The changing policies on covid-19 vaccines and the need for local pharmacovigilance

Building on Success Serving the Nation: Codifying Key Pharmacy Practice Authorities Beyond COVID-19.

This study aimed to characterize attitudes toward novel coronavirus disease 2019 (COVID-19) vaccination and to evaluate factors associated with vaccine uptake among pregnant individuals. An anonymous survey was distributed to a convenience sample of pregnant individuals receiving prenatal care at two large urban academic hospitals in a single health care network in Massachusetts. Individual demographic variables were included in the survey along with questions assessing attitudes toward COVID-19 and vaccination in pregnancy. Data were analyzed using parametric or nonparametric tests when appropriate, and associated odds ratios (OR) were calculated via univariable logistic regression. There were 684 surveys distributed, and 477 pregnant and postpartum individuals completed the survey, for a response rate of 69.7%. Overall, 233 (49.3%) had received or were scheduled to receive a COVID-19 vaccine. Age, White race, non-Hispanic or Latinx ethnicity, working from home, and typical receipt of the influenza vaccine were associated with COVID-19 vaccination. Further, 276 respondents (58.4%) reported that their provider recommended the COVID-19 vaccine in pregnancy; these participants were more likely to have received a vaccine (OR = 5.82, 95% confidence interval [CI]: 3.68-9.26, p < 0.005). Vaccinated individuals were less likely to be worried about the effects of the vaccine on themselves (OR = 0.18, 95% CI: 0.12-0.27, p < 0.005) or their developing babies (OR = 0.17, 95% CI: 0.11-0.26, p < 0.005). Unvaccinated individuals were less likely to report that it is easy to schedule a COVID-19 vaccine (OR = 0.56, 95% CI: 0.34-0.93, p = 0.02), to travel to receive a vaccine (OR = 0.19, 95% CI: 0.10-0.36, p < 0.005), and to miss work to receive a vaccine (OR = 0.30, 95% CI: 0.18-0.48, p < 0.005). Strategies are needed to improve patient education regarding vaccine side effects and safety in pregnancy. Policy changes should focus on making it feasible for patients to schedule a vaccine and miss work without loss of pay to get vaccinated. · There were racial and ethnic disparities in COVID-19 vaccination.. · Unvaccinated respondents were more likely to be concerned about vaccine effects for themselves or their growing babies.. · Unvaccinated respondents cited work and scheduling-related barriers to vaccination, indicating areas for advocacy..

SynopsisIn view of the continued threat of COVID‐19, and to synergize with routine antenatal care, COVID‐19 vaccination should become a default part of routine antenatal care with an opt‐out option.

“I’d do it for my baby”: Lessons learned from qualitative research on COVID-19 vaccination among pregnant women in Côte d’Ivoire

People with diabetes have higher COVID-19 morbidity and mortality. These risks are amplified for racial minorities and people living in rural areas or with low income, who are more likely to experience severe COVID-19 illness, vaccine hesitancy, and unemployment. A survey of adults with type 1, type 2, and other forms of diabetes (n=450, µ age= 52.7 years) receiving care at 41 federally qualified and community health centers in FL and CA examined COVID-19 illness, prevention, and financial and healthcare impacts. Surveys were completed from fall 2021 to summer 2022; all outcomes were self-reported. Descriptive statistics were computed for key outcomes (n, %). Logistic regression assessed independent associations of COVID-19 vaccine receipt. Between-group comparisons were evaluated via Chi-Squared, Fisher’s Exact, and Cochran-Mantel-Haenszel tests. Overall, 29.7% of participants contracted COVID-19; of those, 45.3% sought medical care or were hospitalized. Most (81.3%) received at least 1 COVID-19 vaccine; of those, 97.5% were fully vaccinated. Hispanics had the highest vaccination rate while Non-Hispanic Blacks (NHB) had the lowest (91.1%, 73.9%, p=.0281). Hispanics had 4.63x greater odds of vaccination than Non-Hispanic Whites (NHW) [95% CI=(1.81, 11.89)]. A majority “always” or “very often” wore masks (53.2%). Participants reported income loss (64.9%), more frequently in FL (76.1%, CA: 52.2%, p&amp;lt;.001). NHB had the highest rate of severe income loss (26.4%, p=.0124). Loss of health insurance was greater among NHB (13.3%) than other races (&amp;lt;8%, p=.0422) and in FL (9.7%, CA: 4.5%, p=.039). Participants reported healthcare access changes (62%) and higher diabetes medication costs (41%). These findings demonstrate underserved communities with diabetes suffered significant health and financial challenges from COVID-19, which were especially disparate for NHB and FL residents. Further research, interventions, and policy changes are needed to promote health equity for underserved communities with diabetes. Disclosure J.Maizel: None. L.Figg: None. M.Hechavarria: None. K.G.Malden: None. A.F.Walker: None. M.J.Haller: Board Member; SAB Biotherapeutics, Inc., Consultant; Sanofi, MannKind Corporation. D.M.Maahs: Advisory Panel; Medtronic, LifeScan Diabetes Institute, MannKind Corporation, Consultant; Abbott, Research Support; Dexcom, Inc. A.Addala: None. R.Lal: Advisory Panel; Provention Bio, Inc., Consultant; Abbott Diabetes, Biolinq, Capillary Biomedical, Inc., Deep Valley Labs, Gluroo, Tidepool, PhysioLogic Devices, Morgan Stanley. S.L.Filipp: None. M.J.Gurka: None. S.C.Westen: None. B.Dixon: None. Funding The Leona M. and Harry B. Helmsley Charitable Trust (G-2005-03934)

