Dataset Information

Tozinameran (Pfizer, BioNTech) and Elasomeran (Moderna) Efficacy in COVID-19-A Systematic Review of Randomised Controlled Trial Studies.

ABSTRACT: Background: The objective of this research was to test the efficacy and safety profile of tozinameran (30 μg, BNT162b2, Pfizer, BioNTech) and elasomeran (100 μg, mRNA-1273, Moderna) in COVID-19 prevention in ≥16-year-old patients vaccinated with two doses. Methods: A meta-analysis of the literature was conducted using the MEDLINE and EMBASE databases, following inclusion and exclusion criteria. Eight RCTs have been selected. The results were presented using the risk ratio (RR) with a 95% confidence interval (CI). A fixed-effect model or random-effect model was applied based on the heterogeneity of the results. Results: BNT162b2 and mRNA-1273 vaccines are efficient in preventing COVID-19 in comparison to a placebo (MH, RR 0.08 [0.07, 0.09] p < 0.00001 (95% CI)). It was found that administering the vaccines BNT162b2 and mRNA-1273 was associated with a higher proportion of adverse events in comparison to the placebo (IV, RR 2.14 [1.99, 2.29] p < 0.00001 (95% CI)). Administering the vaccines BNT162b2 and mRNA-1273 was associated with a higher proportion of serious adverse events in comparison to the placebo (MH, RR 0.98 [0.89, 1.08] p = 0.68 (95% CI)). Conclusions: Tozinameran and elasomeran are effective and safe in preventing the occurrence of COVID-19.

SUBMITTER: Ratajczak P

PROVIDER: S-EPMC10252750 | biostudies-literature | 2023 May

REPOSITORIES: biostudies-literature

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Tozinameran (Pfizer, BioNTech) and Elasomeran (Moderna) Efficacy in COVID-19-A Systematic Review of Randomised Controlled Trial Studies.

Ratajczak Piotr P Banach Zuzanna Z Kopciuch Dorota D Paczkowska Anna A Zaprutko Tomasz T Krawczyk Józef J Maciuszek-Bartkowska Barbara B Kus Krzysztof K

Healthcare (Basel, Switzerland) 20230524 11

<b>Background:</b> The objective of this research was to test the efficacy and safety profile of tozinameran (30 μg, BNT162b2, Pfizer, BioNTech) and elasomeran (100 μg, mRNA-1273, Moderna) in COVID-19 prevention in ≥16-year-old patients vaccinated with two doses. <b>Methods:</b> A meta-analysis of the literature was conducted using the MEDLINE and EMBASE databases, following inclusion and exclusion criteria. Eight RCTs have been selected. The results were presented using the risk ratio (RR) with ...[more]

PMID: 37297673

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Project description:The vaccination against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) is an important public health strategy to prevent people from the pandemic. Vaccines are a game-changing tool, it is essential to understand the adverse events after COVID-19 vaccination. This study explored the adverse events of COVID-19 Vaccination Oxford-AstraZeneca, Pfizer-BioNTech, Moderna, Johnson and Johnson on Guillain-Barré Syndrome (GBS). In this study, initially 128 documents were identified from the databases, including Pub-Med, Web of Science-Clarivate Analytics, Scopus, and Google Scholar. The articles on COVID-19 vaccination and GBs were searched using the keywords "SARS-CoV-2, COVID-19, Vaccination, and Guillain Barré Syndrome, GBS", finally, 16 documents were included in the analysis and synthesis. After administering 1,680,042,214 doses of COVID-19 vaccines, 6177 cases were identified with 10.5 cases per million vaccine doses. A significant positive risk was found between COVID-19 vaccine administration and GBS with a risk rate of RR 1.97 (95% CI 1.26-3.08, p = 0.01). The mRNA vaccines were associated with 2076 cases, and 1,237,638,401 vaccine doses were linked with 4.47 GBS events per million vaccine doses. The first dose of the m-RNA vaccine was associated with 8.83 events per million doses compared to the second dose with 02 events per million doses. The viral-vector vaccine doses 193,535,249 were linked to 1630 GBS cases with 11.01 cases per million doses. The incidence of GBS after the first dose was 17.43 compared to 1.47 cases per million in the second dose of the viral-vector vaccine. The adverse events of the Oxford-AstraZeneca vaccine were linked to 1339 cases of GBS following 167,786,902 vaccine doses, with 14.2 cases per million doses. The Oxford-AstraZeneca vaccine significantly increased the risk of GBS RR: 2.96 (95% CI 2.51-3.48, p = 0.01). For the Pfizer-BioNTech vaccine, there were 7.20 cases per million doses of the vaccine, and no significant association was identified between the Pfizer-BioNTech vaccine and GBS incidence RR: 0.99 (95% CI 0.75-1.32, p = 0.96). Moderna vaccine was related with 419 cases of GBS after administering 420,420,909 doses, with 2.26 cases per million doses. However, Johnson and Johnson's vaccination was linked to 235 GBS after 60,256,913 doses of the vaccine with 8.80 cases per million doses. A significant association was seen between the risk of GBS and Ad.26.COV2. S vaccine, RR: 2.47 (95% CI 1.30-4.69, p < 0.01). Overall, a significant association was seen between the COVID-19 vaccines and the risk of GBS. The incidence of GBS was higher after the first dose compared to GBS cases per million in the second dose.

