Antibody Response Before and After the Booster Dose of Inactivated Corona Vaccine in Antibody Deficient Patients.

Patients with inborn errors of immunity (IEI) are among the high-risk groups regarding COVID-19. Receiving booster doses (third and fourth) in addition to the standard doses is recommended in these patients. This study investigated the antibody response before and after a booster dose of Sinopharm vaccine in IEI patients.  Thirty patients (>12 years) with antibody deficiencies, referred to Imam Khomeini Hospital and Children's Medical Center in Tehran, were enrolled in this prospective cross-sectional study. All patients were fully vaccinated with the BBIBP-CorV vaccine (2 doses of Sinopharm). Initial measurements of anti-receptor-binding domain (anti-RBD) and anti-nucleocapsid (anti-N) IgG antibody responses were conducted by enzyme-linked immunosorbent assay (ELISA). Subsequently, all patients received a booster dose of the vaccine. Four to six weeks after booster injection, the levels of antibodies were re-evaluated.  Twenty patients with common variable immunodeficiency (CVID), 7 cases with agammaglobulinemia and 3 patients with hyper IgM syndrome were studied. Anti-RBD IgG and anti-N IgG antibodies increased in all patients after the booster. Our results indicated the need of receiving booster doses of the COVID-19 vaccine in patients with antibody deficiencies, even for enhancing humoral immune response specially in patients with CVID.

Analysis of COVID-19 Vaccine Adverse Drug Reactions Reported Among Sultan Qaboos University Hospital Staff.

Objectives: This study aimed to report any suspected adverse drug reactions (ADRs) experienced by all vaccinated staff and students in a tertiary teaching hospital following COVID-19 vaccination. Methods: This retrospective study was conducted during the COVID-19 vaccination campaign at Sultan Qaboos University and Hospital in Muscat, Oman, from August to September 2021. An online survey was generated and sent to all staff and students via email and text messages. An announcement was made on the hospital website with a link to the survey. Results: A total of 8,421 individuals reported being vaccinated at least once with a total of 11,468 doses administered from January to July 2021; 8,014 staff and students received the Pfizer-Biotech vaccine while 3,454 staff and students received the Oxford-AstraZeneca vaccine. The survey received a total of 3,275 responses (response rate = 38.8%). Of these, 741 individuals (22.6%) experienced an ADR after vaccination and 67.2% (n = 498) were females (P <0.001). The majority of the ADRs reported were fever and chills (19.7%) followed by localised pain and swelling at the injection site (18.8%). Other ADRs such as hair loss (0.5%) were reported, and one staff/student reported a clot in the right leg. Among the responders, 27.0% considered their ADRs as mild while 25.0% considered them as severe. Conclusions: In the study cohort, mild symptoms of COVID-19 vaccines were reported. Females experienced more ADRs compared to males. Long-term observation of ADRs to the vaccines and follow-up monitoring should be done on subjects to preclude any unwanted effects.

COVID-19 Vaccine Effectiveness and Digital Pandemic Surveillance in Germany (eCOV Study): Web Application-Based Prospective Observational Cohort Study.

BACKGROUND: The COVID-19 pandemic posed significant challenges to global health systems. Efficient public health responses required a rapid and secure collection of health data to improve the understanding of SARS-CoV-2 and examine the vaccine effectiveness (VE) and drug safety of the novel COVID-19 vaccines. OBJECTIVE: This study (COVID-19 study on vaccinated and unvaccinated subjects over 16 years; eCOV study) aims to (1) evaluate the real-world effectiveness of COVID-19 vaccines through a digital participatory surveillance tool and (2) assess the potential of self-reported data for monitoring key parameters of the COVID-19 pandemic in Germany. METHODS: Using a digital study web application, we collected self-reported data between May 1, 2021, and August 1, 2022, to assess VE, test positivity rates, COVID-19 incidence rates, and adverse events after COVID-19 vaccination. Our primary outcome measure was the VE of SARS-CoV-2 vaccines against laboratory-confirmed SARS-CoV-2 infection. The secondary outcome measures included VE against hospitalization and across different SARS-CoV-2 variants, adverse events after vaccination, and symptoms during infection. Logistic regression models adjusted for confounders were used to estimate VE 4 to 48 weeks after the primary vaccination series and after third-dose vaccination. Unvaccinated participants were compared with age- and gender-matched participants who had received 2 doses of BNT162b2 (Pfizer-BioNTech) and those who had received 3 doses of BNT162b2 and were not infected before the last vaccination. To assess the potential of self-reported digital data, the data were compared with official data from public health authorities. RESULTS: We enrolled 10,077 participants (aged ≥16 y) who contributed 44,786 tests and 5530 symptoms. In this young, primarily female, and digital-literate cohort, VE against infections of any severity waned from 91.2% (95% CI 70.4%-97.4%) at week 4 to 37.2% (95% CI 23.5%-48.5%) at week 48 after the second dose of BNT162b2. A third dose of BNT162b2 increased VE to 67.6% (95% CI 50.3%-78.8%) after 4 weeks. The low number of reported hospitalizations limited our ability to calculate VE against hospitalization. Adverse events after vaccination were consistent with previously published research. Seven-day incidences and test positivity rates reflected the course of the pandemic in Germany when compared with official numbers from the national infectious disease surveillance system. CONCLUSIONS: Our data indicate that COVID-19 vaccinations are safe and effective, and third-dose vaccinations partially restore protection against SARS-CoV-2 infection. The study showcased the successful use of a digital study web application for COVID-19 surveillance and continuous monitoring of VE in Germany, highlighting its potential to accelerate public health decision-making. Addressing biases in digital data collection is vital to ensure the accuracy and reliability of digital solutions as public health tools.