Stagnating COVID-19 vaccination rates and vaccine hesitancy remain a threat to public health. Improved strategies for real-time tracking and estimation of population-level behavior regarding vaccinations are needed. The aim of this study was to evaluate whether online search trends for COIVD-19 and influenza mirror vaccination rates. State-level weekly fraction of online searches for top vaccination-related search terms and CDC vaccination data were obtained from June 1, 2020, to May 31, 2021. Next, trends in online search and vaccination data for COVID-19 and influenza were analyzed for visual and quantitative correlation patterns using Spearman’s rank correlation analysis. Online searches in the US for COVID-19 vaccinations increased 2.71-fold (95% CI: 1.98-3.45) in the 4 weeks after the FDA emergency authorization compared to the precedent 4 weeks. In March-April 2021, US online searches reached a plateau that was followed by a decline of 83.3% (95% CI: 31.2%-135.3%) until May 31, 2021. The timing of peaks in online searches varied across US states. Online searches were strongly correlated with vaccination rates (r=0.71, 95% CI: 0.45 - 0.87), preceding actual reported vaccination rates in 44 of 51 states. Online search trends preceded vaccination trends by a median of 3.0 weeks (95% CI: 2.0-4.0 weeks) across all states. For influenza vaccination searches, seasonal peaks in September-October between 2016-2020 were noted. Influenza search trends highly correlated with the timing of actual vaccinations for the 2019-2020 (r=0.82, 95% CI: 0.64 – 0.93) and 2020-2021 season (r=0.91, 95% CI: 0.78 – 0.97). Search trends and real-world vaccination rates are highly correlated. Temporal alignment and correlation levels were higher for influenza vaccinations; however, only online searches for COVID-19 vaccination preceded vaccination trends. These findings indicate that US online search data can potentially guide public health efforts, including policy changes and identifying geographical areas to expand vaccination campaigns.

Vaccinations provide an effective solution against the ongoing COVID-19 pandemic. Using a national survey (n = 3958), this study explored vaccination hesitancy for various COVID-19 vaccines and boosters, including the newly released annual vaccine for fall and winter 2023-2024. It also assessed support for federal funding for COVID-19 testing, vaccinations, and treatment. Consistent correlates of past vaccination refusal were perceptions of vaccines as safe and important, previous COVID-19 tests, concern about COVID-19, having voted for President Trump, higher religiosity, being liberal, trust in health institutions, health insurance status, and education. Other predictors showed inconsistent results across the various stages. Drivers of vaccination refusal were concerns about vaccine safety and side effects, perceived lack of information, and having previously contracted COVID-19. Intention to vaccinate was associated with concerns about COVID-19, liberalism, and trust in health institutions. Other factors were intermittently significant. We found consistent support for federal funding for those concerned about COVID-19, those concerned about the effectiveness of existing vaccines, those with trust in health institutions, those who thought vaccines are important, women, and those with lower levels of education. Opposition came from conservatives and Trump voters.

