Safety of COVID-19 vaccines during pregnancy: A systematic review and meta-analysis.

BACKGROUND: Assessment of COVID-19 vaccines safety during pregnancy is urgently needed. METHODS: We conducted a systematic review and meta-analysis to evaluate the safety of COVID-19 vaccines, including their components and technological platforms used in other vaccines during pregnancy and animal studies to complement direct evidence. We searched literature databases from its inception to September 2021 without language restriction, COVID-19 vaccine websites, and reference lists of other systematic reviews and the included studies. Pairs of reviewers independently selected, data extracted, and assessed the risk of bias of the studies. Discrepancies were resolved by consensus. (PROSPERO CRD42021234185). RESULTS: We retrieved 8,837 records from the literature search; 71 studies were included, involving 17,719,495 pregnant persons and 389 pregnant animals. Most studies (94%) were conducted in high-income countries, were cohort studies (51%), and 15% were classified as high risk of bias. We identified nine COVID-19 vaccine studies, seven involving 309,164 pregnant persons, mostly exposed to mRNA vaccines. Among non-COVID-19 vaccines, the most frequent exposures were AS03 and aluminum-based adjuvants. A meta-analysis of studies that adjusted for potential confounders showed no association with adverse outcomes, regardless of the vaccine or the trimester of vaccination. Neither the reported rates of adverse pregnancy outcomes nor reactogenicity exceeded expected background rates, which was the case for ASO3- or aluminum-adjuvanted non-COVID-19 vaccines in the proportion meta-analyses of uncontrolled studies/arms. The only exception was postpartum hemorrhage after COVID-19 vaccination (10.40%; 95% CI: 6.49-15.10%), reported by two studies; however, the comparison with non-exposed pregnant persons, available for one study, found non-statistically significant differences (adjusted OR 1.09; 95% CI 0.56-2.12). Animal studies showed consistent results with studies in pregnant persons. CONCLUSION: We found no safety concerns for currently administered COVID-19 vaccines during pregnancy. Additional experimental and real-world evidence could enhance vaccination coverage. Robust safety data for non-mRNA-based COVID-19 vaccines are still needed.

Safety, immunogenicity, and effectiveness of COVID-19 vaccines for pregnant persons: A protocol for systematic review and meta analysis.

INTRODUCTION: Numerous vaccines have been evaluated and approved for coronavirus disease 2019 (COVID-19). Since pregnant persons have been excluded from most clinical trials of COVID-19 vaccines, sufficient data regarding the safety of these vaccines for the pregnant person and their fetus have rarely been available at the time of product licensure. However, as COVID-19 vaccines have been deployed, data on the safety, reactogenicity, immunogenicity, and efficacy of COVID-19 vaccines for pregnant persons and neonates are becoming increasingly available. A living systematic review and meta-analysis of the safety and effectiveness of COVID-19 vaccines for pregnant persons and newborns could provide the information necessary to help guide vaccine policy decisions. METHODS AND ANALYSIS: We aim to conduct a living systematic review and meta-analysis based on biweekly searches of medical databases (e.g., MEDLINE, EMBASE, CENTRAL) and clinical trial registries to systematically identify relevant studies of COVID-19 vaccines for pregnant persons. Pairs of reviewers will independently select, extract data, and conduct risk of bias assessments. We will include randomized clinical trials, quasi-experimental studies, cohort, case-control, cross-sectional studies, and case reports. Primary outcomes will be the safety, efficacy, and effectiveness of COVID-19 vaccines in pregnant persons, including neonatal outcomes. Secondary outcomes will be immunogenicity and reactogenicity. We will conduct paired meta-analyses, including prespecified subgroup and sensitivity analyses. We will use the grading of recommendations assessment, development, and evaluation approach to evaluate the certainty of evidence.

