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 […]
‘All New Vaccines’ in the U.S. to Undergo Placebo-Controlled Safety Testing
On Apr. 30, 2025, the U.S. Department of Health and Human Services (DHHS) announced that all newly developed vaccines will now be required to undergo placebo-controlled clinical trials before being licensed by the U.S. Food and Drug Administration (FDA). This landmark policy shift comes after years of advocacy from consumer organizations critical of vaccine safety […]
Study Shows Pfizer COVID Shot Has 37 Percent Higher Risk of Mortality Than Moderna Shot
According to a new study, adults who received the Pfizer Comirnaty COVID-19 shot were more likely to die than adults who had the Moderna Spikevax COVID-19 shot. The study looked at 9.2 million adults living in Florida who received either Comirnaty or Spikevax within six weeks, from December 2020 through January 2021. Half of the […]
FDA, CDC Halt Use of Chikungunya Vaccine in Adults 60+ After Two Deaths Reported
On May 9, 2025, the U.S. Food and Drug Administration (FDA) and the U.S. Centers for Disease Control and Prevention (CDC) recommended a temporary pause in the use of Ixchiq, a live virus vaccine designed to prevent chikungunya virus infection, in adults aged 60 years and older. The recommendation follows reports of serious post-marketing adverse […]