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1.
J Med Virol ; 94(3): 1085-1095, 2022 03.
Article in English | MEDLINE | ID: covidwho-1718373

ABSTRACT

Two messenger RNA (mRNA) vaccines developed by Pfizer-BioNTech and Moderna are being rolled out. Despite the high volume of emerging evidence regarding adverse events (AEs) associated with the COVID-19 mRNA vaccines, previous studies have thus far been largely based on the comparison between vaccinated and unvaccinated control, possibly highlighting the AE risks with COVID-19 mRNA vaccination. Comparing the safety profile of mRNA vaccinated individuals with otherwise vaccinated individuals would enable a more relevant assessment for the safety of mRNA vaccination. We designed a comparative safety study between 18 755 and 27 895 individuals who reported to VigiBase for adverse events following immunization (AEFI) with mRNA COVID-19 and influenza vaccines, respectively, from January 1, 2020, to January 17, 2021. We employed disproportionality analysis to rapidly detect relevant safety signals and compared comparative risks of a diverse span of AEFIs for the vaccines. The safety profile of novel mRNA vaccines was divergent from that of influenza vaccines. The overall pattern suggested that systematic reactions like chill, myalgia, fatigue were more noticeable with the mRNA COVID-19 vaccine, while injection site reactogenicity events were more prevalent with the influenza vaccine. Compared to the influenza vaccine, mRNA COVID-19 vaccines demonstrated a significantly higher risk for a few manageable cardiovascular complications, such as hypertensive crisis (adjusted reporting odds ratio [ROR], 12.72; 95% confidence interval [CI], 2.47-65.54), and supraventricular tachycardia (adjusted ROR, 7.94; 95% CI, 2.62-24.00), but lower risk of neurological complications such as syncope, neuralgia, loss of consciousness, Guillain-Barre syndrome, gait disturbance, visual impairment, and dyskinesia. This study has not identified significant safety concerns regarding mRNA vaccination in real-world settings. The overall safety profile patterned a lower risk of serious AEFI following mRNA vaccines compared to influenza vaccines.


Subject(s)
COVID-19 , Influenza Vaccines , Influenza, Human , Adverse Drug Reaction Reporting Systems , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , Humans , Influenza Vaccines/adverse effects , Influenza, Human/prevention & control , Pharmacovigilance , RNA, Messenger/genetics , World Health Organization , mRNA Vaccines
2.
Int J Environ Res Public Health ; 18(11)2021 May 28.
Article in English | MEDLINE | ID: covidwho-1256506

ABSTRACT

Laparoscopy is a procedure that ultimately reduces hospital stay time and speeds up post-operative recovery. It is mainly performed in high-income countries but its implementation in many low- and middle-income countries (LMICs) is increasing. However, no aggregate data exist regarding the outcomes of this procedure in resource-limited settings. We retrospectively reviewed all cases of laparoscopy recorded from January 2007 to March 2017 at the Department of Surgery of Beira to assess the related outcomes. Moreover, we performed a systematic review of the laparoscopic practices and outcomes in low-income countries. Data from the Department of Surgery of Beira identified 363 laparoscopic procedures, mainly relating to gynecological diseases, cholelithiasis, and appendicectomy with only a 1.6% complication rate (6 cases) and a 1.9% conversion rate (7 cases) to open surgery. The systematic review showed a pooled risk of overall complications significantly lower in laparoscopic vs. open appendicectomy (OR = 0.43; 95% CI 0.19-0.97; I2 = 85.7%) and a significantly lower risk of infection (OR = 0.53; 95% CI 0.43-0.65; I2 = 0.00%). The pooled SMD in operation duration in laparoscopic vs. open appendectomy was 0.58 (95% CI -0.00; 1.15; I2 = 96.52), while the pooled SMD in hospitalization days was -1.35 (95% CI -1.87; -0.82; I2 = 96.41). Laparoscopy is an expensive procedure to adopt as it requires new equipment and specialized trained health workers. However, it could reduce post-operative costs and complications, especially in terms of infections. It is crucial to increase its accessibility, acceptability, and quality particularly in LMICs, especially during this COVID-19 era when the reduction of patient hospitalization is essential.


Subject(s)
Appendicitis , COVID-19 , Laparoscopy , Humans , Length of Stay , Retrospective Studies , SARS-CoV-2 , Treatment Outcome
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