To assess the impact of reactogenicity among health care workers and first responders receiving an updated 2024-25 Novavax COVID-19 vaccine as compared with those receiving an updated 2024-25 Pfizer-BioNTech mRNA COVID-19 vaccine

开始日期2024-09-20

申办/合作机构

Novavax, Inc.

[+1]

NCT06409663 / Not yet recruiting临床2/3期

A Phase 3 Open-Label, Single-Arm Study to Evaluate the Safety and Immunogenicity of a JN.1 Subvariant SARS CoV-2 rS Vaccine

Phase 3 study assessing the safety and effectiveness of a single dose of a SARS-CoV-2 nanoparticle vaccine (NVX CoV2705) adjuvanted with Matrix-M™ in previously vaccinated adults. About 100 participants will receive the vaccine and be monitored for safety and immune response for up to 35 days post-vaccination.

开始日期2024-08-05

申办/合作机构

Novavax, Inc.

TCTR20230411008 / Completed临床4期IIT

Safety and Immunogenicity of a Second Booster Dose of Intradermal and Intramuscular COVID-19 Vaccines in Thai Older People (Extended Study of Safety and Immunogenicity of Intradermal and Intramuscular Booster COVID-19 Vaccination following the 2-dose primary series of ChAdOx1 (AstraZeneca) in Thai older people)

开始日期2022-05-08

申办/合作机构-

100 项与 JN.1 Subvariant SARS CoV-2 rS Vaccine(Novavax) 相关的临床结果

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100 项与 JN.1 Subvariant SARS CoV-2 rS Vaccine(Novavax) 相关的转化医学

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100 项与 JN.1 Subvariant SARS CoV-2 rS Vaccine(Novavax) 相关的专利（医药）

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197

项与 JN.1 Subvariant SARS CoV-2 rS Vaccine(Novavax) 相关的文献（医药）

2025-01-01·Journal of Stroke & Cerebrovascular Diseases

Causal association between COVID-19 vaccination and thrombosis-related biomarkers/thrombosis/ischemic stroke: Mendelian randomization study

Article

作者: Ma, Yong ; Peng, Xiaoqi ; Liu, Yingxia ; Zhuo, Lianjia ; Wu, Zeming

BACKGROUND:

Observational studies about the association between coronavirus disease 2019 (COVID-19) vaccination and thrombosis/ischemic stroke are inconsistent. The aim of this study is to assess the causality between COVID-19 vaccination and thrombosis-related biomarkers/thrombosis/ischemic stroke using mendelian randomization (MR) analysis.

METHODS:

A two-sample MR analysis using publicly available genome-wide association study (GWAS) data was conducted. Causal effects were appraised using inverse variance weighted (IVW, as a primary method), with supplementary methods including constrained maximum likelihood and model averaging, MR-Robust Adjusted Profile Score, MR-Egger regression, simple mode, weighted median, and weighted mode. Sensitivity analyses were conducted using Cochran's Q test, MR-Egger intercept test, and leave-one-out analysis.

RESULTS:

Genetically predicted COVID-19 vaccination was negatively associated with C-C motif chemokine 3 [CCL3, odds ratio (OR): 0.694, 95% confidence intervals (CI): 0.484-0.995] and multiple coagulation factor deficiency protein 2 (MCFD2, OR: 0.806, 95% CI: 0.675-0.963). Meanwhile, the IVW analysis revealed significant causal effects between genetically predicted COVID-19 vaccination and ischemic stroke (OR: 1.088, 95% CI: 1.006-1.177), large artery stroke (LAS, OR: 1.251, 95% CI: 1.028-1.521). The leave-one-out analysis revealed that no individual SNP exerted a significant effect on the overall causal estimate.

CONCLUSION:

Our study provided evidence supporting a potential causal association of genetically predicted COVID-19 vaccination with CCL3 levels, MCFD2 levels, ischemic stroke risk and LAS risk. These results provide preliminary evidence of potential adverse associations, but further studies are required to fully understand the mechanisms and to validate these findings across broader populations.

2025-01-01·VACCINE

Effect of COVID-19 vaccination on the risk of developing post-COVID conditions: The VENUS study

Article

作者: Maeda, Megumi ; Murata, Fumiko ; Fukuda, Haruhisa ; Kim, Sung-a ; Kim, Sung-A

INTRODUCTION:

Post-COVID-19 conditions have emerged as a global health challenge. This study examined the long-term effects of COVID-19 vaccination on the incidence and risk of post-COVID-19 conditions in Japan.

METHODS:

This retrospective cohort study was conducted using a database comprising medical claims, COVID-19 case information, and vaccination records of persons residing in four Japanese municipalities. The cohort included COVID-19 cases diagnosed between August 2020 and December 2022. Participants were classified according to the duration between their most recent COVID-19 vaccination and COVID-19 occurrence (≥365 days, 150-364 days, and 14-149 days). The incidences of 36 post-COVID-19 conditions were monitored for 3, 5, and 8 months after infection. Cox proportional hazards models were used to calculate the risk of developing each post-COVID-19 condition within 8 months after infection according to vaccination status.

