, Rämet M, Munjal I, Perez JL, Frenck RW, Lagkadinou E, Swanson KA, Ma H, Xu X, Koury K, Mather S, Belanger TJ, Cooper D, Türeci Ö, Dormitzer PR, Şahin U, Jansen KU, Gruber WC.
PMID: 34752019
N Engl J Med. 2021 Nov 09; doi: 10.1056/NEJMoa2116298. Epub 2021 Nov 09.

BACKGROUND: Safe, effective vaccines against coronavirus disease 2019 (Covid-19) are urgently needed in children younger than 12 years of age.METHODS: A phase 1, dose-finding study and an ongoing phase 2-3 randomized trial are being conducted to investigate the safety,...

RNA-Based COVID-19 Vaccine BNT162b2 Selected for a Pivotal Efficacy Study.

medRxiv : the preprint server for health sciences

Walsh EE, Frenck R, Falsey AR, Kitchin N, Absalon J, Gurtman A, Lockhart S, Neuzil K, Mulligan MJ, Bailey R, Swanson KA, Li P, Koury K, Kalina W, Cooper D, Fontes-Garfias C, Shi PY, Türeci Ö, Thompkins KR, Lyke KE, Raabe V, Dormitzer PR, Jansen KU, Sahin U, Gruber WC.
PMID: 32839784
medRxiv. 2020 Aug 28; doi: 10.1101/2020.08.17.20176651.

BACKGROUND: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections and the resulting disease, coronavirus disease 2019 (COVID-19), have spread to millions of people globally. Multiple vaccine candidates are under development, but no vaccine is currently available.METHODS: Healthy adults 18-55...

Evaluation of the BNT162b2 Covid-19 Vaccine in Children 5 to 11 Years of Age.

The New England journal of medicine

Walter EB, Talaat KR, Sabharwal C, Gurtman A, Lockhart S, Paulsen GC, Barnett ED, Muñoz FM, Maldonado Y, Pahud BA, Domachowske JB, Simões EAF, Sarwar UN, Kitchin N, Cunliffe L, Rojo P, Kuchar E, Rämet M, Munjal I, Perez JL, Frenck RW, Lagkadinou E, Swanson KA, Ma H, Xu X, Koury K, Mather S, Belanger TJ, Cooper D, Türeci Ö, Dormitzer PR, Şahin U, Jansen KU, Gruber WC.
PMID: 34752019
N Engl J Med. 2022 Jan 06;386(1):35-46. doi: 10.1056/NEJMoa2116298. Epub 2021 Nov 09.

BACKGROUND: Safe, effective vaccines against coronavirus disease 2019 (Covid-19) are urgently needed in children younger than 12 years of age.METHODS: A phase 1, dose-finding study and an ongoing phase 2-3 randomized trial are being conducted to investigate the safety,...

A randomized study to evaluate safety and immunogenicity of the BNT162b2 COVID-19 vaccine in healthy Japanese adults.

Nature communications

Haranaka M, Baber J, Ogama Y, Yamaji M, Aizawa M, Kogawara O, Scully I, Lagkadinou E, Türeci Ӧ, Şahin U, Dormitzer PR, Gruber WC, Lockhart S.
PMID: 34907170
Nat Commun. 2021 Dec 14;12(1):7105. doi: 10.1038/s41467-021-27316-2.

We report interim safety and immunogenicity findings from an ongoing phase 1/2 study of BNT162b2 in healthy Japanese adults. Participants were randomized 3:1 to receive 2 intramuscular injections of 30 μg BNT162b2 or placebo 21 days apart. Overall, 160...

Adjuvant is necessary for a robust immune response to a single dose of H1N1 pandemic flu vaccine in mice.

PLoS currents

Dormitzer PR, Rappuoli R, Casini D, O'Hagan D, Runham C, Montomoli E, Baudner B, Donnelly JJ, Lapini G.
PMID: 20029611
PLoS Curr. 2009 Aug 31;1:RRN1025. doi: 10.1371/currents.RRN1025.

Pandemic H1N1 influenza vaccine antigens are currently being manufactured. The MF(59) adjuvant has an established safety profile in humans and a proven ability to increase responses to some influenza vaccines in humans. To inform initial decisions on the use...

Rapidly produced SAM(®) vaccine against H7N9 influenza is immunogenic in mice.

Emerging microbes & infections

Hekele A, Bertholet S, Archer J, Gibson DG, Palladino G, Brito LA, Otten GR, Brazzoli M, Buccato S, Bonci A, Casini D, Maione D, Qi ZQ, Gill JE, Caiazza NC, Urano J, Hubby B, Gao GF, Shu Y, De Gregorio E, Mandl CW, Mason PW, Settembre EC, Ulmer JB, Craig Venter J, Dormitzer PR, Rappuoli R, Geall AJ.
PMID: 26038486
Emerg Microbes Infect. 2013 Aug;2(8):e52. doi: 10.1038/emi.2013.54. Epub 2013 Aug 14.

The timing of vaccine availability is essential for an effective response to pandemic influenza. In 2009, vaccine became available after the disease peak, and this has motivated the development of next generation vaccine technologies for more rapid responses. The...

