Study of immunogenicity and efficacy against Omicron BA.5 of recombinant protein-based COVID-19 vaccine delivered by intramuscular and mucosal routes in nonhuman primates DOI

Ranajit Pal,

Maria Grazia Ferrari,

Yoshikazu Honda‐Okubo

et al.

Vaccine, Journal Year: 2024, Volume and Issue: 42(5), P. 1122 - 1135

Published: Jan. 22, 2024

Language: Английский

Strength and durability of indirect protection against SARS-CoV-2 infection through vaccine and infection-acquired immunity DOI Creative Commons
Sophia T. Tan, Isabel Rodríguez-Barraquer, Ada Kwan

et al.

Nature Communications, Journal Year: 2025, Volume and Issue: 16(1)

Published: Jan. 29, 2025

Abstract Early investigation revealed a reduced risk of SARS-CoV-2 infection among social contacts COVID-19 vaccinated individuals, referred to as indirect protection. However, protection from infection-acquired immunity and its comparative strength durability vaccine-derived in the current epidemiologic context high levels vaccination, prior infection, novel variants are not well characterized. Here, we show that both independently yield close with key differences their waning. Analyzing anonymized surveillance data 9,625 residents California state prisons December 2021 2022, find against Omicron is strongest within three months vaccination [30% (95% confidence interval: 20–38%)] subsequent modest Infection-acquired provides 38% (24–50%) for 6 after moderate persisting over one year. Variant-targeted vaccines (bivalent formulation including subvariants BA.4/BA.5) confer strong at least [40% (3–63%)]. These results demonstrate can reduce transmission which important understanding long-term dynamics guide public health intervention, especially high-risk environments such prisons.

Language: Английский

Citations

1

A phase I/II study of CpG/alum-adjuvanted mammalian-derived quadruple antigen carrying virus-like particle COVID-19 vaccine DOI
İsmail Yılmaz, Emre Mert İpekoğlu,

Berfu Saraydar Golcuklu

et al.

Vaccine, Journal Year: 2025, Volume and Issue: 49, P. 126787 - 126787

Published: Jan. 31, 2025

Language: Английский

Citations

1

Ensitrelvir for the Treatment of Nonhospitalized Adults with COVID-19: Results from the SCORPIO-HR, Phase 3, Randomized, Double-blind, Placebo-Controlled Trial DOI Creative Commons
Anne F. Luetkemeyer, Kara W. Chew,

Stuart R. Lacey

et al.

Clinical Infectious Diseases, Journal Year: 2025, Volume and Issue: unknown

Published: Jan. 20, 2025

Ensitrelvir, a severe acute respiratory syndrome coronavirus-2 main protease inhibitor, has demonstrated clinical and virologic efficacy in previous studies. In this global phase 3 trial, nonhospitalized adults with mild-to-moderate coronavirus disease 2019 (COVID-19) symptom onset within 5 days were randomized (1:1) to receive once-daily ensitrelvir (375 mg day 1, 125 2-5) or blinded matching placebo. The primary endpoint was the restricted mean time sustained (≥2 days) resolution of 15 COVID-19 symptoms, recorded participant daily diaries, through 29 participants starting treatment after onset. Virologic safety assessed. Of 2093 participants, 1888 started Mean 12.5 13.1 placebo, respectively (difference, -0.6 days; 95% confidence interval, -1.38 0.19; P = .14). On 4, reduced least-squares RNA by 0.72 log10 copies/mL more than placebo (95% 0.55-0.90). Among those positive viral cultures at enrollment, 274/287 (95.5%) ensitrelvir-treated versus 210/280 (75.0%) placebo-treated had negative on 4. rebound similar (<1.5%) between groups. proportion ≥1 adverse event (61.5%) (60.6%). No treatment-related serious events deaths occurred. Three (0.3%) 1 (0.1%) COVID-19-related hospitalizations 29. Despite evidence antiviral activity ensitrelvir, trial did not demonstrate significant difference resolution.

Language: Английский

Citations

1

Impact of pre-Omicron COVID-19 vaccine boosters on the risk of Omicron variant infections: A systematic review and meta-regression DOI Creative Commons

Bing-Yi Pan,

IShin Tseng,

Yen‐Chen Anne Feng

et al.

