Efficacy of Six Different SARS-CoV-2 Vaccines during a Six-Month Follow-Up and Five COVID-19 Waves in Brazil and Mexico.

Comparisons among the different vaccines against SARS-CoV-2 are important to understand which type of vaccine provides more protection. This study aimed to evaluate the real-life efficacy through symptomatic infection and the humoral response of six different vaccines against SARS-CoV-2-BNT162b2, mRNA-1273, ChAdOx1-S, CoronaVac, Ad26.COV2, and Ad5-nCoV. This multicentric observational longitudinal study involved hospitals from Mexico and Brazil in which volunteers who received complete vaccination schemes were followed for 210 days after the last dose. SARS-CoV-2 Spike 1-2 IgG levels were taken before receiving the first vaccine, 21 days after each dose, and the last sample at six months (+/-1 month) after the last dose. A total of 1132 individuals exposed to five COVID-19 waves were included. All vaccines induced humoral responses, and mRNA vaccines had the highest antibody levels during follow-up. At six months, there was a decline in the SARS-CoV-2 Spike 1-2 IgG antibody titers of 69.5% and 36.4% in subjects with negative and positive history of infection respectively. Infection before vaccination and after complete vaccination scheme correlated with higher antibody titers. The predictors of infection were vaccination with CoronaVac compared to BNT162b2 and ChAdOx1-S. In the presence of comorbidities such as diabetes, rheumatoid arthritis, or dyslipidemia, CoronaVac lowered the risk of infection.

Evaluation of Transplacental Antibody Transfer in Pregnant Women Immunized with Different SARS-CoV-2 Homologous or Heterologous Schemes.

There is scarce information related to transplacental antibody transfer against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) with different homologous and heterologous vaccination schemes. This study aimed to correlate the magnitude of transplacental transfer anti-SARS-CoV-2 antibodies in different homologous and heterologous schemes. An observational cross-sectional study was developed to identify pregnant women vaccinated against SARS-CoV-2. They were questioned about their immunization status; blood samples from the mother, umbilical cord during labor, and the newborn 72 h after birth were taken to measure anti-S1 and anti-S2 specific IgG antibodies for SARS-CoV-2. We recruited 104 women with a median age of 29 (SD 1.17). We found antibodies in all newborns with vaccinated mothers. Homologous BNT162b2 mRNA regimen had the highest mean (SD) antibody titers (AU/mL) in maternal (994.93 (3.08), p = 0.039), umbilical cord (1316.43 (2.79), p = 0.016), and newborn (1192.02 (3.55), p = 0.020) blood. The generalized linear model showed a positive effect over antibodies with at least one dose in maternal (ß = -1.1, p = 0.002) and newborn (ß= -0.717, p = 0.044) blood, and with two doses (ß = -0.684, p = 0.026) in umbilical cord blood. In conclusion, antibodies were detected in all vaccinated women and their newborns. Transfer of antibodies was found from the first dose, and the levels increased with the number of vaccine doses. Vaccination should be encouraged in pregnant women with any available scheme.

Viral load and its relationship with the inflammatory response and clinical outcomes in hospitalization of patients with COVID-19.

Background: The values of viral load in COVID-19 disease have gained relevance, seeking to understand its prognostic value and its behavior in the course of the disease, although there have been no conclusive results. In this study we sought to analyze serum viral load as a predictor of clinical outcome of the disease, as well as its association with inflammatory markers. Methods: An observational and retrospective study in a private hospital in North Mexico, patients with SARS-COV-2 infection confirmed by reverse transcriptase polymerase chain reaction (RT-PCR) were followed through clinical outcome, viral load measurement, quantification of inflammatory markers and lymphocyte subpopulations. For the analysis, multiple regression models were performed. Results: We studied 105 patients [47 (SD 1.46) years old, 68.6% men]. After analysis with multiple regression models, there was an association between viral load at admission and vaccination schedule (ß-value=-0.279, p= 0.007), age (ß-value= 0.010, p = 0.050), mechanical ventilation (ß-value= 0.872, p = 0.007), lactate dehydrogenase (ß-value= 1.712, p= 0.004), D-dimer values at admission (ß-value= 0.847, p= 0.013) and subpopulation of B lymphocytes at admission (ß-value= -0.527, p= 0.042). There was no association with days of hospitalization, use of nasal prongs or high flux mask. Peak viral load (10 days after symptoms onset) was associated with peak IL-6 (ß-value= 0.470, p= 0.011). Peak viral load matched with peak procalcitonin and minimal lymphocyte values. C-reactive protein peak was before the peak of viral load. The minimum value viral load was documented on day 12 after symptom onset; it matched with the minimum values of IL-6 and ferritin, and the peak of D-dimer. Conclusions: SARS-COV-2 admission viral load is associated with vaccination status, mechanical ventilation, and different inflammatory markers.