A randomized study to evaluate safety and immunogenicity of the BNT162b2 COVID-19 vaccine in healthy Japanese adults.

Nature communications

Haranaka M, Baber J, Ogama Y, Yamaji M, Aizawa M, Kogawara O, Scully I, Lagkadinou E, Türeci Ӧ, Şahin U, Dormitzer PR, Gruber WC, Lockhart S.
PMID: 34907170
Nat Commun. 2021 Dec 14;12(1):7105. doi: 10.1038/s41467-021-27316-2.

We report interim safety and immunogenicity findings from an ongoing phase 1/2 study of BNT162b2 in healthy Japanese adults. Participants were randomized 3:1 to receive 2 intramuscular injections of 30 μg BNT162b2 or placebo 21 days apart. Overall, 160...

A Randomized Phase 1/2 Study of a Respiratory Syncytial Virus Prefusion F Vaccine.

The Journal of infectious diseases

Walsh EE, Falsey AR, Scott DA, Gurtman A, Zareba AM, Jansen KU, Gruber WC, Dormitzer PR, Swanson KA, Radley D, Gomme E, Cooper D, Schmoele-Thoma B.
PMID: 34932102
J Infect Dis. 2021 Dec 21; doi: 10.1093/infdis/jiab612. Epub 2021 Dec 21.

BACKGROUND: Protection against human respiratory syncytial virus (RSV) remains an unmet need potentially addressable by maternal immunization. This phase 1/2 study evaluated a bivalent prefusion F vaccine (RSVpreF) with antigens from RSV subgroups A and B.METHODS: Adults 18-49 years...

Publisher Correction: COVID-19 vaccine BNT162b1 elicits human antibody and T.

Nature

Sahin U, Muik A, Derhovanessian E, Vogler I, Kranz LM, Vormehr M, Baum A, Pascal K, Quandt J, Maurus D, Brachtendorf S, Lörks V, Sikorski J, Hilker R, Becker D, Eller AK, Grützner J, Boesler C, Rosenbaum C, Kühnle MC, Luxemburger U, Kemmer-Brück A, Langer D, Bexon M, Bolte S, Karikó K, Palanche T, Fischer B, Schultz A, Shi PY, Fontes-Garfias C, Perez JL, Swanson KA, Loschko J, Scully IL, Cutler M, Kalina W, Kyratsous CA, Cooper D, Dormitzer PR, Jansen KU, Türeci Ö.
PMID: 33469214
Nature. 2021 Feb;590(7844):E17. doi: 10.1038/s41586-020-03102-w.

No abstract available.

Evaluation of the BNT162b2 Covid-19 Vaccine in Children 5 to 11 Years of Age.

The New England journal of medicine

Walter EB, Talaat KR, Sabharwal C, Gurtman A, Lockhart S, Paulsen GC, Barnett ED, Muñoz FM, Maldonado Y, Pahud BA, Domachowske JB, Simões EAF, Sarwar UN, Kitchin N, Cunliffe L, Rojo P, Kuchar E, Rämet M, Munjal I, Perez JL, Frenck RW, Lagkadinou E, Swanson KA, Ma H, Xu X, Koury K, Mather S, Belanger TJ, Cooper D, Türeci Ö, Dormitzer PR, Şahin U, Jansen KU, Gruber WC.
PMID: 34752019
N Engl J Med. 2022 Jan 06;386(1):35-46. doi: 10.1056/NEJMoa2116298. Epub 2021 Nov 09.

BACKGROUND: Safe, effective vaccines against coronavirus disease 2019 (Covid-19) are urgently needed in children younger than 12 years of age.METHODS: A phase 1, dose-finding study and an ongoing phase 2-3 randomized trial are being conducted to investigate the safety,...

Pathogenesis of wild-type-like rhesus cytomegalovirus strains following oral exposure of immune-competent rhesus macaques.

Journal of virology

Yue Y, Chang WLW, Li J, Nguyen N, Schmidt KA, Dormitzer PR, Yang X, Barry PA.
PMID: 34788083
J Virol. 2021 Nov 17;JVI0165321. doi: 10.1128/JVI.01653-21. Epub 2021 Nov 17.

Rhesus cytomegalovirus (RhCMV) infection of rhesus macaques (

The effect of SARS-CoV-2 D614G mutation on BNT162b2 vaccine-elicited neutralization.

NPJ vaccines

Zou J, Xie X, Fontes-Garfias CR, Swanson KA, Kanevsky I, Tompkins K, Cutler M, Cooper D, Dormitzer PR, Shi PY, Salifu Y, Bayuo J.
PMID: 33767200
NPJ Vaccines. 2021 Mar 25;6(1):44. doi: 10.1038/s41541-021-00313-8.

Initial COVID-19 vaccine candidates were based on the original sequence of SARS-CoV-2. However, the virus has since accumulated mutations, among which the spike D614G is dominant in circulating virus, raising questions about potential virus escape from vaccine-elicited immunity. Here,...

Showing 1 to 12 of 25 entries