How Bodily Autonomy Can Fail Against Vaccination Mandates: The Few vs. the Many.

Humans have been a communal species since inception and continue to be so to this day. Because of this, if even a small scale of a measured population becomes severely ill, the entire remaining population and surrounding area is thrown into absolute chaos. In fact, we have seen these circumstances throughout history and in the recent COVID-19 pandemic yet, some of us have forgotten that the only way this chaos can be curbed, is by enacting a mandatory vaccination policy. Since COVID-19 however, vaccination mandates have become an uneasy topic of conversation in the United States for essentially one main reason, some U.S citizens do not like to be told what to do with their body and what to place inside it, further believing their bodily autonomy to be absolute. Data shows that this ideology recently became more widespread from an increase of mistrust of government and pharmaceutical companies, and from political beliefs and affiliations. Nevertheless, what the data also shows is that these same individuals were asserting their right to bodily autonomy against a vaccination mandate in an unduly aggressive manner, and on a very erroneous understanding of the governing jurisprudence, policies and modern scientific data surrounding said vaccination mandates and large scale disease outbreaks. This article therefore aims to provide a clear and extensive understanding of the proposition that, while bodily autonomy is favored in other aspects of life, this right can fail with respect to deadly disease outbreaks and mandatory vaccinations as there is presently no other practical or feasible alternative. Specifically, this article introduces and/or reminds the U.S. public of well-established governing case law, relevant historical and scientific information and the pertinent legislative authority surrounding vaccines, bodily autonomy, and vaccination mandates.

High SARS-CoV-2 infection rate in children unvaccinated with COVID-19 vaccine in Changzhou, China, shortly after lifting zero-COVID-19 policy in December 2022.

BACKGROUND: China experienced an overwhelming COVID-19 pandemic from middle December 2022 to middle January 2023 after lifting the zero-COVID-19 policy on December 7, 2022. However, the infection rate was less studied. We aimed to investigate the SARS-CoV-2 infection rate in children shortly after discontinuation of the zero-COVID-19 policy. METHODS: From February 20 to April 10, 2023, we included 393 children aged 8 months to less than 3 years who did not receive COVID-19 vaccination and 114 children aged 3 to 6 years who received inactivated COVID-19 vaccines based on the convenience sampling in this cross-sectional study. IgG and IgM antibodies against nucleocapsid (N) and subunit 1 of spike (S1) of SARS-CoV-2 (anti-N/S1) were measured with commercial kits (Shenzhen YHLO Biotech, China). RESULTS: Of the 393 unvaccinated children (1.5 ± 0.6 years; 52.2% boys), 369 (93.9%) were anti-N/S1 IgG positive. Of the 114 vaccinated children (5.3 ± 0.9 years; 48.2% boys), 112 (98.2%) were anti-N/S1 IgG positive. None of the unvaccinated or vaccinated children was anti-N/S1 IgM positive. The median IgG antibody titers in vaccinated children (344.91 AU/mL) were significantly higher than that in unvaccinated children (42.80 AU/mL) (P < 0.0001). The positive rates and titers of anti-N/S1 IgG had no significant difference between boys and girls respectively. CONCLUSION: Vast majority of children were infected with SARS-CoV-2 shortly after ending zero-COVID-19 policy in China. Whether these unvaccinated infected children should receive COVID-19 vaccine merits further investigation.

COVID-19 Vaccination Coverage and Factors Associated With Vaccine Uptake Among People With HIV.