Journal of the Formosan Medical Association, Journal Year: 2025, Volume and Issue: unknown

Published: April 1, 2025

Language: Английский

Citations

1

Tracking the progressive spread of the SARS-CoV-2 Omicron variant in Italy, December 2021 to January 2022 DOI Creative Commons
Paola Stefanelli, Filippo Trentini, Daniele Petrone

et al.

Eurosurveillance, Journal Year: 2022, Volume and Issue: 27(45)

Published: Nov. 10, 2022

Background The SARS-CoV-2 variant of concern Omicron was first detected in Italy November 2021. Aim To comprehensively describe spread the 2 subsequent months and its impact on overall circulation at population level. Methods We analyse data from four genomic surveys conducted across country between December 2021 January 2022. Combining sequencing results with epidemiological records collated by National Integrated Surveillance System, reproductive number exponential growth rate are estimated, as well transmissibility. Results became dominant less than 1 month after detection, representing 3 76.9–80.2% notified infections, a doubling time 2.7–3.3 days. As 17 2022, Delta represented < 6% cases. During expansion 2021, estimated mean net reproduction numbers respectively rose 1.15 to maximum 1.83 for symptomatic cases 1.14 1.36 hospitalised cases, while remaining relatively stable, 0.93 1.21, needing intensive care. Despite reduction relative proportion, infections increased absolute terms throughout contributing an increase hospitalisations. A significant numbers’ decline found mid-January, average estimates dropping below 10 16 Conclusion Estimates suggest marked advantage compared variant, but lower disease severity level possibly due residual immunity against severe outcomes acquired vaccination prior infection.

Language: Английский

Citations

33

Immunogenicity and Reactogenicity of Coadministration of COVID-19 and Influenza Vaccines DOI Creative Commons
Tal Gonen, Noam Barda,

Keren Asraf

et al.

JAMA Network Open, Journal Year: 2023, Volume and Issue: 6(9), P. e2332813 - e2332813

Published: Sept. 8, 2023

COVID-19 and seasonal influenza vaccines were previously given separately, although their coadministration is warranted for vaccination adherence. Limited data on have been published.To compare the reactogenicity immunogenicity of vaccinations administered together with those alone.This prospective cohort study included health care workers at a large tertiary medical center in Israel who received Influvac Tetra (Abbott) vaccine (2022/2023), Omicron BA.4/BA.5-adapted bivalent (Pfizer/BioNTech) vaccine, or both. Vaccination began September 2022, collected until January 2023. Vaccines offered to all employees coadministered separately. Adverse reaction questionnaires sent, serologic samples also collected.Receiving both.The main outcomes analysis symptoms following receipt, assessed by digital questionnaire: any local symptoms; fever; weakness fatigue; systemic duration. The analysis' outcome was postvaccination anti-spike IgG titer.This 2 cohorts separate analyses. 588 participants (of 649 questionnaire responders): 85 vaccine-alone group (median [IQR] age, 71 [58-74] years; 56 [66%] female); 357 55 [40-65] 282 [79%] 146 61 [50-71] 81 [55%] female). 151 participants: 74 67 [56-73] 45 [61%] female) 77 60 [49-73] 42 Compared alone, risk similar (odds ratio, 0.82; 95% CI, 0.43-1.56). Geometric mean titers estimated be 0.84 (95% 0.69-1.04) times lower than group.In this an both, not associated substantially inferior immune response more frequent adverse events compared administration supporting these vaccines.

Language: Английский

Citations

20

Vaccination and the risk of post-acute sequelae after COVID-19 in the Omicron-predominant period DOI
Kyungmin Huh, Young‐Eun Kim,

Gi Hwan Bae

et al.

Clinical Microbiology and Infection, Journal Year: 2024, Volume and Issue: 30(5), P. 666 - 673

Published: Feb. 6, 2024

Language: Английский

Citations

8

Effectiveness of BNT162b2 BA.4/5 Bivalent COVID-19 Vaccine against Long COVID Symptoms: A US Nationwide Study DOI Creative Commons
Manuela Di Fusco, Xiaowu Sun, Kristen E. Allen

et al.

