Editor's Note The Food and Drug Administration (FDA) on September 22 amended the emergency use authorization (EUA) for Pfizer-BioNTech’s COVID-19 vaccine to allow for use of a single booster to be administered at least 6 months after completion of the primary series in those: 65 years of age and older…

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Editor's Note The Food and Drug Administration (FDA), on September 20, identified Medtronic’s recall of its Pipeline Flex Embolization Device and Pipeline Flex Embolization Device with Shield Technology as Class I, the most serious. The devices, which are used to treat brain aneurysms, were recalled because there is a risk…

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Editor's Note In this study, Centers for Disease Control and Prevention (CDC) researchers report on the comparative effectiveness of COVID-19 vaccines against hospitalization of US adults without immunocompromised conditions. Included in the case-control analysis were 3,689 adults aged 18 years and older who were hospitalized at 21 US hospitals between…

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Editor's Note The Food and Drug Administration’s (FDA’s) Vaccines and Related Biological Products Advisory Committee on September 17 voted that there was not enough safety and effectiveness data to approve a third Pfizer COVID-19 vaccine dose for those 16 years and older. The committee did vote to recommend approval of…

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Editor's Note The Food and Drug Administration (FDA) on September 15 identified the recall of Smiths Medical Normoflo irrigation fluid warmers and warming sets as Class I, the most serious. The recall was initiated because of the potential for aluminum ions leaching into warmed fluids, potentially exposing patients to high…

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Editor's Note A new study from the Centers for Disease Control and Prevention (CDC) finds that more than 83% of Americans had COVID-19 antibodies before the surge of the Delta variant began. Researchers examined data from 1,443,519 blood donation specimens obtained before the Delta variant. Overall infection-induced COVID-19 antibodies increased…

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Editor's Note An Axios-Ipsos poll published August 31 finds that COVID-19 vaccine hesitancy may be waning. Among the findings: 20% are not likely at all or not very likely to receive a COVID-19 vaccine, down from 23% 2 weeks ago and 34% in March 68% with K-12 children have either…

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Editors Note The Food and Drug Administration (FDA) on August 23 identified the recall by Cardinal Health of its Monoject Saline Flush Prefilled Syringes as Class I, the most serious. Cardinal Health is recalling three models of the syringes because the syringe plunger may pull air into the syringe after…

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Editor's Note On August 23, the American Nurses Association (ANA), American Medical Association (AMA), and American Hospital Association (AHA) released a joint statement commending the Food and Drug Administration’s (FDA’s) full approval of the Pfizer-BioNTech COVID-19 vaccine. The approval marks an important moment for those concerned about getting vaccinated because…

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Editor's Note The Food and Drug Administration on August 23 announced that it had approved the first COVID-19 vaccine, known as Pfizer-BioNTech. The vaccine will now be marketed as Comirnaty, for the prevention of COVID-19 in those 16 years of age and older. The vaccine will continue to be available…

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