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Article: Safety and Immunogenicity of the Monovalent Omicron XBB.1.5-Adapted BNT162b2 COVID-19 Vaccine in Individuals ≥12 Years Old: A Phase 2/3 Trial.

2024 Volume 12, Issue 2

Abstract: Vaccination remains an important mitigation tool against COVID-19. We report 1-month safety and preliminary immunogenicity data from a substudy of an ongoing, open-label, phase 2/3 study of monovalent Omicron XBB.1.5-adapted BNT162b2 (single 30-μg dose). ...

Abstract	Vaccination remains an important mitigation tool against COVID-19. We report 1-month safety and preliminary immunogenicity data from a substudy of an ongoing, open-label, phase 2/3 study of monovalent Omicron XBB.1.5-adapted BNT162b2 (single 30-μg dose). Healthy participants ≥12 years old (
Language	English
Publishing date	2024-01-24
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2703319-3
ISSN	2076-393X
ISSN	2076-393X
DOI	10.3390/vaccines12020118
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Article ; Online: A Bivalent Omicron-BA.4/BA.5-Adapted BNT162b2 Booster in ≥12-Year-Olds.

Usdan, Lisa / Patel, Sohil / Rodriguez, Hector / Xu, Xia / Lee, Dung-Yang / Finn, Daniel / Wyper, Hayley / Sci, B Biomed / Lowry, Francine S / Mensa, Federico J / Lu, Claire / Cooper, David / Koury, Kenneth / Anderson, Annaliesa S / Türeci, Özlem / Şahin, Uğur / Swanson, Kena A / Gruber, William C / Kitchin, Nicholas

Clinical infectious diseases : an official publication of the Infectious Diseases Society of America

2023

Abstract: Background: Protection against contemporary SARS-CoV-2 variants requires sequence-adapted vaccines.: Methods: In this ongoing phase 2/3 trial, 12-17-year-olds (n=108), 18-55-year-olds (n=313), and >55-year-olds (n=306) who previously received 3 ... ...

Abstract	Background: Protection against contemporary SARS-CoV-2 variants requires sequence-adapted vaccines. Methods: In this ongoing phase 2/3 trial, 12-17-year-olds (n=108), 18-55-year-olds (n=313), and >55-year-olds (n=306) who previously received 3 original BNT162b2 30-µg doses, received a fourth dose (second booster) of 30-µg bivalent original/Omicron-BA.4/BA.5-adapted BNT162b2 (BNT162b2-Omi.BA.4/BA.5). For comparisons with original BNT162b2, participants were selected from another phase 3 trial. Immunologic superiority 1-month post-vaccination, with respect to 50% neutralizing titers (GMR lower bound [LB] 2-sided 95%CI >1), and noninferiority with respect to seroresponse rates (rate-difference LB 2-sided 95%CI >-5%), for Omicron BA.4/BA.5 were assessed in >55-year-olds versus original BNT162b2 as a second booster. Noninferiority with respect to neutralizing titer level (GMR LB 2-sided 95%CI >0.67) and seroresponse rate (rate-difference LB 2-sided 95%CI >-10%) of Omicron BA.4/BA.5 immune response for BNT162b2-Omi.BA.4/BA.5 in 18‒55-year-olds versus >55-year-olds was assessed. Results: One-month post-vaccination in >55-year-olds, model-adjusted GMR of Omicron BA.4/BA.5 neutralizing titers for the BNT162b2-Omi.BA.4/BA.5 versus BNT162b2 group (2.91; 95%CI 2.45-3.44) demonstrated superiority of BNT162b2-Omi.BA.4/BA.5. Adjusted difference in percentages of >55-year-olds with seroresponse (26.77%; 95%CI 19.59-33.95) showed noninferiority of BNT162b2-Omi.BA.4/BA.5 to BNT162b2. Noninferiority of BNT162b2-Omi.BA.4/BA.5 in 18‒55-year-olds to >55-year-olds was met for model-adjusted GMR and seroresponse. GMTs in 12-17-year-olds increased from baseline to 1-month post-vaccination. The BNT162b2-Omi.BA.4/BA.5 safety profile was similar to booster doses of bivalent Omicron BA.1-modified BNT162b2 and original BNT162b2 reported in previous studies. Conclusions: Based on immunogenicity and safety data up to 1-month post-vaccination in participants who previously received 3 original BNT162b2 doses, a BNT162b2-Omi.BA.4/BA.5 30 µg booster has a favorable benefit-risk profile. Clinical trial registration: NCT05472038.
Language	English
Publishing date	2023-11-28
Publishing country	United States
Document type	Journal Article
ZDB-ID	1099781-7
ISSN	1537-6591 ; 1058-4838
ISSN (online)	1537-6591
ISSN	1058-4838
DOI	10.1093/cid/ciad718
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Article: Safety and Immunogenicity of the BNT162b2 Vaccine Coadministered with Seasonal Inactivated Influenza Vaccine in Adults.

