How can COVID-19 vaccines benefit people? A study based on the theory of the commons DOI Creative Commons
Yiqing Su, Yanyan Li,

S. Zhang

et al.

Human Vaccines & Immunotherapeutics, Journal Year: 2023, Volume and Issue: 19(2)

Published: June 20, 2023

COVID−19 vaccination is a fundamental step toward controlling the pandemic and defusing public health crisis it has caused. Existing studies have demonstrated that equitable distribution of vaccines can only be achieved if these are treated as goods. The question remains how to transform into In this paper, based on theory commons governance, theoretical mechanism analyzed realize adequate vaccines. Furthermore, feasible methods benefit people through successful popularization in China summarized. results show ensure supply vaccines, government intervention required because expand vaccine by balancing individual benefits for producing enterprises overall society. also guarantee right every member society receive thus enabling whole nation. By analyzing people, paper further verifies national plays an essential role both developed developing countries. It may mean state play continuing respond major events possible future.

Language: Английский

Immunogenicity of a Fractional Dose of mRNA BNT162b2 COVID-19 Vaccine for Primary Series and Booster Vaccination among Healthy Adolescents DOI Creative Commons
Thanyawee Puthanakit, Napaporn Chantasrisawad,

Kirana Yoohat

et al.

Vaccines, Journal Year: 2022, Volume and Issue: 10(10), P. 1646 - 1646

Published: Sept. 30, 2022

Primary series vaccination with BNT162b2 followed by a booster 5 months later has been recommended for healthy adolescents. We aimed to describe the immunogenicity in fractional dose of BNT162b2. Adolescents aged 12-18 years were randomized into six arms primary administration: 3wPZ30/30 (reference group), 3wPZ30/20, 3wPZ20/20, 6wPZ30/30, 6wPZ30/20, and 6wPZ20/20 μg. A was given at after second using either 10 or 15 μg Immunogenicity following determined IgG against receptor-binding domain (anti-S-RBD IgG; BAU/mL), surrogate virus neutralization test (sVNT; %inhibition) pseudovirus (pVNT;ID50) Omicron. Non-inferiority criteria defined as lower boundary geometric mean ratio (GMR) being greater than 0.67. From September October 2021, 118 adolescents median age (IQR) 14.9 (13.9-16.7) enrolled. Fourteen days series, means (GMs) anti-S-RBD (BAU/mL) 3090 (95% CI 2761-3460) 3wPZ30/30. The GMRs were: 0.80 0.67-0.97) 3wPZ30/20; 1.00 0.83-1.20) 3wPZ20/20; 1.37 1.13-1.65) 6wPZ30/30; 1.24 1.02-1.50) 6wPZ30/20; 1.36 (1.13-1.64) 6wPZ20/20. After (n = 24) BNT162b2, sVNT pVNT Omicron variant 91.6 88.4-94.9) 331 221-495), respectively. In group that received 25), 85.6 80.0-91.6) 397 267-590). Healthy had good immune responses regimen this may be considered an alternative option.

Language: Английский

Citations

7
Dose optimisation and scarce resource allocation: two sides of the same coin DOI Creative Commons
Garth W. Strohbehn, Govind Persad, William F. Parker

et al.

BMJ Open, Journal Year: 2022, Volume and Issue: 12(10), P. e063436 - e063436

Published: Oct. 1, 2022

A deep understanding of the relationship between a scarce drug's dose and clinical response is necessary to appropriately distribute supply-constrained drug along these lines.The vast majority development repurposing during COVID-19 pandemic - an event that has made clear ever-present scarcity in healthcare systems -has been ignorant optimisation's ability help address it.Future trials should obtain optimisation data, as appear enable appropriate resource allocation according societal values.

Language: Английский

Citations

7
Cost effectiveness of fractional doses of COVID-19 vaccine boosters in India DOI Creative Commons
Zhanwei Du, Lin Wang, Yuan Bai

et al.

Med, Journal Year: 2023, Volume and Issue: 4(3), P. 182 - 190.e3

Published: Feb. 13, 2023

Language: Английский

Citations

4
Immunogenicity of Intradermal Versus Intramuscular BNT162b2 COVID-19 Booster Vaccine in Patients with Immune-Mediated Dermatologic Diseases: A Non-Inferiority Randomized Controlled Trial DOI Creative Commons
Chutima Seree-aphinan, Ploysyne Rattanakaemakorn, Poonkiat Suchonwanit

et al.

