Vaccines

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17 pages, 4604 KiB

Open AccessArticle

Long-Term Results of Immunogenicity of Booster Vaccination against SARS-CoV-2 (Hybrid COV-RAPEL TR Study) in Turkiye: A Double-Blind, Randomized, Controlled, Multicenter Phase 2 Clinical Study

by Ihsan Ates, Ayse Batirel, Mehtap Aydin, Fatma Yilmaz Karadag, Abdulsamet Erden, Orhan Kucuksahin, Berkan Armagan, Serdar Can Guven, Ozlem Karakas, Selim Gokdemir, Lutfiye Nilsun Altunal, Aslihan Ayse Buber, Emin Gemcioglu, Oguzhan Zengin, Osman Inan, Enes Seyda Sahiner, Gulay Korukluoglu, Zafer Sezer, Aykut Ozdarendeli, Ahmet Omma and Ates Kara Show full author list Hide full author list

Vaccines 2023, 11(7), 1234; https://doi.org/10.3390/vaccines11071234 - 12 Jul 2023

Cited by 1 | Viewed by 1577

Abstract

The immunogenicity of vaccines decreases over time, causing a need for booster doses. This study aimed to present the long-term (Day 84) immunogenicity results of the double-blind, randomized, controlled, phase II Hybrid COV-RAPEL TR Study (NCT04979949), in which the TURKOVAC or CoronaVac vaccines [...] Read more.

The immunogenicity of vaccines decreases over time, causing a need for booster doses. This study aimed to present the long-term (Day 84) immunogenicity results of the double-blind, randomized, controlled, phase II Hybrid COV-RAPEL TR Study (NCT04979949), in which the TURKOVAC or CoronaVac vaccines were used as a booster after the second dose of primary vaccination with CoronaVac. A total of 190 participants from the Hybrid COV-RAPEL TR Study, who had both Day 28 and Day 84 immunogenicity results, were included. The immunogenicity on Day 84, regarding the neutralizing antibody positivity (Wuhan and Delta variants) and anti-spike immunoglobulin (Ig) G (IgG) antibody positivity, was compared between TURKOVAC and CoronaVac vaccine arms according to sex and age groups. Overall, antibody positivity showed a slight decrease on Day 84 vs. Day 28, but was not different between TURKOVAC and CoronaVac arms either for sexes or for age groups. However, TURKOVAC produced better antibody response against the Delta variant than CoronaVac, while CoronaVac was superior over TURKOVAC regarding neutralizing antibody positivity in the 50–60 years age group, regardless of the variant. A single booster dose, after the completion of the primary vaccination, increases antibody positivity on Day 28 which persists until Day 84 with a slight decrease. However, an additional booster dose may be required thereafter, since the decrease in antibody titer may be faster over time. Full article

(This article belongs to the Special Issue Effectiveness, Safety and Immunogenicity of SARS-CoV-2 Vaccines)

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12 pages, 1684 KiB

Open AccessArticle

Projection of COVID-19 Positive Cases Considering Hybrid Immunity: Case Study in Tokyo

by Sachiko Kodera, Akito Takada, Essam A. Rashed and Akimasa Hirata

Vaccines 2023, 11(3), 633; https://doi.org/10.3390/vaccines11030633 - 13 Mar 2023

Cited by 2 | Viewed by 2381

Abstract

Since the emergence of COVID-19, the forecasting of new daily positive cases and deaths has been one of the essential elements in policy setting and medical resource management worldwide. An essential factor in forecasting is the modeling of susceptible populations and vaccination effectiveness [...] Read more.

Since the emergence of COVID-19, the forecasting of new daily positive cases and deaths has been one of the essential elements in policy setting and medical resource management worldwide. An essential factor in forecasting is the modeling of susceptible populations and vaccination effectiveness (VE) at the population level. Owing to the widespread viral transmission and wide vaccination campaign coverage, it becomes challenging to model the VE in an efficient and realistic manner, while also including hybrid immunity which is acquired through full vaccination combined with infection. Here, the VE model of hybrid immunity was developed based on an in vitro study and publicly available data. Computational replication of daily positive cases demonstrates a high consistency between the replicated and observed values when considering the effect of hybrid immunity. The estimated positive cases were relatively larger than the observed value without considering hybrid immunity. Replication of the daily positive cases and its comparison would provide useful information of immunity at the population level and thus serve as useful guidance for nationwide policy setting and vaccination strategies. Full article

(This article belongs to the Special Issue Effectiveness, Safety and Immunogenicity of SARS-CoV-2 Vaccines)

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12 pages, 2486 KiB

Open AccessArticle

Effectiveness of Inactivated COVID-19 Vaccines against Delta-Variant COVID-19: Evidence from an Outbreak in Inner Mongolia Autonomous Region, China

by Chao Ma, Chang Huang, Wenrui Wang, Yudan Song, Xiaofeng Jiang, Xiaoling Tian, Boxi Liu, Fuli Chi, Shengli Lang, Dongyan Liu, Weiwei Sun, Lin Tang, Dan Wu, Yifan Song, Junhong Li, Lance Rodewald, Zundong Yin and Zhijie An

Vaccines 2023, 11(2), 292; https://doi.org/10.3390/vaccines11020292 - 28 Jan 2023

Cited by 6 | Viewed by 1709

Abstract

Phase 3 clinical trials and real-world effectiveness studies showed that China’s two main inactivated COVID-19 vaccines are very effective against serious illness. In November 2021, an outbreak occurred in the Inner Mongolia Autonomous Region that provided an opportunity to assess the vaccine effectiveness [...] Read more.

Phase 3 clinical trials and real-world effectiveness studies showed that China’s two main inactivated COVID-19 vaccines are very effective against serious illness. In November 2021, an outbreak occurred in the Inner Mongolia Autonomous Region that provided an opportunity to assess the vaccine effectiveness (VE) of these inactivated vaccines against COVID-19 caused by the delta variant. We evaluated VE with a retrospective cohort study of close contacts of infected individuals, using a generalized linear model with binomial distribution and log-link function to estimate risk ratios (RR) and VE. A total of 8842 close contacts were studied. Compared with no vaccination and adjusted for age, presence of comorbidity, and time since last vaccination, full vaccination reduced symptomatic infection by 62%, pneumonia by 64% and severe COVID-19 by 90%; reductions associated with homologous booster doses were 83% for symptomatic infection, 92% for pneumonia and 100% for severe COVID-19. There was no significant decline in two-dose VE for any outcome for up to 325 days following the last dose. There were no differences by vaccine brand. Inactivated vaccines were effective against delta-variant illness, and were highly effective against pneumonia and severe COVID-19; VE was increased by booster doses. Full article

(This article belongs to the Special Issue Effectiveness, Safety and Immunogenicity of SARS-CoV-2 Vaccines)

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21 pages, 1205 KiB

Open AccessArticle

Immunogenicity of BNT162b2, BBIBP-CorV, Gam-COVID-Vac and ChAdOx1 nCoV-19 Vaccines Six Months after the Second Dose: A Longitudinal Prospective Study

by Vladimir Petrović, Vladimir Vuković, Aleksandra Patić, Miloš Marković and Mioljub Ristić

Vaccines 2023, 11(1), 56; https://doi.org/10.3390/vaccines11010056 - 26 Dec 2022

Cited by 5 | Viewed by 2099

Abstract

Many available SARS-CoV-2 vaccines demonstrated good humoral response, but studies directly comparing their immunogenicity in the general population are lacking. We evaluated the medium–term kinetics of anti-S SARS-CoV-2 antibodies (Abs) at one and six months after the second dose of BNT162b2, BBIBP-CorV, and [...] Read more.

Many available SARS-CoV-2 vaccines demonstrated good humoral response, but studies directly comparing their immunogenicity in the general population are lacking. We evaluated the medium–term kinetics of anti-S SARS-CoV-2 antibodies (Abs) at one and six months after the second dose of BNT162b2, BBIBP-CorV, and Gam-COVID-Vac. Immunogenicity at six months was directly compared between BNT162b2, BBIBP-CorV, Gam-COVID-Vac, and ChAdOx1 nCoV-19. Participants ≥ 20 years old from Novi Sad, Serbia, without prior SARS-CoV-2 infection, were included. Anti S1/S2 IgG antibodies were measured using quantitative LIAISON SARS-CoV-2 assay. A total of 368 participants were included: 231 (62.77%) had sera collected at two time points. Two doses of BNT162b2 were received by 37.50% of participants, followed by BBIBP-CorV (22.01%), Gam-COVID-Vac (21.47%), and ChAdOx1 nCoV-19 (19.02%). Mean Ab levels at the 28th day and 6 months were 216.55 (SD = 105.73) AU/mL and 75.68 (SD = 57.30) for BNT162b2, 194.38 (SD = 140.24) and 90.53 (SD = 111.30) for Gam-COVID-Vac, and 72.74 (SD = 80.04) and 24.43 (SD = 38.43) for BBIBP-CorV group (p < 0.01, between two time points across all three groups), with a significant difference between women and men (p < 0.01, for both sexes). At the sixth month post-vaccination, the highest mean Ab level was detected in Gam-COVID-Vac group (91.28 AU/mL, SD = 95.96), followed by BNT162b2 (85.25 AU/mL, SD = 60.02), ChAdOx1 nCoV-19 (64.22 AU/mL, SD = 65.30), and BBIBP-CorV (25.26 AU/mL, SD = 36.92) (p < 0.01). Anti-spike IgG persistence was demonstrated six months post-vaccination with a significant decline in Ab levels. These results suggest a lower protection against SARS-CoV-2 over time. Our findings support the introduction of additional (booster) doses. Full article

(This article belongs to the Special Issue Effectiveness, Safety and Immunogenicity of SARS-CoV-2 Vaccines)

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26 pages, 6245 KiB

Open AccessArticle

mRNA COVID-19 Vaccines—Facts and Hypotheses on Fragmentation and Encapsulation

by Jacques Demongeot and Cécile Fougère

Vaccines 2023, 11(1), 40; https://doi.org/10.3390/vaccines11010040 - 24 Dec 2022

Cited by 4 | Viewed by 3708

Abstract

Background: The adventure of the mRNA vaccine began thirty years ago in the context of influenza. This consisted in encapsulating the mRNA coding for a viral protein in a lipid particle. We show how the mRNA encoding S protein has been modified for [...] Read more.

Background: The adventure of the mRNA vaccine began thirty years ago in the context of influenza. This consisted in encapsulating the mRNA coding for a viral protein in a lipid particle. We show how the mRNA encoding S protein has been modified for that purpose in the context of the anti-SARS-CoV-2 vaccination. Results: by using data coming from genetic and epidemiologic databases, we show the theoretical possibility of fragmentation of this mRNA into small RNA sequences capable of inhibiting important bio-syntheses such as the production of beta-globin. Discussion: we discuss two aspects related to mRNA vaccine: (i) the plausibility of mRNA fragmentation, and (ii) the role of liposomal nanoparticles (LNPs) used in the vaccine and their impact on mRNA biodistribution. Conclusion: we insist on the need to develop lipid nanoparticles allowing personalized administration of vaccines and avoiding adverse effects due to mRNA fragmentation and inefficient biodistribution. Hence, we recommend (i) adapting the mRNA of vaccines to the least mutated virus proteins and (ii) personalizing its administration to the categories of chronic patients at risk most likely to suffer from adverse effects. Full article

(This article belongs to the Special Issue Effectiveness, Safety and Immunogenicity of SARS-CoV-2 Vaccines)

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16 pages, 1338 KiB

Open AccessArticle

Seroepidemiology of SARS-CoV-2 Virus in Healthcare Workers before Circulation of the Omicron Sublineages BA.4/BA.5 in Vojvodina, Serbia

by Mioljub Ristić, Vladimir Vuković, Aleksandra Patić, Miloš Marković and Vladimir Petrović

Vaccines 2022, 10(12), 2168; https://doi.org/10.3390/vaccines10122168 - 16 Dec 2022

Cited by 4 | Viewed by 1567

Abstract

Healthcare workers (HCWs) are a vulnerable and critical population in the ongoing response to the SARS-CoV-2 pandemic. We aimed to estimate the seroprevalence in HCWs considering all of their previous contacts with the SARS-CoV-2 virus and/or the immunity acquired through their immunization against [...] Read more.

