Vaccine: X最新文献

Background

COVID-19 vaccine hesitancy among young adults in Australia is still poorly understood. Young adults aged 25–34 years have been identified as a population subgroup where COVID-19 vaccine-hesitant views are highly prevalent.

Objective

Exploring the attitudes, thoughts, feelings and social environments affecting the decision to have or not have the vaccine can provide vital transferrable lessons in future health campaigns.

Methods

A qualitative phenomenological study was conducted using semi-structured phone interviews between June 2021 and July 2021. Interview questions were adopted from the World Health Organization’s guidance document ‘Data for Action: Achieving High Uptake of COVID-19 Vaccines’. Participants aged 25–34 years (n = 26) were recruited via purposive and snowball sampling methods. Data were analysed thematically.

Results

Overall, participants presented themselves as highly vaccine literate, understanding their social contract with society. Many participants also did not display traditional vaccine-hesitant views. Six themes specifically regarding COVID-19 vaccine hesitancy were identified, namely (1) decision-making complexities, (2) perceived risk of COVID-19 infection, (3) media’s misrepresentation of COVID-19, (4) vaccine-related issues, (5) inconsistent government messaging and program execution, and (6) social benefits assessment. In addition, motivators to COVID-19 vaccine uptake were classified into three categories: (1) tangible benefits, (2) protecting others, and (3) mandates and incentives. Findings suggest the motivators for COVID-19 vaccine uptake in young adults depend on individual benefits, highlighting the importance of recognising and addressing personal concerns.

Conclusion

There is a need to re-examine and redefine the meaning of vaccine hesitancy in young Australian adults. We offer an understanding of prospective challenges with vaccine hesitancy and potential solutions to address them. These include carefully tailored approaches regarding ongoing vaccine safety concerns and the expected personal benefits following vaccination. Combining these factors can aid in developing new methods of public engagement in the next public health crisis.

Lipodystrophy is a medical condition characterized by complete or partial loss of adipose tissue. The etiology of lipoatrophy can be congenital or acquired, including traumatic, iatrogenic, or idiopathic. Rarely, vaccination can cause lipodystrophy. Here, we report the first case of lipodystrophy associated with the COVID-19 Sinopharm vaccine in a 55-year-old woman.

Introduction

Young adults are hesitant to receive the coronavirus disease 2019 (COVID-19) vaccination owing to concerns regarding adverse events despite the effectiveness of vaccines in preventing SARS-CoV-2 infection-associated serious illness, hospitalization, and death.

Methods

A retrospective cohort study was conducted in Gifu University students receiving the mRNA-1273 vaccine and boosters to elucidate the real incidence of adverse events and factors that prevent them. We examined the adverse events and identified potential risk factors through a self-administered questionnaire on the participants’ physical condition after COVID-19 vaccination.

Results

Focal/systemic adverse events were highly frequent among university students after receiving the COVID-19 vaccine; however, there were no life-threatening cases or hospitalizations over two years. A higher number of vaccinations (p < 0.001), female sex (p < 0.001), and lower body mass index (BMI) (p = 0.002) were associated with an increased incidence of adverse events on the day of COVID-19 vaccination or the day after vaccination. Regular breakfast consumption was significantly associated with a decreased incidence of post-vaccination itching (p = 0.019) and abdominal pain and diarrhea (p = 0.042). Sufficient sleep duration was significantly associated with a decreased incidence of post-vaccination abdominal pain and diarrhea (p = 0.042).

Conclusions

High frequency of adverse events of COVID-19 mRNA-1273 among Japanese university students was reported. A higher number of shots, female sex, and lower BMI were associated with a higher incidence of adverse events. Regular breakfast and sufficient sleep were associated with fewer adverse events. This study may provide a possible solution to the worldwide problem of vaccine hesitancy.

In Veneto Region, HPV vaccine has been actively offered to 12 year-old females since 2008, and to 12 year-old males since 2015. The study aims to analyze the safety profile of HPV4v and HPV9v vaccines and perform a case-by-case review of conditions of interest.

Spontaneous reports related to HPV uploaded to the database of the Regional Pharmacovigilance Center between 2008–2022 were included. HPV vaccine doses administered until April 2022 in the Veneto Region were considered to calculate the reporting rate (RR).

Potential “safety concerns” examined as conditions of interest were included through Standardized MedDRA or preferred terms searching queries. The level of diagnostic certainty was evaluated as per the Brighton Collaboration case definition criteria.

A total of 637 reports and 1316 Adverse Events Following Immunizations (AEFI) were retrieved: 469 for HPV4v (73.6 %) and 168 for HPV9v (26.4 %). Serious reports were 71 (11.1 %): 49 (10.4 %) for HPV4v and 22 (13.1 %) for HPV9v. The RR for serious events between 2008–2022 was 6.9/100,000 administered doses, with no differences by vaccine type. Females and adults showed higher overall RR compared to males and to children and adolescents (p < 0.001), this result was confirmed by stratifying analysis by vaccine type. One case of Guillain Barré syndrome, anaphylactic shock, thrombocytopenia, Henoch Schoenlein purpura and four generalized seizures were reviewed.

