CDC Advisors Support Updated COVID Shots for All
The CDC’s Advisory Committee on Immunization Practices (ACIP) voted 13 to 1 in favor of recommending updated, monovalent, XBB-targeting COVID-19 shots for everyone age 6 months and up. Specifically, the language in the recommendation supports the “2023-2024” vaccines as authorized or approved by the FDA — in order to cover the recently green-lighted mRNA shots, […]
CDC Advisors Back Therapeutic to Prevent RSV in Infants
The CDC’s Advisory Committee on Immunization Practices (ACIP) voted unanimously — 10 to 0 — in favor of nirsevimab (Beyfortus) for protecting a wide swath of at-risk infants from respiratory syncytial virus (RSV). At a meeting on Thursday, ACIP recommended that all infants younger than 8 months who are born during or approaching their first […]
ACIP Endorses 20-Valent Pneumococcal Vaccine for Kids
The CDC’s Advisory Committee on Immunization Practices (ACIP) agreed unanimously on Thursday to include the 20-valent pneumococcal conjugate vaccine (PCV20; Prevnar) as an option for U.S. children. All 14 members voted in favor of the following four proposals: Routine use in children ages 2-23 months: ACIP recommended either the 15-valent PCV (PCV15; Vaxneuvance) or PCV20, […]
FDA Panel Endorses mAb to Prevent RSV in Infants
An FDA advisory committee on Thursday gave strong backing to a monoclonal antibody against respiratory syncytial virus (RSV) to prevent lower respiratory tract disease (LRTD) in infants as well as in at-risk children up to 24 months of age. In a unanimous vote, all 21 members of the Antimicrobial Drugs Advisory Committee agreed that the […]
Antibody for Infant RSV Prevention to Face FDA Panel
An FDA advisory committee on Thursday will consider whether to recommend a shot of a monoclonal antibody against respiratory syncytial virus (RSV) to prevent lower respiratory tract disease in both infants and in at-risk children up to age 2 years. The Antimicrobial Drugs Advisory Committee will examine a biologics license application approval for nirsevimab, a […]
Thumbs Down From FDA Panel on Plastic Meniscus Replacement
An FDA advisory committee voted 6-2, with one absention, that a novel, synthetic knee meniscus replacement’s benefits do not outweigh its risks, and thus is not suitable for marketing. Members of the Orthopaedic and Rehabilitation Devices Panel of the FDA’s Medical Devices Advisory Committee said the efficacy data were too weak, and a nearly 50% […]
Do Away With ‘Lockout’ Period in iPLEDGE, FDA Advisors Urge
An FDA advisory committee on Wednesday voted 17-4 (with one abstention) to recommend removing a “lockout period” from a risk evaluation and mitigation strategy (REMS) for isotretinoin prescribing that requires patients to wait an extra 19 days — and take an additional pregnancy test — if they miss a 7-day window for picking up their […]
Proposed User Instructions for OTC Narcan Has FDA Concerned
Ahead of an advisory committee meeting, FDA staff highlighted ongoing concerns about labeling for what could possibly be the first naloxone (Narcan) product approved for over-the-counter (OTC) use, labeling it “essential” in the emergency setting of an overdose. At a joint meeting of the Nonprescription Drug Advisory Committee and Anesthetic and Analgesic Drug Products Advisory […]
Thumbs Down for Genetic Test for Opioid Use Disorder, FDA Advisors Say
An FDA advisory committee on Thursday voted strongly against AvertD, a prescription genetic risk assessment tool for opioid use disorder (OUD). In an 11-2 decision, the Clinical Chemistry and Clinical Toxicology Devices Advisory Committee said the probable benefits of the AvertD device did not outweigh its probable risks, taking into account risks and benefits of […]
Genetic Testing for Opioid Use Disorder Heads to FDA Advisors
On Thursday, members of the FDA’s Clinical Chemistry and Clinical Toxicology Devices Advisory Committee will meet to discuss AvertD, a prescription genetic risk assessment tool for opioid use disorder (OUD). AvertD detects the presence or absence of 15 single nucleotide polymorphisms (SNPs) to help identify adults with an increased genetic risk of OUD. It’s intended […]