RESULTS:

From among 84,464 participants, 9642 (11.4 %) developed post-COVID-19 conditions over 8 months. The 8-month risks of developing 28 (including various respiratory conditions, cardiovascular conditions, inflammatory and immune diseases, physical conditions, psychiatric conditions, and endocrine disorders) of the 36 target conditions were significantly lower when individuals had been recently vaccinated (14-149 days) before infection.

CONCLUSIONS:

COVID-19 vaccination can reduce the incidence and risk of post-COVID-19 conditions if administered within 5 months before infection. Despite having the highest mean age and prevalence of comorbidities, individuals who were most recently vaccinated had a lower risk of developing post-COVID-19 conditions. These results provide important evidence for future COVID-19 vaccination strategies.

2024-12-31·Emerging Microbes & Infections

COVID-19 vaccination modified the effect of nirmatrelvir–ritonavir on post-acute mortality and rehospitalization: a retrospective cohort study

Article

作者: Hui, David S. C. ; Mok, Chris Ka Pun ; Hung, Chi Tim ; Guo, Zihao ; Jia, Katherine Min ; Li, Kehang ; Jiang, Xiaoting ; Wang, Huwen ; Yam, Carrie Ho Kwan ; Wei, Yuchen ; Li, Conglu ; Boyer, Christopher ; Chong, Ka Chun ; Yang, Aimin ; Chow, Tsz Yu ; Yeoh, Eng Kiong ; Lin, Guozhang ; Zhao, Shi ; Wang, Yawen

While previous research examined coronavirus disease 2019 (COVID-19) antiviral-vaccine interactions through exploratory subgroup analysis, none specifically designed for examining this interaction or its impact on post-acute outcomes. This study examined the interaction between nirmatrelvir-ritonavir and complete COVID-19 vaccination on reducing the risk of post-acute outcomes among COVID-19 patients. We followed COVID-19 patients hospitalized between 11 March 2022 and 10 October 2023, until 31 October 2023 in Hong Kong. Exposure groups were based on nirmatrelvir-ritonavir usage and vaccination status (fully or not fully vaccinated). Post-acute death and all-cause rehospitalization were the study outcomes. Propensity score weighting was applied to balance covariates among exposure groups, including age, sex, Charlson Comorbidity Index, and concomitant treatments. Multiplicative and additive interactions between nirmatrelvir-ritonavir and vaccination status were assessed. A total of 50,438 COVID-19 patients were included in this study and arranged into four exposure groups. Significant additive interaction on post-acute rehospitalization was observed (relative excess risk, 0.10; 95% CI, 0.02-0.19; p-value, 0.018; attributable proportion, 0.07; 95% CI, 0.01-0.12; p-value, 0.017; synergy index, 1.26; 95% CI, 1.02-1.55; p-value, 0.032). The interaction on post-acute mortality was marginally significant. In the subgroup analysis, the interaction effect is more pronounced in older adults, female, and CoronaVac recipients. In conclusion, our study demonstrated an additive interaction between nirmatrelvir-ritonavir and complete vaccination on post-acute outcomes, suggesting greater long-term benefits of the antiviral for fully vaccinated individuals compared to not fully vaccinated patients.

584

项与 JN.1 Subvariant SARS CoV-2 rS Vaccine(Novavax) 相关的新闻（医药）

2024-11-25

·drugs

COVID-19, Flu, RSV Vaccine Coverage Low for Adults in 2024 to 2025 Season

MONDAY, Nov. 25, 2024 -- COVID-19 , influenza , and respiratory syncytial virus (RSV) vaccination coverage is low among adults so far this respiratory virus season (2024 to 2025), according to research published in the Nov. 21 issue of the U.S. Centers for Disease Control and Prevention Morbidity and Mortality Weekly Report . Jennifer L. Kriss, Ph.D., from the CDC in Atlanta, and colleagues used data from the National Immunization Survey-Adult COVID Module for U.S. adults aged 18 years and older to monitor influenza, COVID-19, and RSV vaccination coverage. The researchers found that an estimated 34.7 percent of adults reported having received an influenza vaccine by the week ending Nov. 9, 2024; 17.9 percent reported having received a COVID-19 vaccine for the 2024 to 2025 respiratory virus season; and 39.7 and 31.6 percent of adults aged 75 years and older and 60 to 74 years, respectively, with an increased risk for severe RSV had ever received an RSV vaccine. There was variation seen in coverage by jurisdiction and demographic characteristics, with younger adults and those without health insurance having the lowest coverage. Many adults seemed open to vaccination, with about 35 and 41 percent reporting that they definitely or probably will receive or were unsure about receiving influenza and COVID-19 vaccines, respectively; among those 75 years and older, 40 percent reported that they definitely or probably will receive or are unsure about receiving the RSV vaccine. "Health care providers and immunization programs still have time to expand outreach and promote vaccination activities to improve vaccination coverage, especially before persons gather with friends and family during the winter holidays," the authors write. Abstract/Full Text Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