Healthcare workers (HCWs) are a vulnerable and critical population in the ongoing response to the SARS-CoV-2 pandemic. We aimed to estimate the seroprevalence in HCWs considering all of their previous contacts with the SARS-CoV-2 virus and/or the immunity acquired through their immunization against COVID-19 before the advent of the Omicron variants BA.4/BA.5. Serum samples were collected from 28 March to 10 June 2022. We covered 25% out of all the people who worked in some of the government healthcare centers (primary, secondary, and tertiary level) across the entire Autonomous Province of Vojvodina (Northern Serbia). Two serological tests (Anti-SARS-CoV-2 QuantiVac ELISA and LIAISON^® SARS-CoV-2 TrimericS) were used to detect anti-spike IgG antibodies. The overall prevalence of the SARS-CoV-2 antibody among the 6936 HCWs was 92.96% [95% CI 92.33–93.55]. Regarding the type of serological test, there was a statistically significant (p = 0.0079) difference of the seropositivity obtained by the LIAISON^® SARS-CoV-2 TrimericS (93.87%, 95% CI 92.97–94.69) and Anti-SARS-CoV-2 QuantiVac ELISA (92.23%, 95% CI 91.34–93.06) tests. Seropositivity to SARS-CoV-2 significantly (p < 0.0001) increased with the number of SARS-CoV-2 infections combined with the number of doses of the SARS-CoV-2 vaccines received. A vast majority of the HCWs in Vojvodina had detectable levels of antibodies to the spike protein of SARS-CoV-2, but despite this high seropositivity, it is unknown whether this herd immunity among HCWs is protective against the new variants of concern. Further research should evaluate the rates of reinfections and the associated severity of COVID-19 caused by the Omicron sublineages and/or new variants of SARS-CoV-2 among HCWs. Full article

(This article belongs to the Special Issue Effectiveness, Safety and Immunogenicity of SARS-CoV-2 Vaccines)

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12 pages, 1688 KiB

Open AccessArticle

Heterologous Booster Dose with CORBEVAX following Primary Vaccination with COVISHIELD Enhances Protection against SARS-CoV-2

by Shashidhar Jaggaiahgari, Apoorva Munigela, Sasikala Mitnala, Deepika Gujjarlapudi, Venu Simhadri and Nageshwar Reddy D

Vaccines 2022, 10(12), 2146; https://doi.org/10.3390/vaccines10122146 - 14 Dec 2022

Cited by 6 | Viewed by 3257

Abstract

Despite effective vaccination programs, waning immunity in the vaccinated populations and the emergence of variants of concern posed a risk of breakthrough infections. A booster dose was demonstrated to provide substantially increased protection against symptomatic disease and hospitalization. We aimed to evaluate immune [...] Read more.

Despite effective vaccination programs, waning immunity in the vaccinated populations and the emergence of variants of concern posed a risk of breakthrough infections. A booster dose was demonstrated to provide substantially increased protection against symptomatic disease and hospitalization. We aimed to evaluate immune memory and the efficacy of reducing the rate of SARS-CoV-2 infection post heterologous booster with CORBEVAX after primary vaccination with two doses of COVISHIELD. SARS-CoV-2 S1/S2 spike IgG and RBD-specific antibody responses were elicited with both booster vaccines, with a greater response in individuals receiving heterologous booster. T and B memory responses were increased with booster dose, whereas B memory needed a longer duration to develop in individuals who received a homologous booster (90 days) in comparison to a heterologous booster (30 days). RBD-specific B memory and antibody-secreting (non-memory) B lymphocytes were enhanced with both boosters; however, the duration of response was longer with the heterologous booster compared to the homologous, indicating greater protection with the heterologous booster. The rate of infection 14 days after administration of the heterologous booster was comparatively lower than that of the homologous booster, with the symptoms being much less or asymptomatic. Full article

(This article belongs to the Special Issue Effectiveness, Safety and Immunogenicity of SARS-CoV-2 Vaccines)

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11 pages, 1919 KiB

Open AccessArticle

Neutralizing Antibody Responses Elicited by Inactivated Whole Virus and Genetic Vaccines against Dominant SARS-CoV-2 Variants during the Four Epidemic Peaks of COVID-19 in Colombia

by Diego A. Álvarez-Díaz, Ana Luisa Muñoz, María T. Herrera-Sepúlveda, Pilar Tavera-Rodríguez, Katherine Laiton-Donato, Carlos Franco-Muñoz, Héctor Alejandro Ruiz-Moreno, Marisol Galindo, Jenssy D. Catama, Andrea Bermudez-Forero and Marcela Mercado-Reyes

Vaccines 2022, 10(12), 2144; https://doi.org/10.3390/vaccines10122144 - 14 Dec 2022

Cited by 3 | Viewed by 2005

Abstract

Several SARS-CoV-2 variants of concern (VOC) and interest (VOI) co-circulate in Colombia, and determining the neutralizing antibody (nAb) responses is useful to improve the efficacy of COVID-19 vaccination programs. Thus, nAb responses against SARS-CoV-2 isolates from the lineages B.1.111, P.1 (Gamma), B.1.621 (Mu), [...] Read more.

Several SARS-CoV-2 variants of concern (VOC) and interest (VOI) co-circulate in Colombia, and determining the neutralizing antibody (nAb) responses is useful to improve the efficacy of COVID-19 vaccination programs. Thus, nAb responses against SARS-CoV-2 isolates from the lineages B.1.111, P.1 (Gamma), B.1.621 (Mu), AY.25.1 (Delta), and BA.1 (Omicron), were evaluated in serum samples from immunologically naïve individuals between 9 and 13 weeks after receiving complete regimens of CoronaVac, BNT162b2, ChAdOx1, or Ad26.COV2.S, using microneutralization assays. An overall reduction of the nAb responses against Mu, Delta, and Omicron, relative to B.1.111 and Gamma was observed in sera from vaccinated individuals with BNT162b2, ChAdOx1, and Ad26.COV2.S. The seropositivity rate elicited by all the vaccines against B.1.111 and Gamma was 100%, while for Mu, Delta, and Omicron ranged between 32 to 87%, 65 to 96%, and 41 to 96%, respectively, depending on the vaccine tested. The significant reductions in the nAb responses against the last three dominant SARS-CoV-2 lineages in Colombia indicate that booster doses should be administered following complete vaccination schemes to increase the nAb titers against emerging SARS-CoV-2 lineages. Full article

(This article belongs to the Special Issue Effectiveness, Safety and Immunogenicity of SARS-CoV-2 Vaccines)

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19 pages, 1354 KiB

Open AccessArticle

COVID-19 Vaccination in Young People with Functional Neurological Disorder: A Case-Control Study

by Natalie Lim, Nicholas Wood, Archana Prasad, Karen Waters, Davinder Singh-Grewal, Russell C. Dale, Joseph Elkadi, Stephen Scher and Kasia Kozlowska

Vaccines 2022, 10(12), 2031; https://doi.org/10.3390/vaccines10122031 - 28 Nov 2022

Cited by 4 | Viewed by 3873

Abstract

Background: The emergence of acute-onset functional neurological symptoms, the focus of this study, is one of three stress responses related to immunisation. This case–control study documents the experience of 61 young people with past or current functional neurological disorder (FND) in relation to [...] Read more.

Background: The emergence of acute-onset functional neurological symptoms, the focus of this study, is one of three stress responses related to immunisation. This case–control study documents the experience of 61 young people with past or current functional neurological disorder (FND) in relation to the COVID-19 vaccination program in Australia. Methods: Information about the young person’s/parent’s choice and response pertaining to COVID-19 vaccination was collected as part of routine clinical care or FND research program follow-up. Results: 61 young people treated for FND (47 females, mean age = 16.22 years) and 46 healthy controls (34 females, mean age = 16.37 years) were included in the study. Vaccination rates were high: 58/61 (95.1%) in the FND group and 45/46 (97.8%) in the control group. In the FND group, 2 young people (2/61, 3.3%) presented with new-onset FND following COVID-19 vaccination; two young people with resolved FND reported an FND relapse (2/36, 5.56%); and two young people with unresolved FND (2/20, 10.0%) reported an FND exacerbation. In the control group no FND symptoms were reported. Conclusions: Acute-onset FND symptoms following COVID-19 vaccination are uncommon in the general population. In young people prone to FND, COVID-19 vaccination can sometimes trigger new-onset FND, FND relapse, or FND exacerbation. Full article

(This article belongs to the Special Issue Effectiveness, Safety and Immunogenicity of SARS-CoV-2 Vaccines)

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15 pages, 338 KiB

Open AccessArticle

Cytokines and Chemokines in Breastmilk of SARS-CoV-2 Infected or COVID-19 Vaccinated Mothers

by Felicia Trofin, Olivia Simona Dorneanu, Daniela Constantinescu, Eduard Vasile Nastase, Cătălina Luncă, Luminița Smaranda Iancu, Ioana-Maria Andrioaie, Alexandru Duhaniuc, Corina Maria Cianga, Mariana Pavel-Tanasa, Dana-Teodora Anton-Păduraru and Petru Cianga

Vaccines 2022, 10(12), 2001; https://doi.org/10.3390/vaccines10122001 - 24 Nov 2022

Cited by 3 | Viewed by 2241

Abstract

Introduction: The COVID-19 disease and anti-SARS-CoV-2 vaccination were accompanied by alterations in several inflammatory markers. The aim of our research was to check to what extent such cytokines are transferred to infants via the breastmilk of SARS-CoV-2-infected or vaccinated mothers. Thus, we wanted [...] Read more.

Introduction: The COVID-19 disease and anti-SARS-CoV-2 vaccination were accompanied by alterations in several inflammatory markers. The aim of our research was to check to what extent such cytokines are transferred to infants via the breastmilk of SARS-CoV-2-infected or vaccinated mothers. Thus, we wanted to check if breastfeeding is safe during SARS-CoV-2 infection or after COVID-19 mRNA-vaccination. Material and method: The Luminex Multiplexing Assay was used for quantifying 10 cytokine in the human breastmilk of SARS-CoV-2-infected or COVID-19-vaccinated mothers, compared with anti-SARS-CoV-2 IgG naïve mothers. Two milk samples were collected at 30 and 60 days either after the booster dose or afterthe onset of symptoms. A single milk sample was collected from the mothers within the control group. Results: The cytokine concentrations were mostly found within the reference intervals for all mothers. The status of the vaccinated/infected mother, the age of the breastfed child, the parity of the mother and the maternal age were variation factors of the above-mentioned cytokine concentrations. The type of birth and the presence of IgG in the milk had no influence on these cytokine concentrations in milk. Furthermore, no statistically significant differences were recorded between the cytokine concentrations of the two milk samples. Conclusion: Our study provides data that support the safety of breastfeeding in the case of mild COVID-19 infection or after Pfizer or Moderna vaccinations. Full article

(This article belongs to the Special Issue Effectiveness, Safety and Immunogenicity of SARS-CoV-2 Vaccines)

12 pages, 863 KiB

Open AccessArticle

Immunogenicity of an mRNA-Based COVID-19 Vaccine among Adolescents with Obesity or Liver Transplants

by Chomchanat Tubjaroen, Sittichoke Prachuapthunyachart, Nattakoon Potjalongsilp, Pimpayao Sodsai, Nattiya Hirankarn, Peera Jaru-Ampornpan and Voranush Chongsrisawat

Vaccines 2022, 10(11), 1867; https://doi.org/10.3390/vaccines10111867 - 4 Nov 2022

Cited by 7 | Viewed by 2172

Abstract

There are limited data regarding the immunogenicity of mRNA-based SARS-CoV-2 vaccine BNT162b2 among immunosuppressed or obese adolescents. We evaluated the humoral immune response in adolescents with obesity and adolescent liver transplant recipients (LTRs) after receiving two BNT162b2 doses. Sixty-eight participants (44 males; mean [...] Read more.

