Association between COVID-19 Vaccine Side Effects and Body Mass Index in Spain

Iguacel, Isabel; Maldonado, Aurelio Luna; Ruíz-Cabello, Aurelio Luna; Casaus, Marta; Moreno, Luís A.; Martı́nez-Jarreta, Begoña

doi:10.3390/vaccines9111321

Cited by 45 publications

(58 citation statements)

References 29 publications

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“…Specifically, we found that females had a statistically significant probability of risk for injection site pain and swelling, fatigue, chills, dizziness, nausea, and feeling unwell after Vaxzevria vaccine. These findings are in agreement with previous works reporting lower adverse effects in males [ 32 ].…”

Section: Discussionsupporting

confidence: 94%

Gender and AB0 Blood Type Differences in a Unicentric Group of University Professors in Southern Italy Who Received the Vaxzevria COVID-19 Vaccine: A Cross-Sectional Survey of Vaccine Side Effects, Attitudes, and Hesitation

et al. 2022

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Vaccination has been a key protective behavior for COVID-19. This study investigated the clinical status of university professors administered the Vaxzevria COVID-19 vaccine, to monitor for any adverse reaction, and to understand attitude and hesitancy to vaccination. Data were collected through an online survey. The study received approval from the relevant ethics committee “Comitato Etico Campania Sud”. Multivariate logistic regressions were used to calculate significant predictors of the outcomes of interest. A gender and AB0 blood type difference in adverse vaccine reactions was found. The multivariate logistic regression model showed that female gender, city residence, blood type A+ and B−, and chronic underlying medical conditions or comorbidities were more strongly implicated in the occurrence of adverse reactions, whereas blood type 0 Rh+ or blood type A Rh− were protective factors of adverse reactions to the Vaxzevria vaccine. Both genders did not show serious adverse reactions to the Vaxzevria vaccine. Based on our results, we are able to support the hypothesis that AB0 blood type and gender difference appear as predictors of Vaxzevria COVID-19 vaccine reactogenicity. Furthermore, in the study population, the degree of concern and hesitation to undergo vaccination was minimal.

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Section: Discussionsupporting

confidence: 94%

Gender and AB0 Blood Type Differences in a Unicentric Group of University Professors in Southern Italy Who Received the Vaxzevria COVID-19 Vaccine: A Cross-Sectional Survey of Vaccine Side Effects, Attitudes, and Hesitation

et al. 2022

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“…This is not surprising, since it was well-known, even before the COVID-19 pandemic, that biological sex differences could influence the vaccine uptake, responses, and outcome [ 89 ]. Recent studies showed that the side effects of the Pfizer-BioNTech [ 87 , 90 , 91 ], AstraZeneca [ 90 , 91 , 92 ], Sinopharm [ 12 ], Sputnik V [ 11 ], SinoVac [ 91 , 93 ], Johnson & Johnson and Moderna [ 90 ] vaccines were significantly more frequent in females. With a view to reducing post-vaccination side effects in females and increasing immunogenicity in males, Ciarambino et al [ 94 ] recommended that the vaccine development should be sex-specific, and that sex-related variables should be examined in pre-clinical and clinical vaccine trials.…”

Section: Discussionmentioning

confidence: 99%

“…Moreover, the comparison of age groups showed that participants aged 20 to 39 years were more likely to experience almost the majority of post-vaccination side effects, and they constituted the largest proportion of participants who suffered from severe side effects. Studies on different populations also showed that the side effects of different COVID-19 vaccines were significantly more frequent in younger individuals compared to in the elderly [ 11 , 90 , 91 , 92 ].…”

Section: Discussionmentioning

confidence: 99%

Reported Adverse Effects and Attitudes among Arab Populations Following COVID-19 Vaccination: A Large-Scale Multinational Study Implementing Machine Learning Tools in Predicting Post-Vaccination Adverse Effects Based on Predisposing Factors

et al. 2022

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Background: The unprecedented global spread of coronavirus disease 2019 (COVID-19) has imposed huge challenges on the healthcare facilities, and impacted every aspect of life. This has led to the development of several vaccines against COVID-19 within one year. This study aimed to assess the attitudes and the side effects among Arab communities after receiving a COVID-19 vaccine and use of machine learning (ML) tools to predict post-vaccination side effects based on predisposing factors. Methods: An online-based multinational survey was carried out via social media platforms from June 14 to 31 August 2021, targeting individuals who received at least one dose of a COVID-19 vaccine from 22 Arab countries. Descriptive statistics, correlation, and chi-square tests were used to analyze the data. Moreover, extensive ML tools were utilized to predict 30 post vaccination adverse effects and their severity based on 15 predisposing factors. The importance of distinct predisposing factors in predicting particular side effects was determined using global feature importance employing gradient boost as AutoML. Results: A total of 10,064 participants from 19 Arab countries were included in this study. Around 56% were female and 59% were aged from 20 to 39 years old. A high rate of vaccine hesitancy (51%) was reported among participants. Almost 88% of the participants were vaccinated with one of three COVID-19 vaccines, including Pfizer-BioNTech (52.8%), AstraZeneca (20.7%), and Sinopharm (14.2%). About 72% of participants experienced post-vaccination side effects. This study reports statistically significant associations (p < 0.01) between various predisposing factors and post-vaccinations side effects. In terms of predicting post-vaccination side effects, gradient boost, random forest, and XGBoost outperformed other ML methods. The most important predisposing factors for predicting certain side effects (i.e., tiredness, fever, headache, injection site pain and swelling, myalgia, and sleepiness and laziness) were revealed to be the number of doses, gender, type of vaccine, age, and hesitancy to receive a COVID-19 vaccine. Conclusions: The reported side effects following COVID-19 vaccination among Arab populations are usually non-life-threatening; flu-like symptoms and injection site pain. Certain predisposing factors have greater weight and importance as input data in predicting post-vaccination side effects. Based on the most significant input data, ML can also be used to predict these side effects; people with certain predicted side effects may require additional medical attention, or possibly hospitalization.

