scholarly journals Adverse events of inactivated COVID-19 vaccine in HIV-infected adults

2021 ◽  
Vol 18 (1) ◽  
Author(s):  
Songjie Wu ◽  
Yubin Zhang ◽  
Fangzhao Ming ◽  
Shi Zou ◽  
Mengmeng Wu ◽  
...  

AbstractThis study aims to evaluate the safety of inactivated COVID-19 vaccine among adult people living with HIV (PLWH). In total, 259 PLWH who received at least one dose of inactivated COVID-19 vaccine were enrolled, and post-vaccination adverse events (AEs) were evaluated seven days following each vaccination dose. The overall AE frequency was 22.8% after dose one, which was higher than after dose two (10.2%) (P < 0.001). No severe side event or vaccine safety concern was observed. Our finding was essential in reducing vaccine hesitancy among PLWH.

2021 ◽  
Author(s):  
Songjie Wu ◽  
Yubin Zhang ◽  
Fangzhao Ming ◽  
Shi Zou ◽  
Mengmeng Wu ◽  
...  

Abstract This study aims to evaluate the safety of inactivated COVID-19 vaccineamong adult people living with HIV (PLWH). In total, 259 PLWH who received at least one dose of inactivated COVID-19 vaccine were enrolled, and post-vaccination adverse events (AEs) were evaluated seven days following each vaccination dose. The overall AE frequency was 22.8% after dose one, which was higher than after dose two(10.2%)(P<0.001). No severe side event or vaccine safety concern was observed. Our finding was essential in reducing vaccine hesitancy among PLWH.


Vaccines ◽  
2021 ◽  
Vol 9 (12) ◽  
pp. 1458
Author(s):  
Ying Liu ◽  
Junyan Han ◽  
Xin Li ◽  
Danying Chen ◽  
Xuesen Zhao ◽  
...  

The administration of COVID-19 vaccines is the primary strategy used to prevent further infections by COVID-19, especially in people living with HIV (PLWH), who are at increased risk for severe symptoms and mortality. However, the vaccine hesitancy, safety, and immunogenicity of COVID-19 vaccines among PLWH have not been fully characterized. We estimated vaccine hesitancy and status of COVID-19 vaccination in Chinese PLWH, explored the safety and impact on antiviral therapy (ART) efficacy and compared the immunogenicity of an inactivated vaccine between PLWH and healthy controls (HC). In total, 27.5% (104/378) of PLWH hesitated to take the vaccine. The barriers included concerns about safety and efficacy, and physician counselling might help patients overcome this vaccine hesitancy. A COVID-19 vaccination did not cause severe side effects and had no negative impact on CD4+ T cell counts and HIV RNA viral load. Comparable spike receptor binding domain IgG titer were elicited in PLWH and HC after a second dose of the CoronaVac vaccine, but antibody responses were lower in poor immunological responders (CD4+ T cell counts < 350 cells/µL) compared with immunological responders (CD4+ T cell counts ≥ 350 cells/µL). These data showed that PLWH have comparable safety and immune response following inactivated COVID-19 vaccination compared with HC, but the poor immunological response in PLWH is associated with impaired humoral response.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Hossein Azarpanah ◽  
Mohsen Farhadloo ◽  
Rustam Vahidov ◽  
Louise Pilote