Murdoch, Louise / Quan, Karen / Baber, James A / Ho, Agnes W Y / Zhang, Ying / Xu, Xia / Lu, Claire / Cooper, David / Koury, Kenneth / Lockhart, Stephen P / Anderson, Annaliesa S / Türeci, Özlem / Şahin, Uğur / Swanson, Kena A / Gruber, William C / Kitchin, Nicholas

Infectious diseases and therapy

2023 Volume 12, Issue 9, Page(s) 2241–2258

Abstract: Introduction: Vaccination is a critical tool for preventing coronavirus disease 2019 (COVID-19) and influenza illnesses. Coadministration of the COVID-19 vaccine, BNT162b2, with seasonal inactivated influenza vaccine (SIIV) can provide substantial ... ...

Abstract	Introduction: Vaccination is a critical tool for preventing coronavirus disease 2019 (COVID-19) and influenza illnesses. Coadministration of the COVID-19 vaccine, BNT162b2, with seasonal inactivated influenza vaccine (SIIV) can provide substantial benefits, including streamlining vaccine delivery. Methods: In this phase 3 study, healthy 18- to 64-year-olds who had received three previous doses of BNT162b2 were randomized (1:1) to the coadministration group (month 0, BNT162b2 + SIIV; month 1, placebo) or the separate-administration group (month 0, placebo + SIIV; month 1, BNT162b2). The primary immunogenicity objective was to demonstrate that the immune responses elicited by BNT162b2 and SIIV [measured by full-length S-binding immunoglobulin G (IgG) levels and strain-specific hemagglutination inhibition assay (HAI) titers against four influenza strains 1 month post-vaccination, respectively] when coadministered were noninferior to those elicited by either vaccine administered alone, based on a prespecified 1.5-fold noninferiority margin [lower bound 95% CI for geometric mean ratio (GMR) > 0.67]. Reactogenicity and adverse event (AE) rates were evaluated. Results: Randomized participants who received study vaccination (N = 1128; coadministration group, n = 564; separate-administration group, n = 564) had a median age of 39 years. Model-adjusted GMRs for coadministration to separate administration were 0.83 (95% CI 0.77, 0.89) for full-length S-binding IgG levels and 0.89-1.00 (lower bound of all 95% CIs > 0.67) for the four influenza strain-specific HAI titers, with all endpoints achieving the prespecified noninferiority criterion. Reactogenicity events were mostly mild or moderate when BNT162b2 was coadministered with SIIV. Serious AEs were reported in < 1% of participants within 1 month after any vaccination; none were considered vaccine-related. Conclusions: BNT162b2 coadministered with SIIV elicited immune responses that were noninferior to those elicited by BNT162b2 alone and SIIV alone, and BNT162b2 had an acceptable safety profile when coadministered with SIIV. The results of this study support the coadministration of BNT162b2 and SIIV in adults. Trial registration: ClinicalTrials.gov registration: NCT05310084.
Language	English
Publishing date	2023-09-12
Publishing country	New Zealand
Document type	Journal Article
ZDB-ID	2701611-0
ISSN	2193-6382 ; 2193-8229
ISSN (online)	2193-6382
ISSN	2193-8229
DOI	10.1007/s40121-023-00863-5
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Article: Efficacy and safety of the BNT162b2 mRNA COVID-19 vaccine in participants with a history of cancer: subgroup analysis of a global phase 3 randomized clinical trial

Thomas, Stephen J. / Perez, John L. / Lockhart, Stephen P. / Hariharan, Subramanian / Kitchin, Nicholas / Bailey, Ruth / Liau, Katherine / Lagkadinou, Eleni / Türeci, Özlem / Şahin, Ugur / Xu, Xia / Koury, Kenneth / Dychter, Samuel S. / Lu, Claire / Gentile, Teresa C. / Gruber, William C.

