Human Vaccines & Immunotherapeutics最新文献

With the pandemic, there has been a global reduction in influenza virus circulation, with WHO reporting, during 2021/22 season, laboratory testing positivity rate for influenza of less than 3%. Influenza surveillance systems anticipated a peak of influenza cases in the Northern Hemisphere during 2022/2023 season and the Italian Ministry of Health recommended the routinary co-administration of influenza with bivalent COVID-19 vaccines for the 2022/2023 season. At the Vaccination Hub of the University Hospital (UH) of Palermo, more than 700 subjects received influenza and COVID-19 booster doses in co-administration, during the 2021/2022 season. A cross-sectional study analyzing attitudes and factors associated with adherence to influenza and COVID-19 seasonal vaccines co-administration was conducted at the Vaccination Hub of the UH of Palermo, from October to December 2022. Among the 1,263 respondents, 74.7% (n = 944) received the co-administration of seasonal influenza and COVID-19 vaccines. The main reason reported for accepting it was confidence in the recommendations of the Health Ministry (41.3%). At the multivariable analysis, subjects aged ≤ 59 y old (AdjOR: 2.48; CIs95%: 1.89-3.65), male (AdjOR: 1.51; CIs95%: 1.27-1.75), Health-care professionals (HCPs) (AdjOR: 1.66; CIs95%: 1.08-2.57) and those who received co-administration during 2021/2022 (AdjOR: 41.6; CIs95%: 25.5-67.9) were significantly more prone to receive co-administration during 2022/23 season. From data obtained, the role of HCPs in accepting and then promoting co-administration of COVID-19 and influenza vaccines is crucial, as well as receiving co-administration in the previous season that represented the main drive for accepting it in the following seasons, supporting safety and effectiveness of this procedure.

In Aotearoa New Zealand, there has been a marked decrease in the uptake of routine childhood vaccinations since the onset of the COVID-19 pandemic, particularly among Māori and Pacific children. This Māori and Pacific-centered research used an interpretive description methodology. We undertook culturally informed interviews and discussions with Māori and Pacific caregivers (n = 24) and healthcare professionals (n = 13) to understand their perceptions of routine childhood vaccines. Data were analyzed using reflexive thematic analysis and privileged respective Māori and Pacific worldviews. Four themes were constructed. "We go with the norm" reflected how social norms, health personnel and institutions promoted (and sometimes coerced) participants' acceptance of routine vaccines before the pandemic. "Everything became difficult" explains how the pandemic added challenges to the daily struggles of whānau (extended family networks) and healthcare professionals. Participants noted how information sources influenced disease and vaccine perceptions and health behaviors. "It needed to have an ethnic-specific approach" highlighted the inappropriateness of Western-centric strategies that dominated during the initial pandemic response that did not meet the needs of Māori and Pacific communities. Participants advocated for whānau-centric vaccination efforts. "People are now finding their voice" expressed renewed agency among whānau about vaccination following the immense pressure to receive COVID-19 vaccines. The pandemic created an opportune time to support informed parental vaccine decision-making in a manner that enhances the mana (authority, control) of whānau. Māori and Pacific-led vaccination strategies should be embedded in immunization service delivery to improve uptake and immunization experiences for whānau.

The objective of the study was to assess the safety and immunogenicity of mRNA-1273 COVID-19 booster vaccination when co-administered with an egg-based standard dose seasonal quadrivalent influenza vaccine (QIV). This was a phase 3, randomized, open-label study. Eligible adults aged ≥ 18 years were randomly assigned (1:1) to receive mRNA-1273 (50 µg) booster vaccination and QIV 2 weeks apart (Seq group) or concomitantly (Coad group). Primary objectives were non-inferiority of haemagglutinin inhibition (HI) and anti-Spike protein antibody responses in the Coad compared to Seq group. 497/498 participants were randomized and vaccinated in the Seq/Coad groups, respectively. The adjusted geometric mean titer/concentration ratios (95% confidence intervals) (Seq/Coad) for HI antibodies were 1.02 (0.89-1.18) for A/H1N1, 0.93 (0.82-1.05) for A/H3N2, 1.00 (0.89-1.14] for B/Victoria, and 1.04 (0.93-1.17) for B/Yamagata; and 0.98 (0.84-1.13) for anti-Spike antibodies, thus meeting the protocol-specified non-inferiority criteria. The most frequently reported adverse events in both groups were pain at the injection site and myalgia. The 2 groups were similar in terms of the overall frequency, intensity, and duration of adverse events. In conclusion, co-administration of mRNA-1273 booster vaccine with QIV in adults was immunologically non-inferior to sequential administration. Safety and reactogenicity profiles were similar in both groups (clinicaltrials.gov NCT05047770).