Vaccines, Journal Year: 2024, Volume and Issue: 12(2), P. 183 - 183

Published: Feb. 11, 2024

Background: Long COVID has become a central public health concern. This study characterized the effectiveness of BNT162b2 BA.4/5 bivalent COVID-19 vaccine (bivalent) against long symptoms. Methods: Symptomatic US adult outpatients testing positive for SARS-CoV-2 were recruited between 2 March and 18 May 2023. Symptoms assessed longitudinally using CDC-based symptom questionnaire at Week 4, Month 3, 6 following infection. The odds ratio (OR) vaccination groups was by mixed-effects logistic models, adjusting multiple covariates. Results: At among 505 participants, 260 (51%) vaccinated with 245 (49%) unvaccinated. Mean age 46.3 years, 70.7% female, 25.1% had ≥1 comorbidity, 43.0% prior infection, 23.0% reported Nirmatrelvir/Ritonavir use. 6, cohort 41% lower risk ≥3 symptoms (OR: 0.59, 95% CI, 0.36–0.96, p = 0.034) 37% ≥2 0.63, 0.41–0.96, 0.030). fewer less durable throughout six-month follow-up, driven neurologic general symptoms, especially fatigue. Conclusions: Compared unvaccinated participants associated approximately 40% burden over duration.

Language: Английский

Citations

8

COVID-19 Modified mRNA “Vaccines”: Lessons Learned from Clinical Trials, Mass Vaccination, and the Bio-Pharmaceutical Complex, Part 1 DOI
M. Nathaniel Mead, Stephanie Seneff, Russ Wolfinger

et al.

International Journal of Vaccine Theory Practice and Research, Journal Year: 2024, Volume and Issue: 3(2), P. 1112 - 1178

Published: June 29, 2024

Our understanding of COVID-19 synthetic, modified mRNA (modmRNA) products and their public health impact has evolved substantially since December 2020. Published reports from the original randomized placebo-controlled trials concluded that modmRNA injections could greatly reduce symptoms. However, premature termination both obviated any reliable assessment potential adverse events due to an insufficient timeframe for proper safety evaluation. Following authorization global distribution, problems with methods execution have emerged. The usual testing protocols toxicology requirements were bypassed. Many key trial findings either misreported or omitted entirely published reports. By implication, secondary estimates excess morbidity mortality in must be deemed underestimates. Rigorous re-analyses data post-marketing surveillance studies indicate a substantial degree modmRNA-related harms than was initially reported. Confidential Pfizer documents had revealed 1.6 million by August 2022. A third serious injuries cardiovascular, neurological, thrombotic, immunological, reproductive systems, along alarming increase cancers. Moreover, well-designed shown repeated cause immune dysfunction, thereby potentially contributing heightened susceptibility SARS-CoV-2 infections increased risks COVID-19. This paper also discusses insidious influence Bio-Pharmaceutical Complex, closely coordinated collaboration between organizations, pharmaceutical companies, regulatory agencies. We recommend moratorium on until toxicological are conducted.

Language: Английский

Citations

7

The effect of dose-interval on antibody response to mRNA COVID-19 vaccines: a prospective cohort study DOI Creative Commons
N. Almeida,

Ian Schiller,

Danbing Ke

et al.

Frontiers in Immunology, Journal Year: 2024, Volume and Issue: 15

Published: Feb. 16, 2024

Background Vaccination against COVID-19 is highly effective in preventing severe disease and hospitalization, but primary COVID mRNA vaccination schedules often differed from those recommended by the manufacturers due to supply chain issues. We investigated impact of delaying second dose on antibody responses mRNA-vaccines a prospective cohort health-care workers Quebec. Methods recruited participants McGill University Health Centre who provided serum or participant-collected dried blood samples (DBS) at 28-days, 3 months, 6 months post-second 28-days after third dose. IgG antibodies SARS-CoV2 spike (S), receptor-binding domain (RBD), nucleocapsid (N) neutralizing ancestral strain were assessed enzyme-linked immunosorbent assay (ELISA). examined associations between long (≤89 days) versus short (&lt;89 between-dose intervals response through multivariable mixed-effects models adjusted for age, sex, prior covid infection status, time since vaccine dose, batch. Findings The included 328 received up three doses (&gt;80% Pfizer-BioNTech). Weighted averages (n=744) DBS (n=216) results showed that anti-S was 31% higher (95% CI: 12% 53%) anti-RBD 37% 14% 65%) vs . interval participants, across all points. Interpretation Our study indicates extending series beyond 89 days (approximately months) provides stronger than less days. demonstration more robust with longer reassuring as logistical challenges are navigated low-resource settings.

Language: Английский

Citations

6