BackgroundVaccines are effective biological interventions that reduce health burdens. However, during the COVID-19 pandemic, there were concerns about varying levels of COVID-19 vaccination coverage in the Zimbabwean population. This study aimed to understand facilitators and barriers to COVID-19 vaccine uptake in the Zimbabwean population.MethodsIn September–October 2023, key informant interviews (KIIs) and focus group discussions (FGDs) were conducted with a sample comprising health workers, village health workers, church leaders, traditional healers, teachers, youth leaders and the general population selected across the country. At each site, the participant sample was homogeneous. Data were collected using audiotapes, transcribed verbatim, and translated into English. Data were analysed manually using thematic analysis.ResultsTen FGDs and 30 KIIs were conducted across the country. Among the facilitators of COVID-19 vaccine uptake were the perceived benefits of COVID-19 vaccination, such as protection from infection, severe disease and death. People also complied with COVID-19 vaccination because of the government’s call for mandatory vaccination, travel restrictions, restrictions when entering some premises for services, visiting, working, learning and functions. Barriers to COVID-19 vaccine uptake included low-risk perception, negative attitudes emanating from concerns about the origins of the vaccines, COVID-19 cases or death of vaccinated people, negative peer influence, religious doctrines, cultural beliefs and misconceptions circulating through social media. Other barriers included knowledge gaps on COVID-19 vaccines, safety, effectiveness, side effects, access-related challenges to COVID-19 services and concerns over the changing policy on COVID-19 vaccination.ConclusionsThe study has shown the importance of community engagement and data-driven public health communication strategies to facilitate behaviour change for increased uptake of a vaccine. In future epidemics, public health campaigns should focus on the timely provision of information explaining the benefits of an intervention, addressing safety concerns more effectively. To build trust and hence improve vaccine uptake by the public, there is a need for continuous engagement with people and to provide platforms for dialogue to address issues contributing to low vaccine uptake.

BackgroundThe success of the COVID-19 vaccination roll-out depended on clear policy communication and guidance to promote and facilitate vaccine uptake. The rapidly evolving pandemic circumstances led to many vaccine policy amendments. The impact of changing policy on effective vaccine communication and its influence in terms of societal response to vaccine promotion are underexplored; this qualitative research addresses that gap within the extant literature.MethodsPolicy communicators and community leaders from urban and rural Ontario participated in semi-structured interviews (N = 29) to explore their experiences of COVID-19 vaccine policy communication. Thematic analysis was used to produce representative themes.ResultsAnalysis showed rapidly changing policy was a barrier to smooth communication and COVID-19 vaccine roll-out. Continual amendments had unintended consequences, stimulating confusion, disrupting community outreach efforts and interrupting vaccine implementation. Policy changes were most disruptive to logistical planning and community engagement work, including community outreach, communicating eligibility criteria, and providing translated vaccine information to diverse communities.ConclusionsVaccine policy changes that allow for prioritized access can have the unintended consequence of limiting communities’ access to information that supports decision making. Rapidly evolving circumstances require a balance between adjusting policy and maintaining simple, consistent public health messages that can readily be translated into action. Information access is a factor in health inequality that needs addressing alongside access to vaccines.

The current challenge worldwide is the administration of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine. Considering that the COVID-19 vaccination represents the best possibility to resolve this pandemic, this systematic review aims to clarify the major aspects of fatal adverse effects related to COVID-19 vaccines, with the goal of advancing our knowledge, supporting decisions, or suggesting changes in policies at local, regional, and global levels. Moreover, this review aims to provide key recommendations to improve awareness of vaccine safety. All studies published up to 2 December 2021 were searched using the following keywords: “COVID-19 Vaccine”, “SARS-CoV-2 Vaccine”, “COVID-19 Vaccination”, “SARS-CoV-2 Vaccination”, and “Autopsy” or “Post-mortem”. We included 17 papers published with fatal cases with post-mortem investigations. A total of 38 cases were analyzed: 22 cases were related to ChAdOx1 nCoV-19 administration, 10 cases to BNT162b2, 4 cases to mRNA-1273, and 2 cases to Ad26.COV2.S. Based on these data, autopsy is very useful to define the main characteristics of the so-called vaccine-induced immune thrombotic thrombocytopenia (VITT) after ChAdOx1 nCoV-19 vaccination: recurrent findings were intracranial hemorrhage and diffused microthrombi located in multiple areas. Moreover, it is fundamental to provide evidence about myocarditis related to the BNT162B2 vaccine. Finally, based on the discussed data, we suggest several key recommendations to improve awareness of vaccine safety.

Addressing the social inequities of vaccination: an imperative to close the gap

The attitudes of reproductive-age individuals toward COVID-19 vaccination during pregnancy are still not well understood. We aimed to explore the attitudes toward COVID-19 vaccines during pregnancy and the determinants among the Chinese reproductive-age population. An anonymous cross-sectional study was conducted in China from July 4 to August 11, 2023. Structured questionnaires on vaccine hesitancy during pregnancy, socio-demographic characteristics, behavior characteristics, health-related factors, and mental health status were sent online to reproductive-age individuals (both males and females). Among 2966 participants of reproductive age, 86.9% exhibited significant hesitancy toward receiving the COVID-19 vaccine during pregnancy. Participants of older age (30–34: aOR = 1.71, 95% CI: 1.62–2.52; 35–39: aOR = 1.72, 95% CI: 1.11–2.66), nonsmokers (aOR = 1.42, 95% CI: 1.07–1.89), with a longer duration since their last COVID-19 vaccination (aOR = 2.37, 95% CI: 1.20–4.70), and exhibiting marked pandemic fatigue (moderate: aOR = 1.98, 95% CI: 1.56–2.52; high: aOR = 3.49, 95% CI: 2.41–5.05) were prone to refuse COVID-19 vaccines during pregnancy. The presence of generalized anxiety disorder may push the vaccination (aOR = 0.75, 95% CI: 0.57–0.99). The top three reasons for hesitation were concerns about the adverse health effects of vaccines on pregnant women (77.72%), fetuses (72.13%), and newborns/infants (58.77%), respectively. Therefore, under the context of the existing circumstances and the WHO’s encouragement, this study provides data support for possible future policy changes and emphasizes the importance of public health strategies.