Vaccinovigilance data from the Veneto Region reaffirm a good safety profile for HPV vaccination and found no vaccine-related unexpected events. Such a detailed analysis may assist healthcare providers to advocate properly for HPV vaccination.

Background

NVX-CoV2373 is one of the vaccines marketed for COVID-19 prevention in Japan. Information on its cost-effectiveness is important for making well-informed decisions on the future of Japan’s COVID-19 vaccination programme from the public healthcare payer’s perspective. The aim of this study was to evaluate the cost-effectiveness of NVX-CoV2373 vaccination in the elderly Japanese population.

Methods

Two analysis populations that included elderly Japanese individuals (aged ≥ 65 years) were defined in this study: those who had not received a COVID-19 vaccine or had not completed a primary vaccination series (i.e., first two vaccinations) with an approved COVID-19 vaccine (analysis population 1), and those who had received two primary vaccinations with an approved COVID-19 vaccine (analysis population 2). A literature-informed Markov model for each analysis population was developed to evaluate the cost-effectiveness of vaccination with NVX-CoV2373 against no vaccination with NVX-CoV2373 from the public healthcare payer’s perspective as a base-case analysis and from the societal perspective as a scenario analysis. Vaccine efficacy was estimated from a phase 3 study of NVX-CoV2373 (EudraCT number: 2020–004123-16). Cost-effectiveness was assessed using a willingness-to-pay threshold of Japanese yen (JPY) 5 million per quality-adjusted life-year (QALY). Deterministic and probabilistic sensitivity analyses were also performed.

Results

For analysis population 1, NVX-CoV2373 primary and booster vaccinations would reduce costs by JPY 37,647 and prolong QALYs by 0.01601. Therefore, NVX-CoV2373 primary and booster vaccinations were considered to be dominant over no vaccination. For analysis population 2, an NVX-CoV2373 booster vaccination would increase costs by JPY 5010 and prolong QALYs by 0.00550, with the incremental cost-effectiveness ratio of JPY 910,566 per QALY gained.

Conclusions

Our analyses suggest that a vaccination strategy with NVX-CoV2373 is cost-effective in the elderly population (aged ≥ 65 years) of Japan.

Background

CV-NCOV-005 was conducted to generate additional safety and immunogenicity data for the former CVnCoV SARS-CoV-2 mRNA vaccine candidate in healthcare workers (HCW).

Methods

Randomised, observer blinded, placebo-controlled, phase 3 trial performed at the University Medical Center Mainz, Germany. HCWs aged ≥18 years with no history of SARS-CoV-2 infection/positive serology were randomly assigned to receive two doses of CVnCoV, or two doses of placebo (0.9% NaCl). The primary objectives were to expand the safety database of CVnCoV and assess antibody responses against SARS-CoV-2. Primary safety and reactogenicity outcomes included solicited adverse events (AEs) within 7 days after each dose and unsolicited AEs within 28 days after each dose, with safety follow-up for 13 months after first vaccination. Since HCWs became eligible to receive an authorised vaccine during enrolment and efficacy results from HERALD CVnCoV trial were made available on 30^th of June 2021, this study was unblinded and converted to an open label design.

Results

Most participants in the CVnCoV group reported at least one solicited AE, a relatively high number being Grade 3 (43.3% in CVnCoV group and 6.4% in placebo group). Most AEs were short in duration and did not affect vaccine compliance. The percentage of participants with unsolicited AEs up to 28 days after any dose was slightly higher in CVnCoV group (37.0%) compared with placebo group (31.2%). IgG binding antibodies against the receptor binding domain of the SARS-CoV-2 spike protein were observed after vaccination, with higher seroconversion rates and antibody levels after the second dose.

Conclusion

No safety concerns for CVnCoV were identified up to 1 year post second dose. IgG responses against SARS-CoV-2 were observed after two doses, with a higher seroconversion rate and antibody levels observed after second vaccination.

Study registration: ClinicalTrials.gov NCT04674189, study period: 23^rd of December 2020 to 8^th of June 2022.

A meeting held in Lisbon, Portugal, in February 2023 focused on critical aspects of clinical trial design for respiratory syncytial virus (RSV) preventative therapies. The meeting addressed two primary areas: enhancing the efficiency and success of randomized controlled trials (RCTs) for RSV preventative therapies and designing RCTs to better inform post-licensure decision-making. Topics included the selection of primary endpoints, innovative approaches to incorporating multiple endpoints and historical data, and the challenges and benefits of sequential trial designs. The discussion also touched on meta-regression models for obtaining more robust, context-specific estimates of vaccine efficacy. Overall, the meeting underscored the importance of balancing efficiency and robustness in RSV vaccine trial design, while recognizing the need for further discussions involving regulatory and advisory bodies.

Introduction

This study recognized the lack of information regarding recruitment and retention factors associated with implementing HIV vaccine trials from the perspective of de facto participants. It aimed to describe the motives and experiences of 31 young adults who participated in a phase II HIV vaccine clinical trial conducted in Maputo, Mozambique.