This study employed sero-epidemiological methods to estimate the incidence of pertussis within a healthy population located in eastern China. The aim was to gain deeper insights into the epidemiological characteristics and burden of pertussis within the country. Blood samples were collected from healthy individuals in Jiangsu Province between June 2019 and December 2022. The levels of IgG antibodies against pertussis toxin (anti-PT) and filamentous hemagglutinin (anti-FHA) in the serum were quantitatively measured using enzyme-linked immunosorbent assay (ELISA). Additionally, pertussis case data reported in Jiangsu Province were collected from the China Information System for Disease Control and Prevention and compared with the results of this study. In 2022, the reported incidence of pertussis stood at 1.0 per 100,000 individuals, marking the highest rate observed in the past two decades. Among 1,909 patients examined, the geometric mean concentration (GMC) of anti-PT IgG antibody was 20.2 (18.5-21.9) IU/ml, while that of anti-FHA IgG antibody was 27.0 (25.4-28.7) IU/ml. The IgG-PT and IgG-FHA seropositivity rate (>20.0 IU/ml) was highest in the 1 ~ 2 y old group and decreased rapidly to the lowest in the 3 ~ 4 y old group and then increased gradually with age. The estimated rate of pertussis infection based on seroprevalence was approximately 25,625-fold higher than the reported notification rate in the ≥15 year age group. Our findings highlight decreased immunity post-vaccination, stressing the importance of additional booster shots for adolescents and adults to maintain immunity and reduce severe illness. Additionally, they offer vital guidance for policymakers to enhance immunization strategies.

Despite the high effectiveness of HPV vaccines in preventing infection, vaccine hesitancy remains a concern, particularly in China. This study aimed to explore college students' attitudes toward HPV vaccination and identify associated factors. Data was collected through a cross-sectional survey using self-administered questionnaires in four cities from May to June 2022. Chi-square tests and logistic regression analyses were conducted to identify factors. Additionally, an integrated structural equation model (SEM) based on the 3Cs (confidence, convenience, complacency) was developed to understand underlying factors contributing to hesitancy. The results from 2261 valid questionnaires were enlightening. A significant 89.47% (59.4% for females) considered HPV vaccination necessary, with 9.82% remaining neutral and only 0.71% deeming it unnecessary. Factors like higher education, being a medical student, residing in urban areas, having medical insurance, more extraordinary living expenses, a family history of tumors, and a solid understanding of HPV played a role in perceiving the vaccine as necessary. Among the 1438 female respondents, 84.36% had no hesitancy toward HPV vaccination, 13.53% expressed hesitancy, and 2.11% refused vaccination. Factors like age, understanding of HPV, medical staff recommendations, living expenses, and family history influenced hesitancy levels. SEM revealed that the 3Cs significantly affected vaccine hesitancy. Factors like price, booking process, vaccination times, trust in vaccines, medical staff recommendations, efficiency, and risk perception collectively influenced hesitancy. In conclusion, this study found high acceptance of HPV vaccination but acknowledged the complexity of hesitancy factors. It recommends medical staff disseminate scientific knowledge, offer recommendations, simplify booking procedures, and expand vaccination sites to address vaccine hesitancy effectively.

Biosimilar vaccines and immunotherapeutic are innovative approaches in medical research. This commentary addresses the current disparities in regulations of biosimilar vaccines and immunotherapeutic products across different nations. It also navigates the benefits of global regulatory alignment and challenges that may be encountered. The current discrepancies in regulations across different countries, which pose significant challenges for the development and approval of biosimilar vaccines and immunotherapeutic products. These disparities often lead to delayed market access, increased development costs, and hindered innovation. The commentary stresses that such obstacles could be mitigated through harmonized regulations, resulting in faster approvals, reduced healthcare costs, and improved patient outcomes. Moreover, the commentary explores the specific complexities associated with biosimilar vaccines and immunotherapeutic, such as the intricate evaluation of biosimilarity due to their molecular composition and immunogenic properties. In conclusion, the editorial advocates for collaborative efforts to overcome the challenges in achieving global regulatory harmonization for biosimilars. This includes establishing uniform standards, fostering international cooperation among regulatory agencies, and promoting educational initiatives for healthcare providers and regulators. The ultimate goal is to ensure that patients worldwide have timely access to safe, effective, and affordable biosimilar treatments.

Respiratory syncytial virus (RSV) is the leading cause of lower respiratory tract infections in young children and associated with most bronchiolitis- and pneumonia-related hospitalizations. A new preventive monoclonal antibody (MAb), nirsevimab, has been launched in the United States, Luxembourg, and France, and was recently approved to be given in a population-based manner throughout Spain. This study aimed to have a first pre-immunization insight into the Spanish parental knowledge about bronchiolitis, RSV, and nirsevimab immunization. Parents in Murcia with children <2 years of age up to the date of September 1, 2023, were selected to complete a questionnaire. The primary endpoint was the parental knowledge about bronchiolitis, RSV, and nirsevimab. A total of 3,217 responses were analyzed. The majority (95.8%) were aware of bronchiolitis. Meanwhile, 46.6% of the respondents knew about RSV, most of them only after the first child's birth. Information about RSV or bronchiolitis was mainly obtained from family members, with only 4.8% reporting having been informed by Health care Professionals (HCPs). Only 11.2% of respondents were aware of nirsevimab. Nonetheless, these were not entirely satisfied with the information received (score of 3.3 out of 5) and shared that HCPs should be the primary source of information. The present survey then highlights the need for better and more efficient educational strategies directed to all parents/legal guardians. It also sheds some light on the different factors that should be considered to improve awareness of RSV immunization to decrease its burden in Spain and beyond.