FDA Committee Supports Janssen COVID-19 Vaccine Booster
The panel reviewed safety and efficacy data from the phase 3 ENSEMBLE 2 study.
COVID19
Convalescent Plasma Unlikely to Improve Outcomes in Severe COVID-19
Likelihood of improvement in organ support-free days low in critically ill adults with COVID-19 receiving convalescent plasma
COVID-19 Infection Risk Drops With Increasing Immunity Within Family
Risk for COVID-19 infection progressively lower for nonimmune family members as number of family members with immunity increases
MPR Weekly Dose Podcast Episode 96
This week the USPSTF update aspirin recommendations for those 60 years and older; The FDA take a stance on needle-free devices for injecting dermal fillers; REMS requirements are updated for isotretinoin products; A new treatment is approved for pediatric congenital athymia; An Emergency Use request is submitted for an oral antiviral COVID treatment; And the FDA advisory panel vote on boosters for the Moderna vaccine.
FDA Panel Votes in Favor of Moderna COVID-19 Vaccine Booster for Certain Groups
The need for a booster dose was prompted by real-world data suggesting waning protection, particularly against variants of concern, approximately 6 months after receipt of the primary series.
REGEN-COV Gets Priority Review for COVID-19 Treatment, Prophylaxis
The BLA submission is supported by data from two phase 3 trials that included more than 6000 patients.
Myocarditis Reported After BNT162b2 Vaccination in Israel
Estimated incidence highest among males 16 to 29 years; second study shows highest standardized incidence ratio for males 16 to 19 years
Emergency Use Request Submitted for Molnupiravir for Mild to Moderate COVID-19
The submission is based on data from the phase 3 MOVe-OUT trial, which evaluated molnupiravir in 775 nonhospitalized adults with mild to moderate COVID-19.
Protection Against SARS-CoV-2 Wanes Months After BNT162b2 Vaccination
Declines seen in humoral responses, effectiveness against SARS-CoV-2 infection, within several months after the second dose
Glucose-Regulating Drugs Aid COVID-19 Outcomes in Patients With Diabetes
Findings include GLP-1R agonists and pioglitazone use, with drop in hospital admissions