Importance: People with HIV (PWH) may be at increased risk for severe outcomes with COVID-19 illness compared with people without HIV. Little is known about COVID-19 vaccination coverage and factors associated with primary series completion among PWH. Objectives: To evaluate COVID-19 vaccination coverage among PWH and examine sociodemographic, clinical, and community-level factors associated with completion of the primary series and an additional primary dose. Design, Setting, and Participants: This retrospective cohort study used electronic health record data to assess COVID-19 vaccination information from December 14, 2020, through April 30, 2022, from 8 health care organizations of the Vaccine Safety Datalink project in the US. Participants were adults diagnosed with HIV on or before December 14, 2020, enrolled in a participating site. Main Outcomes and Measures: The percentage of PWH with at least 1 dose of COVID-19 vaccine and PWH who completed the COVID-19 vaccine primary series by December 31, 2021, and an additional primary dose by April 30, 2022. Rate ratios (RR) and 95% CIs were estimated using Poisson regression models for factors associated with completing the COVID-19 vaccine primary series and receiving an additional primary dose. Results: Among 22 058 adult PWH (mean [SD] age, 52.1 [13.3] years; 88.8% male), 90.5% completed the primary series by December 31, 2021. Among 18 374 eligible PWH who completed the primary series by August 12, 2021, 15 982 (87.0%) received an additional primary dose, and 4318 (23.5%) received a booster dose by April 30, 2022. Receipt of influenza vaccines in the last 2 years was associated with completion of the primary series (RR, 1.17; 95% CI, 1.15-1.20) and an additional primary dose (RR, 1.61; 95% CI, 1.54-1.69). PWH with uncontrolled viremia (HIV viral load ≥200 copies/mL) (eg, RR, 0.90 [95% CI, 0.85-0.95] for viral load 200-10 000 copies/mL vs undetected or <200 copies/mL for completing the primary series) and Medicaid insurance (eg, RR, 0.89 [95% CI, 0.87-0.90] for completing the primary series) were less likely to be fully vaccinated. By contrast, greater outpatient utilization (eg, RR, 1.07 [95% CI, 1.05-1.09] for ≥7 vs 0 visits for primary series completion) and residence in counties with higher COVID-19 vaccine coverage (eg, RR, 1.06 [95% CI, 1.03-1.08] for fourth vs first quartiles for primary series completion) were associated with primary series and additional dose completion (RRs ranging from 1.01 to 1.21). Conclusions and Relevance: Findings from this cohort study suggest that, while COVID-19 vaccination coverage was high among PWH, outreach efforts should focus on those who did not complete vaccine series and those who have uncontrolled viremia.

Understanding the determinants of vaccine hesitancy in the United States: A comparison of social surveys and social media.

The COVID-19 pandemic prompted governments worldwide to implement a range of containment measures, including mass gathering restrictions, social distancing, and school closures. Despite these efforts, vaccines continue to be the safest and most effective means of combating such viruses. Yet, vaccine hesitancy persists, posing a significant public health concern, particularly with the emergence of new COVID-19 variants. To effectively address this issue, timely data is crucial for understanding the various factors contributing to vaccine hesitancy. While previous research has largely relied on traditional surveys for this information, recent sources of data, such as social media, have gained attention. However, the potential of social media data as a reliable proxy for information on population hesitancy, especially when compared with survey data, remains underexplored. This paper aims to bridge this gap. Our approach uses social, demographic, and economic data to predict vaccine hesitancy levels in the ten most populous US metropolitan areas. We employ machine learning algorithms to compare a set of baseline models that contain only these variables with models that incorporate survey data and social media data separately. Our results show that XGBoost algorithm consistently outperforms Random Forest and Linear Regression, with marginal differences between Random Forest and XGBoost. This was especially the case with models that incorporate survey or social media data, thus highlighting the promise of the latter data as a complementary information source. Results also reveal variations in influential variables across the five hesitancy classes, such as age, ethnicity, occupation, and political inclination. Further, the application of models to different MSAs yields mixed results, emphasizing the uniqueness of communities and the need for complementary data approaches. In summary, this study underscores social media data's potential for understanding vaccine hesitancy, emphasizes the importance of tailoring interventions to specific communities, and suggests the value of combining different data sources.

Reaching the unreached through building trust: a mixed-method study on COVID-19 vaccination in rural Lao PDR.