疫苗临床结果

2024-11-21

·Pharmaceutical Technology

FDA’s Marks says RFK Jr dialogue gives chance to have “lies debunked” on vaccines

FDA’s CBER director Peter Marks was speaking virtually at the Jefferies London Healthcare Conference held from 19 to 21 November. Image credit: Robert Barrie / GlobalData. The US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) director has said that a dialogue on vaccines, which is expected to intensify under the new administration, will be important to have “lies debunked”. “I don’t doubt that we are going to have a very vigorous dialogue about the benefits and risks of vaccines, [especially] around Covid-19 vaccines and paediatric vaccines. I hope that that dialogue allows us the opportunity to bring forth the data [to show] the facts,” Peter Marks said at the Jefferies London Healthcare Conference on 21 November. US President-elect Donald Trump’s decision to appoint Robert F Kennedy (RFK) Jr as head of the Department of Health and Human Services (HHS) in the new administration has caused uncertainty within the pharmaceutical sector. RFK Jr has previously stated views on vaccine safety unsupported by science and accused the FDA of waging a war on public health by cosying up to big pharma. One of RFK Jr’s most dangerous false claims is the positive link between the measles, mumps, and rubella (MMR) vaccine and autism. The relationship has been disproven in multiple studies since fraudulent data suggested the theory in 1998. “I don’t think there’s a lot to argue about. Measles kills people at a rate of about one in 1,000 if people aren’t vaccinated,” Marks said. Marks stated that a public debate around vaccines is not necessarily a bad thing because it provides an open setting for people to hear correct information about the drugs: “[Vaccine] misinformation has become a wastebasket term for lies…It would be nice to have some of the lies debunked in public…and false beliefs aired and corrected.” Regarding what policies Trump and RFK Jr will look to implement once in office, Marks said it is “too soon to know anything with certainty”. RFK Jr has insisted he is not “anti-vaccine”, but his comments suggest that routine childhood vaccination programmes and mandates could be altered. Executives from big pharma companies with vaccine products, including GSK and BMS have said at the Jefferies conference that the pharma industry will need to “adjust” and “adapt” to the new administration. RFK Jr has also vowed to shake up the FDA, suggesting some departments are no longer needed. Donald Trump will likely choose the Johns Hopkins surgeon and writer Martin Makary as the new FDA chief, as reported by Reuters today [21 November]. Amid the potential sweep of changes, Marks confirmed he is staying on in his position as CBER head as long as he is needed. “I will stay around as long as I’m considered to be welcome,” Marks said. “My intention is not to go anywhere. I think it’s very important that people see that there’s constant leadership [at the FDA], that we are here to work with either side of the aisle.” And while RFK Jr may look to overhaul the FDA, pushback will be inevitable. “I’ve been very heartened to know that there are some people I can’t name, who will be there for us as a backstop to help us make sure that we’re able to [pursue] the public health mission, for rare disease communities and vaccines,” Marks added. “I have to believe that at least some degree of moderation will prevail.”

高管变更疫苗

2024-11-19

·PRNewswire

Nagase Viita to Launch Injectable-grade Pharmaceutical Excipient "SUCROSE SG" in 2025

OKAYAMA, Japan, Nov. 19, 2024 /PRNewswire/ -- Nagase Viita Co., Ltd., a member of the NAGASE Group headquartered in Okayama Japan, is set to expand the line of SOLBIOTE (TM), saccharide-based pharmaceutical excipients, with the launch of high-purity and low-endotoxin SUCROSE SG by June 2025. The portfolio of SOLBIOTE (TM) includes TREHALOSE SG and MALTOSE PH, which are the signature products of pharmaceutical ingredients, and with the addition of SUCROSE SG to the portfolio, it offers a comprehensive range of solutions for stability in biopharmaceutical development. Image1: Sucrose is widely used as a stabilizer in biopharmaceuticals, a rapidly growing market. It helps maintain the quality of antibody drugs and lipid nanoparticles (LNPs) formulated with nucleic acid, such as COVID-19 vaccines. Since its founding, sustainability and biotechnology have been at the core of Nagase Viita's business. SUCROSE SG is produced in an environmentally friendly way by using water instead of solvents. Image2: The name SOLBIOTE (TM) is derived from "Sol + Bio," representing biotechnology and the sun's gift of starch ("Sol" meaning "sun" in Latin). Nagase Viita's excipients are designed to provide innovative solutions for biopharmaceuticals, offering a stable supply and guaranteeing exceptional quality. Find out more about SOLBIOTE (TM): WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED