Regulation, approval, and access of spinal implants in low-middle-income countries: a narrative review and case study.

Introduction: Spinal implants play a vital role in healthcare delivery, and regulations are necessary to ensure their quality, approval, access, and use. In this article, we examine the current state of regulation and approval procedures for medical devices in low- and middle-income countries (LMICs), emphasizing the situation in Tanzania.

Areas Covered: We conducted a systematic literature search and interviewed a local spine implant representative to investigate the approval, availability, and access of surgical and spinal implants in LMICs, particularly in Africa.

Reported rates of all-cause serious adverse events following immunization with BNT-162b in 5-17-year-old children in the United States.

Vaccine development against COVID-19 has mitigated severe disease. However, reports of rare but serious adverse events following immunization (sAEFI) in the young populations are fuelling parental anxiety and vaccine hesitancy. With a very early season of viral illnesses including COVID-19, respiratory syncytial virus (RSV), influenza, metapneumovirus and several others, children are facing a winter with significant respiratory illness burdens.

Analyses of reported severe adverse events after immunization with SARS-CoV-2 vaccines in the United States: One year on.

Objective: To analyze rates of reported severe adverse events after immunization (sAEFI) attributed to SARS-CoV-2 vaccines in the United States (US) using safety surveillance data.

Methods: Observational study of sAEFI reported to the vaccine adverse events reporting system (VAERS) between December 13, 2020, to December 13, 2021, and attributed to SARS-CoV-2 vaccination programs across all US states and territories. All sAEFI in conjunction with mRNA (BNT-162b2 or mRNA-1273) or adenovector (Ad26.