INTRODUCTION: The global COVID-19 vaccine rollout has been impacted by socioeconomic disparities and vaccine hesitancy, but few studies examine reasons for changed attitudes. In Lao People's Democratic Republic (Lao PDR), a nationwide government-led initiative was developed in response to COVID-19, focused on community health ownership and trust in primary healthcare. The intervention team including health and governance sectors conducted capacity-building workshops with local staff and community representatives and visited villages for vaccination outreach. This study investigates the impact of this intervention on COVID-19 vaccine acceptance in rural communities. METHODS: Conducted in Xiengkhuang province, Lao PDR, from December 2022 to February 2023, the study employed a sequential mixed-methods research design. Data on vaccinated individuals from 25 villages were collected from 11 primary healthcare units; pre-post analysis was applied. Qualitative data, gathered through interviews and focus group discussions with villagers, village authorities, health staff and local government (n=102) in six villages, underwent inductive thematic analysis. RESULTS: First-dose vaccine uptake after the intervention increased significantly (6.9 times). Qualitative analysis identified key reasons for vaccination hesitancy: (1) mistrust due to rumours and past experiences; (2) poor communication and inconsistent messaging and (3) challenges in access for priority groups. Influencing factors during the intervention included (1) effective local-context communication; (2) leveraging existing community structures and influential individuals in a multisectoral approach and (3) increased community motivation through improved satisfaction, ownership and relationships. CONCLUSION: This study highlights the impact and methods of building trust with unreached populations in health interventions, emphasising locally led solutions. Successful reversal of vaccine hesitancy was achieved by addressing root causes and fostering ownership at community and local government levels through a 'positive approach'. This diverges from conventional supplemental immunisation activities and holds potential for systematically building trust between unreached populations and health systems. Further research could explore the impacts of routine vaccination for sustained improvements in health equity.

Non-pharmaceutical interventions in containing COVID-19 pandemic after the roll-out of coronavirus vaccines: a systematic review.

BACKGROUND: Non-pharmaceutical interventions (NPIs) have been widely utilised to control the COVID-19 pandemic. However, it is unclear what the optimal strategies are for implementing NPIs in the context of coronavirus vaccines. This study aims to systematically identify, describe, and evaluate existing ecological studies on the real-world impact of NPIs in containing COVID-19 pandemic following the roll-out of coronavirus vaccines. METHODS: We conducted a comprehensive search of relevant studies from January 1, 2021, to June 4, 2023 in PubMed, Embase, Web of science and MedRxiv. Two authors independently assessed the eligibility of the studies and extracted the data. A risk of bias assessment tool, derived from a bibliometric review of ecological studies, was applied to evaluate the study design, statistical methodology, and the quality of reporting. Data were collected, synthesised and analysed using qualitative and quantitative methods. The results were presented using summary tables and figures, including information on the target countries and regions of the studies, types of NPIs, and the quality of evidence. RESULTS: The review included a total of 17 studies that examined the real-world impact of NPIs in containing the COVID-19 pandemic after the vaccine roll-out. These studies used five composite indicators that combined multiple NPIs, and examined 14 individual NPIs. The studies had an average quality assessment score of 13 (range: 10-16), indicating moderately high quality. NPIs had a larger impact than vaccination in mitigating the spread of COVID-19 during the early stage of the vaccination implementation and in the context of the Omicron variant. Testing policies, workplace closures, and restrictions on gatherings were the most effective NPIs in containing the COVID-19 pandemic, following the roll-out of vaccines. The impact of NPIs varied across different time frames, countries and regions. CONCLUSION: NPIs had a larger contribution to the control of the pandemic as compared to vaccination during the early stage of vaccine implementation and in the context of the omicron variant. The impact of NPIs in containing the COVID-19 pandemic exhibited variability in diverse contexts. Policy- and decision-makers need to focus on the impact of different NPIs in diverse contexts. Further research is needed to understand the policy mechanisms and address potential future challenges.

SARS-CoV-2 Vaccination is Not Associated With Involuntary Childlessness in Female Healthcare Workers: A Multicenter Cohort Study.

