FDA Allows Extra Doses of Bivalent COVID Vax for Immunocompromised Tots
The FDA has authorized additional doses of Pfizer/BioNTech’s bivalent COVID-19 vaccine for young immunocompromised children, the agency announced on Friday. In kids ages 6 months to 4 years with certain types of immunocompromising conditions (i.e., solid-organ transplant recipients, or those considered to have a similar level of immunocompromise), and who previously received three primary 0.2-mL […]
FDA Authorizes First At-Home Test That Can Detect Flu And COVID-19
The Food and Drug Administration (FDA) authorized the first over-the-counter at-home test to detect and differentiate influenza (commonly known as the flu) and COVID-19. The test, made by California-based Lucira Health, works similarly to standard at-home COVID tests where users swirl a self-collected nasal swab in a vial and place it in a test unit. […]
FDA Authorizes At-Home Test for Both Flu and COVID
The FDA has authorized the first over-the-counter (OTC) home test to detect both influenza A and B and COVID-19, the agency announced Friday. The Lucira COVID-19 & Flu Test is a single-use at-home test kit that provides results in about 30 minutes. The test is designed for those with symptoms of a respiratory tract infection. […]
CDC: Bivalent COVID Vaccines Stop Illness From XBB.1.5
Currently authorized bivalent COVID-19 boosters demonstrated similar protection against symptomatic illness from the XBB/XBB.1.5 Omicron subvariants as from BA.5-related subvariants, according to a CDC study. From December 2022 to January 2023, the bivalent boosters’ vaccine effectiveness (VE) against symptomatic infection was a similar 48% versus XBB/XBB.1.5-related strains and 52% versus BA.5-related sublineages, reported Ruth Link-Gelles, […]
Hopeful Dads Can Relax About COVID Vax: No Link to Infertility
Researchers of a recent study looking at whether the authorized COVID-19 vaccines harm male fertility were deluged with hundreds of emails from freaked-out men and their worried partners leading up to publication. Now, the findings from 45 vaccinated men are in: none showed any significant signs of lower sperm counts after getting their shots. It’s […]
FDA Authorizes One More Dose of Pfizer’s COVID Vaccine for Some
A third dose of Pfizer’s COVID-19 vaccine (Comirnaty) was authorized for use in older adults and high-risk populations, the FDA announced late on Wednesday. The agency amended Pfizer’s emergency use authorization (EUA) for the vaccine to include a third dose at least 6 months following the primary series in adults 65 and older, adults ages […]
Clearing the Hurdles to Safe Injection Facilities
Rhode Island authorized the first ever safe injection facilities (SIFs) or “harm reduction centers” in the U.S. last week, but many states still face an uphill battle to opening their own sites. The bill calls for launching a two-year pilot program which would permit harm reduction centers or SIFs to serve as a community resource, […]
FDA Authorizes IL-6 Inhibitor for Severe COVID-19 Patients
Tocilizumab (Actemra), an interleukin-6 (IL-6) inhibitor, was authorized to treat certain hospitalized COVID-19 patients, the FDA announced late on Thursday. The drug received emergency use authorization (EUA) for hospitalized patients ages 2 and up who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). It is […]