There are limited data regarding the immunogenicity of mRNA-based SARS-CoV-2 vaccine BNT162b2 among immunosuppressed or obese adolescents. We evaluated the humoral immune response in adolescents with obesity and adolescent liver transplant recipients (LTRs) after receiving two BNT162b2 doses. Sixty-eight participants (44 males; mean age 14.9 ± 1.7 years), comprising 12 LTRs, 24 obese, and 32 healthy adolescents, were enrolled. Immunogenicity was evaluated by anti-SARS-CoV-2 spike protein immunoassay and surrogate viral neutralization tests (sVNT) against the Delta and Omicron (BA.1) variants. At 27.1 ± 3.2 days after the second dose, the antibody levels were 1476.6 ± 1185.4, 2999.4 ± 1725.9, and 4960.5 ± 2644.1 IU/mL in the LTRs, obese adolescents, and controls, respectively (p < 0.001). Among obese individuals, liver stiffness <5.5 kPa was associated with higher antibody levels. The %inhibition of sVNT was significantly lower for the Omicron than that for the Delta variant. Injection site pain was the most common local adverse event. Nine participants (three obese and six controls) developed COVID-19 at 49 ± 11 days after the second vaccination; four were treated with favipiravir. All infections were mild, and the patients recovered without any consequences. Our study supports the need for the booster regimen in groups with an inferior immunogenic response, including LTRs and obese individuals. Full article

(This article belongs to the Special Issue Effectiveness, Safety and Immunogenicity of SARS-CoV-2 Vaccines)

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17 pages, 2018 KiB

Open AccessArticle

Efficacy, Immunogenicity, and Safety of the Two-Dose Schedules of TURKOVAC versus CoronaVac in Healthy Subjects: A Randomized, Observer-Blinded, Non-Inferiority Phase III Trial

by Mine Durusu Tanriover, Ozlem Altuntas Aydin, Rahmet Guner, Orhan Yildiz, Ilhami Celik, Hamdi Levent Doganay, Sukran Kose, Sila Akhan, Emin Halis Akalin, Zafer Sezer, Aykut Ozdarendeli, Serhat Unal and on behalf of the TURKOVAC Study Group

Vaccines 2022, 10(11), 1865; https://doi.org/10.3390/vaccines10111865 - 4 Nov 2022

Cited by 10 | Viewed by 3638

Abstract

We present the interim results of the efficacy, immunogenicity, and safety of the two-dose schedules of TURKOVAC versus CoronaVac. This was a randomized, observer-blinded, non-inferiority trial (NCT04942405). Volunteers were 18–55 years old and randomized at a 1:1 ratio to receive either TURKOVAC or [...] Read more.

We present the interim results of the efficacy, immunogenicity, and safety of the two-dose schedules of TURKOVAC versus CoronaVac. This was a randomized, observer-blinded, non-inferiority trial (NCT04942405). Volunteers were 18–55 years old and randomized at a 1:1 ratio to receive either TURKOVAC or CoronaVac at Day 0 and Day 28, both of which are 3 μg/0.5 mL of inactivated severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) adsorbed to aluminum hydroxide. The primary efficacy outcome was the prevention of polymerase chain reaction (PCR)-confirmed symptomatic coronavirus disease 2019 (COVID-19) at least 14 days after the second dose in the modified per-protocol (mPP) group. Safety analyses were performed in the modified intention-to-treat (mITT) group. Between 22 June 2021 and 7 January 2022, 1290 participants were randomized. The mITT group consisted of 915 participants, and the mPP group consisted of 732 participants. During a median follow-up of 90 (IQR 86–90) days, the relative risk reduction with TURKOVAC compared to CoronaVac was 41.03% (95% CI 12.95–60.06) for preventing PCR-confirmed symptomatic COVID-19. The incidences of adverse events (AEs) overall were 58.8% in TURKOVAC and 49.7% in CoronaVac arms (p = 0.006), with no fatalities or grade four AEs. TURKOVAC was non-inferior to CoronaVac in terms of efficacy and demonstrated a good safety and tolerability profile. Full article

(This article belongs to the Special Issue Effectiveness, Safety and Immunogenicity of SARS-CoV-2 Vaccines)

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10 pages, 887 KiB

Open AccessArticle

Slower Waning of Anti-SARS-CoV-2 IgG Levels Six Months after the Booster Dose Compared to Primary Vaccination

by Sanja Zember, Kristian Bodulić, Nataša Cetinić Balent, Radojka Mikulić, Alemka Markotić and Oktavija Đaković Rode

Vaccines 2022, 10(11), 1813; https://doi.org/10.3390/vaccines10111813 - 28 Oct 2022

Cited by 5 | Viewed by 1951

Abstract

Anti-SARS-CoV-2 IgG titer decreases rapidly after primovaccination, leading to a mandatory booster vaccination. We analysed anti-SARS-CoV-2 Spike RBD IgG levels (positive ≥ 50 AU/mL) in 405 healthcare workers (3010 sera) who received a booster dose (BD) 9 months after two-dose BNT162b2 primovaccination. Median [...] Read more.

Anti-SARS-CoV-2 IgG titer decreases rapidly after primovaccination, leading to a mandatory booster vaccination. We analysed anti-SARS-CoV-2 Spike RBD IgG levels (positive ≥ 50 AU/mL) in 405 healthcare workers (3010 sera) who received a booster dose (BD) 9 months after two-dose BNT162b2 primovaccination. Median antibody titer at the time of BD (582.6 AU/mL) was 1.7-fold and 16.4-fold lower than the peak titer after the first (961.5 AU/mL) and the second vaccine dose (SVD) (10,232.6 AU/mL), respectively. One month after vaccination, IgG titer increased 40.6-fold after BD compared with a 10.8-fold increase after primovaccination. Three months after vaccination, post-booster antibodies decreased significantly slower (2.2-fold) than after primovaccination (3.3-fold). At six months, antibodies decreased slower after BD (4.5-fold; median 5556.0 AU/mL) than after primovaccination (9.6-fold; median 1038.5 AU/mL). Antibody titers before and one month after BD correlated weakly (r = 0.30) compared with a strong correlation (r = 0.65) between the corresponding post-primovaccination titers. Pre-vaccination COVID-19 had no effect on IgG levels after BD compared with a positive effect after primovaccination. Despite high post-booster IgG levels, 22.5% of participants contracted mild COVID-19. The trend of IgG decline indicates the need for further revaccination, but the vaccine type should be defined according to viral mutations. Full article

(This article belongs to the Special Issue Effectiveness, Safety and Immunogenicity of SARS-CoV-2 Vaccines)

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12 pages, 1662 KiB

Open AccessArticle

Safety and Immunogenicity of a Heterologous Booster of Protein Subunit Vaccine MVC-COV1901 after Two Doses of Adenoviral Vector Vaccine AZD1222

by Shu-Hsing Cheng, Yi-Chun Lin, Cheng-Pin Chen and Chien-Yu Cheng

Vaccines 2022, 10(10), 1701; https://doi.org/10.3390/vaccines10101701 - 11 Oct 2022

Cited by 4 | Viewed by 4097

Abstract

We report the safety and immunogenicity results in participants administrated with a booster dose of protein subunit vaccine MVC-COV1901 at 12 (Group A) or 24 (Group B) weeks after two doses of AZD1222 (ChAdOx1 nCoV-19). The administration of the MVC-COV1901 vaccine as a [...] Read more.

We report the safety and immunogenicity results in participants administrated with a booster dose of protein subunit vaccine MVC-COV1901 at 12 (Group A) or 24 (Group B) weeks after two doses of AZD1222 (ChAdOx1 nCoV-19). The administration of the MVC-COV1901 vaccine as a booster dose in both groups was generally safe. There were no serious adverse events related to the intervention as adverse events reported were “mild” or “moderate” in nature. In subjects fully vaccinated with two doses of AZD1222, waning antibody immunity was apparent within six months of the second dose of AZD1222. At one month after the MVC-COV1901 booster dose, those who were vaccinated within 12 weeks after the last AZD1222 dose (Group A) had anti-SARS-CoV-2 spike IgG antibody titers and neutralizing antibody titers which were 14- and 6.5-fold increased, respectively, when compared to the titer levels on the day of the booster dose. On the other hand, fold-increase a month post-booster in people who had a booster 24 weeks after the last AZD1222 dose (Group B) were 19.5 and 14.0 times for anti-SARS-CoV-2 spike IgG antibody titers and neutralizing antibody titers, respectively. Among those who were vaccinated within 12 weeks after the last AZD1222 dose, we also observed 5.2- and 5.6-fold increases in neutralizing titer levels against ancestral strain and Omicron variant pseudovirus after the booster dose, respectively. These results support the use of MVC-COV1901 as a heterologous booster for individuals vaccinated with AZD1222. Furthermore, regardless of the dosing schedule, the combination of AZD1222 primary series and MVC-COV1901 booster can be cost-effective and suitably applied to low- and middle-income countries (LMIC). Full article

(This article belongs to the Special Issue Effectiveness, Safety and Immunogenicity of SARS-CoV-2 Vaccines)

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11 pages, 813 KiB

Open AccessArticle

Impact of Anti-TNFα Treatment on the Humoral Response to the BNT162b2 mRNA COVID-19 Vaccine in Pediatric Inflammatory Bowel Disease Patients

by Kosuke Kashiwagi, Keisuke Jimbo, Mitsuyoshi Suzuki, Nobuyasu Arai, Takahiro Kudo and Toshiaki Shimizu

Vaccines 2022, 10(10), 1618; https://doi.org/10.3390/vaccines10101618 - 27 Sep 2022

Cited by 3 | Viewed by 1674

Abstract

The efficacy of the COVID-19 mRNA vaccine, including the third vaccination in pediatric inflammatory bowel disease (PIBD) patients is not fully understood. This study aimed to evaluate the humoral immunogenicity of the BNT162b2 vaccine and the changes in durability until 20–28 weeks after [...] Read more.