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“…However, the majority of solicited AEs in the mRNA-1273 group were grade 1–2 in severity and generally resolved within a few days in both studies. The difference in incidence rate of solicited AEs might be due to the same vaccine dose being administered to participants in Japan and US irrespective of mean body mass, which was higher among the US participants [15] . In the present study, mean body mass index was 22.39 (±2.65) kg/m 2 in the mRNA-1273 arm whereas in the US study participants had a mean body mass index of 29.3 (±6.9) kg/m 2 [5] .…”

Section: Discussionmentioning

confidence: 97%

A phase 1/2 randomised placebo-controlled study of the COVID-19 vaccine mRNA-1273 in healthy Japanese adults: An interim report

Masuda

Murakami

Sugiura

et al. 2022

Vaccine

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Introduction The mRNA vaccine, mRNA-1273/TAK-919, encodes the prefusion-stabilised spike protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). We report interim results of the first study evaluating safety and immunogenicity of mRNA-1273 in healthy Japanese participants. Methods This phase 1/2, randomised, observer-blind, placebo-controlled trial, conducted in Japan (two sites), enrolled healthy adults aged ≥20 years with no prior exposure to investigational coronavirus vaccines/treatments, and no known history/risk of SARS-CoV-2 infection. Participants were stratified by age (<65/≥65 years) and randomised to receive two doses of 100 μg mRNA-1273 or placebo administered as intramuscular injections 28 days apart. Primary outcomes were safety and immunogenicity assessed by anti-SARS-CoV-2-spike protein-binding antibody level (bAb). A secondary outcome was SARS-CoV-2 neutralising antibody (nAb) response. Results Participants were enrolled between 21 January and 3 February, 2021, and 200 were randomised: mRNA-1273, n=150 (<65 years, n=100; ≥65 years, n=50); placebo, n=50 (<65 years, n=40; ≥65 years, n=10). Solicited adverse events (AEs) through 7 days after each vaccination occurred in 144/150 (96%) and 19/50 (38%) participants in the mRNA-1273 and placebo arms, respectively. In the mRNA-1273 arm, injection-site pain, myalgia and fatigue were the most frequently reported solicited AEs after each vaccination irrespective of age. Robust immune responses occurred with mRNA-1273 (n=147) with a bAb geometric mean fold rise (95% confidence interval [CI]) from baseline of 1009 (865, 1177) and a nAb of 21.7 (19.8, 23.8) at day 57. Seroconversion rates (95% CI) for bAb and nAb were both 100% (97.5, 100) at day 57. No such response occurred with placebo (n=49). Conclusion Two doses of 100 μg mRNA-1273 given 28 days apart demonstrated an acceptable safety profile and induced significant anti–SARS-CoV-2 immune responses in a Japanese population aged ≥20 years. Funding: Takeda Pharmaceutical Company Limited and Japan Agency for Medical Research and Development (AMED). ClinicalTrials.gov: NCT04677660.

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Association between COVID-19 Vaccine Side Effects and Body Mass Index in Spain

Cited by 45 publications

References 29 publications

Gender and AB0 Blood Type Differences in a Unicentric Group of University Professors in Southern Italy Who Received the Vaxzevria COVID-19 Vaccine: A Cross-Sectional Survey of Vaccine Side Effects, Attitudes, and Hesitation

Gender and AB0 Blood Type Differences in a Unicentric Group of University Professors in Southern Italy Who Received the Vaxzevria COVID-19 Vaccine: A Cross-Sectional Survey of Vaccine Side Effects, Attitudes, and Hesitation

Reported Adverse Effects and Attitudes among Arab Populations Following COVID-19 Vaccination: A Large-Scale Multinational Study Implementing Machine Learning Tools in Predicting Post-Vaccination Adverse Effects Based on Predisposing Factors

A phase 1/2 randomised placebo-controlled study of the COVID-19 vaccine mRNA-1273 in healthy Japanese adults: An interim report

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