Effect of Vitamin D3 Supplementation vs. Dietary-Hygienic Measures on SARS-CoV-2 Infection Rates in Hospital Workers with 25-Hydroxyvitamin D3 [25(OH)D3] Levels ≥20 ng/mL.

Background: There is scant information on the effect of supplementation with vitamin D3 in SARS-CoV-2 infection cases when patient 25-hydroxyvitamin D3 [25(OH)D3] levels are between 20-100 ng/mL. We aimed to evaluate the effect of supplementation with vitamin D3 vs. dietary-hygienic measures on the SARS-CoV-2 infection rate in participants with serum 25(OH)D3 levels ≥20 ng/mL. Methods: This study was quasi-experimental. We invited hospital workers with 25(OH)D3 levels between 20-100 ng/mL and no previous SARS-CoV-2 infection. They were randomized as follows: treatment options were a) vitamin D3 supplementation (52,000 IU monthly, G1) or b) dietary-hygienic measures (G2). We conducted a 3- to 6-month follow-up of SARS-CoV-2 infections. Participants with 25(OH)D3 levels <20 ng/mL were also analyzed. We divided these latter participants depending on whether they were supplemented (G3) or not (G4). Results: We analyzed 198 participants, with an average age of 44.4 (SD 9) years, and 130 (65.7%) were women. G1 had fewer cases of SARS-CoV-2 infection than G2 after a follow-up of 3- to 6-months (p < 0.05). There were no differences between G3 and G4 at the 3- and 6-month follow-up cutoff points (p > 0.05). Using a mixed effect Cox regression analysis in the 164 participants that completed six months of follow-up, vitamin D3 supplementation appeared to act as a protective factor against SARS-CoV-2 infection (HR 0.21, p = 0.008) in G1 and G2. None of the participants treated with the supplementation doses had serum 25(OH)D3 levels >100 ng/mL. Conclusions: Vitamin D3 supplementation in participants with 25(OH)D3 levels between 20-100 ng/mL have a lower rate of SARS-CoV-2 infection compared with the use of dietary-hygienic measures at six months follow-up.

Analysis of immunization time, amplitude, and adverse events of seven different vaccines against SARS-CoV-2 across four different countries.

Background: Scarce information exists in relation to the comparison of seroconversion and adverse events following immunization (AEFI) with different SARS-CoV-2 vaccines. Our aim was to correlate the magnitude of the antibody response to vaccination with previous clinical conditions and AEFI. Methods: A multicentric comparative study where SARS-CoV-2 spike 1-2 IgG antibodies IgG titers were measured at baseline, 21-28 days after the first and second dose (when applicable) of the following vaccines: BNT162b2 mRNA, mRNA-1273, Gam-COVID-Vac, Coronavac, ChAdOx1-S, Ad5-nCoV and Ad26.COV2. Mixed model and Poisson generalized linear models were performed. Results: We recruited 1867 individuals [52 (SD 16.8) years old, 52% men]. All vaccines enhanced anti-S1 and anti-S2 IgG antibodies over time (p<0.01). The highest increase after the first and second dose was observed in mRNA-1273 (p<0.001). There was an effect of previous SARS-CoV-2 infection; and an interaction of age with previous SARS-CoV-2 infection, Gam-COVID-Vac and ChAdOx1-S (p<0.01). There was a negative correlation of Severe or Systemic AEFI (AEs) of naïve SARS-CoV-2 subjects with age and sex (p<0.001); a positive interaction between the delta of antibodies with Gam-COVID-Vac (p=0.002). Coronavac, Gam-COVID-Vac and ChAdOx1-S had less AEs compared to BNT162b (p<0.01). mRNA-1273 had the highest number of AEFIs. The delta of the antibodies showed an association with AEFIs in previously infected individuals (p<0.001). Conclusions: The magnitude of seroconversion is predicted by age, vaccine type and SARS-CoV-2 exposure. AEs are correlated with age, sex, and vaccine type. The delta of the antibody response only correlates with AEs in patients previously exposed to SARS-CoV-2. Registration number: ClinicalTrials.gov, identifier NCT05228912.