The efficacy of the COVID-19 mRNA vaccine, including the third vaccination in pediatric inflammatory bowel disease (PIBD) patients is not fully understood. This study aimed to evaluate the humoral immunogenicity of the BNT162b2 vaccine and the changes in durability until 20–28 weeks after the initial vaccine series in PIBD patients on immunosuppressive drugs. The safety of the initial vaccine series and the booster effect of the third vaccination were also evaluated. A single-center, prospective cohort study was conducted, and 63 participants (anti-TNFα: 11; non-anti-TNFα: 31; 5-ASA: 21), with a mean age of 15.2 (range 9.6–17.9) years, were enrolled. All PIBD patients were seroconverted, with no serious short-term AEs. PIBD patients on anti-TNFα had significantly lower antibody titers than those on other medications at all measurement points. Furthermore, antibody titers waned over time with anti-TNFα and were significantly lower at 20–28 weeks than at 3–9 weeks after a two-vaccine series. In all 10 patients (anti-TNFα: 5; non-anti-TNFα including 5-ASA: 5), the third vaccination led to antibody concentrations significantly higher than those at the same time point after the second vaccination. PIBD patients on anti-TNFα need to remain vigilant about COVID-19 even after two vaccinations, and a third vaccination may be considered. Full article

(This article belongs to the Special Issue Effectiveness, Safety and Immunogenicity of SARS-CoV-2 Vaccines)

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11 pages, 1170 KiB

Open AccessArticle

Sinopharm’s BBIBP-CorV Vaccine and ChAdOx1 nCoV-19 Vaccine Are Associated with a Comparable Immune Response against SARS-CoV-2

by Ahmed Samir Abdelhafiz, Asmaa Ali, Mahmoud M. Kamel, Eman Hasan Ahmed, Douaa M. Sayed and Rania M. Bakry

Vaccines 2022, 10(9), 1462; https://doi.org/10.3390/vaccines10091462 - 3 Sep 2022

Cited by 6 | Viewed by 1838

Abstract

Coronavirus disease 2019 (COVID-19) has affected millions of people worldwide. During the early stages of vaccination in Egypt, the ChAdOx1 nCoV-19 and BBIBP-CorV vaccines were the most distributed. The aim of this study was to compare the immune responses and short-term efficacies of [...] Read more.

Coronavirus disease 2019 (COVID-19) has affected millions of people worldwide. During the early stages of vaccination in Egypt, the ChAdOx1 nCoV-19 and BBIBP-CorV vaccines were the most distributed. The aim of this study was to compare the immune responses and short-term efficacies of these two vaccines. We recruited adults who received two doses of either vaccine. Samples were collected after the first dose of ChAdOx1 nCoV-1 and after the second dose of both vaccines. Antibodies against SARS-CoV-2 antigens were measured using LABScreen™ COVID Plus kits, and cell-mediated immune responses were assessed using flow cytometry. Of the 109 recruited subjects, 60 (55%) received the ChAdOx1 nCoV-19 vaccine, and the remainder received the BBIBP-CorV vaccine. The total antibody level did not significantly differ between the two groups. The level of the anti-spike subunit 2 (S2) antibody was significantly higher in the ChAdOx1 nCoV-19 group. The percentages of both total T cells and B cells were unaffected by the type of vaccination. However, the ChAdOx1 nCoV-1 vaccine was significantly associated with a higher percentage of CD8+ cells. The vaccines did not significantly differ in the number or severity of infections postvaccination. None of the participants were admitted to the hospital or died of COVID-19 infection. In conclusion, the BBIBP-CorV vaccine is associated with an immune response and protection against infection that is comparable to that of the ChAdOx1 nCoV-1 vaccine. Follow-up is needed to study the long-term protective effects of both vaccines. Inactivated vaccines are easier to manufacture in developing countries and their limited side effects may lead to better economic benefits by limiting the number of absences from work. Full article

(This article belongs to the Special Issue Effectiveness, Safety and Immunogenicity of SARS-CoV-2 Vaccines)

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12 pages, 245 KiB

Open AccessArticle

Real-Time Survey of Vaccine Safety of the mRNA-1273 SARS-CoV-2 Vaccine in Workplace Vaccination at Keio University

by Kaho Okumura, Azusa Hara, Isa Inada, Daisuke Sugiyama, Takahiro Hoshino, Takahiro Yakoh, Hirokazu Yokoyama and Hisashi Urushihara

Vaccines 2022, 10(9), 1461; https://doi.org/10.3390/vaccines10091461 - 3 Sep 2022

Cited by 2 | Viewed by 3898

Abstract

The mRNA-1273 Moderna COVID-19 vaccine was introduced to combat the COVID-19 global pandemic in 2020. Although the safety of the vaccine has been investigated worldwide, real-world safety data is scarce in Japan. An online, real-time survey of adverse events following immunization (AEFIs) with [...] Read more.

The mRNA-1273 Moderna COVID-19 vaccine was introduced to combat the COVID-19 global pandemic in 2020. Although the safety of the vaccine has been investigated worldwide, real-world safety data is scarce in Japan. An online, real-time survey of adverse events following immunization (AEFIs) with mRNA-1273 was conducted in the setting of a workplace vaccination program at the School of Pharmacy, Keio University from 26 June 2021, to 11 June 2022. Participants were requested to take four surveys during a seven-day follow-up period after each of the first, second, and third booster doses. The maximum number of responses, from 301 respondents, was obtained on day 0 (vaccination date) for the first dose. 98% of respondents reported local and systemic AEFIs for the second dose on day 1. No noticeable difference in local reactions was seen among the three doses. Females reported more AEFIs than males, and the young group (18–29 years) reported a higher rate than the middle age group (≥30 years) after the first dose. Age and gender differences in rates decreased at the second and third doses. This survey confirmed that the safety profile of mRNA-1273 in a real-world setting was similar to that derived from the clinical trials, and that the agent was well-tolerated. Full article

(This article belongs to the Special Issue Effectiveness, Safety and Immunogenicity of SARS-CoV-2 Vaccines)

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Open AccessArticle

Antibody Response and Adverse Events of AZD1222 COVID-19 Vaccination in Patients Undergoing Dialysis: A Prospective Cohort Study

by Hsi-Hao Wang, Jia-Ling Wu, Min-Yu Chang, Hsin-Mian Wu, Li-Chun Ho, Po-Jui Chi, Ching-Fang Wu, Wan-Chia Lee, Hung-Hsiang Liou, Shih-Yuan Hung and Yi-Che Lee

Vaccines 2022, 10(9), 1460; https://doi.org/10.3390/vaccines10091460 - 3 Sep 2022

Cited by 3 | Viewed by 7568

Abstract

This study observed the antibody response and adverse events of AZD1222 (Oxford/AstraZeneca) vaccination in dialysis patients. A prospective cohort study was conducted in E-Da Healthcare Group hospitals between 1 July and 30 November 2021. Patients receiving hemodialysis (HD, n = 204) or peritoneal [...] Read more.

This study observed the antibody response and adverse events of AZD1222 (Oxford/AstraZeneca) vaccination in dialysis patients. A prospective cohort study was conducted in E-Da Healthcare Group hospitals between 1 July and 30 November 2021. Patients receiving hemodialysis (HD, n = 204) or peritoneal dialysis (PD, n = 116) were enrolled alongside healthy subjects (control, n = 34). Anti-SARS-CoV-2 S1 RBD IgG antibodies were measured before the first vaccination (T0), four to six weeks afterwards (T1), one week before the second dose (T2), and four to six weeks afterwards (T3). Adverse events were recorded one week after each dose. The positive IgG rates in the HD (T1: 72%; T2: 62%) and PD (T1: 69%; T2: 70%) groups were lower than the control group (T1: 97%; T2: 91%), with lower median antibody titers. At T3, the positive antibody response rates (HD: 94%; PD: 93%; control: 100%) and titers were similar. Titers were higher after the second dose in all groups. Adverse events were more severe after the first dose and less common with HD than PD or controls. Dialysis patients exhibited lower antibody responses than controls after the first dose of the AZD1222 vaccine but achieved similar responses after consecutive vaccination. Age, health status, two vaccine doses, and alcohol consumption may influence antibody levels. Full article

(This article belongs to the Special Issue Effectiveness, Safety and Immunogenicity of SARS-CoV-2 Vaccines)

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10 pages, 254 KiB

Open AccessArticle

Efficacy and Safety of COVID-19 Vaccine in Patients on Renal Replacement Therapy

by Michela Frittoli, Matthias Cassia, Alessandra Barassi, Paola Ciceri, Andrea Galassi, Ferruccio Conte and Mario Gennaro Cozzolino

Vaccines 2022, 10(9), 1395; https://doi.org/10.3390/vaccines10091395 - 25 Aug 2022

Cited by 7 | Viewed by 1834

Abstract

Patients with CKD on RRT are at high risk for severe disease and mortality in COVID-19 disease. We decided to conduct an observational prospective study to evaluate antibody response after vaccination for COVID-19 in a cohort of 210 adult patients on RRT (148 [...] Read more.

Patients with CKD on RRT are at high risk for severe disease and mortality in COVID-19 disease. We decided to conduct an observational prospective study to evaluate antibody response after vaccination for COVID-19 in a cohort of 210 adult patients on RRT (148 on HD; 20 on PD; and 42 kidney transplant recipients). Blood samples were taken before and 4 weeks after vaccination. Antibody levels were evaluated with CLIA immunoassay testing for IgG anti-trimeric spike protein of SARS-CoV-2. A positive antibody titer was present in 89.9% of HD patients, 90% of PD patients, and 52.4% of kidney transplant recipients. Non-responders were more frequent among patients on immunosuppressive therapy. Mycophenolate use in kidney transplant patients was associated with lower antibody response. The median antibody titer was 626 (228–1480) BAU/mL; higher in younger patients and those previously exposed to the virus and lower in HD patients with neoplasms and/or on immunosuppressive therapy. Only two patients developed COVID-19 in the observation period: they both had mild disease and antibody titers lower than 1000 BAU/mL. Our data show a valid response to COVID-19 mRNA vaccination in HD and PD patients and a reduced response in kidney transplant recipients. Mycophenolate was the most relevant factor associated with low response. Full article

(This article belongs to the Special Issue Effectiveness, Safety and Immunogenicity of SARS-CoV-2 Vaccines)

11 pages, 391 KiB

Open AccessArticle

Protective Effect of Inactivated COVID-19 Vaccines against Progression of SARS-CoV-2 Omicron and Delta Variant Infections to Pneumonia in Beijing, China, in 2022

by Juan Li, Rui Song, Zheng Yuan, Zheng Xu, Luodan Suo, Qing Wang, Yuan Li, Yanlin Gao, Xiaomei Li, Xiaoyou Chen and Jiang Wu

Vaccines 2022, 10(8), 1215; https://doi.org/10.3390/vaccines10081215 - 29 Jul 2022

Cited by 14 | Viewed by 2324

Abstract

This real-world study explores the effect of coronavirus disease 2019 (COVID-19) inactivated vaccines on the prevention of asymptomatic or mild Delta or Omicron variant infections progressing to pneumonia. Association between severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pneumonia cases and vaccination was measured [...] Read more.

This real-world study explores the effect of coronavirus disease 2019 (COVID-19) inactivated vaccines on the prevention of asymptomatic or mild Delta or Omicron variant infections progressing to pneumonia. Association between severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pneumonia cases and vaccination was measured with a multivariable logistic regression, stratified by genotype and age groups. We recruited 265 cases (111 (41.9%) infected with Delta and 154 (58.1%) with Omicron variants). There were 22 asymptomatic infected individuals, 156 mild cases without pneumonia, and 87 moderate cases with pneumonia. There was a markedly increased risk of progression to pneumonia in Delta infected cases, unvaccinated, or partially vaccinated COVID-19 patients with diabetes and those aged ≥60 years. Patients who had completed booster doses of inactivated vaccines had a reduced risk of 81.6% (95% CI: 55.6–92.4%) in progressing to pneumonia over those who were unvaccinated or partially vaccinated. The risk of progressing to pneumonia was less reduced by 88.7% (95% CI: 56.6–97%) and 73.9% (95% CI: 1.4–93.1%) among Delta and Omicron-infected patients, and was reduced by 78.5% (95% CI: 45.3–91.6%) and 94.1% (95% CI: 21.5–99.6%) among patients aged <60 and ≥60 years, respectively. Our data indicated that a complete vaccination with a booster reduced the risk of asymptomatic or mild Delta or Omicron variant COVID-19 progressing to pneumonia and, thus, reduced the pressure of severe illness on medical resources. Full article

(This article belongs to the Special Issue Effectiveness, Safety and Immunogenicity of SARS-CoV-2 Vaccines)

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10 pages, 579 KiB

Open AccessArticle

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

by Maria Elena Romero-Ibarguengoitia, Arnulfo González-Cantú, Diego Rivera-Salinas, Yodira Guadalupe Hernández-Ruíz, Ana Gabriela Armendariz-Vázquez, Irene Antonieta Barco-Flores, Rosalinda González-Facio and Miguel Ángel Sanz-Sánchez

Vaccines 2022, 10(7), 1139; https://doi.org/10.3390/vaccines10071139 - 17 Jul 2022

Cited by 8 | Viewed by 2472

Abstract

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 [...] Read more.