This study aims to evaluate the acceptance and risk perception of pregnant and non pregnant women towards COVID-19 vaccines using a cross-sectional matched-sample study approach. A web-based questionnaire with closed- and open-ended questions was administered to adults older than 18 years in the sub-Saharan African (SSA) region. Respondents (n = 131) were grouped based on their pregnancy status (54 pregnant and 77 non pregnant women) and matched for comparison by age. The matched groups were compared using the chi-square test and the t-test where appropriate. Compared to non pregnant women, pregnant women reported significantly lower risk perception scores of COVID-19 infection (3.74 vs. 5.78, p < 0.001) and were less likely to take the COVID-19 vaccine (odds ratio = 0.12, 95% confidence interval (CI) 0.06-0.27, p < 0.001). A similar proportion of pregnant and non pregnant women believed in false information about the COVID-19 vaccine, and 40% of unvaccinated pregnant women (n = 40) were concerned about the safety of the vaccine. After adjustment, women's education, marital status, belief in misconceptions and risk perception were associated with non-vaccination among pregnant women. The content analysis revealed that pregnant women refused the vaccine due to mistrust of their countries' health systems, concerns about the country where the vaccines were manufactured and a lack of confidence in the production process of the vaccines. This study shows the poor acceptance of COVID-19 vaccines among pregnant women in SSA, who perceived a lower risk of COVID-19 infection. Understanding the reasons for non-acceptance and the motivation to accept the COVID-19 vaccine could guide the development of health education and promotion programmes, and aid governments and policymakers in implementing targeted policy changes.

PurposeVAccine Study COVID-19 (VASCO) is a cohort study with a 5-year follow-up that was initiated when COVID-19 vaccination was introduced in the Netherlands. The primary objective is to estimate real-world...

IntroductionRacial, ethnic, sexual, and gender minoritized groups are considered historically excluded groups and have been disproportionately affected by the coronavirus disease 2019 (COVID-19) pandemic. The influence of social determinants of health (SDOH), including access to screening and treatment, and other systemic and structural factors are largely responsible for these disparities. Primary care practitioner (PCP) competence in culturally responsive screening practices will be critical to reducing the impact of systemic and structural factors serving as barriers to screening and treatment. Correspondingly, improving the capacity of PCPs to communicate with patients in a culturally responsive manner may influence improved screening and treatment outcomes for minoritized groups related to COVID-19. This scoping literature review aims to determine the current breadth of literature on culturally responsive communication (CRC) in regard to COVID-19 vaccination screening for historically excluded, or minoritized groups. Results from this review will inform the development of a training series and social marketing campaign to improve PCPs capacity in CRC. This manuscript provides details on our study protocol.ObjectivesThis scoping literature review aims to analyze existing literature on culturally responsive COVID-19 vaccinations between PCPs and patients in the U.S., specifically for racial, ethnic, sexual, and gender minoritized groups. Results of this scoping review will inform the development of a training series and social marketing campaign to improve capacity of PCPs in this area. Additionally, the review will inform recommendations for future research.Materials and methodsThis scoping review will be performed following the framework of Arksey and O’Malley and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for scoping reviews (PRISMA-ScR). Relevant studies between the years 2019–2022 were identified using a rigorous search strategy across four databases: MEDLINE (via PubMed), Scopus, Cochrane (CENTRAL; via Wiley), and CINAHL (via EBSCO), using Boolean and Medical Subject Headings (MeSH) search terms. Studies will be uploaded to the data extraction tool, Covidence, to remove duplicates and perform a title/abstract screening, followed by a full-text screening.ResultsThe data extraction and analysis phases of the scoping review are in progress. Data will be analyzed for themes related to culturally responsive COVID-19 screening practices in clinical encounters with the identified study populations. Results will be reported by theme and align to PRISMA-ScR guidelines.DiscussionTo our knowledge, this is the first study to use scoping methods to investigate the barriers and facilitators to CRC of COVID-19 vaccine screening for historically excluded communities in the U.S. The work and results from this research will be directly utilized for the development of nationally-accessible, continuing medical education materials to teach PCPs about CRC, as well as other materials to influence relevant policy changes within the healthcare landscape.