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Adverse events reported by Iranian patients with multiple sclerosis after the first dose of Sinopharm BBIBP-CorV.

ABSTRACT: MS patients were one of the first populations vaccinated in Iran. To date, the most used vaccine brand on Iranian MS patients is Sinopharm COVID-19 vaccine. Here is the first study on the adverse events after the first dose of Sinopharm vaccine on 583 Iranian MS patients. A Google form link was sent to MS patients through social networks, between May 1, 2021 and May 22, 2021. No serious adverse event was reported. At least one complaint (mostly transient) was reported by 350 (60%) of vaccine recipients. Constitutional symptoms (malaise, fatigue, fever, shivering, & generalized body pain) (51%) and headache (9%) were the most reported complaints. We found a relation between gender and prior infection with COVID-19 and reported symptoms (p value less than 0.05). Only five recipients (0.9%) reported MS relapse after vaccination. MS worsening was a minor incident related to fever.

SUBMITTER: Ali Sahraian M

PROVIDER: S-EPMC8458008 | biostudies-literature | 2021 Oct

REPOSITORIES: biostudies-literature

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Adverse events reported by Iranian patients with multiple sclerosis after the first dose of Sinopharm BBIBP-CorV.

Ali Sahraian Mohammad M Ghadiri Fereshteh F Azimi Amirreza A Naser Moghadasi Abdorreza A

Vaccine 20210923 43

MS patients were one of the first populations vaccinated in Iran. To date, the most used vaccine brand on Iranian MS patients is Sinopharm COVID-19 vaccine. Here is the first study on the adverse events after the first dose of Sinopharm vaccine on 583 Iranian MS patients. A Google form link was sent to MS patients through social networks, between May 1, 2021 and May 22, 2021. No serious adverse event was reported. At least one complaint (mostly transient) was reported by 350 (60%) of vaccine rec ...[more]

PMID: 34579974

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Project description:ObjectiveTo estimate the prevalence of post-vaccination seropositivity against SARS-CoV-2 and identify its predictors in Peruvian Social Health Insurance (EsSalud) personnel in 2021.MethodsWe conducted a cross-sectional study in a representative simple stratified sample of EsSalud workers. We evaluated IgG anti-SARS-CoV-2 antibodies response (seropositivity) by passive (previous infection) and active immunization (vaccination), and epidemiological and occupational variables obtained by direct interview and a data collection form. Descriptive and inferential statistics were used with correction of sample weights adjusted for non-response rate, and crude and adjusted odds ratio (OR) and geometric mean ratio (GMR) with their respective 95% confidence intervals (95%CI) were estimated.ResultsWe enrolled 1077 subjects. Seropositivity was 67.4% (95%CI: 63.4-71.1). Predictors of seropositivity were age (negative relation; p < 0.001), previous infection (aOR = 11.7; 95%CI: 7.81-17.5), working in COVID-19 area (aOR = 1.47; 95%CI: 1.02-2.11) and time since the second dose. In relation to antibody levels measured by geometric means, there was an association between male sex (aGMR = 0.77; 95%CI: 0.74-0.80), age (negative relation; p < 0.001), previous infection (aGMR = 13.1; 95%CI:4.99-34.40), non-face-to-face/licensed work modality (aGMR = 0.78; 95%CI: 0.73-0.84), being a nursing technician (aGMR = 1.30; 95%CI: 1.20-1.41), working in administrative areas (aGMR = 1.17; 95%CI: 1.10-1.25), diagnostic support (aGMR = 1.07; 95%CI: 1.01-1.15), critical care (aGMR = 0.85; 95%CI: 0.79-0.93), and in a COVID-19 area (aGMR = 1.30; 95%CI: 1.24-1.36) and time since receiving the second dose (negative relation; p < 0.001).ConclusionsSeropositivity and antibody levels decrease as the time since receiving the second dose increases. Older age and no history of previous infection were associated with lower seropositivity and antibody values. These findings may be useful for sentinel antibody surveillance and the design of booster dose strategies.

Project description:BackgroundTo investigate the safety (adverse events [AEs] and post-vaccination multiple sclerosis [MS] activity within 6 weeks), clinical efficacy (protection against coronavirus disease 2019 [COVID-19]), and vaccine-induced humoral immunogenicity (SARS-CoV-2 neutralizing antibody, anti-nucleocapsid IgG, and anti-spike IgG) of the Sinopharm (BBIBP-CorV) vaccine among people with MS (PwMS) receiving different disease-modifying therapies (DMTs).MethodsThis prospective cohort study was conducted between November 2021 and May 2022. PwMS were followed for six months after the 2nd dose of vaccination. Antibody responses were measured 2-16 weeks after the 2nd dose injection. Multivariate logistic regression was employed to assess the impact of each DMT on dichotomous antibody responses, adjusting for age, sex, MS phenotype, expanded disability status scale, disease duration, and vaccination-antibody titration interval.ResultsAmong the 261 screened PwMS, 209 (aged 38.23 ± 9.73 years, female: 70.8%; relapsing-remitting MS: 80.4%) were included. The frequencies of experiencing non-serious AEs and post-vaccination MS activity were 66.0% and 4.8%, respectively. Breakthrough COVID-19 infection was observed in 14.8% of the PwMS. A subcohort of 125 PwMS was assessed for antibody responses. Positive neutralizing antibodies, anti-nucleocapsid IgG, and anti-spike IgG were detected in 36.8%, 35.2%, and 52.0% of the PwMS, respectively. Multivariate regression indicated a 96% (OR: 0.04 [95% CI: 0.00, 0.51], P = 0.013), 93% (OR: 0.07 [0.01, 0.64], P = 0.019), and 89% (OR: 0.11 [0.01, 0.96], P = 0.045) reduced odds of positive neutralizing antibody, anti-nucleocapsid IgG, and anti-spike IgG, respectively, among fingolimod-receivers. Additionally, anti-CD20s-receivers had 88% (OR: 0.12 [0.02, 0.85], P = 0.034) lower odds of being positive for anti-nucleocapsid IgG.ConclusionsBBIBP-CorV appeared to be well tolerated in PwMS, with promising clinical efficacy. However, a suboptimal humoral response was observed in PwMS receiving fingolimod and anti-CD20s. Future research should investigate the relationship between humoral responses and the frequency and severity of COVID-19 infection across various DMTs.