Cost-effectiveness of COVID-19 vaccination in Latin America and the Caribbean: an analysis in Argentina, Brazil, Chile, Colombia, Costa Rica, Mexico, and Peru. (preprint)

Objective. Our study analyzes the cost-effectiveness of the COVID-19 vaccination campaign in Argentina, Brazil, Chile, Colombia, Costa Rica, Mexico, and Peru.  Methods. Using a previously published SVEIR model, we analyzed the impact of a vaccination campaign (2021) from a national healthcare perspective. The primary outcomes were quality adjusted life years (QALYs) lost and total costs. Other outcomes included COVID-19 cases, hospitalizations, deaths, and life years. We applied a discount rate of 3% for health outcomes. We modeled a realistic vaccination campaign in each country (the country-specific campaign implemented). Additionally, we assessed a standard campaign (similar, “typical“ for all countries), and an optimized campaign (similar in all countries with higher but plausible population coverage). One-way deterministic sensitivity analyses were performed.  Findings. Vaccination was health improving as well as cost-saving in almost all countries and scenarios. Our analysis shows that vaccination in this group of countries prevented 573,141 deaths (508,826 standard; 685,442 optimized) and gained 5.07 million QALYs (4.53 standard; 6.03 optimized). Despite the incremental costs of vaccination campaigns, they had a total net cost saving to the health system of US$16.29 billion (US$16.47 standard; US$18.58 optimized). The realistic vaccination campaign in Chile was the only scenario, which was not cost saving, but it was still highly cost-effective with an ICER of US$22 per QALY gained. Main findings were robust in the sensitivity analyses.  Interpretation. The COVID-19 vaccination campaign in seven Latin American and Caribbean countries -that comprise nearly 80% of the region- was beneficial for population health and was also cost-saving or highly cost-effective.

[Impact of COVID-19 related lockdown on the metabolic profile of people with HIV infection in Argentina]. / Impacto de la cuarentena por COVID-19 en el perfil metabólico de personas con infección por VIH en Argentina.

BACKGROUND: The spread of SARS-CoV-2 required widespread lockdown to mitigate the pandemic. Argentine authorities imposed preventive social isolation for 234 days (March 20th to November 9th 2020). This measure led to major changes in the population's lifestyle. AIM: To examine the influence of COVID-19 lockdown measures on the metabolic profile of HIV-infected patients in Argentina. METHODS: Retrospective cohort study of 10,239 HIV-infected patients under follow up in a private clinic for HIV care. Adult patients with ongoing antiretroviral therapy (ART) and a baseline determination of blood glucose, total cholesterol, HDL-cholesterol and triglycerides done before lockdown (BL: second semester of 2019) and a second determination during lockdown (DL: May 2020) were included. Patients with recent changes in ART that may have metabolic impact, those starting lipid/glucose lowering agents and pregnant women were excluded. Categorical variables were compared using the χ2 test or Fisher's exact test, and continuous variables using the t-test or the Mann-Whitney test. A two-tailed value of p < 0.05 was considered significant. RESULTS: 540 individuals were included, median of age was 47 years and 74.6% were male. Median body mass index was 26.1 and 94.6% had low cardiovascular risk. There was a significant increase in the percentage of patients that met criteria for hyperglycemia (BL 4.8% and DL 8.5%, p < 0.001). We also observed significant (p < 0.001) increase in median (IQR) BL vs DL values in LDL-cholesterol [109 (90-128) vs 118 (97-139) mg/dL]; and triglycerides [120 (87-172) vs. 132 mg/dL (96-184)]. The proportion of patients with hyper-LDL cholesterolemia according to individual cardiovascular risk increased from 12.6 to 17.2% (p = 0.04). CONCLUSION: Our results suggest that quarantine, at least in its initial phases, may have a negative impact on the metabolic profile of this population.

Impact of COVID-19-Related Stress and Lockdown on Mental Health Among People Living With HIV in Argentina.