Vaccines, Journal Year: 2024, Volume and Issue: 12(1), P. 73 - 73

Published: Jan. 11, 2024

The intradermal route has emerged as a dose-sparing alternative during the coronavirus disease 2019 (COVID-19) pandemic. Despite its efficacy in healthy populations, immunogenicity not been tested immune-mediated dermatologic (IMDD) patients. This assessor-blinded, randomized-controlled, non-inferiority trial recruited patients with two representative IMDDs (i.e., psoriasis and autoimmune bullous diseases) to vaccinate fractionated-dose (fID) or standard intramuscular (sIM) BNT162b2 vaccines fourth booster dose under block randomization stratified by age, sex, their skin diseases. Post-vaccination SARS-CoV-2-specific IgG interferon-γ responses measured 4 12 weeks post-intervention were serological surrogates used for demonstrating treatment effects. Mean differences log-normalized outcome estimates calculated multivariable linear regression adjusting baseline values, systemic immunosuppressants used, prior COVID-19 vaccination history. margin was set fID retain >80% of sIM. With 109 participants included, 53 received (all entered an intention-to-treat analysis). demonstrated sIM humoral (mean sIM: 3.3, ΔfID-sIM [mean, 95%CI]: -0.1, -0.3 0.0) cellular 3.2, 0.1, -0.2 0.3) outcomes. Two from arm (3.8%) developed injection-site Koebner's phenomenon. Fewer recipients experienced post-vaccination fever (fID vs. 1.9% 12.5%,

Language: Английский

Citations

1
Federated X-armed Bandit DOI Open Access
Wenjie Li,

Qifan Song,

Jean Honorio

et al.

Proceedings of the AAAI Conference on Artificial Intelligence, Journal Year: 2024, Volume and Issue: 38(12), P. 13628 - 13636

Published: March 24, 2024

This work establishes the first framework of federated X-armed bandit, where different clients face heterogeneous local objective functions defined on same domain and are required to collaboratively figure out global optimum. We propose algorithm for such problems, named Fed-PNE. By utilizing topological structure inside hierarchical partitioning weak smoothness property, our achieves sublinear cumulative regret with respect both number evaluation budget. Meanwhile, it only requires logarithmic communications between central server clients, protecting client privacy. Experimental results synthetic real datasets validate advantages Fed-PNE over various centralized baseline algorithms.

Language: Английский

Citations

1
Targeted randomization dose optimization trials enable fractional dosing of scarce drugs DOI Creative Commons
Philip S. Boonstra, Alex Tabarrok, Garth W. Strohbehn

et al.

PLoS ONE, Journal Year: 2023, Volume and Issue: 18(10), P. e0287511 - e0287511

Published: Oct. 30, 2023

Administering drug at a dose lower than that used in pivotal clinical trials, known as fractional dosing, can stretch scarce resources. Implementing dosing with confidence requires understanding drug's dose-response relationship. Clinical trials aimed describing scarce, efficacious drugs risk underdosing, leading dose-finding to not be pursued despite their obvious potential benefit. We developed new set of response-adaptive randomized and demonstrate, series simulated across diverse curves, these designs' efficiency identifying the minimum achieves satisfactory efficacy. Compared conventional designs, have higher probabilities doses while reducing risks both population- subject-level underdosing. strongly recommend that, upon demonstration efficacy, pandemic development swiftly proceeds trials. This unified strategy ensures effective produce maximum social benefits.

Language: Английский

Citations

3
A Quantitative Clinical Pharmacology-Based Framework For Model-Informed Vaccine Development DOI Creative Commons
Rajat Desikan, Massimiliano Germani, Piet H. van der Graaf

et al.

Journal of Pharmaceutical Sciences, Journal Year: 2023, Volume and Issue: 113(1), P. 22 - 32

Published: Nov. 2, 2023

Historically, vaccine development and dose optimization have followed mostly empirical approaches without clinical pharmacology model-informed playing a major role, in contrast to conventional drug development. This is attributed the complex cascade of immunobiological mechanisms associated with vaccines lack quantitative frameworks for extracting dose-exposure-efficacy-toxicity relationships. However, Covid-19 pandemic highlighted sufficient immunogenicity due suboptimal dosing regimens need well-designed, trials which enhance probability selection optimal regimens. In this perspective, we attempt develop pharmacology-based approach that integrates dose-efficacy-toxicity across various stages into unified framework term as dose-optimization (MIVD). We highlight scenarios where adoption MIVD may strategic advantage compared practices vaccines.

Language: Английский

Citations

3
Immunogenicity, safety, and reactogenicity of a half- versus full-dose BNT162b2 (Pfizer-BioNTech) booster following a two-dose ChAdOx1 nCoV-19, BBIBP-CorV, or Gam-COVID-Vac priming schedule in Mongolia: a randomised, controlled, non-inferiority trial DOI Creative Commons
Tsetsegsaikhan Batmunkh, Kerryn A. Moore,

Helen Thomson

et al.