Analysis of Immunization, Adverse Events, and Efficacy of a Fourth Dose of BNT162b2 Vaccine in Health Workers in Mexico, a Pilot Study.

There is scarce information on seroconversion and adverse events after immunization (AEFI) with the fourth dose of BNT162b2. Our aim was to correlate the magnitude of the antibody response to this vaccination regimen in terms of clinical conditions and AEFI. This was an observational pilot study in which SARS-CoV-2 S1-S2 IgG antibodies titers were measured 21-28 days after the first and second dose, three months after the second dose, 1-7 and 21-28 days after the third dose, before the fourth dose, and 21-28 days after the fourth dose. We recruited 112 subjects in a hospital in Mexico, 74% women, with an average age of 43 (SD 9) years. After the first dose, subjects had a median IgG AU/mL (IQR) of 122 (1904) that increased to 1875 (2095), 3020 (2330), and 4230 (3393) 21-28 days after the second, third, and fourth doses, respectively (p < 0.01). The number (%) who experienced any AEFI between the first and fourth doses was 90 (80.4), 89 (79), 65 (58), and 69 (61.5), respectively (p < 0.001). After the fourth dose, the most frequent of AEFI was pain at the injection site (87%). There was a correlation between AEFI and gender after the fourth dose, as well as with antibody levels (p < 0.05). During the Omicron outbreak, six (5.3%) had mild COVID-19 for 8-28 days after the fourth dose. The median increase in S1/S2 IgG was 30.8-fold after the fourth BNT162b2 dose when compared with the first dose and caused mild AEFI.

Effect of Heterologous Vaccination Regimen with Ad5-nCoV CanSinoBio and BNT162b2 Pfizer in SARS-CoV-2 IgG Antibodies Titers.

The efficacy of one dose Ad5-nCoV has been concerning. This study aimed to evaluate the effect of a single dose BNT162b2 in individuals after a completed Ad5-nCoV vaccination regiment compared to a group without this boost measuring SARS-CoV-2 Spike 1-2 IgG antibodies in plasma. This observational study included a subgroup analysis of patients who were immunized with Ad5-nCoV in a northern city of Mexico. During follow-up, some patients self-reported having received a BNT162b2 booster. We report baseline IgG levels, 21-28 days after the Ad5-nCoV dose, three months, and an additional 21-28 days after BNT162b2 (four months after Ad5-nCoV). Seventeen patients, age 40 (16), 52.9% men, were analyzed. We created four groups: G1 and G2 refer to patients without a history of SARS-CoV-2 infection, vaccinated with Ad5-nCoV and Ad5-nCoV/BNT162b2 (n = 4 and n = 6), respectively; G3 and G4 included patients with a history of SARS-CoV-2 infection and immunized with Ad5-nCoV and Ad5-nCoV/BNT162b2 (n = 5 and n = 2), respectively. The Ad5-nCoV/BNT162b2 protocol reported higher antibody titers after 21-28 days. Median (IQR) values were: G1 46.7 (-), G2 1077.5 (1901), G3 1158.5 (2673.5), and G4 2090 (-) (p < 0.05). Headache and pain at injection site were the most frequent adverse reactions associated with Ad5-nCoV (n = 10, 83%) and BNT162b2 (n = 5, 83.3%), respectively. Patients receiving BNT162b2 after Ad5-nCoV had higher SARS-CoV-2 spike 1-2 IgG antibody titers and had no severe adverse reactions.

Effect of the third dose of BNT162b2 vaccine on quantitative SARS-CoV-2 spike 1-2 IgG antibody titers in healthcare personnel.

