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COVID-19 vaccine (ARCT 154 / Kostaive / ARCT154)

✓ Approved

Arcturus Therapeutics, Inc. · Vaccine · Vaccine

What is COVID-19 vaccine?

COVID-19 vaccine is a vaccine developed by Arcturus Therapeutics, Inc.. It is approved for therapeutic indications via injectable (others) or intramuscular (im) injection.

Drug Profile

Brand NamesARCT 154, Kostaive, ARCT154
CompanyArcturus Therapeutics, Inc.
Drug ClassVaccine
RouteInjectable (Others), Intramuscular (IM) Injection
StatusApproved
Sources: ClinicalTrials.gov, Arcturus Therapeutics, Inc.

Therapeutic Indications

COVID-19 vaccine is developed for 1 unique indication across 1 therapeutic area.

Therapeutic AreaConditionPhase
Infections and infestationsCOVID-19✓ Approved

Related Research Articles

PubMedAAPS PharmSciTech2026-09-19

Comprehensive Stability Assessment of Squalene in a Nanoemulsion Adjuvant and the SpiN-Tec Vaccine: HPLC Quantification, Stress Testing, and Stability Studies.

Gomes Isabela Pereira IP, Rivelli Graziella Gomes GG, Bagno Flávia Fonseca FF, Hojo-Souza Natália Satchiko NS et al.

Squalene-based nanoemulsions are widely used as adjuvants in vaccine formulations, but their stability can be affected by environmental factors such as pH, oxidative stress, temperature, and light. We have produced a squalene nanoemulsion (CTVad1) to support the clinical development of new vaccines. This study aimed to develop and validate an HPLC method for squalene quantification in SpiN-Tec, a recombinant protein vaccine against COVID-19. We also aimed to evaluate the stability of the CTVad1 adjuvant and SpiN-Tec under controlled storage conditions. A reversed-phase HPLC method was developed and validated, and comprehensive forced degradation studies were performed on the raw material and SpiN-Tec under acidic, basic, oxidative, thermal, and photolytic conditions to demonstrate the stability-indicating capability of the method. Physicochemical, morphological, and biological characteristics were assessed, and stability studies of both the vaccine and the CTVad1 adjuvant were performed under accelerated and long-term conditions. The HPLC method was selective, precise, accurate, linear, and robust. Squalene raw material degraded under all tested conditions, whereas formulation in nano-sized globules improved its stability, with degradation observed only under hydrogen peroxide and light exposure. CTVad1 remained stable over time, exhibiting only minor, non-critical changes within the specification limits in both accelerated and long-term stability studies, regardless of the glass packaging used (clear or amber). In addition, the SpiN-Tec vaccine maintained its physicochemical and biological integrity under all tested conditions, with all evaluated parameters remaining within the established specification ranges. Our findings demonstrate that proper formulation, packaging, and storage conditions can preserve squalene stability in nanoemulsion-based vaccines, ensuring the quality, safety, and efficacy of the SpiN-Tec vaccine and its adjuvant throughout shelf life.

PMID 42760453
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PubMedMedicine2026-09-19

Association between COVID-19 and exacerbation of allergic skin diseases: A retrospective questionnaire-based cross-sectional study in Western China.