Vaccine. 2022 Mar. 01, v. 40, no. 10

2022

Abstract: Individuals with an underlying malignancy have high risk of poor COVID-19 outcomes. In clinical trials, COVID-19 vaccines were safe and efficacious against infection, hospitalization, and death, but most trials excluded participants with cancer. We ... ...

Abstract	Individuals with an underlying malignancy have high risk of poor COVID-19 outcomes. In clinical trials, COVID-19 vaccines were safe and efficacious against infection, hospitalization, and death, but most trials excluded participants with cancer. We report results from participants with a history of past or active neoplasm (malignant or benign/unknown) and up to 6 months’ follow-up post-dose 2 from the placebo-controlled, observer-blinded trial of the 2-dose BNT162b2 mRNA COVID-19 vaccine. Between July 2020–January 2021, 46,429 participants aged ≥ 12 years were randomized at 152 sites in 6 countries. Healthy participants with pre-existing stable neoplasm could participate; those receiving immunosuppressive therapy were excluded. Data are reported for participants, aged ≥ 16 years for safety and ≥ 12 years for efficacy, who had any history of neoplasm at baseline (data cut-off: March 13, 2021). Adverse-event (AE) data are controlled for follow-up time before unblinding and reported as incidence rates (IRs) per 100 person-years follow-up. At baseline, 3813 participants had a history of neoplasm; most common malignancies were breast (n = 460), prostate (n = 362), and melanoma (n = 223). Four BNT162b2 and 71 placebo recipients developed COVID-19 from 7 days post-dose 2; vaccine efficacy was 94.4% (95% CI: 85.2, 98.5) after up to 6 months’ follow-up post-dose 2. This compares favorably with vaccine efficacy of 91.1% in the overall trial population after the same follow-up. AEs were reported at IRs of 95.4(BNT162b2) and 48.3 (placebo) per 100 person-years. Most common AEs were reactogenicity events (injection-site pain, fatigue, pyrexia). Three BNT162b2 and 1 placebo recipients withdrew because of vaccine-related AEs. No vaccine-related deaths were reported. In participants with past or active neoplasms, BNT162b2 vaccine has a similar efficacy and safety profile as in the overall trial population. These results can inform BNT162b2 use during the COVID-19 pandemic and future trials in participants with cancer. Clinical trial number: NCT04368728.
Keywords	COVID-19 infection ; breasts ; death ; fever ; immunosuppression ; injection site ; melanoma ; pain ; placebos ; risk ; vaccines
Language	English
Dates of publication	2022-0301
Size	p. 1483-1492.
Publishing place	Elsevier Ltd
Document type	Article
ZDB-ID	605674-x
ISSN	1873-2518 ; 0264-410X
ISSN (online)	1873-2518
ISSN	0264-410X
DOI	10.1016/j.vaccine.2021.12.046
Database	NAL-Catalogue (AGRICOLA)

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Article ; Online: Immunogenicity and Safety of a Third COVID-19 BNT162b2 mRNA Vaccine Dose in 5- to 11-Year Olds.

Journal of the Pediatric Infectious Diseases Society

2023 Volume 12, Issue 4, Page(s) 234–238

Abstract: In this ongoing study, substantially increased ancestral SARS-CoV-2 neutralizing responses were observed 1 month after a third 10-µg BNT162b2 dose given to 5 to 11-year olds versus neutralizing responses post-dose 2. After dose 3, increased neutralizing ... ...