Abstract Background Vaccine hesitancy has been a growing challenge for public health in recent decades. Among factors contributing to vaccine hesitancy, concerns regarding vaccine safety and Adverse Events (AEs) play the leading role. Moreover, cognitive biases are critical in connecting such concerns to vaccine hesitancy behaviors, but their role has not been comprehensively studied. In this study, our first objective is to address concerns regarding vaccine AEs to increase vaccine acceptance. Our second objective is to identify the potential cognitive biases connecting vaccine hesitancy concerns to vaccine-hesitant behaviors and identify the mechanism they get triggered in the vaccine decision-making process. Methods First, to mitigate concerns regarding AEs, we quantitatively analyzed the U.S. Vaccine Adverse Event Reporting System (VAERS) from 2011 to 2018 and provided evidence regarding the non-severity of the AEs that can be used as a communicable summary to increase vaccine acceptance. Second, we focused on the vaccination decision-making process. We reviewed cognitive biases and vaccine hesitancy literature to identify the most potential cognitive biases that affect vaccine hesitancy and categorized them adopting the Precaution Adoption Process Model (PAPM). Results Our results show that the top frequent AEs are expected mild reactions like injection site erythema (4.29%), pyrexia (3.66%), and injection site swelling (3.21%). 94.5% of the reports are not serious and the average population-based serious reporting rate over the 8 years was 25.3 reports per 1 million population. We also identified 15 potential cognitive biases that might affect people’s vaccination decision-making and nudge them toward vaccine hesitancy. We categorized these biases based on the factors that trigger them and discussed how they contribute to vaccine hesitancy. Conclusions This paper provided an evidence-based communicable summary of VAERS. As the most trusted sources of vaccine information, health practitioners can use this summary to provide evidence-based vaccine information to vaccine decision-makers (patients/parents) and mitigate concerns over vaccine safety and AEs. In addition, we identified 15 potential cognitive biases that might affect the vaccination decision-making process and nudge people toward vaccine hesitancy. Any plan, intervention, and message to increase vaccination uptake should be modified to decrease the effect of these potential cognitive biases.


2020 ◽  
Vol 24 (1) ◽  
pp. 65-72 ◽  
Author(s):  
Larissa Negromonte Azevedo ◽  
Ricardo Arraes de Alencar Ximenes ◽  
Polyana Monteiro ◽  
Ulisses Ramos Montarroyos ◽  
Demócrito de Barros Miranda-Filho

2021 ◽  
Vol 19 ◽  
Author(s):  
Zubairu Iliyasu ◽  
Aminatu A. Kwaku ◽  
Amina A. Umar ◽  
Fatimah Tsiga-Ahmed ◽  
Nafisa S. Nass ◽  
...  

Background: People living with HIV (PLHIV) are at increased risk of COVID-19 acquisition, severe disease, and poor outcomes. Yet, little is known about COVID-19 vaccine hesitancy among PLHIV in high HIV burden countries such as Nigeria. Objective: This study aims to assess the acceptability of the COVID-19 vaccine and identify predictors and reasons for vaccine hesitancy among patients living with HIV and attending a tertiary hospital in Kano, northern Nigeria. Methods: Using a mixed-methods design, structured questionnaires were administered to a clinic-based sample of patients living with HIV (n=344), followed by 20 in-depth interviews with a sub-sample. Logistic regression and the framework approach were used to analyze the data. Results: Less than half (46.2%, n=159) of the respondents were willing to take the COVID-19 vaccine. Vaccine acceptance was higher among non-Muslim PLHIV (Adjusted Odds Ratio (aOR)=1.26, 95% Confidence Interval (95%CI): 1.10-4.00), persons with high-risk perception (aOR=2.43, 95%CI:1.18-5.00), those who were not worried about infertility-related rumors (aOR=13.54, 95%CI:7.07-25.94) and persons who perceived antiretroviral drugs are protective against COVID-19 (aOR = 2.76, 95%CI: 1.48-5.14). In contrast, vaccine acceptance was lower among persons who were not more concerned about the potential effects of COVID-19-HIV co-infection (aOR=0.20, 95%CI:0.10-0.39). The most common reasons for vaccine hesitancy included doubts about the existence of COVID-19, low-risk perception, anxiety about antiretroviral treatment-vaccine interactions, safety concerns, and infertility-related rumors. Conclusion: Covid-19 vaccine acceptance was low among PLHIV. COVID-19 vaccine acceptance was associated with respondents’ faith, risk perception, perception of the protective effects of antiretroviral treatment, concerns about COVID-19-HIV co-infection, and infertility-related rumors. Vaccination counseling should be integrated into HIV treatment services to improve COVID-19 vaccine uptake among PLHIV in Kano and similar settings.