Liu Yu-Ling YL, Zhang Zeng-Yun-Ou ZY, Chen Xiao-Mei XM

Coronavirus disease 2019 (COVID-19) has been linked to systemic immune dysregulation and various cutaneous manifestations, but its association with chronic allergic skin diseases, including atopic dermatitis (AD) and chronic urticaria (CU), remains unclear. This retrospective questionnaire-based cross-sectional study enrolled patients with AD and/or CU from a tertiary dermatology outpatient center in Western China. Self-administered questionnaires collected data on COVID-19 infection status, clinical characteristics, medication use, and self-reported changes in disease status within 14 days of COVID-19 symptom onset or diagnosis. Outcomes were self-reported rather than based on validated severity scores, and no prospective longitudinal follow-up was performed. Multivariable logistic regression analyses were conducted to identify factors associated with self-reported exacerbation. Covariates were selected a priori based on clinical relevance, and no missing data were present. A total of 509 patients with AD and/or CU were included. Compared with the non-COVID-19 group, participants with COVID-19 more frequently reported current alcohol consumption, pre-COVID-19 antihistamine use, insomnia, allergic rhinitis, and discontinuation of dermatological medications. COVID-19 infection was associated with self-reported exacerbation of allergic skin diseases in both the baseline-adjusted model (odds ratio [OR] = 4.611, 95% confidence interval [CI] = 2.268-9.377) and the fully adjusted model (OR = 4.445, 95% CI = 2.159-9.151). Among participants with COVID-19, fever, headache, fatigue, taste loss, reported use of antipyretics and antibiotics, and nervousness differed between the exacerbation and non-exacerbation groups. After multivariable adjustment, fatigue (OR = 1.601, 95% CI = 1.049-2.443), taste loss (OR = 1.654, 95% CI = 1.004-2.723), and the reported use of antibiotics (OR = 1.609, 95% CI = 1.036-2.499) and antipyretics (OR = 1.575, 95% CI = 1.037-2.392) were associated with self-reported exacerbation, although the medication-related associations likely reflected confounding by indication. Sensitivity analyses yielded consistent results. In this retrospective questionnaire-based cross-sectional study conducted during the omicron wave, COVID-19 infection was associated with self-reported exacerbation of AD and CU within 14 days of symptom onset or diagnosis. Because the outcome was based on participants' recall of symptom change rather than objective clinical assessment, the findings should be interpreted with caution, and their generalizability is limited by the single-center, omicron-period design. Associations with antipyretics and antibiotics likely reflect confounding by indication rather than direct pharmacological effects. Prospective multicenter studies with standardized outcome measures are needed to validate these findings.

PMID 42760740
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PubMedmedRxiv : the preprint server for health sciences2026-09-19

Trends in Why Americans Delayed Dental Care From Pre-Pandemic to the COVID-19 Era: Implications for Aging and Oral Public Health.

Zanwar Preeti Pushpalata PP, Patel Jay Sureshbhai JS, Shen Chan C

To describe age-group differences in inability to afford dental treatment and cost related dental delay, among the US community-dwelling population. Descriptive analysis of nationally representative survey data. Using nationally representative Medical Expenditure Panel Survey data (2018-2021), we examined trends in inability to afford dental treatment and cost-related dental treatment delays across four age groups (2-17, 18-39, 40-64, ≥65 years). Weighted analyses accounted for the complex survey design; statistical significance was set at p<0.001. Cost-related delays declined modestly from 2018 to 2021 but remained most prevalent among adults aged 40-64 (4.8% for ages 40-64, 3.4% for ages 18-64, 2.2% for ages≥65 in 2021; p<0.001). Middle-aged adults seem to experience delays due to cost, underscoring the need for dental coverage to expand dental coverage for this group and to reduce their out-of-pocket costs.

PMID 42760958
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PubMedOcular immunology and inflammation2026-09-19

Bilateral Maculopathy in an Infant Following Measles, Mumps, Rubella, and Varicella-Zoster (MMRV) Vaccination.

