The FDA has expanded its Emergency Use Authorization for the adjuvanted protein subunit COVID-19 vaccine manufactured by Novavax to include use of the vaccine as a two-dose primary series in adolescents 12-17 years old. The vaccine was authorized for primary immunization of adults in July 2022.

The possibility that use of mifepristone (Mifeprex, and generics) may be restricted has led to questions about alternatives for medication abortion.

Recombinant interferon alfa-2b (Intron A - Schering) was recently approved by the US Food and Drug Administration (FDA) for intralesional treatment of genital warts (condylomata acuminata). Interferon was previously available only for treatment of hairy-cell leukemia (Medical Letter, 28:78, 1986).

Since the last Medical Letter article on this subject (volume 25, page 54, 1983), transplantation of various organs has become routine, but problems of supply and demand have persisted. The United Network for Organ Sharing (UNOS), which has contracted with the federal government to maintain a list of patients waiting for transplantation and a registry of patients who have received an organ, reports that 18,251 patients received an organ transplant in 1994, and as of June 1995 more than 40,000 patients were waiting for one.

The FDA has licensed MenQuadfi (Sanofi Pasteur), a quadrivalent polysaccharide conjugate vaccine that uses tetanus toxoid as a protein carrier, for prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W, and Y (MenACWY) in persons ≥2 years old.

Two recombinant vaccines, Arexvy (GSK) and Abrysvo (Pfizer), have been approved by the FDA for prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in adults ≥60 years old. They are the first RSV vaccines to be approved in the US. Abrysvo is also approved for use in pregnant women at 32-36 weeks' gestation to prevent LRTD caused by RSV in their infants from birth through 6 months of age.

An advertisement in a recent issue of Ophthalmology introduces PreserVision Eye Vitamin AREDS 2 Formula from Bausch & Lomb. No specific indication is mentioned, but the ad states that “…[the new product] builds on the original PreserVision Eye Vitamin AREDS Formula, the only formula proven to slow the progression of moderate-to-advanced AMD.”

Fungal infections of the fingernails or toenails can persist for months or years despite topical and systemic antimicrobial therapy. The FDA has cleared several short-pulse laser systems for treatment of this mainly cosmetic disorder.

The FDA has approved the MiniMed 530G (Medtronic), an insulin pump used in combination with a continuous glucose monitoring sensor (Enlite) that can stop delivery of insulin when interstitial glucose reaches a prespecified low level. It is the only sensoraugmented insulin pump available in the US with this capability.

The American College of Obstetricians and Gynecologists (ACOG) and the US Preventive Services Task Force (USPSTF) have recommended that women at risk for preeclampsia take low-dose aspirin daily after the first trimester.