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. Full article

(This article belongs to the Special Issue Effectiveness, Safety and Immunogenicity of SARS-CoV-2 Vaccines)

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19 pages, 1268 KiB

Open AccessArticle

A Comparative Analysis of a Self-Reported Adverse Events Analysis after Receiving One of the Available SARS-CoV-2 Vaccine Schemes in Ecuador

by Esteban Ortiz-Prado, Juan S. Izquierdo-Condoy, Raul Fernandez-Naranjo, Katherine Simbaña-Rivera, Jorge Vásconez-González, Eddy P. Lincango Naranjo, Simone Cordovez, Barbara Coronel, Karen Delgado-Moreira and Ruth Jimbo-Sotomayor

Vaccines 2022, 10(7), 1047; https://doi.org/10.3390/vaccines10071047 - 30 Jun 2022

Cited by 7 | Viewed by 3668

Abstract

The COVID-19 pandemic has put a lot of pressure on health systems worldwide. Mass vaccination against SARS-CoV-2 has reduced morbidity and mortality worldwide. Despite their safety profiles, vaccines, as with any other medical product, can cause adverse events. Yet, in countries with poor [...] Read more.

The COVID-19 pandemic has put a lot of pressure on health systems worldwide. Mass vaccination against SARS-CoV-2 has reduced morbidity and mortality worldwide. Despite their safety profiles, vaccines, as with any other medical product, can cause adverse events. Yet, in countries with poor epidemiological surveillance and monitoring systems, reporting vaccine-related adverse events is a challenge. The objective of this study was to describe self-reported vaccine adverse events after receiving one of the available COVID-19 vaccine schemes in Ecuador. A cross-sectional analysis based on an online, self-reported, 32-item questionnaire was conducted in Ecuador from 1 April to 15 July 2021. Participants were invited by social media, radio, and TV to voluntarily participate in our study. A total of 6654 participants were included in this study. Furthermore, 38.2% of the participants reported having at least one comorbidity. Patients received AstraZeneca, Pfizer, and Sinovac vaccines, and these were distributed 38.4%, 31.1%, and 30.5%, respectively. Overall, pain or swelling at the injection site 17.2% (n = 4500) and headache 13.3% (n = 3502) were the most reported adverse events. Women addressed events supposedly attributable to vaccination or immunization [ESAVIs] (66.7%), more often than men (33.2%). After receiving the first dose of any available COVID-19 vaccine, a total of 19,501 self-reported ESAVIs were informed (87.0% were mild, 11.5% moderate, and 1.5% severe). In terms of the vaccine type and brand, the most reactogenic vaccine was AstraZeneca with 57.8%, followed by Pfizer (24.9%) and Sinovac (17.3%). After the second dose, 6776 self-reported ESAVIs were reported (87.1% mild, 10.9% moderate, and 2.1% severe). AstraZeneca vaccine users reported a higher proportion of ESAVIs (72.2%) in comparison to Pfizer/BioNTech (15.9%) and Sinovac Vaccine (11.9%). Swelling at the injection site, headache, muscle pain, and fatigue were the most common ESAVIs for the first as well as second doses. In conclusion, most ESAVIs were mild. AstraZeneca users were more likely to report adverse events. Participants without a history of COVID-19 infection, as well as those who received the first dose, were more prone to report ESAVIs. Full article

(This article belongs to the Special Issue Effectiveness, Safety and Immunogenicity of SARS-CoV-2 Vaccines)

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15 pages, 702 KiB

Open AccessArticle

Self-Reported COVID-19 Vaccines’ Side Effects among Patients Treated with Biological Therapies in Saudi Arabia: A Multicenter Cross-Sectional Study

by Lama T AlMutairi, Wesal Y Alalayet, Sondus I Ata, Khalidah A Alenzi and Yazed AlRuthia

Vaccines 2022, 10(6), 977; https://doi.org/10.3390/vaccines10060977 - 20 Jun 2022

Viewed by 2757

Abstract

Objective: The aim of this study was to explore the side effects of COVID-19 vaccines among a mixed gender sample of patients on monoclonal antibody biologics (mAbs) in Saudi Arabia. Methods: This was a prospective questionnaire-based cross-sectional study in which adult patients (≥18 [...] Read more.

Objective: The aim of this study was to explore the side effects of COVID-19 vaccines among a mixed gender sample of patients on monoclonal antibody biologics (mAbs) in Saudi Arabia. Methods: This was a prospective questionnaire-based cross-sectional study in which adult patients (≥18 years) on mAbs who had received at least one dose of COVID-19 vaccine from three tertiary care centers in Saudi Arabia were included. Descriptive statistics and univariate logistic regressions were conducted to present the vaccine side effects and examine the association between the reported side effects and vaccine type. Results: Four-hundred and seventeen patients, with a mean age of 39 years, consented to participate. Approximately 82% and 18% of the participants received Pfizer–BioNTech and Oxford–AstraZeneca vaccines, respectively, and nearly 71% received two doses of the vaccine. Diarrhea (9.59%), fever (51.32%), headache (32.13%), hypotension (13.67%), palpitation (9.11%), and temporary loss of smell (5.28%) were the most commonly reported side effects. Conclusion: COVID-19 vaccines are generally safe for patients treated with mAbs. Future studies should examine the rates of side effects across different COVID-19 vaccines among patients on mAbs using more robust study designs and representative samples. Full article

(This article belongs to the Special Issue Effectiveness, Safety and Immunogenicity of SARS-CoV-2 Vaccines)

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9 pages, 1363 KiB

Open AccessArticle

Significant Increase in Antibody Titers after the 3rd Booster Dose of the Pfizer–BioNTech mRNA COVID-19 Vaccine in Healthcare Workers in Greece

by Konstantina Kontopoulou, Christos T. Nakas and Georgios Papazisis

Vaccines 2022, 10(6), 876; https://doi.org/10.3390/vaccines10060876 - 30 May 2022

Cited by 18 | Viewed by 2927

Abstract

The aim of our study was to assess the immunogenicity of the third dose of the BNT162b2 mRNA COVID-19 vaccine (Comirnaty) in a cohort of 129 health-care workers in Greece whose anti-S1 RBD IgG titers were monitored over the course of nine months. [...] Read more.

The aim of our study was to assess the immunogenicity of the third dose of the BNT162b2 mRNA COVID-19 vaccine (Comirnaty) in a cohort of 129 health-care workers in Greece whose anti-S1 RBD IgG titers were monitored over the course of nine months. Titers were measured for each participant just before the third dose (nine months after the second dose) and also one month after the third dose. Of the 129 participants, 19 had been previously infected before starting the vaccination scheme. The SARS-CoV-2 IgG II Quant assay on the Architect System was employed to longitudinally assess the titers of IgG against the receptor-binding domain of the S1 subunit of the spike protein (anti-S1 RBD). Boosters raised Geometric Mean Concentrations (GMCs) by a factor of approximately 47 relative to levels at 9 months and by a factor of approximately 23 relative to levels at 6 months. The immune response one month after the third dose was significantly higher than the response achieved one month after the second dose (p = 0.008). In conclusion, our findings verify the potent immunogenicity elicited by the third dose in all age and prior COVID-19 status groups, suggesting that the timely administration of the third (booster) dose maximizes the immunogenic potential of the vaccine. Full article

(This article belongs to the Special Issue Effectiveness, Safety and Immunogenicity of SARS-CoV-2 Vaccines)

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11 pages, 861 KiB

Open AccessArticle

The Benefits of Vaccination against SARS-CoV-2 during Pregnancy in Favor of the Mother/Newborn Dyad

by Daniela-Eugenia Popescu, Cosmin Cîtu, Ana Maria Cristina Jura, Nicoleta Lungu, Dan Navolan, Marius Craina, Alin Semenescu, Florin Gorun, Mihai-Andrei Jura, Valerica Belengeanu and Marioara Boia

Vaccines 2022, 10(6), 848; https://doi.org/10.3390/vaccines10060848 - 26 May 2022

Cited by 16 | Viewed by 2906

Abstract

When the first vaccines against SARS-CoV-2 emerged, pregnant women were excluded from clinical trials, so vaccine recommendations were initially adjourned, with late initiation for this populational category. The present study aims to quantify the serum and breastmilk values of SARS-CoV-2 spike protein antibodies [...] Read more.

When the first vaccines against SARS-CoV-2 emerged, pregnant women were excluded from clinical trials, so vaccine recommendations were initially adjourned, with late initiation for this populational category. The present study aims to quantify the serum and breastmilk values of SARS-CoV-2 spike protein antibodies in both the mother and her newborn after complete vaccination during pregnancy. Ninety-one vaccinated patients were included, some of whom presented COVID-19 infection during pregnancy. In the delivery room, venous blood was collected from the mother and umbilical cord blood from her offspring. All samples were processed using the ECLIA (electrochemiluminescence) method. Breastmilk was collected and tested during the third postnatal day. The highest maternal serum values were 19,523 U/mL (detection limit > 0.8 U/mL) and in breastmilk, 206.7 U/mL. Every single newborn had antibody values higher than 0, with a mean serum value (M = 5288.37, SD = 5661.49) significantly higher than 0, t(90) = 8.91, p < 0.001. Consequently, this study intents to emphasize the importance of vaccination against SARS-CoV-2 during pregnancy. This double kind of neonatal protection, attained by placental and breastmilk transfer, can be accomplished by encouraging vaccination, breastfeeding, bonding, and providing maternal empowerment to participate in her infant’s care. Full article

(This article belongs to the Special Issue Effectiveness, Safety and Immunogenicity of SARS-CoV-2 Vaccines)

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16 pages, 2107 KiB

Open AccessArticle

Longitudinal Dynamics of SARS-CoV-2 IgG Antibody Responses after the Two-Dose Regimen of BNT162b2 Vaccination and the Effect of a Third Dose on Healthcare Workers in Japan

by Atsuhiko Sakamoto, Michinobu Yoshimura, Ryota Itoh, Ryo Ozuru, Kazunari Ishii, Yusuke Sechi, Shigeki Nabeshima and Kenji Hiromatsu

Vaccines 2022, 10(6), 830; https://doi.org/10.3390/vaccines10060830 - 24 May 2022

Cited by 6 | Viewed by 2689

Abstract

Analysis of longitudinal dynamics of humoral immune responses to the BNT162b2 COVID-19 vaccine might provide useful information to predict the effectiveness of BNT162b2 in preventing SARS-CoV-2 infection. Herein, we measure anti-RBD IgG at 1, 3 and 6 months (M) after the second dose [...] Read more.