BACKGROUND: There is debate about the causes of the recent birth rate decline in high-income countries worldwide. During the pandemic, concern about the effects on reproductive health has caused vaccine hesitancy. We investigated the association of SARS-CoV-2 vaccination and infection with involuntary childlessness. METHODS: Females in fertility age within a prospective multicenter cohort of healthcare workers (HCW) were followed since August 2020. Data on baseline health, SARS-CoV-2-infection, and vaccination were obtained and regularly updated, in which serum samples were collected repetitively and screened for anti-nucleocapsid and anti-spike antibodies. In October 2023, participants indicated the presence of involuntary childlessness with onset during the pandemic, whereas those indicating an onset before the pandemic were excluded. The association of involuntary childlessness and SARS-CoV-2-vaccination and infection was investigated using univariable and multivariable analysis. Sensitivity analysis was performed to compare those reporting involuntary childlessness with those birthing a child since 2020. RESULTS: Of 798 participants, 26 (3.2%) reported involuntary childlessness starting since the pandemic. Of the involuntary childless women, 73.1% (19/26) were vaccinated compared to 86.0% (664/772) without involuntary childlessness (p = 0.73). SARS-CoV-2 infection was reported by 76.9% (20/26) compared to 72.4% (559/772) of controls (p = 0.64). Neither SARS-CoV-2 vaccination (aOR 0.91 per dose, 95%CI 0.67-1.26) nor infection (aOR per infection 1.05, 95%CI 0.62-1.71) was associated with involuntary childlessness. Sensitivity analysis confirmed these results. CONCLUSIONS: Among female HCW of fertility age, 3.2% indicated involuntary childlessness, which is comparable to pre-pandemic data. No association between involuntary childlessness and SARS-CoV-2 vaccination or infection was found.

Impacts of travel duration on urban-rural resident free vaccination behavior: Chinese COVID-19 vaccine booster dose evidence.

This study aimed to evaluate how the duration of travel affects the behavior of urban and rural residents regarding free COVID-19 vaccination, and provide scientific evidence for promoting free vaccination and building an immune barrier to cope with future epidemics. From August 3, 2022 to February,18,2023, A follow-up survey was conducted in urban and rural adults in four cities in China to collect information on socio-demographic factors, vaccination status and travel time for vaccination. Propensity score matching (PSM) analysis was deployed to measure the net difference of the enhanced vaccination rate between urban and rural residents in different traffic time distribution. A total of 5780 samples were included in the study. The vaccination rate of the booster dose of COVID-19 vaccine among rural residents was higher than that of urban residents with a significant P-value (69.36% VS 64.49%,p < .001). The traffic time had a significant negative impact on the COVID-19 booster vaccination behavior of urban and rural residents. There was a significant interaction between the travel time to the vaccination point and the level of trust in doctors. Travel time had a negative impact on the free vaccination behavior of both urban and rural residents. The government should optimize and expand the number of vaccination sites and enhance residents' trust in the medical system. This is crucial for promoting free vaccination and effective epidemic management in the future.

Trends in the administration of COVID-19 vaccines with other vaccines in the United States reported to V-safe during December 14, 2020-May 19, 2023.

Introduction COVID-19 vaccines may be administered with other vaccines during the same healthcare visit. COVID-19 monovalent (Fall 2021) and bivalent (Fall 2022) vaccine recommendations coincided with annual seasonal influenza vaccination. Data describing the frequency of the co-administration of COVID-19 vaccines with other vaccines are limited. Methods We used V-safe, a voluntary smartphone-based U.S. safety surveillance system established by the CDC, to describe trends in the administration of COVID-19 vaccines with other vaccines reported to V-safe during December 14, 2020 - May 19, 2023. Results Of the 21 million COVID-19 vaccinations reported to V-safe, 2.2% (459,817) were administered with at least 1 other vaccine. Co-administration most frequently occurred during the first week of October 2023 (27,092; 44.1%). Most reports of co-administration included influenza vaccine (393,003; 85.5%). Co-administration was most frequently reported for registrants aged 6 months-6 years (4,872; 4.4%). Conclusion Reports of co-administration to V-safe peaked during October 2023, when influenza vaccination most often occurs, possibly reflecting increased opportunities for multiple vaccinations and greater acceptability of the co-administration of COVID-19 vaccine with other vaccines, especially influenza vaccine.

Neurovascular Adverse Effects of Sars-Cov-2 Vaccination.

The global deployment of SARS-CoV-2 vaccines has been pivotal in curbing the COVID-19 pandemic, reducing morbidity and mortality associated with the virus. While most of these vaccines have demonstrated high efficacy and overall safety, emerging reports have highlighted potential neurovascular adverse effects, albeit uncommon, associated with these vaccinations. This review aims to assess and summarize the current knowledge on the neurovascular complications arising post-SARS-CoV-2 vaccination. We conducted an extensive literature review, focusing on clinical studies and case reports to identify reported neurovascular events, such as ischemic stroke, cerebral sinus venous thrombosis, intracerebral hemorrhage, pituitary apoplexy and primary CNS angiitis Despite the relative rarity of these events, their impact on affected individuals underscores the importance of ongoing surveillance, early detection, and management strategies. We aim to provide healthcare professionals with the latest evidence on neurovascular adverse effects, facilitating informed decision-making in the context of SARS-CoV-2 vaccination programs. Furthermore, we highlight areas requiring further research to understand the pathophysiology of these adverse events better and to develop targeted prevention and treatment strategies.