Project description:BackgroundAdverse events following immunization (AEFI) against SARS-CoV-2 are common as reported by clinical trials and contemporary evidence. The objective of the present study was to evaluate the local and systemic adverse events following vaccination with ChAdOx1 nCoV-19 and BBIBP-CorV among the healthcare professionals (HCPs) of Nepal.MethodsThis cross-sectional study was conducted among 606 vaccinated HCPs of Kathmandu, Nepal. Data was collected from June 15 to 30, 2021 using a self-administered online survey tool. Multiple binary logistic regression models were used to predict the adverse events according to the vaccine types and doses after adjusting for age, sex, comorbidity and previous SARS-CoV-2 infection.ResultsThe mean (SD) age of the participants was 35.6 (13.2) years and 52% of them were female. Almost 59% of participants were vaccinated with two doses and around 54% of total of them took the ChAdOx1 nCoV-19 vaccine. At least one local and systemic adverse event was reported by 54% and 62% of participants after the first dose and 37% and 49% after the second dose of ChAdOx1 nCoV-19 and by 37% and 43% after the first dose and 42% and 36% after the second dose of BBIBP-CorV vaccine respectively. Injection site pain, swelling and tenderness at the injection site were the most frequently reported local AEFI while, fatigue, headache, fever and myalgia were the most frequently reported systemic AEFI. The logistic model demonstrated that the risk of both local and systemic adverse events was higher among the ChAdOx1 nCoV-19 vaccine recipients compared to the BBIBP-CorV vaccine. Almost 10% of individuals reported a post-vaccination SARS-CoV-2 infection and most of them occurred after taking the first dose of vaccine.ConclusionsRecipients of both the ChAdOx1 nCoV-19 and BBIBP-CorV vaccine among the HCPs of Nepal reported only mild and constitutional symptoms including injection site pain and tenderness, headache, fever, fatigue, etc. after vaccination.

Project description:BackgroundBooster vaccine doses against SARS-CoV-2 have been advocated to address evidence of waning immunity, breakthrough infection, and the emergence of immune-evasive variants. A heterologous prime-boost vaccine strategy may offer advantages over a homologous approach, but the safety and efficacy of this approach with the mRNA vaccine BNT162b2 (BNT: Pfizer) and inactivated BBIBP-CorV (BBIBT: Sinopharm) vaccines have not been studied.MethodsWe conducted a non-randomized, non-blinded phase II observational community trial acrossBahrain, investigating the reactogenic and immunogenic responseof participants who had previously received two doses of BBIBP, followed by a third booster dose of either BBIBP (homologous booster) or BNT (heterologous booster). Immunogenicity through serological statuswas determined at baseline and on the following 8thweek. Reactogenicity data (safety and adverse events) were collected throughout study period, in addition to participant-led electronic journaling.Results305 participants (152 BBIBP and 153 BNT booster) were enrolled in the study,with 246 (127 BBIBP and 119 BNT booster) included in the final analysis. There was a significant increase in anti-SARS-CoV-2 antibody levels post booster administration in both groups; however, the heterologous BNT arm demonstrated a significantly larger mean increase in the level of spike (S) antigen-specific antibodies (32.7-fold increase versus 2.6, p < 0.0001) and sVNT neutralising antibodies (3.4-fold increase versus 1.8, p < 0.0001), whereas the homologous arm demonstrated a significant increase in the levels of nucleocapsid (N) antigen-specific antibodies (3.8-fold increase versus none). Non-serious adverse events (injection site pain, fever, and fatigue) were more commonly reported in the heterologous arm, but no serious adverse events occurred.ConclusionHeterologous prime-boost vaccination with the mRNA BNT162b2 (Pfizer) vaccine in those who had received two doses of inactivated virus BBIBP-CorV (Sinopharm) vaccine demonstrated a more robust immune response against SARS-CoV-2 than the homologous BBIBP booster and appears safe and well tolerated. Clinical Trial Registry Number (ClinicalTrials.gov): NCT04993560.

Dataset Information

Adverse events reported by Iranian patients with multiple sclerosis after the first dose of Sinopharm BBIBP-CorV.

Publications

Adverse events reported by Iranian patients with multiple sclerosis after the first dose of Sinopharm BBIBP-CorV.

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