BACKGROUND: The spread of severe acute respiratory syndrome coronavirus 2, causative agent of the coronavirus disease 2019 (COVID-19), has necessitated widespread lockdown to mitigate the pandemic. This study examines the influence of resilience on the impact of COVID-related stress and enforced lockdown on mental health, drug use, and treatment adherence among people living with HIV (PLWH) in Argentina. SETTING: PLWH residing predominantly in Buenos Aires Metropolitan Area and urban regions of Argentina were identified from a private clinic electronic database. METHODS: Participants completed an anonymous online survey to evaluate the impact of COVID-19 on economic disruption, resilience, mental health outcomes (depression, anxiety, stress, and loneliness), adherence to HIV treatment, and substance use. We performed ordinary least squares and logistic regressions to test whether resilient coping buffered the impact of economic disruption on mental health and drug use during quarantine. RESULTS: A total of 1336 PLWH aged 18-82 were enrolled. The impact of economic disruption on mental health ΔF(1,1321) = 8.86, P = 0.003 and loneliness ΔF(1,1326) = 5.77, P = 0.016 was buffered by resilience. A 3-way interaction between resilient buffering, stress, and sex was significant ΔF(1,1325) = 4.76, P = 0.029. Participants reported less than excellent adherence to medication (33%), disruption to mental health services (11%), and disruption to substance abuse treatment (1.3%) during lockdown. DISCUSSION: The impact of COVID-stress and lockdown on emotional distress seemed mitigated by resilience coping strategies, and the buffering impact of resilience on perceived stress was greater among women. Results highlight PLWH's capacity to adhere to treatment in challenging circumstances and the importance of developing resilience skills for better coping with stress and adversity.

Clinical characteristics and outcomes of hospitalized patients with SARS-CoV-2 infection in a Latin American country: Results from the ECCOVID multicenter prospective study.

BACKGROUND: Clinical features and outcomes of SARS-CoV-2 infections diverge in different countries. The aim of this study was to describe clinical characteristics and outcomes in a cohort of patients hospitalized with SARS-CoV-2 in Argentina. METHODS: Multicenter prospective cohort study of ≥18 years-old patients with confirmed SARS-CoV-2 infection consecutively admitted to 19 hospitals in Argentina. Multivariable logistic regression models were used to identify variables associated with 30-day mortality and admission to intensive care unit (ICU). RESULTS: A total of 809 patients were analyzed. Median age was 53 years, 56% were males and 71% had at least one comorbidity. The most common comorbidities were hypertension (32%), obesity (23%) and diabetes (17%). Disease severity at admission was classified as mild 25%, moderate 51%, severe 17%, and critical 7%. Almost half of patients (49%) required supplemental oxygen, 18% ICU, and 12% invasive ventilation. Overall, 30-day mortality was 11%. Factors independently associated with ICU admission were male gender (OR 1.81; 95%CI 1.16-2.81), hypertension (OR 3.21; 95%CI 2.08-4.95), obesity (OR 2.38; 95%CI 1.51-3.7), oxygen saturation ≤93% (OR 6.45; 95%CI 4.20-9.92) and lymphopenia (OR 3.21; 95%CI 2.08-4.95). Factors independently associated with 30-day mortality included age ≥60 years-old (OR 2.68; 95% CI 1.63-4.43), oxygen saturation ≤93% (OR 3.19; 95%CI 1.97-5.16) and lymphopenia (OR 2.65; 95%CI 1.64-4.27). CONCLUSIONS: This cohort validates crucial clinical data on patients hospitalized with SARS-CoV-2 in Argentina.

Safety of components and platforms of COVID-19 vaccines considered for use in pregnancy: A rapid review.

