Human vaccines & immunotherapeutics
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Vaccines have changed modern medicine, and are a mainstay in reducing morbidity and mortality from infections. Our research group recently published a study in which we found that vaccines approved by the US Food and Drugs Administration were safe with few clinically important post-approval adverse effects. The current COVID-19 pandemic presents regulators with the unprecedented challenge of balancing a public demand for the rapid development and approval of a safe and effective SARS-CoV-2 vaccine without compromising the strict pre-marketing requirements used for previous vaccines. Here, we review the approval process and safety profiles of FDA approved vaccines and discuss some of the challenges currently facing the FDA regarding the SARS-CoV-2 vaccine approval.
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Subcutaneous vaccine (SC) administration is an outmoded practice which complicates vaccine administration recommendations. Local adverse events following immunization (AEFIs) are a recognized determinant of vaccine hesitancy/refusal which can lead to an increased prevalence of vaccine-preventable disease. ⋯ This, combined with moderate grade evidence that IM injection generates significantly greater immune response compared with SC injection, allows a strong recommendation to be made for the IM injection of all vaccines except BCG and Rotavirus. This will simplify vaccination practice, minimize the inadvertent misadministration of vaccines and potentially improve public trust in vaccination.