Ben-Avi Ravid R, Amer Radgonde R

To report on the long-term clinical outcome of a healthy infant who presented with posterior uveitis following the administration of the combined measles, mumps, rubella, and varicella (MMRV) vaccine. Descriptive case report. A 13-month-old infant presented with bilateral visual loss two weeks after receiving the MMRV vaccine. Ophthalmic examination revealed bilateral retinitis and retinal vasculitis with exudative retinal detachment. Extensive infectious work-up was conducted including serologic exams and PCR testing of blood, aqueous humor, cerebrospinal fluid and urine. Serological tests for measles yielded positive IgM and IgG titers. PCR testing for measles in the aqueous humor and urine was negative. Neurologic assessment and neuroimaging were unremarkable, excluding central nervous system involvement. Empiric systemic antiviral and corticosteroid therapy was initiated. Gradual resolution of posterior uveitis ensued, culminating in bilateral macular scars. Over a six-year follow-up period, the patient demonstrated stable ocular findings with no evidence of recurrent inflammation or systemic autoimmune disease. Final visual acuity was 6/9 in each eye. This case represents a rare occurrence of non-necrotizing retinitis following MMRV vaccination. To our knowledge, this is the first report describing the sequential OCT characteristics of presumed measles vaccine-associated retinitis. The prolonged follow-up period supports the absence of an alternative etiology and provides valuable insight into the long-term course and visual prognosis of vaccine-associated retinopathy.

PMID 42760840
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PubMedCanadian journal of public health = Revue canadienne de sante publique2026-09-19

Developing a vision for public health surveillance in Canada: An engagement and expert consensus process.

Giang Elissa E, Wong Louis L, Anderson Maureen M, Halliday Barrett B et al.

Public health surveillance (PHS) supports the detection of health threats, monitoring of population health, and coordinated public health action. While its core functions remain unchanged, Canada's last national vision for PHS was articulated in 2016, and the public health landscape has since evolved considerably. These changes have been shaped by lessons from the COVID-19 pandemic, advances in data systems and technologies, evolving data governance expectations, and increasing demand for timely, integrated public health information. We therefore sought to develop a renewed vision for PHS in Canada through broad engagement, qualitative synthesis, and expert consensus. This work used a two-phase, multi-method approach. First, national engagement with public health interest holders was conducted between September 2023 and March 2024 through regional consultations, an expert meeting, and an online survey. Qualitative data were analyzed using reflexive thematic analysis to generate draft vision components and statements. Second, a three-round modified Delphi process with Canadian PHS experts was used to iteratively review, refine, and assess agreement on the draft statements. Engagement activities captured input from 1740 participants across Canada, generating 38 draft statements organized within a conceptual framework. Through the Delphi process, experts refined statements based on quantitative agreement measures and qualitative feedback, achieving consensus on a final set of 30 statements. The resulting vision provides a shared reference point for public health professionals and partners to align efforts to strengthen and modernize PHS systems in Canada.

PMID 42760381
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PubMedMedScience2026-09-19

Neoantigen cancer vaccines for gastrointestinal tumors: opportunities and challenges.

Zhao Zixuan Z, Du Xinyu X, Gao Xiaoliang X, Zhao Sheng S et al.

Gastrointestinal tumors are characterized by high global incidence and mortality rates. Although immune checkpoint inhibitors (ICIs) have achieved breakthroughs in some of these cancers, their overall response rate remains low. Neoantigen cancer vaccines have emerged as a promising new strategy for immunotherapy in gastrointestinal tumors due to their high specificity and strong immunogenicity. These vaccines effectively activate specific T-cell immunity and can produce synergistic effects when combined with ICIs. Various vaccine platforms offer distinct advantages, and clinical trials have shown encouraging potential in inducing immune responses and extending progression-free survival. Meanwhile, current challenges and future directions cannot be ignored. Key challenges primarily involve the accuracy of neoantigen prediction, tumor heterogeneity, and optimal treatment timing. Future directions include artificial intelligence (AI)-assisted multi-omics screening, the development of universal vaccines, optimization of novel delivery systems, and multimodal combination strategies. These advances are expected to promote the application of neoantigen cancer vaccines in postoperative recurrence prevention and early-stage treatment, ultimately moving toward personalized precision immunotherapy. This article systematically reviews the clinical progress and prospects of neoantigen cancer vaccines in treating gastrointestinal tumors, aiming to provide insights for immunotherapy in this field and offer new perspectives for further optimization of such vaccines.

PMID 42760419
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