Author(s):  
Ashley T Longley ◽  
Kashmira Date ◽  
Stephen P Luby ◽  
Pankaj Bhatnagar ◽  
Adwoa D Bentsi-Enchill ◽  
...  

Abstract Background In December 2017, the World Health Organization (WHO) prequalified the first typhoid conjugate vaccine (TCV) (Typbar-TCV). While no safety concerns were identified in pre- and post-licensure studies, WHO’s Global Advisory Committee on Vaccine Safety recommended robust safety evaluation with large-scale TCV introductions. During July–August 2018, the Navi Mumbai Municipal Corporation (NMMC) launched the world’s first public sector TCV introduction. Per administrative reports, 113,420 children 9 months–14 years old received TCV. Methods We evaluated adverse events following immunization (AEFI) using passive and active surveillance via 1) reports from the passive NMMC AEFI surveillance system, 2) telephone interviews with 5% of caregivers of vaccine recipients 48 hours and 7 days post-vaccination, and 3) chart abstraction for adverse events of special interest (AESI) among patients admitted to 5 hospitals using the Brighton Collaboration criteria followed by ascertainment of vaccination status. Results We identified 222/113,420 (0.2%) AEFI through the NMMC AEFI surveillance system: 211 (0.19%) minor, 2 (0.002%) severe, and 9 (0.008%) serious. At 48 hours post-vaccination, 1,852/5,605 (33%) caregivers reported one or more AEFI, including injection site pain (n=1,452, 26%), swelling (n=419, 7.5%), and fever (n=416, 7.4%). Of the 4,728 interviews completed at 7 days post-vaccination, the most reported AEFI included fever (n=200, 4%), pain (n=52, 1%), and headache (n=42, 1%). Among 525 hospitalized children diagnosed with an AESI, 60 were vaccinated; no AESI were causally associated with TCV. Conclusions No unexpected safety signals were identified with TCV introduction. This provides further reassurance for the large-scale use of Typbar-TCV among children 9 months–14 years old.


2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S496-S496
Author(s):  
Mark Cinquegrani ◽  
M Gabriela Cabanilla ◽  
Keenan L Ryan ◽  
Catia Marzolini ◽  
Bernadette Jakeman

Abstract Background People living with HIV (PLWH) are aging and experience age-related comorbidities as well as physiological changes leading to a higher risk for polypharmacy, drug-drug interactions, inappropriate prescribing and related adverse events (AE). Prior studies have highlighted a growing concern for inappropriate prescribing in older PLWH. The objective of this study was to examine the prevalence of AEs resulting from inappropriate prescribing in PLWH &gt; 65 years of age. Methods This was a retrospective chart review. PLWH followed-up at the outpatient HIV clinic at the University Hospital in New Mexico between 01/01/2015 and 08/21/ 2018 were eligible if they were &gt; 65 years of age and had &gt;1 potentially inappropriate prescriptions (PIP). PIP were identified using the Beers and STOPP/START criteria for inappropriate mediations in elderly, as well as drugs incorrectly dosed, and potentially deleterious drug-drug interactions (DDI). The University of Liverpool’s HIV interaction checker and Lexicomp’s interaction checker were used to screen for DDI between HIV and non-HIV drugs, and between non-HIV drugs. AEs related to PIPs were collected and their severity was classified using the WHO scale for grading of AEs. Results A total of 104 PLWH &gt;65 years of age fulfilled the eligibility criteria. Most patients were male (88.5%) with an average age of 69 years. The majority of patients were virologically suppressed (89%), with an average CD4 cell count of 650 cells/µL. Polypharmacy (&gt;5 non-HIV medications) was identified in all 104 patients; average number of non-HIV medications was 9.4 + 4.8. 30 (28.8%) patients experienced &gt;1 AE, with a total of 53 AEs identified. Of those, 20 (67%) presented with a serious AE. 14 patients (47%) had to seek treatment at an emergency department and 2 patients (7%) had to be hospitalized. The most common AEs included falls (27/53 events; 51%), bleeds (7/53 events; 13%), fractures (4/53 events; 8%). Risk for an AE was significantly associated with increasing number of medications (OR 1.16; 95% CI 1.05-1.29). Conclusion PIP and related AEs are common in older PLWH. Interventions to prevent harm including medication reconciliation, medication review, and medication prioritization according to the risks/benefits of individual patients are warranted. Disclosures Keenan L. Ryan, PharmD, PhC, Theravance (Advisor or Review Panel member)


2021 ◽  
Author(s):  
Kapil Madi Poudel ◽  
Neha Shah ◽  
Manab Prakash ◽  
Santosh Kumar Deo ◽  
Sunita Bhandari ◽  
...  