Patients with advanced cancer were treated with immune checkpoint inhibitors and injected with COVID-19 vaccine to improve their prognosis without increasing pancreatic related adverse events.

To investigate immune checkpoint inhibitors (ICIs) induced pancreatic injury (ICIPI), the prognostic effect of COVID-19 vaccine on cancer patients, and whether COVID-19 vaccine increases the incidence of ICIPI. We conducted a retrospective study of 256 stage IV cancer patients treated with ICIs at The First Affiliated Hospital of Anhui Medical University from January 2020 to November 2022. Data collected included pancreatic enzyme levels, treatment outcomes, and vaccination status. Statistical significance was determined using the χ2 test and Kaplan-Meier method (p < .05). Compared to the control group, the vaccinated group (p < .0001) and the group with elevated pancreatic enzyme levels (p = .044) demonstrated higher disease control rates, indicating a direct benefit of vaccination and enzyme monitoring on treatment outcomes. Additionally, vaccinated patients demonstrated longer overall survival versus unvaccinated patients (23.9 months [95% CI, 22.3-25.5] vs 23.6 months [95% CI, 21.1-26.2], HR = 0.45 [95% CI, 0.24-0.86], p = .015) and progression-free survival (17.2 months [95% CI, 14.3-20.1] vs 13.7 months [95% CI, 11.3-16.1], HR = 0.54 [95% CI, 0.36-0.82], p = .004). Importantly, the analysis revealed no significant association between vaccination and pancreatic injury (p = .46). Monitoring pancreatic enzymes can effectively evaluate the therapeutic impact in patients using ICIs. Patients vaccinated against COVID-19 experience better immunotherapy outcomes without an increased risk of ICIPI.

SARS-CoV-2 Seroprevalence Trends in the Netherlands in the Variant of Concern Era: Input for Future Response.

BACKGROUND: To inform future response planning we aimed to assess SARS-CoV-2 trends in infection- and/or vaccine-induced immunity, including breakthrough infections, among (sub)groups, professions and regions in the Dutch population during the Variant of Concern (VOC)-era. METHODS: In this prospective population-based cohort, randomly selected participants (n = 9985) aged 1-92 years (recruited early-2020) donated home-collected fingerstick-blood samples at six timepoints in 2021/2022, covering waves dominated by Alpha, Delta, and multiple Omicron (sub-)variants. IgG antibody assessment against Spike-S1 and Nucleoprotein was combined with vaccination- and testing data to estimate infection-induced (inf) and total (infection- and vaccination-induced) seroprevalence. RESULTS: Nationwide inf-seroprevalence rose modestly from 12% (95% CI 11-13) since Alpha to 26% (95% CI 24-28) amidst Delta, while total seroprevalence increased rapidly to 87% (95% CI 85-88), particularly in elderly and those with comorbidities (i.e., vulnerable groups). Interestingly, highest infection rates were noticeable among low/middle educated elderly, non-Western, those in contact professions, adolescents and young adults, and in low-vaccination coverage regions. Following Omicron emergence, inf-seroprevalence elevated sharply to 62% (95% CI 59-65) and further to 86% (95% CI 83-90) in late-2022, with frequent breakthrough infections and decreasing seroprevalence dissimilarities between most groups. Whereas > 90% of < 60-year-olds had been infected at least once, 30% of vaccinated vulnerable individuals had still not acquired hybrid immunity. CONCLUSIONS: Groups identified to have been infected disproportionally during the acute phase of the pandemic require specific attention in evaluation of control measures and future response planning worldwide. Furthermore, ongoing tailored vaccination efforts and (sero-)monitoring of vulnerable groups may remain important.

Time to SARS-CoV-2 clearance in African, Caucasian, and Asian ethnic groups.

