New 2024-2025 formulations of the mRNA COVID-19 vaccines manufactured by Pfizer/BioNTech (Comirnaty) and Moderna (Spikevax) that more closely target currently circulating variants have been licensed by the FDA for persons ≥12 years old and made available under FDA Emergency Use Authorizations (EUAs) for use in persons 6 months to 11 years old.1-3 A 2024-2025 formulation of the adjuvanted protein subunit COVID-19 vaccine manufactured by Novavax is expected to become available soon for persons ≥12 years old.

The FDA has approved anthrax vaccine adsorbed (AVA; BioThrax – Emergent BioSolutions) for prevention of anthrax disease in adults following exposure to Bacillus anthracis and intravenous anthrax immune globulin (Anthrasil – Emergent BioSolutions) for treatment of inhalation anthrax in adults and children. AVA has been available since 1970 for prevention of anthrax disease in persons at high risk of exposure.

The IV antiviral drug remdesivir (Veklury – Gilead) has been available for treatment of COVID-19 in hospitalized patients since 2020. Now, the FDA has approved remdesivir for treatment of mild to moderate COVID-19 in outpatients ≥12 years old who weigh ≥40 kg and are at high risk for progression to severe disease, including hospitalization or death; they also issued an Emergency Use Authorization (EUA) allowing its use in any other high-risk outpatient who weighs ≥3.5 kg.

The FDA has approved a subcutaneously administered 20% solution of human immune globulin (Cuvitru – Shire) for replacement therapy in patients ≥2 years old with a primary humoral immunodeficiency. Hizentra (CSL Behring), another subcutaneously administered 20% immune globulin solution, was approved in 2010 for the same indication. The IgG component of Cuvitru is similar to that of Gammagard Liquid and HyQvia, two subcutaneously administered 10% immune globulin formulations also manufactured by Shire and approved for treatment of primary...

An outbreak of mumps has occurred among students at Fordham University in New York. All of those who developed mumps had been vaccinated against the disease.

The FDA has expanded its Emergency Use Authorizations (EUAs) for the COVID-19 vaccines manufactured by Pfizer/BioNTech (Comirnaty) and Moderna (Spikevax) to permit use of the bivalent formulations of these products (containing mRNA from the original and BA.4/5 Omicron strains of SARS-CoV-2) as a booster dose in children as young as 5 years old (Pfizer) or 6 years old (Moderna). The bivalent Pfizer vaccine had previously been authorized for use in persons ≥12 years old and the bivalent Moderna vaccine in persons ≥18 years old. Bivalent vaccines are not authorized for...

On May 10, 2021, the FDA expanded its Emergency Use Authorization (EUA) for the Pfizer/BioNTech mRNA-based COVID-19 vaccine to include adolescents 12-15 years old.1The vaccine has been authorized for use in persons ≥16 years old since December 2020.

Rimantadine hydrochloride (Flumadine - Forest), the alpha-methyl derivative of amantadine (Symmetrel, and others), was recently approved by the US Food and Drug Administration for prevention and treatment of influenza A virus infections in adults and for prevention of influenza in children.

The FDA has expanded its Emergency Use Authorizations (EUAs) for the COVID-19 vaccines manufactured by Pfizer/BioNTech (Comirnaty) and Moderna (Spikevax) to permit use of the bivalent formulations of these products (containing mRNA from the original and BA.4/5 Omicron strains of SARS-CoV-2) in children as young as 6 months. The bivalent Pfizer vaccine is authorized for use as the final dose of a 3-dose primary series in children 6 months to 4 years old. The bivalent Moderna vaccine is authorized for use as a booster dose in children 6 months to 5 years old who completed a primary...

The FDA has expanded the Emergency Use Authorizations (EUAs) for the mRNA COVID-19 vaccines manufactured by Pfizer-BioNTech (Comirnaty) and Moderna (Spikevax) to allow for their use as a second booster dose ≥4 months after a first booster dose in adults ≥50 years old and in persons aged ≥12 years (Pfizer) or ≥18 years (Moderna) who have undergone solid organ transplantation or have a condition that compromises the immune system to a similar extent.