Abstract	In this ongoing study, substantially increased ancestral SARS-CoV-2 neutralizing responses were observed 1 month after a third 10-µg BNT162b2 dose given to 5 to 11-year olds versus neutralizing responses post-dose 2. After dose 3, increased neutralizing responses against Omicron BA.1 and BA.4/BA.5 strains were also observed. The safety/tolerability profile was acceptable. (NCT04816643).
MeSH term(s)	Humans ; Antibodies, Viral ; BNT162 Vaccine ; COVID-19/prevention & control ; Immunogenicity, Vaccine ; SARS-CoV-2 ; mRNA Vaccines
Chemical Substances	Antibodies, Viral ; BNT162 Vaccine
Language	English
Publishing date	2023-03-16
Publishing country	England
Document type	Clinical Trial ; Journal Article
ZDB-ID	2668791-4
ISSN	2048-7207 ; 2048-7193
ISSN (online)	2048-7207
ISSN	2048-7193
DOI	10.1093/jpids/piad015
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Article ; Online: Efficacy and safety of the BNT162b2 mRNA COVID-19 vaccine in participants with a history of cancer: subgroup analysis of a global phase 3 randomized clinical trial.

Thomas, Stephen J / Perez, John L / Lockhart, Stephen P / Hariharan, Subramanian / Kitchin, Nicholas / Bailey, Ruth / Liau, Katherine / Lagkadinou, Eleni / Türeci, Özlem / Şahin, Ugur / Xu, Xia / Koury, Kenneth / Dychter, Samuel S / Lu, Claire / Gentile, Teresa C / Gruber, William C

Vaccine

2021 Volume 40, Issue 10, Page(s) 1483–1492

Abstract: Introduction: Individuals with an underlying malignancy have high risk of poor COVID-19 outcomes. In clinical trials, COVID-19 vaccines were safe and efficacious against infection, hospitalization, and death, but most trials excluded participants with ... ...

Abstract	Introduction: Individuals with an underlying malignancy have high risk of poor COVID-19 outcomes. In clinical trials, COVID-19 vaccines were safe and efficacious against infection, hospitalization, and death, but most trials excluded participants with cancer. We report results from participants with a history of past or active neoplasm (malignant or benign/unknown) and up to 6 months' follow-up post-dose 2 from the placebo-controlled, observer-blinded trial of the 2-dose BNT162b2 mRNA COVID-19 vaccine. Patients and methods: Between July 2020-January 2021, 46,429 participants aged ≥ 12 years were randomized at 152 sites in 6 countries. Healthy participants with pre-existing stable neoplasm could participate; those receiving immunosuppressive therapy were excluded. Data are reported for participants, aged ≥ 16 years for safety and ≥ 12 years for efficacy, who had any history of neoplasm at baseline (data cut-off: March 13, 2021). Adverse-event (AE) data are controlled for follow-up time before unblinding and reported as incidence rates (IRs) per 100 person-years follow-up. Results: At baseline, 3813 participants had a history of neoplasm; most common malignancies were breast (n = 460), prostate (n = 362), and melanoma (n = 223). Four BNT162b2 and 71 placebo recipients developed COVID-19 from 7 days post-dose 2; vaccine efficacy was 94.4% (95% CI: 85.2, 98.5) after up to 6 months' follow-up post-dose 2. This compares favorably with vaccine efficacy of 91.1% in the overall trial population after the same follow-up. AEs were reported at IRs of 95.4(BNT162b2) and 48.3 (placebo) per 100 person-years. Most common AEs were reactogenicity events (injection-site pain, fatigue, pyrexia). Three BNT162b2 and 1 placebo recipients withdrew because of vaccine-related AEs. No vaccine-related deaths were reported. Conclusion: In participants with past or active neoplasms, BNT162b2 vaccine has a similar efficacy and safety profile as in the overall trial population. These results can inform BNT162b2 use during the COVID-19 pandemic and future trials in participants with cancer. Clinical trial number: NCT04368728.
MeSH term(s)	Adolescent ; BNT162 Vaccine ; COVID-19 ; COVID-19 Vaccines ; Child ; Humans ; Male ; Neoplasms ; Pandemics ; RNA, Messenger ; SARS-CoV-2
Chemical Substances	COVID-19 Vaccines ; RNA, Messenger ; BNT162 Vaccine (N38TVC63NU)
Language	English
Publishing date	2021-12-24
Publishing country	Netherlands
Document type	Clinical Trial, Phase III ; Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	605674-x
ISSN	1873-2518 ; 0264-410X
ISSN (online)	1873-2518
ISSN	0264-410X
DOI	10.1016/j.vaccine.2021.12.046
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Article ; Online: Causal and Candidate Gene Variants in a Large Cohort of Women With Primary Ovarian Insufficiency.