Methods

This was an ancillary study with a mixed-method approach that employed a convergent design, combining both quantitative and qualitative methodologies. Data collection involved questionnaire surveys, in-depth interviews, and focus group discussions. Participants were assessed before and after learning whether they received the experimental vaccine or placebo. Thematic analysis was used for qualitative data, while descriptive analysis and statistical tests such as Fischer’s test and McNemar’s exact test were applied to quantitative data. The study also utilized the Health Belief Model to understand the decision-making process of participating in an HIV vaccine study.

Results

Most of our participants were young females, single, with limited financial resources. Participants joined the trial with the belief that they had a unique opportunity to help the fight against HIV and contribute to the research for the discovery of an HIV vaccine. Positive experiences related to trial participation include gaining knowledge about HIV and personal health and receiving risk reduction counseling. Participants reported blood collection as a negative experience and that they suffered social harm because of trial participation. Participants felt abandoned after the trial ended.

Conclusion

Preventive HIV vaccine trials should integrate a social-behavioral component to assess reasons for participation and refusal in real-time. Providing ongoing personal attention is crucial for young individuals who have committed 1–2 years to trial participation, extending beyond the trial period. Implementing tailored strategies for HIV risk assessment and reduction during and after the trial is essential. Addressing these factors can enhance preventive HIV vaccine trial implementation.

Objective

To investigate the real-world effectiveness of COVID-19 vaccine boosters during China’s Omicron wave.

Methods

In January 2023, we surveyed Shenzhen, China residents via online questionnaires to investigate their COVID-19 symptoms and vaccination history. The outcomes of interest included fever, other COVID-19-related symptoms, severity of symptoms, whether early onset (before December 23, 2022) and duration. Respondents were categorized as no booster, one booster 6mo ago, one booster within 6mo, or two boosters based on dose count and vaccination timing. We used multivariable logistic regressions and Tobit models to assess COVID-19 vaccine booster impacts.

Results

Compared to the no booster group, two booster recipients had a lower fever risk (OR = 0.35, 95 %CI = 0.16–0.76) but not lower risks of COVID-19-related symptoms (OR = 0.74, 95 %CI = 0.26–2.06) and self-reported severe symptoms (OR = 0.47, 95 %CI = 0.19–1.15). Nor did the two booster recipients had a shorter illness duration (marginal effect = -0.79 days, 95 %CI = -1.65–0.07) and a lower risk of symptom onset delay (OR = 0.48, 95 %CI = 0.19–1.23). Compared to the no booster group, both one booster within six months (OR = 2.17, 95 %CI = 1.34–3.52) and one booster six months ago (OR = 1.30, 95 %CI = 0.92–1.82) did not reduce the risks of fever and symptoms (one booster within six months: OR = 1.57, 95 %CI = 0.84–2.90; one booster six months ago: OR = 1.23, 95 %CI = 0.79–1.93). Regardless of timing, one booster did not reduce illness duration (within six months: marginal effect = 0.25 days, 95 %CI = -0.20–0.70; six months ago: marginal effect = 0.27 days, 95 %CI = -0.08–0.62). However, receiving one booster within six months delayed symptom onset (OR = 0.54, 95 %CI = 0.34–0.86), while one booster six months ago did not (OR = 1.03, 95 %CI = 0.74–1.44).

Conclusions

Receiving two booster doses reduced the onset of fever during the Omicron outbreak in mainland China.

Background

Influenza is a significant contributor to acute respiratory infections (ARI), and children < 5 years are at increased risk of severe influenza disease. In Kenya the influenza vaccine is not included in the Kenya Expanded Programme on Immunization (KEPI). To inform roll-out of a national influenza vaccination program, we implemented an influenza vaccine demonstration project in Nakuru and Mombasa counties in Kenya from 2019 to 2021 and set out to establish factors driving influenza vaccine acceptance and hesitancy among caregivers of children aged 6–23 months.

Methods

Using semi-structured questionnaires, we conducted eight focus group discussions among community members and twelve key informant interviews among healthcare workers to elicit both lay and expert opinions. Thematic analysis of the interviews was conducted using the World Health Organization’s “3 Cs” model of vaccine hesitancy to determine reasons for acceptance or hesitancy of the influenza vaccine.

Results

The influenza vaccine was well received among community members and healthcare workers though concerns were raised. Vaccine hesitancy was fuelled by misconceptions about reasons for introducing the vaccine (confidence), perceptions that influenza was not a serious disease (complacency) and administrative fees required at some facilities (convenience). Despite the use of various advocacy, communication and social mobilisation strategies targeted at educating the community on the influenza disease and importance of vaccination, there remained a perception of inadequate reach of the sensitization among some community members. Contextual factors such as the COVID-19 pandemic affected uptake, and parents expressed concern over the growing number of vaccines recommended for children.

Conclusion

Despite lingering concerns, caregivers had their children vaccinated indicating that vaccine hesitancy exists, even among those who accepted the vaccine for their children. Efforts targeted at increasing confidence in and reducing misconceptions towards vaccines through effective communication strategies, are likely to lead to increased vaccine uptake.