Analysis of longitudinal dynamics of humoral immune responses to the BNT162b2 COVID-19 vaccine might provide useful information to predict the effectiveness of BNT162b2 in preventing SARS-CoV-2 infection. Herein, we measure anti-RBD IgG at 1, 3 and 6 months (M) after the second dose of BNT162b2, and at 1 M after a third dose of BNT162b2 vaccination in 431 COVID-19-naïve healthcare workers (HCWs) in Japan. All HCWs mounted high-anti-RBD IgG responses after the two-dose regimen of BNT162b2 vaccinations. Older persons and males presented lower anti-RBD IgG responses than younger adults and females, respectively. The decay in anti-RBD IgG started from 1 M after the second dose of BNT162b2 and anti-RBD IgG titers dropped to nearly one-tenth at 6 M after the second vaccination. Subsequently, the participants received a third dose of BNT162b2 at 8 M after the second dose of BNT162b2 vaccine. Anti-RBD antibody titers 1 M after the third dose of BNT162b2 increased seventeen times that of 6 M after the second dose, and was twice higher than the peak antibody titers at 1 M after the second dose of vaccination. The negative effect of age for the male gender on anti-RBD IgG antibody titers was not observed at 1 M after the third dose of BNT162b2 vaccine. There were no notable adverse events reported, which required hospitalization in these participants. These results suggest that the third dose of BNT162b2 safely improves humoral immunity against SARS-CoV-2 with no major adverse events. Full article

(This article belongs to the Special Issue Effectiveness, Safety and Immunogenicity of SARS-CoV-2 Vaccines)

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9 pages, 1596 KiB

Open AccessArticle

Retention of Neutralizing Response against SARS-CoV-2 Omicron Variant in Sputnik V-Vaccinated Individuals

by Daniele Lapa, Daria M. Grousova, Giulia Matusali, Silvia Meschi, Francesca Colavita, Aurora Bettini, Giulia Gramigna, Massimo Francalancia, Anna Rosa Garbuglia, Enrico Girardi, Vincenzo Puro, Andrea Antinori, Anna V. Kovyrshina, Inna V. Dolzhikova, Dmitry V. Shcheblyakov, Amir I. Tukhvatulin, Olga V. Zubkova, Vladimir A. Gushchin, Denis Y. Logunov, Boris S. Naroditsky, Francesco Vaia and Alexander L. Gintsburg Show full author list Hide full author list

Vaccines 2022, 10(5), 817; https://doi.org/10.3390/vaccines10050817 - 21 May 2022

Cited by 20 | Viewed by 6433

Abstract

The new Omicron variant of SARS-CoV-2, first identified in November 2021, is rapidly spreading all around the world. Omicron has become the dominant variant of SARS-CoV-2. There are many ongoing studies evaluating the effectiveness of existing vaccines. Studies on the neutralizing activity of [...] Read more.

The new Omicron variant of SARS-CoV-2, first identified in November 2021, is rapidly spreading all around the world. Omicron has become the dominant variant of SARS-CoV-2. There are many ongoing studies evaluating the effectiveness of existing vaccines. Studies on the neutralizing activity of vaccinated sera against the Omicron variant are currently being carried out in many laboratories. In this study, we have shown the neutralizing activity of sera against the SARS-CoV-2 Omicron variant compared to the reference Wuhan D614G variant in individuals vaccinated with two doses of Sputnik V up to 6 months after vaccination and in individuals who experienced SARS-CoV-2 infection either before or after vaccination. As a control to our study we also measured neutralizing antibody titers in individuals vaccinated with two doses of BNT162b2. The decrease in NtAb titers to the Omicron variant was 8.1-fold for the group of Sputnik V-vaccinated individuals. When the samples were stratified for the time period after vaccination, a 7.6-fold or 8.8-fold decrease in NtAb titers was noticed after up to 3 and 3-to-6 months after vaccination. We observed a 6.7- and 5-fold decrease in Sputnik V-vaccinated individuals experiencing asymptomatic or symptomatic infection, respectively. These results highlight the observation that the decrease in NtAb to the SARS-CoV-2 Omicron variant compared to the Wuhan variant occurs for different COVID-19 vaccines in use, with some showing no neutralization at all, confirming the necessity of a third booster vaccination. Full article

(This article belongs to the Special Issue Effectiveness, Safety and Immunogenicity of SARS-CoV-2 Vaccines)

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11 pages, 1738 KiB

Open AccessCommunication

Influence of a Heterologous (ChAdOx1-nCoV-19/BNT162b2) or Homologous (BNT162b2/BNT162b2) Vaccination Regimen on the Antibody and T Cell Response to a Third Vaccination with BNT162b2

by Rieke Reiter, Pia Von Blanckenburg, Reinier Mutters, Julia Thiemer, Reinhard Geßner and Ulf Seifart

Vaccines 2022, 10(5), 788; https://doi.org/10.3390/vaccines10050788 - 16 May 2022

Cited by 2 | Viewed by 2160

Abstract

Emerging numbers of SARS-CoV-2 infections are currently combated with a third vaccination. Considering the different vaccination regimens used for the first two vaccine doses, we addressed whether the previous vaccination influences the immune response to the booster. Participants for this prospective study were [...] Read more.

Emerging numbers of SARS-CoV-2 infections are currently combated with a third vaccination. Considering the different vaccination regimens used for the first two vaccine doses, we addressed whether the previous vaccination influences the immune response to the booster. Participants for this prospective study were recruited from among healthcare workers. N = 20 participants were previously vaccinated with two doses of BNT162b2, and n = 53 received a priming dose of ChAdOx1-nCoV-19 followed by a BNT162b2 dose. Participants were vaccinated with a third dose of BNT162b2 in December 2021. Antibody concentrations were determined after vaccination, and in a subset of n = 19 participants, T cell responses were evaluated. Anti-S concentrations and IFNγ production increased during the first 21 days. The choice of the first and second vaccineshad no influence on the final outcome of the booster vaccination. Before booster vaccination, antibody concentrations were lower for older participants but increased more strongly over time. Full article

(This article belongs to the Special Issue Effectiveness, Safety and Immunogenicity of SARS-CoV-2 Vaccines)

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14 pages, 1046 KiB

Open AccessArticle

Modelling SARS-CoV-2 Binding Antibody Waning 8 Months after BNT162b2 Vaccination

by Angelos Hatzakis, Andreas Karabinis, Sotirios Roussos, Nikos Pantazis, Dimitrios Degiannis, Antigoni Chaidaroglou, Konstantinos Petsios, Ioanna Pavlopoulou, Sotirios Tsiodras, Dimitrios Paraskevis, Vana Sypsa and Mina Psichogiou

Vaccines 2022, 10(2), 285; https://doi.org/10.3390/vaccines10020285 - 13 Feb 2022

Cited by 12 | Viewed by 2939

Abstract

Several lines of evidence suggest that binding SARS-CoV-2 antibodies such as anti-SARS-CoV-2 RBD IgG (anti-RBD) and neutralising antibodies (NA) are correlates of protection against SARS-CoV-2, and the correlation of anti-RBD and NA is very high. The effectiveness (VE) of BNT162b2 in preventing SARS-CoV-2 [...] Read more.

Several lines of evidence suggest that binding SARS-CoV-2 antibodies such as anti-SARS-CoV-2 RBD IgG (anti-RBD) and neutralising antibodies (NA) are correlates of protection against SARS-CoV-2, and the correlation of anti-RBD and NA is very high. The effectiveness (VE) of BNT162b2 in preventing SARS-CoV-2 infection wanes over time, and this reduction is mainly associated with waning immunity, suggesting that the kinetics of antibodies reduction might be of interest to predict VE. In a study of 97 health care workers (HCWs) vaccinated with the BNT162b2 vaccine, we assessed the kinetics of anti-RBD 30–250 days after vaccination using 388 individually matched plasma samples. Anti-RBD levels declined by 85%, 92%, and 95% at the 4th, 6th, and 8th month from the peak, respectively. The kinetics were estimated using the trajectories of anti-RBD by various models. The restricted cubic splines model had a better fit to the observed data. The trajectories of anti-RBD declines were statistically significantly lower for risk factors of severe COVID-19 and the absence of vaccination side effects. Moreover, previous SARS-CoV-2 infection was associated with divergent trajectories consistent with a slower anti-RBD decline over time. These results suggest that anti-RBD may serve as a harbinger for vaccine effectiveness (VE), and it should be explored as a predictor of breakthrough infections and VE. Full article

(This article belongs to the Special Issue Effectiveness, Safety and Immunogenicity of SARS-CoV-2 Vaccines)

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11 pages, 6071 KiB

Open AccessArticle

Attenuation of Antibody Titers from 3 to 6 Months after the Second Dose of the BNT162b2 Vaccine Depends on Sex, with Age and Smoking Risk Factors for Lower Antibody Titers at 6 Months

by Yushi Nomura, Michiru Sawahata, Yosikazu Nakamura, Ryousuke Koike, Otohiro Katsube, Koichi Hagiwara, Seiji Niho, Norihiro Masuda, Takaaki Tanaka and Kumiya Sugiyama

Vaccines 2021, 9(12), 1500; https://doi.org/10.3390/vaccines9121500 - 18 Dec 2021

Cited by 23 | Viewed by 3571

Abstract

Objective: We aimed to determine antibody titers at six months and their percentage change from three to six months after the second dose of the BNT162b2 coronavirus disease 2019 (COVID-19) mRNA vaccine (Pfizer/BioNTech) and to explore clinical variables associated with titers in Japan. [...] Read more.

Objective: We aimed to determine antibody titers at six months and their percentage change from three to six months after the second dose of the BNT162b2 coronavirus disease 2019 (COVID-19) mRNA vaccine (Pfizer/BioNTech) and to explore clinical variables associated with titers in Japan. Methods: We enrolled 365 healthcare workers (250 women, 115 men) whose three-month antibody titers were analyzed in our previous study and whose blood samples were collected 183 ± 15 days after the second dose. Participant characteristics, collected previously, were used. The relationships of these factors with antibody titers at six months and percentage changes in antibody titers from three to six months were analyzed. Results: Median age was 44 years. Median antibody titer at six months was 539 U/mL. Older participants had significantly lower antibody titers (20s, 752 U/mL; 60s–70s, 365 U/mL). In age-adjusted analysis, smoking was the only factor associated with lower antibody titers. Median percentage change in antibody titers from three to six months was −29.4%. The only factor significantly associated with the percentage change in Ab titers was not age or smoking, but sex (women, −31.6%; men, −25.1%). Conclusion: The most important factors associated with lower antibody titers at six months were age and smoking, as at three months, probably reflecting their effect on peak antibody titers. However, the only factor significantly associated with the attenuation in Ab titers from three to six months was sex, which reduced the sex difference seen during the first three months. Antibody titers may be affected by different factors at different time points. Full article

(This article belongs to the Special Issue Effectiveness, Safety and Immunogenicity of SARS-CoV-2 Vaccines)

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15 pages, 1437 KiB

Open AccessArticle

The Differences in the Level of Anti-SARS-CoV-2 Antibodies after mRNA Vaccine between Convalescent and Non-Previously Infected People Disappear after the Second Dose—Study in Healthcare Workers Group in Poland

by Joanna Kwiecińska-Piróg, Jana Przekwas, Zuzanna Kraszewska, Alicja Sękowska, Sylwia Brodzka, Natalia Wiktorczyk-Kapischke, Katarzyna Grudlewska-Buda, Ewa Wałecka-Zacharska, Maciej Zacharski, Aneta Mańkowska-Cyl, Eugenia Gospodarek-Komkowska and Krzysztof Skowron

Vaccines 2021, 9(12), 1402; https://doi.org/10.3390/vaccines9121402 - 27 Nov 2021

Cited by 3 | Viewed by 2585

Abstract

(1) Background: In many infections, antibodies play a crucial role in controlling infection. In COVID-19, the dynamics of the immune system response to SARS-CoV-2 is not fully understood. (2) Methods: The study was conducted on 120 healthcare workers from Dr. Antoni Jurasz University [...] Read more.