Gorsi, Bushra / Hernandez, Edgar / Moore, Marvin Barry / Moriwaki, Mika / Chow, Clement Y / Coelho, Emily / Taylor, Elaine / Lu, Claire / Walker, Amanda / Touraine, Philippe / Nelson, Lawrence M / Cooper, Amber R / Mardis, Elaine R / Rajkovic, Aleksander / Yandell, Mark / Welt, Corrine K

The Journal of clinical endocrinology and metabolism

2021 Volume 107, Issue 3, Page(s) 685–714

Abstract: Context: A genetic etiology likely accounts for the majority of unexplained primary ovarian insufficiency (POI).: Objective: We hypothesized that heterozygous rare variants and variants in enhanced categories are associated with POI.: Design: The ... ...

Abstract	Context: A genetic etiology likely accounts for the majority of unexplained primary ovarian insufficiency (POI). Objective: We hypothesized that heterozygous rare variants and variants in enhanced categories are associated with POI. Design: The study was an observational study. Setting: Subjects were recruited at academic institutions. Patients: Subjects from Boston (n = 98), the National Institutes of Health and Washington University (n = 98), Pittsburgh (n = 20), Italy (n = 43), and France (n = 32) were diagnosed with POI (amenorrhea with an elevated follicle-stimulating hormone level). Controls were recruited for health in old age or were from the 1000 Genomes Project (total n = 233). Intervention: We performed whole exome sequencing (WES), and data were analyzed using a rare variant scoring method and a Bayes factor-based framework for identifying genes harboring pathogenic variants. We performed functional studies on identified genes that were not previously implicated in POI in a D. melanogaster model. Main outcome: Genes with rare pathogenic variants and gene sets with increased burden of deleterious variants were identified. Results: Candidate heterozygous variants were identified in known genes and genes with functional evidence. Gene sets with increased burden of deleterious alleles included the categories transcription and translation, DNA damage and repair, meiosis and cell division. Variants were found in novel genes from the enhanced categories. Functional evidence supported 7 new risk genes for POI (USP36, VCP, WDR33, PIWIL3, NPM2, LLGL1, and BOD1L1). Conclusions: Candidate causative variants were identified through WES in women with POI. Aggregating clinical data and genetic risk with a categorical approach may expand the genetic architecture of heterozygous rare gene variants causing risk for POI.
MeSH term(s)	Adolescent ; Adult ; Case-Control Studies ; DNA Mutational Analysis ; Female ; Heterozygote ; Humans ; Mutation ; Primary Ovarian Insufficiency/genetics ; Exome Sequencing ; Young Adult
Language	English
Publishing date	2021-10-09
Publishing country	United States
Document type	Journal Article ; Multicenter Study ; Observational Study ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	3029-6
ISSN	1945-7197 ; 0021-972X
ISSN (online)	1945-7197
ISSN	0021-972X
DOI	10.1210/clinem/dgab775
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Article ; Online: Bivalent Omicron BA.1-Adapted BNT162b2 Booster in Adults Older than 55 Years.

Winokur, Patricia / Gayed, Juleen / Fitz-Patrick, David / Thomas, Stephen J / Diya, Oyeniyi / Lockhart, Stephen / Xu, Xia / Zhang, Ying / Bangad, Vishva / Schwartz, Howard I / Denham, Douglas / Cardona, Jose F / Usdan, Lisa / Ginis, John / Mensa, Federico J / Zou, Jing / Xie, Xuping / Shi, Pei-Yong / Lu, Claire /

Buitrago, Sandra / Scully, Ingrid L / Cooper, David / Koury, Kenneth / Jansen, Kathrin U / Türeci, Özlem / Şahin, Uğur / Swanson, Kena A / Gruber, William C / Kitchin, Nicholas

The New England journal of medicine

2023 Volume 388, Issue 3, Page(s) 214–227

Abstract: Background: The emergence of immune-escape variants of severe acute respiratory syndrome coronavirus 2 warrants the use of sequence-adapted vaccines to provide protection against coronavirus disease 2019.: Methods: In an ongoing phase 3 trial, adults ...