BACKGROUND: COVID-19 may become a seasonal disease. SARS-CoV-2 active circulation coupled with vaccination efforts has undoubtedly modified the virus dynamic. It is therefore important investigate SARS-CoV-2 dynamic in different groups of population following the course of spatiotemporal variance and immunization. METHODS: To investigate SARS-CoV-2 clearance in different ethnic groups and the impact of immunization, we recruited 777 SARS-CoV-2-positive patients (570 Africans, 156 Caucasians, and 51 Asians). Participants were followed and regularly tested for 2 months until they had two negative tests. RESULTS: The vaccination rate was 64.6%. African individuals were less symptomatic (2%), Caucasians (41%) and Asians (36.6%). On average, viral clearance occurred after 10.5 days. Viral load at diagnosis was inversely correlated with viral clearance (p < 0.0001). The time of SARS-CoV-2 clearance was higher in Africans and Caucasians than in Asians (Dunn's test p < 0.0001 and p < 0.05, respectively). On average, viral clearance occurred within 9.5 days during the second semester (higher rate of vaccination and SARS-CoV-2 exposition), whereas it took 13.6 days during the first semester (lower rate of vaccination and SARS-CoV-2 exposition) (Mann-Whitney t-test p < 0.0001). CONCLUSION: In conclusion, ethnicity and spatiotemporal changes including SARS-CoV-2 exposition and immunization affect SARS-CoV-2 clearance.

Clinical development of SpikoGen®, an Advax-CpG55.2 adjuvanted recombinant spike protein vaccine.

Recombinant protein vaccines represent a well-established, reliable and safe approach for pandemic vaccination. SpikoGen® is a recombinant spike protein trimer manufactured in insect cells and formulated with Advax-CpG55.2 adjuvant. In murine, hamster, ferret and non-human primate studies, SpikoGen® consistently provided protection against a range of SARS-CoV-2 variants. A pivotal Phase 3 placebo-controlled efficacy trial involving 16,876 participants confirmed the ability of SpikoGen® to prevent infection and severe disease caused by the virulent Delta strain. SpikoGen® subsequently received a marketing authorization from the Iranian FDA in early October 2021 for prevention of COVID-19 in adults. Following a successful pediatric study, its approval was extended to children 5 years and older. Eight million doses of SpikoGen® have been delivered, and a next-generation booster version is currently in development. This highlights the benefits of adjuvanted protein-based approaches which should not overlook when vaccine platforms are being selected for future pandemics.

SpikoGen is a more traditional COVID-19 vaccine comprising SARS-CoV-2 spike protein extracellular domain formulated with Advax-CpG adjuvantSpikoGen differs from the Novavax vaccine in major ways including its use of the soluble secreted spike protein ECD rather than nanoparticle formulation and the use of a different adjuvantSpikoGen demonstrates robust protection against homologous and heterologous SARS-CoV-2 strains in hamster, ferret and non-human primate challenge modelsSpikoGen induces broadly cross-neutralizing antibodies, but still protects even after these antibody levels waneIn a pivotal Phase 3 clinical trial, SpikoGen reduced the risk of severe infection by 77.5% and was not associated with myocarditis, thrombosis or any other adverse safety signalsSpikoGen received an Emergency Use Authorization in the Middle East on 6 October 2021, making it the first recombinant spike protein vaccine to achieve this milestoneEight million doses of SpikoGen vaccine have been safely delivered to dateProtein-based vaccines have a long history of reliability and safety.

How effective is the BNT162b2 mRNA vaccine against SARS-CoV-2 transmission and infection? A national programme analysis in Monaco, July 2021 to September 2022.

BACKGROUND: We quantified SARS-CoV-2 dynamics in different community settings and the direct and indirect effect of the BNT162b2 mRNA vaccine in Monaco for different variants of concern (VOC). METHODS: Between July 2021 and September 2022, we prospectively investigated 20,443 contacts from 6320 index cases using data from the Monaco COVID-19 Public Health Programme. We calculated secondary attack rates (SARs) in households (n = 13,877), schools (n = 2508) and occupational (n = 6499) settings. We used binomial regression with a complementary log-log link function to measure adjusted hazard ratios (aHR) and vaccine effectiveness (aVE) for index cases to infect contacts and contacts to be infected in households. RESULTS: In households, the SAR was 55% (95% CI 54-57) and 50% (48-51) among unvaccinated and vaccinated contacts, respectively. The SAR was 32% (28-36) and 12% (10-13) in workplaces, and 7% (6-9) and 6% (3-10) in schools, among unvaccinated and vaccinated contacts respectively. In household, the aHR was lower in contacts than in index cases (aHR 0.68 [0.55-0.83] and 0.93 [0.74-1.1] for delta; aHR 0.73 [0.66-0.81] and 0.89 [0.80-0.99] for omicron BA.1&2, respectively). Vaccination had no significant effect on either direct or indirect aVE for omicron BA.4&5. The direct aVE in contacts was 32% (17, 45) and 27% (19, 34), and for index cases the indirect aVE was 7% (- 17, 26) and 11% (1, 20) for delta and omicron BA.1&2, respectively. The greatest aVE was in contacts with a previous SARS-CoV-2 infection and a single vaccine dose during the omicron BA.1&2 period (45% [27, 59]), while the lowest were found in contacts with either three vaccine doses (aVE - 24% [- 63, 6]) or one single dose and a previous SARS-CoV-2 infection (aVE - 36% [- 198, 38]) during the omicron BA.4&5 period. CONCLUSIONS: Protection conferred by the BNT162b2 mRNA vaccine against transmission and infection was low for delta and omicron BA.1&2, regardless of the number of vaccine doses and previous SARS-CoV-2 infection. There was no significant vaccine effect for omicron BA.4&5. Health authorities carrying out vaccination campaigns should bear in mind that the current generation of COVID-19 vaccines may not represent an effective tool in protecting individuals from either transmitting or acquiring SARS-CoV-2 infection.