(1) Background: In many infections, antibodies play a crucial role in controlling infection. In COVID-19, the dynamics of the immune system response to SARS-CoV-2 is not fully understood. (2) Methods: The study was conducted on 120 healthcare workers from Dr. Antoni Jurasz University Hospital No. 1 in Bydgoszcz, between June and December 2020. In all participants, IgA and IgG antibody serum concentrations were measured using the semi-quantitative Anti-SARS-CoV-2 ELISA test (Euroimmun). After vaccination, in January and February 2021, antibody levels were examined using the quantitative IgG Anti-SARS-CoV-2 Quantivac ELISA test (Euroimmun). (3) Results: During the whole study period, the SARS-CoV-2 infection was confirmed in 29 (24.2%) participants. In all infected participants, IgA and IgG antibodies were detectable after infection by semi-quantitative serological tests. Levels of antibodies were higher one month after the first dose in the convalescents than in the non-previously infected participants. In this second group, the level of antibodies increased significantly after the second dose of vaccines compared to the first dose. (4) Conclusions: The level of antibodies after the first dose of vaccine in the convalescents’ group is higher than in the SARS-CoV-2 non-infected group, but the differences disappear after the second vaccination. Full article

(This article belongs to the Special Issue Effectiveness, Safety and Immunogenicity of SARS-CoV-2 Vaccines)

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Review

Jump to: Research, Other

14 pages, 679 KiB

Open AccessReview

Efficacy, Safety and Immunogenicity of Anti-SARS-CoV-2 Vaccines in Patients with Cirrhosis: A Narrative Review

by Konstantina Toutoudaki, Melitini Dimakakou and Theodoros Androutsakos

Vaccines 2023, 11(2), 452; https://doi.org/10.3390/vaccines11020452 - 16 Feb 2023

Cited by 5 | Viewed by 2299

Abstract

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causing coronavirus disease 2019 (COVID-19), has led to a pandemic with more than 6.5 million deaths worldwide. Patients with liver cirrhosis (PWLC) are regarded as prone to severe COVID-19. Vaccination against SARS-CoV-2 has been proven to [...] Read more.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causing coronavirus disease 2019 (COVID-19), has led to a pandemic with more than 6.5 million deaths worldwide. Patients with liver cirrhosis (PWLC) are regarded as prone to severe COVID-19. Vaccination against SARS-CoV-2 has been proven to be the most effective measure against COVID-19 and a variety of different vaccines have been approved for use; namely mRNA and vector-based, inactivated, whole virion, and protein subunit vaccines. Unfortunately, only a small number of PWLC were included in phase I–III vaccine trials, raising concerns regarding their efficacy and safety in this population. The authors, in this review, present available data regarding safety and efficacy of anti-SARS-CoV-2 vaccination in PWLC and discuss post-vaccination antibody responses. Overall, all vaccines seem to be extremely safe, with only a few and insignificant adverse events, and efficient, leading to lower rates of hospitalization and COVID-19-related mortality. T- and B-cell responses, on the other hand, remain an enigma, especially in patients with decompensated disease, since these patients show lower titers of anti-SARS-CoV-2 antibodies in some studies, with a more rapid waning. However, this finding is not consistent, and its clinical impact is still undetermined. Full article

(This article belongs to the Special Issue Effectiveness, Safety and Immunogenicity of SARS-CoV-2 Vaccines)

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16 pages, 1115 KiB

Open AccessReview

Booster COVID-19 Vaccines for Immune-Mediated Inflammatory Disease Patients: A Systematic Review and Meta-Analysis of Efficacy and Safety

by Ainsley Ryan Yan Bin Lee, Shi Yin Wong and Sen Hee Tay

Vaccines 2022, 10(5), 668; https://doi.org/10.3390/vaccines10050668 - 22 Apr 2022

Cited by 16 | Viewed by 4087

Abstract

Background: Seroconversion and longevity of vaccine-induced immune response is blunted in immune-mediated inflammatory disease (IMID) patients owing to immunosuppressive regimens. COVID-19 booster vaccines after a primary series have been proposed with inconclusive evidence on efficacy to date. Methods: This PROSPERO-registered systematic review (CRD42022302534) [...] Read more.

Background: Seroconversion and longevity of vaccine-induced immune response is blunted in immune-mediated inflammatory disease (IMID) patients owing to immunosuppressive regimens. COVID-19 booster vaccines after a primary series have been proposed with inconclusive evidence on efficacy to date. Methods: This PROSPERO-registered systematic review (CRD42022302534) was conducted according to PRISMA guidelines. PubMed, EMBASE, CENTRAL, Web of Science, CORD-19, WHO ICTRP, and medRxiv were searched up to 28 February 2022 for eligible studies. Risk of bias was assessed using the Joanna Briggs Institute critical appraisal tools. Results: From 6647 records, 17 prospective studies were included for systematic review and 12 in meta-analysis of primary series non-responders. The risk of bias was low. Pooling 340 non-responders, a booster dose proved effective with 0.47 seroconverting (95% CI: 0.32–0.63, I2 = 82%). Rituximab therapy was associated with significant impairment, with risks of 0.25 (95% CI: 0.17–0.36, I2 = 50.7%) versus 0.81 (95% CI: 0.72–0.87, I2 = 0.0%) for those without rituximab therapy. A systematic review of antibody levels against COVID-19 showed several-fold increases across studies. Incidence of local and systemic adverse events, including disease flares, were either comparable or slightly increased after the booster dose compared to primary series. No major events such as myocarditis or death were reported. Conclusion: Our results show that booster doses are effective in eliciting seroconversion in non-responders, bolstering immunity to COVID-19. It has also not been associated with major adverse events. Full article

(This article belongs to the Special Issue Effectiveness, Safety and Immunogenicity of SARS-CoV-2 Vaccines)

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Other

Jump to: Research, Review

19 pages, 4521 KiB

Open AccessSystematic Review

A Systematic Review and Meta-Analysis on the Real-World Effectiveness of COVID-19 Vaccines against Infection, Symptomatic and Severe COVID-19 Disease Caused by the Omicron Variant (B.1.1.529)

by Hassen Mohammed, Dan Duy Pham-Tran, Zi Yi Michelle Yeoh, Bing Wang, Mark McMillan, Prabha H. Andraweera and Helen S. Marshall

Vaccines 2023, 11(2), 224; https://doi.org/10.3390/vaccines11020224 - 19 Jan 2023

Cited by 25 | Viewed by 4693

Abstract

Real-world data on the effectiveness of COVID-19 vaccines against the Omicron variant (B.1.1.529) is limited. This systematic review aimed to investigate the real-world effectiveness and durability of protection conferred by primary course and booster vaccines against confirmed Omicron infection, and severe outcomes. We [...] Read more.

Real-world data on the effectiveness of COVID-19 vaccines against the Omicron variant (B.1.1.529) is limited. This systematic review aimed to investigate the real-world effectiveness and durability of protection conferred by primary course and booster vaccines against confirmed Omicron infection, and severe outcomes. We systematically searched literature up to 1 August 2022. Meta-analysis was performed with the DerSimonian-Laird random-effects model to estimate the pooled vaccine effectiveness (VE). Overall, 28 studies were included representing 11 million individuals. The pooled VE against Omicron infection was 20.4% (95%CI: 12.1–28.7%) and 23.4% (95%CI: 13.5–33.3%) against symptomatic infection with variation based on vaccine type and age groups. VE sharply declined from 28.1% (95%CI: 19.1–37.1%) at three months to 3.9% (95%CI: −24.8–32.7%) at six months. Similar trends were observed for symptomatic Omicron infection. A booster dose restored protection against Omicron infection up to 51.1% (95%CI: 43.8–58.3%) and 57.3% (95%CI: 54.0–60.5%) against symptomatic infection within three months; however, this waned to 32.8% (95%CI: 16.8–48.7%) within six months. VE against severe Omicron infection following the primary course was 63.6% (95%CI: 57.5–69.7%) at three months, decreased to 49% (95%CI: 35.7–63.4%) within six months, and increased to 86% after the first or second booster dose. Full article

(This article belongs to the Special Issue Effectiveness, Safety and Immunogenicity of SARS-CoV-2 Vaccines)

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14 pages, 1303 KiB

Open AccessSystematic Review

Effectiveness of the BNT162b2 (Pfizer-BioNTech) Vaccine in Children and Adolescents: A Systematic Review and Meta-Analysis

by Jewel Maria Sabu, Izza Zahid, Namitha Jacob, Faith O. Alele and Bunmi S. Malau-Aduli

Vaccines 2022, 10(11), 1880; https://doi.org/10.3390/vaccines10111880 - 7 Nov 2022

Cited by 15 | Viewed by 4043

Abstract

Efforts to control the COVID-19 pandemic have expanded to the vaccination of children and adolescents. This systematic review assesses the utility of the BNT162b2 (Pfizer-BioNTech) vaccine in children and adolescents aged 5–18 years, considering its effectiveness against COVID infection, hospital and intensive care [...] Read more.

Efforts to control the COVID-19 pandemic have expanded to the vaccination of children and adolescents. This systematic review assesses the utility of the BNT162b2 (Pfizer-BioNTech) vaccine in children and adolescents aged 5–18 years, considering its effectiveness against COVID infection, hospital and intensive care admission and duration of effectiveness after vaccination. Six databases were searched following the PRISMA guidelines. Pooled estimates and 95% confidence intervals (CIs) were calculated using meta-analysis. Fifteen studies were included in the systematic review, while 12 studies were included in the meta-analysis. Evidence suggests that the two-dose vaccination regime provided high effectiveness of 92% (95% CI, 86–96) against COVID infection. Vaccination also conferred high protection against hospitalisation (91%) and intensive care admission (85%). The vaccine was highly protective against the Delta variant of the virus, but showed a lower protection against the Omicron variant. Most adverse effects were transient and mild, commonly including pain at the injection site, fatigue and headache. Current findings are suggestive of waning immunity over time; however, further research is needed to investigate the relevance of booster doses in this age group. In summary, the Pfizer-BioNTech BNT162b2 vaccine demonstrated high levels of protection against COVID-19 infection and its complications while maintaining an adequate safety profile in children and adolescents. Full article

(This article belongs to the Special Issue Effectiveness, Safety and Immunogenicity of SARS-CoV-2 Vaccines)

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10 pages, 1877 KiB

Open AccessBrief Report

Comparative Characterization of Human Antibody Response Induced by BNT162b2 Vaccination vs. SARS-CoV-2 Wild-Type Infection

by Theano Lagousi, John Routsias, Maria Mavrouli, Ioanna Papadatou, Maria Geropeppa and Vana Spoulou

Vaccines 2022, 10(8), 1210; https://doi.org/10.3390/vaccines10081210 - 29 Jul 2022

Cited by 6 | Viewed by 2028

Abstract

Humoral immunity after SARS-CoV-2 immunization or natural infection is thought to be evanescent. In our study, we aimed to longitudinally characterize the kinetics of antibody titers after dual BNT162b2 immunization or wild-type infection. Vaccinated and recovered individuals displayed distinct antibody kinetics, as convalescents [...] Read more.