Abstract	Background: The emergence of immune-escape variants of severe acute respiratory syndrome coronavirus 2 warrants the use of sequence-adapted vaccines to provide protection against coronavirus disease 2019. Methods: In an ongoing phase 3 trial, adults older than 55 years who had previously received three 30-μg doses of the BNT162b2 vaccine were randomly assigned to receive 30 μg or 60 μg of BNT162b2, 30 μg or 60 μg of monovalent B.1.1.529 (omicron) BA.1-adapted BNT162b2 (monovalent BA.1), or 30 μg (15 μg of BNT162b2 + 15 μg of monovalent BA.1) or 60 μg (30 μg of BNT162b2 + 30 μg of monovalent BA.1) of BA.1-adapted BNT162b2 (bivalent BA.1). Primary objectives were to determine superiority (with respect to 50% neutralizing titer [NT Results: A total of 1846 participants underwent randomization. At 1 month after vaccination, bivalent BA.1 (30 μg and 60 μg) and monovalent BA.1 (60 μg) showed neutralizing activity against BA.1 superior to that of BNT162b2 (30 μg), with NT Conclusions: The candidate monovalent or bivalent omicron BA.1-adapted vaccines had a safety profile similar to that of BNT162b2 (30 μg), induced substantial neutralizing responses against ancestral and omicron BA.1 strains, and, to a lesser extent, neutralized BA.4, BA.5, and BA.2.75 strains. (Funded by BioNTech and Pfizer; ClinicalTrials.gov number, NCT04955626.).
MeSH term(s)	Humans ; Antibodies, Neutralizing/immunology ; Antibodies, Viral/immunology ; BNT162 Vaccine/adverse effects ; BNT162 Vaccine/immunology ; BNT162 Vaccine/therapeutic use ; COVID-19/genetics ; COVID-19/immunology ; COVID-19/prevention & control ; COVID-19/virology ; SARS-CoV-2/drug effects ; SARS-CoV-2/genetics ; SARS-CoV-2/immunology ; Vaccination ; Vaccines, Combined/therapeutic use ; Middle Aged
Chemical Substances	Antibodies, Neutralizing ; Antibodies, Viral ; BNT162 Vaccine ; Vaccines, Combined
Language	English
Publishing date	2023-01-17
Publishing country	United States
Document type	Clinical Trial, Phase III ; Journal Article ; Randomized Controlled Trial
ZDB-ID	207154-x
ISSN	1533-4406 ; 0028-4793
ISSN (online)	1533-4406
ISSN	0028-4793
DOI	10.1056/NEJMoa2213082
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Article ; Online: Safety and Efficacy of a Third Dose of BNT162b2 Covid-19 Vaccine.

Moreira, Edson D / Kitchin, Nicholas / Xu, Xia / Dychter, Samuel S / Lockhart, Stephen / Gurtman, Alejandra / Perez, John L / Zerbini, Cristiano / Dever, Michael E / Jennings, Timothy W / Brandon, Donald M / Cannon, Kevin D / Koren, Michael J / Denham, Douglas S / Berhe, Mezgebe / Fitz-Patrick, David / Hammitt, Laura L / Klein, Nicola P / Nell, Haylene /

Keep, Georgina / Wang, Xingbin / Koury, Kenneth / Swanson, Kena A / Cooper, David / Lu, Claire / Türeci, Özlem / Lagkadinou, Eleni / Tresnan, Dina B / Dormitzer, Philip R / Şahin, Uğur / Gruber, William C / Jansen, Kathrin U

The New England journal of medicine

2022 Volume 386, Issue 20, Page(s) 1910–1921

Abstract: Background: Active immunization with the BNT162b2 vaccine (Pfizer-BioNTech) has been a critical mitigation tool against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection during the coronavirus disease 2019 (Covid-19) pandemic. In ... ...