The Lancet Regional Health - Western Pacific, Journal Year: 2023, Volume and Issue: 42, P. 100953 - 100953

Published: Nov. 21, 2023

BackgroundCOVID-19 vaccine booster doses restore effectiveness lost from waning immunity and emerging variants. Fractional dosing may improve COVID-19 acceptability uptake will reduce the per-dose cost of programmes. We sought to quantify immunogenicity, reactogenicity, safety a half-dose BNT162b2 (Pfizer-BioNTech) relative standard formulation.MethodsThis randomised, controlled, non-inferiority trial recruited adults in Mongolia primed with two-dose homologous ChAdOx1 nCov-19 (Oxford-AstraZeneca, n = 129 participants), BBIBP-CorV (Sinopharm (Beijing), 399), or Gam-COVID-Vac (Gamaleya, 70) schedule. Participants were randomised (1:1) receive 15 μg (half-dose) 30 (full-dose) booster. study staff assessing reactogenicity blinded up day 28. Co-primary endpoints Wuhan-Hu-1 anti-spike S1 IgG seroresponse 28 days post-boosting within 7 boosting. The margin for absolute difference was −10%. Differences estimated logistic regression marginal standardisation. Geometric mean ratios also estimated. ClinicalTrials.gov Identifier: NCT05265065.FindingsBetween May 27th September 30th, 2022, 601 participants randomized full-dose (n 300) 301). 598 included analyses, 587 immunological analyses. frequency grade 3–4 reactions similar between arms (half-dose: 4/299 [1.3%]; full-dose: 6/299 [2.0%]). Across all severity grades, recipients reported fewer local systemic (60% versus 72% 25% 32%, respectively). Seroresponse 84.7% (250/295) 86.6% (253/292) arms, respectively (Difference: −2.8%; 95% CI −7.7, 2.1). titres those receiving full boosters groups, but lower arm Gam-COVID-Vac-primed (GMR: 0.71; 0.54, 0.93).InterpretationHalf-dose boosting elicited an immune response that non-inferior full-dose, reactions, BBIBP-CorV. Half-dose not be suitable Gam-COVID-Vac. considered populations BBIBP-CorV.FundingCoalition Epidemic Preparedness Innovations (CEPI).

Language: Английский

Citations

3
A Randomized Clinical Trial of a Fractional Low Dose of BNT162b2 Booster in Adults Following AZD1222 DOI Creative Commons
Rapisa Nantanee, Watsamon Jantarabenjakul, Peera Jaru-Ampornpan

et al.

Vaccines, Journal Year: 2022, Volume and Issue: 10(6), P. 914 - 914

Published: June 8, 2022

In the era of globally predominant omicron strains, a COVID-19 booster vaccine is needed. Our study aimed to evaluate immunogenicity half-dose BNT162b2 after AZD1222 in healthy adults. A randomized trial volunteers aged 18–69 years who received two-dose was conducted. The participants were receive intramuscularly—half (15 µg) vs. standard dose (30 µg). evaluated by surrogate virus neutralization test (sVNT) against variants and anti-spike-receptor-binding-domain IgG (anti-S-RBD IgG). From November–December 2021, 100 adults with median age 59.3 (IQR 33.4–65.5) enrolled. given at 98 days 92–128) AZD1222. At day 14, geometric means (GMs) anti-S-RBD half- standard-dose group 2329.8 2574.7 BAU/mL, mean ratio (GMR) 0.90 (0.77–1.06). GMs sVNT variant groups 74.4% inhibition (95% CI 68.8–80.5) 67.3% (57.9–78.1), respectively, GMR 0.95 (0.69–1.30). 90, indicated 22.3% 14.9–33.4) 20.4% (13.1–32.0), 1.09 (0.60–1.98). fractional low-dose mRNA provided non-inferior responses. During shortage supply, low should be considered for vaccination program.

Language: Английский

Citations

4
Fractional Dosing of Yellow Fever Live Attenuated 17D Vaccine: A Perspective DOI Creative Commons
Clairissa A. Hansen, J. Erin Staples, Alan D.T. Barrett

et al.

Infection and Drug Resistance, Journal Year: 2023, Volume and Issue: Volume 16, P. 7141 - 7154

Published: Nov. 1, 2023

Yellow fever virus (YFV) is a mosquito-borne flavivirus that causes over 109,000 severe infections and 51,000 deaths annually in endemic areas of sub-Saharan Africa tropical South America. The has transmission cycle involving mosquitoes humans or non-human primates (NHPs) as the vertebrate hosts. Although yellow (YF) prevented by live attenuated vaccine (strain 17D), recent epidemics Angola, Democratic Republic Congo (DRC), Brazil put great pressure on stockpiles. This resulted World Health Organization (WHO) Pan American (PAHO) implementing, an emergency basis only, off-label dose-sparing techniques policies during 2016-2018 to protect many people DRC possible from disease unexpected large outbreaks YF. Subsequently non-inferiority studies full doses compared fractional indicated promising results, leading some policy-makers scientists consider utilizing YF non-emergency scenarios. additional data immunogenicity safety are promising, there several questions considerations remain regarding use doses, including differences initial antibody kinetics, immune response certain populations, durability doses. Until remaining knowledge gaps addressed, instead should continue be used unless insufficient available control

Language: Английский

Citations

2