Humoral immunity after SARS-CoV-2 immunization or natural infection is thought to be evanescent. In our study, we aimed to longitudinally characterize the kinetics of antibody titers after dual BNT162b2 immunization or wild-type infection. Vaccinated and recovered individuals displayed distinct antibody kinetics, as convalescents had detectable RBD-, S1-specific, and neutralizing IgG antibody titers two weeks post-infection that gradually increased longitudinally, while RBD-, S1-specific, and neutralizing IgG were detected in vaccinees after the first dose, increased significantly 3 weeks post the second dose and decreased significantly 4–5 months thereafter. Neutralizing IgG was significantly higher initially in convalescent individuals; however, vaccines displayed significantly higher neutralizing antibodies 4–5 months post the second dose. In both groups, there was a strong negative association between elapsed time and antibody levels. The avidity of anti-RBD antibody titers increased significantly in patients longitudinally, while in vaccinees initially increased, with subsequent decrease, remaining however higher than antibody avidity of recovered individuals at all time-points. Anti-RBD antibodies were strongly correlated with neutralizing and anti-S1 antibodies in both groups at all time-points. This study facilitates our further understanding of immune response to SARS-CoV-2 and vaccines. Full article

(This article belongs to the Special Issue Effectiveness, Safety and Immunogenicity of SARS-CoV-2 Vaccines)

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6 pages, 490 KiB

Open AccessBrief Report

Short-Term Drop in Antibody Titer after the Third Dose of SARS-CoV-2 BNT162b2 Vaccine in Adults

by Jonas Herzberg, Bastian Fischer, Heiko Becher, Ann-Kristin Becker, Human Honarpisheh, Salman Yousuf Guraya, Tim Strate and Cornelius Knabbe

Vaccines 2022, 10(5), 805; https://doi.org/10.3390/vaccines10050805 - 20 May 2022

Cited by 5 | Viewed by 2107

Abstract

Little is known about the longevity of antibodies after a third dose of the mRNA-based SARS-CoV-2 vaccine BNT162b2 (BioNTech/Pfizer, Mainz, Germany). Therefore, serum antibody levels were evaluated after a third dose of BNT162b2 in healthy adult healthcare workers in Germany. These antibody levels [...] Read more.

Little is known about the longevity of antibodies after a third dose of the mRNA-based SARS-CoV-2 vaccine BNT162b2 (BioNTech/Pfizer, Mainz, Germany). Therefore, serum antibody levels were evaluated after a third dose of BNT162b2 in healthy adult healthcare workers in Germany. These antibody levels dropped significantly within a short period of 11 weeks from 4155.59 ± 2373.65 BAU/mL to 2389.10 ± 1433.90 BAU/mL, p-value < 0.001 but remained higher than after the second dose (611.92 ± 450.31 BAU/mL). To evaluate the quality of the humoral immune response, we additionally measured neutralizing antibodies, which also showed a small but significant decrease within this short period. These data underline the positive effect of a third dose of BNT162b2 concerning antibody re-induction but also shows a drop of Anti-SARS-CoV-2-IgG within a short span of time. Full article

(This article belongs to the Special Issue Effectiveness, Safety and Immunogenicity of SARS-CoV-2 Vaccines)

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9 pages, 384 KiB

Open AccessBrief Report

Cross-Reactivity between Half Doses of Pfizer and AstraZeneca Vaccines—A Preliminary Study

by Krzysztof Lukaszuk, Amira Podolak, Paulina Malinowska, Jakub Lukaszuk and Grzegorz Jakiel

Vaccines 2022, 10(4), 521; https://doi.org/10.3390/vaccines10040521 - 27 Mar 2022

Cited by 3 | Viewed by 3155

Abstract

Media reports have caused a significant drop in confidence in the AstraZeneca ChAdOx1 nCoV-19 COVID-19 vector vaccine (Vaxzevria, AstraZeneca Södertälje, Sweden). This has caused many people, already vaccinated with the first dose of AstraZeneca, to refuse vaccination with this product. On the other [...] Read more.

Media reports have caused a significant drop in confidence in the AstraZeneca ChAdOx1 nCoV-19 COVID-19 vector vaccine (Vaxzevria, AstraZeneca Södertälje, Sweden). This has caused many people, already vaccinated with the first dose of AstraZeneca, to refuse vaccination with this product. On the other hand, the increased demand for mRNA vaccines has resulted in a greater shortage of mRNA vaccines and cases of people being vaccinated with the AstraZeneca vaccine after the first dose of the Pfizer/BioNTech BNT162b2 COVID-19 vaccine (Comirnaty, Pfizer/BioNTech, Mainz, Germany). Moreover, currently, 60.9% of the global population have received at least one dose of a COVID-19 vaccine, while only 10% of people in low-income countries have received at least one dose. Even less people are fully vaccinated. The present pilot study evaluated the administration of half doses of AstraZeneca and Pfizer vaccines and included the enrollment of 26 subjects who were vaccinated with a different vaccine the first and second time. The reference group included individuals undergoing vaccination with two full doses of the Pfizer vaccine (21-day interval) monitored for their antibody levels as part of a parallel study. The distribution of antibody levels was not significantly different between those who received the Pfizer vaccine alone and those receiving the AstraZeneca vaccine plus Pfizer or Pfizer and AstraZeneca. To prepare for the next pandemic waves, solving the problem of the matching of booster vaccine to the previously received doses would be advisable. The topic is important and emerging as most of the population in low-income countries is still not vaccinated. We strongly believe that vaccine equity is the most important aspect of vaccination strategies. Full article

(This article belongs to the Special Issue Effectiveness, Safety and Immunogenicity of SARS-CoV-2 Vaccines)

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6 pages, 920 KiB

Open AccessCase Report

Frequent Onsets of Cellulitis in Lower Limbs with Lymphedema Following COVID-19 mRNA Vaccination

by Tatsuma Okazaki, Momoko Matashiro, Gaku Kodama, Takeshi Tshubota, Yoshihito Furusawa and Shin-Ichi Izumi

Vaccines 2022, 10(4), 517; https://doi.org/10.3390/vaccines10040517 - 26 Mar 2022

Cited by 7 | Viewed by 11493

Abstract

Four patients with secondary lower limb lymphedema developed cellulitis at their lymphedema lesion following COVID-19 mRNA vaccinations. They did not develop adverse effects at their vaccination site. All the patients were Japanese females aged <60 years. Three patients developed cellulitis following the first [...] Read more.

Four patients with secondary lower limb lymphedema developed cellulitis at their lymphedema lesion following COVID-19 mRNA vaccinations. They did not develop adverse effects at their vaccination site. All the patients were Japanese females aged <60 years. Three patients developed cellulitis following the first vaccination. The date of onset of cellulitis following the first vaccination varied from 0 to 21 days. Two received BNT162b2 mRNA vaccines and the others received mRNA-1273 vaccines. All the patients were treated with oral antibiotics and recovered. Two patients had repeated cellulitis. The patients with the repeated development of cellulitis could not perform good skincare. One patient had joint contractures in their lower limbs and could not reach her lymphedema lesions, and the other patient could not master the skincare. According to previous studies, the development of cellulitis following vaccination was rare. In this study, four patients aged <60 years developed cellulitis among the eight patients that regularly visited our hospital for rehabilitation for their lower limb lymphedema. In patients with lymphedema, prolonged inflammation may impair lymphatic functions and worsen edema. Therefore, at the time of vaccination, we should keep in mind the prevention and immediate management of cellulitis using intensive skincare and antibiotic treatment. Full article

(This article belongs to the Special Issue Effectiveness, Safety and Immunogenicity of SARS-CoV-2 Vaccines)

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6 pages, 583 KiB

Open AccessBrief Report

Immunogenicity of SARS-CoV-2 BNT162b2 Vaccine in People with Diabetes: A Prospective Observational Study

by Eleni Papadokostaki, Anastasios Tentolouris, Ioanna A. Anastasiou, Mina Psichogiou, Evangelia Iliaki, Ioanna Eleftheriadou, Angelos Hatzakis and Nikolaos Tentolouris

Vaccines 2022, 10(3), 382; https://doi.org/10.3390/vaccines10030382 - 2 Mar 2022

Cited by 19 | Viewed by 2839

Abstract

The mRNA-based BNT162b2 vaccine has demonstrated high efficacy against severe SARS-CoV-2. However, data regarding immune response in people with diabetes mellitus (DM) after vaccination with the BNT162b2 vaccine are limited. In this prospective observational study, we examined humoral immune response in participants with [...] Read more.

The mRNA-based BNT162b2 vaccine has demonstrated high efficacy against severe SARS-CoV-2. However, data regarding immune response in people with diabetes mellitus (DM) after vaccination with the BNT162b2 vaccine are limited. In this prospective observational study, we examined humoral immune response in participants with and without DM after vaccination with the BNT162b2 mRNA vaccine. A total of 174 participants (58 with and 116 without diabetes, matched for age) were included. Antibodies were measured 21 days after the first dose, 7–15 days after the second dose, and 70–75 days after the second and before the third dose of the vaccine. Antibodies were measured by an anti-SARS-CoV-2 receptor-binding domain IgG (Abs-RBD-IgG) assay by a chemiluminescent microparticle immune assay; values > 50 AU/mL are considered protective from severe disease. Almost 17% of participants with DM did not develop adequate humoral immune response to the BNT162b2 mRNA vaccine after the first dose; however, it was high and similar after the second dose in both participants with and without DM and remained so almost 2 months after the second dose of the vaccine. Geometric mean values of Abs-RBD-IgG were not significantly different between participants with and without DM during the study. At least two doses of the BNT162b2 vaccine are necessary to ensure adequate and sustainable immune response in people with DM. Full article

(This article belongs to the Special Issue Effectiveness, Safety and Immunogenicity of SARS-CoV-2 Vaccines)

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9 pages, 4098 KiB

Open AccessBrief Report

Neutralization of SARS-CoV-2 Variants by rVSV-ΔG-Spike-Elicited Human Sera

by Yfat Yahalom-Ronen, Noam Erez, Morly Fisher, Hadas Tamir, Boaz Politi, Hagit Achdout, Sharon Melamed, Itai Glinert, Shay Weiss, Inbar Cohen-Gihon, Ofir Israeli, Marina Izak, Michal Mandelboim, Yoseph Caraco, Noa Madar-Balakirski, Adva Mechaly, Eilat Shinar, Ran Zichel, Daniel Cohen, Adi Beth-Din, Anat Zvi, Hadar Marcus, Tomer Israely and Nir Paran Show full author list Hide full author list

Vaccines 2022, 10(2), 291; https://doi.org/10.3390/vaccines10020291 - 14 Feb 2022

Cited by 18 | Viewed by 3750

Abstract

The emergence of rapidly spreading variants of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) poses a major challenge to the ability of vaccines and therapeutic antibodies to provide immunity. These variants contain mutations of specific amino acids that might impede vaccine efficacy. BriLife [...] Read more.

The emergence of rapidly spreading variants of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) poses a major challenge to the ability of vaccines and therapeutic antibodies to provide immunity. These variants contain mutations of specific amino acids that might impede vaccine efficacy. BriLife^® (rVSV-ΔG-spike) is a newly developed SARS-CoV-2 vaccine candidate currently in phase II clinical trials. It is based on a replication-competent vesicular stomatitis virus (VSV) platform. The rVSV-ΔG-spike contains several spontaneously acquired spike mutations that correspond to SARS-CoV-2 variants’ mutations. We show that human sera from BriLife^® vaccinees preserve comparable neutralization titers towards alpha, gamma, and delta variants and show less than a three-fold reduction in the neutralization capacity of beta and omicron compared to the original virus. Taken together, we show that human sera from BriLife^® vaccinees overall maintain a neutralizing antibody response against all tested variants. We suggest that BriLife^®-acquired mutations may prove advantageous against future SARS-CoV-2 VOCs. Full article

(This article belongs to the Special Issue Effectiveness, Safety and Immunogenicity of SARS-CoV-2 Vaccines)

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