Abstract	Background: Active immunization with the BNT162b2 vaccine (Pfizer-BioNTech) has been a critical mitigation tool against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection during the coronavirus disease 2019 (Covid-19) pandemic. In light of reports of waning protection occurring 6 months after the primary two-dose vaccine series, data are needed on the safety and efficacy of offering a third (booster) dose in persons 16 years of age or older. Methods: In this ongoing, placebo-controlled, randomized, phase 3 trial, we assigned participants who had received two 30-μg doses of the BNT162b2 vaccine at least 6 months earlier to be injected with a third dose of the BNT162b2 vaccine or with placebo. We assessed vaccine safety and efficacy against Covid-19 starting 7 days after the third dose. Results: A total of 5081 participants received a third BNT162b2 dose and 5044 received placebo. The median interval between dose 2 and dose 3 was 10.8 months in the vaccine group and 10.7 months in the placebo group; the median follow-up was 2.5 months. Local and systemic reactogenicity events from the third dose were generally of low grade. No new safety signals were identified, and no cases of myocarditis or pericarditis were reported. Among the participants without evidence of previous SARS-CoV-2 infection who could be evaluated, Covid-19 with onset at least 7 days after dose 3 was observed in 6 participants in the vaccine group and in 123 participants in the placebo group, which corresponded to a relative vaccine efficacy of 95.3% (95% confidence interval, 89.5 to 98.3). Conclusions: A third dose of the BNT162b2 vaccine administered a median of 10.8 months after the second dose provided 95.3% efficacy against Covid-19 as compared with two doses of the BNT162b2 vaccine during a median follow-up of 2.5 months. (Funded by BioNTech and Pfizer; C4591031 ClinicalTrials.gov number, NCT04955626.).
MeSH term(s)	BNT162 Vaccine/adverse effects ; BNT162 Vaccine/therapeutic use ; COVID-19/prevention & control ; COVID-19 Vaccines/adverse effects ; COVID-19 Vaccines/therapeutic use ; Humans ; Immunization, Secondary/adverse effects ; Pandemics ; SARS-CoV-2 ; Treatment Outcome
Chemical Substances	COVID-19 Vaccines ; BNT162 Vaccine (N38TVC63NU)
Language	English
Publishing date	2022-03-23
Publishing country	United States
Document type	Clinical Trial, Phase III ; Journal Article ; Randomized Controlled Trial
ZDB-ID	207154-x
ISSN	1533-4406 ; 0028-4793
ISSN (online)	1533-4406
ISSN	0028-4793
DOI	10.1056/NEJMoa2200674
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Article ; Online: 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 / Şahin, Uğur / Jansen, Kathrin U / Gruber, William C

The New England journal of medicine

2022 Volume 388, Issue 7, Page(s) 621–634

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 ... ...

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 2:1 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.).
MeSH term(s)	Adolescent ; Child ; Child, Preschool ; Humans ; Infant ; Young Adult ; Antibodies, Viral/blood ; Antibodies, Viral/immunology ; BNT162 Vaccine/administration & dosage ; BNT162 Vaccine/adverse effects ; BNT162 Vaccine/immunology ; BNT162 Vaccine/therapeutic use ; COVID-19/blood ; COVID-19/immunology ; COVID-19/prevention & control ; COVID-19 Vaccines/administration & dosage ; COVID-19 Vaccines/adverse effects ; COVID-19 Vaccines/immunology ; COVID-19 Vaccines/therapeutic use ; Immunoglobulin G/blood ; Immunoglobulin G/immunology ; Vaccines/adverse effects ; Vaccines/therapeutic use ; Immunogenicity, Vaccine ; Treatment Outcome ; Vaccine Efficacy
Chemical Substances	Antibodies, Viral ; BNT162 Vaccine ; COVID-19 Vaccines ; Immunoglobulin G ; Vaccines
Language	English
Publishing date	2022-12-19
Publishing country	United States
Document type	Clinical Trial, Phase II ; Clinical Trial, Phase III ; Journal Article ; Randomized Controlled Trial
ZDB-ID	207154-x
ISSN	1533-4406 ; 0028-4793
ISSN (online)	1533-4406
ISSN	0028-4793
DOI	10.1056/NEJMoa2211031
Database	MEDical Literature Analysis and Retrieval System OnLINE

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