Human vaccines & immunotherapeutics
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Hum Vaccin Immunother · May 2021
"This choice does not just affect me." Attitudes of pregnant women toward COVID-19 vaccines: a mixed-methods study.
Public health experts agree that pregnant women who fall into priority groups may be offered a Coronavirus Disease 2019 (COVID-19) vaccine. However, little is known about attitudes of pregnant women toward COVID-19 vaccination. We surveyed 300 pregnant women during the roll out of the Pfizer-BioNTech vaccine in Ireland. ⋯ Safety of their unborn infant was the primary driver of decision making among survey participants, but specific safety concerns differed according to likely acceptance of a vaccine. Communication about COVID-19 vaccines to pregnant women must explicitly address safety. Pregnant women and their health-care providers should be supported with accessible interpretations of data so that they can make the best choice for their individual risk profile.
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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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The development of COVID-19 vaccines is occurring at a rapid pace, with the potential for a vaccine to be available within 6 months. So who should be prioritized for vaccination when in the first instance, there will be insufficient supply to meet demand? There is no doubt that health-care workers in all settings should be vaccinated first, but who comes next will be a complex decision based on local epidemiology, societal values, and the ability of the vaccines to prevent both severe disease and to reduce transmission thereby eliciting herd protection. ⋯ In some settings, the elderly may be prioritized, in others, it may be the population most likely to get infected and responsible for community spread. To support decision-making on who to be prioritized for vaccination requires urgent additional research on the epidemiology of COVID-19; preexisting immunity and who is responsible for transmission in a variety of settings; the safety, immunogenicity, and efficacy of COVID-19 vaccines in children and pregnant women; and determining whether COVID-19 vaccines prevent asymptomatic infection and transmission.
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Hum Vaccin Immunother · May 2021
Randomized Controlled TrialA phase 1, randomized, placebo-controlled study to evaluate the safety and immunogenicity of an mRNA-based RSV prefusion F protein vaccine in healthy younger and older adults.
Respiratory Syncytial Virus (RSV) causes lower respiratory tract infections that can be severe and sometimes fatal. The risk for severe RSV infection is highest in infants and older adults. A safe and effective RSV vaccine for older adults represents a serious unmet medical need due to higher morbidity and mortality in this age group. ⋯ Primary objectives were safety and tolerability and secondary objectives included humoral and cell-mediated immunogenicity. All dose levels of mRNA-1777 (V171) were generally well tolerated and no serious adverse events related to the vaccine were reported. Immunization with mRNA-1777 (V171) elicited a humoral immune response as measured by increases in RSV neutralizing antibody titers, serum antibody titers to RSV prefusion F protein, D25 competing antibody titers to RSV prefusion F protein, and cell-mediated immune responses to RSV-F peptides.
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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.