FDA Licenses Moderna’s mNEXSPIKE COVID Shot for Individuals at High Risk for Severe COVID Disease
On May 30, 2025, the U.S. Food and Drug Administration (FDA) licensed mNEXSPIKE (mRNA-1283), a newly developed mRNA COVID-19 biologic for individuals who have previously received any COVID shots and are either 65 years of age or older, or between 12 and 64 years old with at least one underlying medical condition that increases their […]
Moderna Withdraws Application for Combination COVID and Flu Vaccine
Moderna, Inc. withdrew its application for United States licensure for its combination COVID-19/Influenza vaccine known as mRNA-1083. The company stated the decision came “in consultation with” the U.S. Food and Drug Administration (FDA).1 The decision came just one day after the FDA announced the agency would require new clinical trials for approval of annual COVID […]
Meningitis B Vaccine to Be Used for Gonorrhea in England
In August 2025, England will become the first country to offer a vaccine for gonorrhea after cases exceed 85,000 in 2023—the highest gonorrhea levels since recordkeeping began in 1918. The program, offered through the United Kingdom’s National Health Service (NHS), will repurpose the meningitis B vaccine, routinely given to infants, in an attempt to reduce […]
FDA Approves Novavax’s COVID-19 Vaccine With Restrictions
On May 16, 2025, the U.S. Food and Drug Administration (FDA) approved licensure of Novavax, Inc.’s Nuvaxovid protein-based COVID-19 vaccine, which has been available in the United States under Emergency Use Authorization (EUA) since July 2022.1 The decision for a full licensure was postponed while the new agency leadership under the current administration conducted a […]
“Universal Flu Vaccine” Unveiled by DHHS
On May 1, 2025, the U.S. Department of Health and Human Services (DHHS) announced plans to develop a universal influenza vaccine that would eliminate the need for annual flu shots and offer protection against other pandemic influenza threats, including bird flu and respiratory disease caused by coronaviruses. The initiative, called “Generation Gold Standard,” will cost […]
U.S. Government Expands Mpox Vaccine Stockpile With $144 Million Order for Freeze-Dried Jynneos
The U.S. government is bolstering its emergency vaccine reserves with a $144 million purchase of a freeze-dried version of the Jynneos vaccine, designed to protect against both mpox (also known as monkeypox) and smallpox. Danish pharmaceutical company Bavarian Nordic A/S, the vaccine’s manufacturer, announced it will begin production and supply in 2026.1 2 Freeze-Dried Vaccine […]