Seasonal human coronavirus humoral responses in AZD1222 (ChaAdOx1 nCoV-19) COVID-19 vaccinated adults reveal limited cross-immunity.

Background: Immunity to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is now widespread; however, the degree of cross-immunity between SARS-CoV-2 and endemic, seasonal human coronaviruses (HCoVs) remains unclear. Methods: SARS-CoV-2 and HCoV cross-immunity was evaluated in adult participants enrolled in a US sub-study in the phase III, randomized controlled trial (NCT04516746) of AZD1222 (ChAdOx1 nCoV-19) primary-series vaccination for one-year. Anti-HCoV spike-binding antibodies against HCoV-229E, HCoV-HKU1, HCoV-OC43, and HCoV-NL63 were evaluated in participants following study dosing and, in the AZD1222 group, after a non-study third-dose booster. Timing of SARS-CoV-2 seroconversion (assessed via anti-nucleocapsid antibody levels) and incidence of COVID-19 were evaluated in those who received AZD1222 primary-series by baseline anti-HCoV titers. Results: We evaluated 2,020/21,634 participants in the AZD1222 group and 1,007/10,816 in the placebo group. At the one-year data cutoff (March 11, 2022) mean duration of follow up was 230.9 (SD: 106.36, range: 1-325) and 94.3 (74.12, 1-321) days for participants in the AZD1222 (n = 1,940) and placebo (n = 962) groups, respectively. We observed little elevation in anti-HCoV humoral titers post study-dosing or post-boosting, nor evidence of waning over time. The occurrence and timing of SARS-CoV-2 seroconversion and incidence of COVID-19 were not largely impacted by baseline anti-HCoV titers. Conclusion: We found limited evidence for cross-immunity between SARS-CoV-2 and HCoVs following AZD1222 primary series and booster vaccination. Susceptibility to future emergence of novel coronaviruses will likely persist despite a high prevalence of SARS-CoV-2 immunity in global populations.

Support for Mandatory COVID-19 Vaccines for 5- to 11-Year-Old Children: Cross-sectional study of Omani mothers.

Objectives: This study aimed to investigate the variables that influenced a sample of Omani mothers' support for mandatory COVID-19 vaccines for children. The vaccination against COVID-19 averted millions of fatalities during the COVID-19 pandemic. Nevertheless, a considerable number of parents and caregivers opposed mandating COVID-19 vaccines for children. Methods: This cross-sectional study was conducted at several healthcare facilities in Oman using a structured questionnaire between February and March 2022. Univariable and multivariable logistic regression models were used to analyse the data. Results: A total of 700 Omani mothers (response rate = 73.4%) who had children aged 5-11 years old were included. The median age of the mothers was 38 ± 5.19 years. The results of multivariable logistic regression were generally consistent with those of the univariable analysis except for age (odds ratio [OR] = 1.06, 95% confidence interval [CI]: 0.58-1.93; P = 0.86) and income (OR = 1.09, 95% CI: 0.58-2.03; P = 0.79). Mothers who were vaccine hesitant (OR = 9.82, 95% CI: 5.27-18.28; P <0.001), tested positive for COVID-19 (OR = 3.25, 95% CI: 1.80-5.86; P <0.001) and had one or two doses of COVID-19 vaccines (OR = 5.41, 95% CI: 2.92-10.03; P <0.001) were more likely to refuse mandating COVID-19 vaccines for children 5-11 years old. Conclusion: Mothers who were vaccine hesitant, tested positive for COVID-19 and had one or two doses of COVID-19 vaccines were more likely to oppose mandatory COVID-19 vaccines for young children. The findings should aid public health authorities in designing future childhood vaccine literacy programmes with specific attention to some subgroups in Oman to help reduce opposition to vaccines in future pandemics among mothers.