BACKGROUND: Vaccination is our main strategy to control SARS-CoV-2 infection. Given the decrease in quantitative SARS-CoV-2 spike 1-2 IgG antibody titers three months after the second BNT162b2 dose, healthcare workers received a third booster six months after completing the original protocol. This study aimed to analyze the quantitative SARS-CoV-2 spike 1-2 IgG antibody titers and the safety of the third dose. MATERIAL AND METHODS: A prospective longitudinal cohort study included healthcare workers who received a third booster six months after completing the BNT162b2 regimen. We assessed the quantitative SARS-CoV-2 spike 1-2 IgG antibody titers 21-28 days after the first and second dose, three months after the completed protocol, 1-7 days following the third dose, and 21-28 days after booster administration. RESULTS: The cohort comprised 168 participants aged 41(10) years old, 67% of whom were female. The third dose was associated with an increase in quantitative antibody titers, regardless of previous SARS-CoV-2 history. In cases with a negative SARS-CoV-2 history, the median (IQR) antibody titer values increased from 379 (645.4) to 2960 (2010) AU/ml, whereas in cases with a positive SARS-CoV-2 history, from 590 (1262) to 3090 (2080) AU/ml (p<0.001). The third dose caused a lower number of total (local and systemic) adverse events following immunization (AEFI) compared with the first two vaccines. However, in terms of specific symptoms such as fatigue, myalgia, arthralgia, fever, and adenopathy, the proportion was higher in comparison with the first and second doses (p<0.05). The most common AEFI after the third BNT162b2 vaccine was pain at the injection site (n = 82, 84.5%), followed by fatigue (n = 45, 46.4%) of mild severity (n = 36, 37.1%). CONCLUSION: The third dose applied six months after the original BNT162b2 regimen increased the quantitative SARS-CoV-2 spike 1-2 IgG antibody titers. The booster dose was well tolerated and caused no severe AEFI.

Effect in self-care behavior and difficulties in coping with diabetes during the COVID-19 pandemic

In this study, difficulties in coping with diabetes were evaluated during the coronavirus disease 2019 (COVID-19) lock-down. Similarly, the change in diabetes self-care activities was evaluated in patients with a recent assessment before COVID-19 lockdown in Mexico City. In 212 patients with type 2 diabetes (T2D) and regular primary care, a designed questionnaire was used to evaluate the presence/absence of difficulties in self-care related to diet, physical activity/exercise, glucose monitoring, treatment adherence, getting pharmacological treatment, and confinement adherence. The Summary of Diabetes Self-Care Activities tool was used to compare the frequency of self-care behaviors in the past 7 days. Self-reported difficulties in coping with T2D were documented and included difficulties in self-care behaviors related to diet (41.6%), physical activity/exercise (40.5%), glucose monitoring (23.7%), getting pharmacological treatment (22.9%), pharmacological treatment adherence (19%), and home-confinement adherence (11.7%). In the group of patients with a recent previous-lockdown evaluation, global self-care behavior decreased from 5.15±0.9 to 4.49 ± 1.02 days/week, p 0.001. Diabetes self-care was a predictor for the presence of difficulties in coping with diabetes. Patients with T2D reported difficulties in coping with T2D and decreased diabetes self-care activities during the COVID-19 lockdown in Mexico City. Health-care policies must be designed and implemented to attenuate diabetes disease burden caused by this ongoing and future health-contingencies. En el presente estudio se evaluaron las dificultades para hacer frente a la diabetes por los pacientes durante el confinamiento por COVID-19. Así mismo, se evaluó el cambio en las actividades de autocuidado de diabetes en pacientes con evaluación reciente antes del confinamiento por COVID-19 en la Ciudad de México. En 212 pacientes con diabetes tipo 2 (DT2), se utilizó un cuestionario diseñado para evaluar la presencia/ausencia de dificultades para el autocuidado. La herramienta Summary of Diabetes Self-Care Activities (SDCA) se utilizó para comparar las actividades de autocuidado, reportado en días a la semana. Las dificultades reportadas por los pacientes incluyeron las relacionadas con: alimentación (41.6%), actividad física/ejercicio (40.5%), monitoreo de glucosa (23.7%), acceso al tratamiento farmacológico (22.9%), adherencia al tratamiento farmacológico (19%) y adherencia al confinamiento (11.7%). En el grupo de pacientes con una evaluación reciente previa al confinamiento, la actividad global de autocuidado disminuyó de 5,15±0,9 a 4,49±1,02 días/semana, valorp 0,001. El autocuidado en diabetes fue predictor de la presencia de dificultades para hacer frente a la diabetes. Los pacientes informaron dificultades para afrontar la diabetes y disminuyeron las actividades de auto-cuidado durante el confinamiento por COVID-19. Políticas de atención médica deben diseñarse e implementarse para atenuar la carga de la enfermedad causado por esta y futuras contingencias en salud.