Restricting the recommended use of COVID-19 vaccines in the U.S. wasn’t enough. Now the Children’s Health Defense (CHD) is trying to get the FDA to revoke the BLAs for all versions of the Moderna Inc. and Pfizer Inc.-Biontech SE COVID-19 vaccines.

In 2025, the biopharma industry has undergone a wave of workforce reductions that surpasses previous years’ trends. Multiple major pharma companies have announced sizeable job cuts, driven by a convergence of shifting regulatory terrain, vaccine slowdowns and cost-structure rationalization.

Moderna Inc. stopped its efforts to develop mRNA-1647 as a vaccine for preventing congenital cytomegalovirus infection, the most common infectious cause of birth defects in the U.S. The pivotal and placebo-controlled phase III CMVictory study of mRNA-1647 missed the primary efficacy endpoint, which was preventing the infection in seronegative females ages 16 to 40.

While U.S. policymakers are scaling back funding on mRNA vaccine research, Australia is accelerating investment in the technology. At the center of this effort is Moderna Inc., which is establishing an mRNA research and manufacturing footprint in the country and banking on decades of local expertise to bring new therapies to the clinic and serve as a regional hub for Asia Pacific.

The second day’s meeting of the U.S. CDC’s Advisory Committee for Immunization Practices (ACIP) took up guidelines related to COVID-19 vaccines, of which an outspoken skeptic is Health and Human Services Secretary Robert Kennedy – who in June fired all 17 members of ACIP and replaced them with names more to his liking.

The second day’s meeting of the U.S. CDC’s Advisory Committee for Immunization Practices (ACIP) took up guidelines related to COVID-19 vaccines, of which an outspoken skeptic is Health and Human Services Secretary Robert Kennedy – who in June fired all 17 members of ACIP and replaced them with names more to his liking.

South Korea’s Ministry of Food and Drug Safety approved Moderna Inc.’s Spikevax LP.8.1 vaccine as an updated shot for COVID-19 targeting the LP.8.1 variant, according to Moderna Korea’s announcement Sept. 1. The regulatory clearance comes days after the U.S. FDA accepted, on Aug. 27, Moderna’s supplemental BLAs for two of its COVID-19 vaccines, Spikevax and Mnexspike.

Partly focused on delivery challenges that have limited the reach of RNA medicines, new biotech company Axelyf Inc. closed a $2.6 million seed round to support development of its AXL technology and to advance lead autoimmune candidate AXL-003.

Partly focused on delivery challenges that have limited the reach of RNA medicines, new biotech company Axelyf Inc. closed a $2.6 million seed round to support development of its AXL technology and to advance lead autoimmune candidate AXL-003.