BACKGROUND: Rapid assessment of COVID-19 vaccine safety during pregnancy is urgently needed. METHODS: We conducted a rapid systematic review, to evaluate the safety of COVID-19 vaccines selected by the COVID-19 Vaccines Global Access-Maternal Immunization Working Group in August 2020, including their components and their technological platforms used in other vaccines for pregnant persons. We searched literature databases, COVID-19 vaccine pregnancy registries, and explored reference lists from the inception date to February 2021 without language restriction. Pairs of reviewers independently selected studies through COVIDENCE, and performed the data extraction and the risk of bias assessment. Discrepancies were resolved by consensus. Registered on PROSPERO (CRD42021234185). RESULTS: We retrieved 6757 records and 12 COVID-19 pregnancy registries from the search strategy; 38 clinical and non-clinical studies (involving 2,398,855 pregnant persons and 56 pregnant animals) were included. Most studies (89%) were conducted in high-income countries and were cohort studies (57%). Most studies (76%) compared vaccine exposures with no exposure during the three trimesters of pregnancy. The most frequent exposure was to AS03 adjuvant, in the context of A/H1N1 pandemic influenza vaccines, (n = 24) and aluminum-based adjuvants (n = 11). Only one study reported exposure to messenger RNA in lipid nanoparticles COVID-19 vaccines. Except for one preliminary report about A/H1N1 influenza vaccination (adjuvant AS03), corrected by the authors in a more thorough analysis, all studies concluded that there were no safety concerns. CONCLUSION: This rapid review found no evidence of pregnancy-associated safety concerns of COVID-19 vaccines or of their components or platforms when used in other vaccines. However, the need for further data on several vaccine platforms and components is warranted, given their novelty. Our findings support current WHO guidelines recommending that pregnant persons may consider receiving COVID-19 vaccines, particularly if they are at high risk of exposure or have comorbidities that enhance the risk of severe disease.

Mental Health, Coping, and Social Support Among People Living with HIV in the Americas: A Comparative Study Between Argentina and the USA During the SARS-CoV-2 Pandemic.

The COVID-19 pandemic poses a risk to mental health and may disproportionately affect people living with HIV (PLWH). This study examined the interaction of social support and resilient coping in predicting depressive symptoms among PLWH. PLWH residing in Buenos Aires, Argentina and in Miami, Florida (US) were asked to complete an anonymous survey on the impact of COVID-19. Statistical analysis included ordinary least squares regression. A total of 1,554 participants were included. Mean age was 47.30 years; 63.70% were men. A test of three-way interaction of social support × resilient coping × study site indicated differences by site (b = -0.63, p = 0.04, 95%CI [-1.24, -0.02]). In Argentina, higher levels of social support and resilient coping were associated with lower depressive symptoms. Lower levels of social support and resilient coping were associated with higher depressive symptoms. The impact of COVID-19 on mental health illustrates the need for developing innovative strategies to support resilience and to enhance coping with stress and adversity among PLWH.

RESUMEN: La pandemia de COVID-19 presenta riesgos importantes para la salud mental y puede afectar desproporcionadamente a personas con VIH. Este estudio examinó el efecto entre el apoyo social y la resiliencia para afrontar situaciones difíciles en predecir síntomas depresivos en personas con VIH. Personas con VIH residentes de Buenos Aires (Argentina) y Miami, Florida (EE.UU) completaron una encuesta anónima sobre el impacto del COVID-19. El análisis estadístico incluyó un modelo clásico de regresión lineal con mínimos cuadrados ordinarios. Se incluyeron 1554 participantes. La edad promedio fue 47.30 años y 63.7% eran hombres. La prueba de interacción de apoyo social × resiliencia para hacer frente a situaciones difíciles × país indicó diferencias entre países (b = −0.63, p = 0.043, IC 95% [1.24, −0.02]). En Argentina, los participantes con mayor apoyo social y resiliencia para hacer frente a situaciones difíciles mostraron síntomas depresivos más bajos; y aquellos con menor apoyo social y resiliencia para hacer frente a situaciones difíciles, mostraron síntomas depresivos más altos. Este efecto no se observó en los participantes de Miami. El impacto de COVID-19 en la salud mental en personas con VIH ilustra la necesidad de desarrollar estrategias innovadoras para apoyar la resiliencia y mejorar el enfrentamiento del estrés y la adversidad.