Abstract Background: Vaccination is the most effective method to prevent the spread of infectious diseases and helps reduce mortality rate and economic costs associated with the pandemic. Despite these advantages, misinformation and rumors on vaccine safety and efficacy can lead to increased hesitation or fear towards vaccination. This study reports the incidence of adverse events following Covishield vaccination, their associated factors, medication used for their management, and attitudes about vaccine safety. Methods: A randomised cross-sectional study was conducted from the sample of Covishield-vaccinated individuals from a secondary hospital, two primary health centres, and 36 health posts in eastern Nepal. Individuals (n = 602) were randomly sampled from a population (N = 1013) who had received the first dose of Covishield, namely frontline workers and other high-risk populations. The second-round follow-up had 516 participants. Association of incidence and severity of post-vaccination events with socio-demographic variables, comorbidity status, and medication use were estimated. Results: Among the 79.9% of participants who reported adverse events after receiving the first dose, two-thirds of complaints were mild (67.4%, 95% CI 63.2–71.6) with the most common complaint being pain at the injection site (86.5%). Paracetamol or its combination were used in majority cases (95.2%). After the second dose, only 31.2% (95% CI 27.2–35.2) reported adverse events, the overwhelming majority of which were mild (95.7%) and required a lower frequency of medication (7.4% vs. 25.9%). Adverse Event following immunization were significantly associated with being 18–30 years old (χ2 = 16.9, df = 3, p < 0.001) and female gender (χ2 = 5.2, df = 1, p < 0.05). Prior to the first dose, 86.0% of participants (95% CI 83.3–88.8%) perceived the vaccine to be safe, and 96.0% recommended the vaccine post-vaccination, while 96.8% were interested in receiving the second dose.Conclusions: Overall, vaccination associated events were mild and majority were managed with paracetamol or its combination. Effective counselling about adverse events before vaccination should be prioritised to reduce hesitation and fear.


2019 ◽  
Vol 30 (11) ◽  
pp. 1105-1115 ◽  
Author(s):  
Yongle Zhan ◽  
Xuan Liu ◽  
Yahui Feng ◽  
Sansan Wu ◽  
Yu Jiang

The current evidence regarding the safety and immunogenicity of human papillomavirus (HPV) vaccinations for people living with HIV (PLWH) is unclear. We searched PubMed, Embase, Cochrane Library and Web of Science databases from inception to 23 November 2018. The pooled proportion, relative risk (RR) and the standardized mean difference (SMD) with 95% confidence intervals (CIs) were calculated. Twenty-four studies consisting of 7507 participants were identified. The pooled proportion of adverse events in HIV-infected vaccinees was 60% and the antibody seroconversion rates in HPV-6, -11, -16, -18 subtypes were all above 90%. When compared with the placebo groups, the risk of adverse events was not different except for the injection site reactions (RR: 2.63, 95% CI: 1.72–4.01, p < 0.001), and the level of CD4 was relatively lower (SMD: −0.17, 95% CI: −0.29 to −0.04, p = 0.01) in the HIV-positive vaccinees groups. When compared with HIV-negative vaccinees, the risk of adverse events was not different, but the pooled RR and SMD indicated that antibody seroconversion and geometric mean titer for HPV-18 in HIV-positive groups was lower (RR: 0.91, 95% CI: 0.87–0.95, p < 0.001; SMD: −0.43, 95% CI: −0.62 to −0.24, p < 0.001). The study proves that HPV vaccine is safe and efficacious for PLWH and has important implications for international guidelines and strategies for HPV vaccination.


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