Project description:BackgroundmRNA COVID-19 vaccines manufactured by Pfizer-BioNTech (BNT162b2) and Moderna (mRNA-1273) have been shown to be efficacious but have not been compared in head-to-head clinical trials.MethodsWe designed this observational study to emulate a target trial of COVID-19 vaccination by BNT162b2 versus mRNA-1273 among persons who underwent vaccination in the national U.S. Veterans Affairs (VA) healthcare system from 11/12/2020 to 25/03/2021 using combined VA and Medicare electronic health records. We identified the best matching mRNA-1273 recipient(s) for each BNT162b2 recipient, using exact/coarsened-exact matching (calendar week, VA integrated service network, age buckets and Charlson comorbidity index buckets) followed by propensity score matching. Vaccine recipients were followed from the date of first vaccine dose until 25/08/2021 for the development of SARS-CoV-2 infection, SARS-CoV-2-related hospitalization or SARS-CoV-2-related death.FindingsEach group included 902,235 well-matched vaccine recipients, followed for a mean of 192 days, during which 16,890 SARS-CoV-2 infections, 3591 SARS-CoV-2-related hospitalizations and 381 SARS-CoV-2-related deaths were documented. Compared to BNT162b2, mRNA-1273 recipients had significantly lower risk of SARS-CoV-2 infection (adjusted hazard ratio [aHR] 0.736, 95% CI 0.696-0.779) and SARS-CoV-2-related hospitalization (aHR 0.633, 95% CI 0.562-0.713), which persisted across all age groups, comorbidity burden categories and black/white race. The differences between mRNA-1273 and BNT162b2 in risk of infection or hospitalization were progressively greater when the follow-up period was longer, i.e. extending to March 31, June 30 or August 25, 2021. These differences were more pronounced when we analyzed separately the outcomes that occurred during the follow-up period from July 1 to August 25, 2021 when the Delta variant became predominant in the U.S. (aHR for infection 0.584, 95% CI 0.533-0.639 and aHR for hospitalization 0.387, 95% 0.311-0.482). SARS-CoV-2-related deaths were less common in mRNA-1273 versus BNT162b2 recipients (168 versus 213) but this difference was not statistically significant (aHR 0.808, 95% CI 0.592-1.103).InterpretationIn conclusion, although absolute rates of infection, hospitalization and death in both vaccine groups were low regardless of the vaccine received, our data suggests that compared to BNT162b2, vaccination with mRNA-1273 resulted in significantly lower rates of SARS-CoV-2-infection and SARS-CoV-2-related hospitalization. These differences were greater with longer follow-up time since vaccination and even more pronounced in the Delta variant era.FundingU.S. Department of Veterans Affairs, grant numbers COVID19-8900-11 and C19 21-278.

Project description:The Pfizer-BioNTech coronavirus disease 2019 (COVID-19) vaccine has been offered to nonallergic ≥16-year-old Israeli adults since December 19, 2020. Data regarding factors associated with vaccine ineffectiveness are limited. The aim of this study is to assess the impact of hepatic fibrosis on the efficacy of the BioNTech vaccine. Serum severe acute respiratory syndrome coronavirus 2 spike immunoglobulins (S IgG) obtained at least 7 days following vaccination completion was correlated with the prevaccine calculated Fibrosis-4 (FIB-4) score among 719 employees in the Hadassah Medical Center, Jerusalem. Positive vaccine response (S IgG levels ≥ 19 AU/mL) was found in 708 of 719 individuals (98.5%). Vaccine failure (S IgG levels < 19) was found in 11 (1.5%); of these, 7 were immunosuppressed. Mean FIB-4 available in 501 of 708 vaccine responders was 1.13 ± 0.66, mean age 51.4 ± 12.4 years (29.3% males), and mean S IgG titers 239.7 ± 86.1 AU/mL. Similar to the general population, 70.5% had normal FIB-4 (<1.3), 26.8% undetermined FIB-4 (1.3-2.67), and 2.7% advanced FIB-4 (>2.67). When divided into response subgroups, 158 of 501 individuals (30.1%) with IgG titers 19-100 AU/mL had a mean FIB-4 of 1.48 ± 0.82; 198 (39.5%) with IgG titers 101-200 AU/mL had mean FIB-4 of 1.22 ± 0.76; 83 (16.6%) with titers 201-300 AU/mL had mean FIB-4 of 1.04 ± 0.48; 38 (7.6%) individuals with IgG titers 301-400 AU/ml had a mean FIB-4 of 1.08 ± 0.63; and 121 (24.2%) with IgG titers >400 AU/mL had mean FIB-4 of 1.18 ± 0.87. Increased FIB-4, age, and male gender significantly correlated with lower postvaccine IgG titers (P < 0.001). FIB-4 results were confirmed using FibroScan data displaying advanced fibrosis impact on weakened COVID-19 vaccine response. Conclusion: Immune suppression, older age, male gender, and advanced chronic liver disease are risk factors for lower vaccine response. The FIB-4 provides a simple tool to prioritize candidates for third-dose vaccine booster.

Dataset Information

Tozinameran (Pfizer, BioNTech) and Elasomeran (Moderna) Efficacy in COVID-19-A Systematic Review of Randomised Controlled Trial Studies.

Publications

Tozinameran (Pfizer, BioNTech) and Elasomeran (Moderna) Efficacy in COVID-19-A Systematic Review of Randomised Controlled Trial Studies.

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