Mothers' intentions to vaccinate their children for COVID-19.

Parents' intentions to vaccinate their children is an important area of investigation in light of the COVID-19 pandemic. There is a growing body of research examining factors that influence parents' vaccine intentions. The current study investigated factors that would influence maternal intent to vaccinate their children for COVID-19, shortly before the CDC approved vaccines for children 11 and younger. We had a sample of n = 176 mothers (Mchildage = 71.63 months, 52% White) from California fill out an online survey during February-April 2021. Our results suggest that perceived COVID-19 threat predicts mothers' intention to vaccinate their children (b = 0.370, p < 0.001), controlling for mothers' age, socioeconomic status, race, and child age. Child age (b = 0.027, p = 0.008), SES (b = 0.396, p = 0.018), and child previous flu shot (b = 0.725, p < 0.001) also positively predicted mothers' intention to vaccinate their children. Results are discussed in light of prior research on maternal vaccine intentions and hesitancy.

A review of clinical efficacy data supporting emergency use authorization for COVID-19 therapeutics and lessons for future pandemics.

Emergency Use Authorization (EUA) allows the US Food and Drug Administration (FDA) to expedite the availability of therapeutics in the context of a public health emergency. To date, an evidentiary standard for clinical efficacy to support an EUA has not yet been established. This review examines the clinical data submitted in support of EUA for antiviral and anti-inflammatory therapeutics for coronavirus disease 2019 (COVID-19) through December of 2021 and the resilience of the authorization as new clinical data arose subsequent to the authorization. In the vast majority of cases, EUA was supported by at least one well-powered randomized controlled trial (RCT) where statistically significant efficacy was demonstrated. This included branded medications already approved for use outside of the context of COVID-19. When used, the standard of a single RCT seemed to provide adequate evidence of clinical efficacy, such that subsequent clinical studies generally supported or expanded the EUA of the therapeutic in question. The lone generic agent that was granted EUA (chloroquine/hydroxychloroquine) was not supported by a well-controlled RCT, and the EUA was withdrawn within 3 months time. This highlighted not only the ambiguity of the EUA standard, but also the need to provide avenues through which high quality clinical evidence for the efficacy of a generic medication could be obtained. Therefore, maintaining the clinical trial networks assembled during the COVID-19 pandemic could be a critical component of our preparation for future pandemics. Consideration could also be given to establishing a single successful RCT as regulatory guidance for obtaining an EUA.