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.
The U.S. Department of Health and Human Services reported Aug. 27 that Susan Monarez no longer occupies the post of director for the CDC, a development that arose within hours of the FDA’s approval of two COVID-19 vaccines with historically restrictive labeled indications.
For more than 30 years, the U.S. CDC’s Advisory Committee for Immunization Practices (ACIP) and the American Academy of Pediatrics (AAP) worked together to harmonize their evidence-based vaccine schedules. Not anymore.
Korea Disease Control and Prevention Agency (KDCA) secured 5.3 million doses of COVID-19 vaccines made by Pfizer Inc./Biontech SE and Moderna Inc., officially including the mRNA-based vaccines in the country’s national immunization program on Aug. 5.
The other shoe dropped on the U.S. CDC’s Advisory Committee for Immunization Practices (ACIP) when at least nine liaison organizations were informed by email late July 31 that they would no longer be involved in ACIP’s process of reviewing scientific evidence and informing vaccine recommendations.
The news that Vinay Prasad has stepped down as CBER director at the U.S. FDA had some biotech stocks literally jumping in joy as the market opened July 30. Meanwhile, Prasad’s decisions regarding vaccine development, as well as actions by Makary and HHS Secretary Robert Kennedy, are coming under fire.
It’s not surprising that, of all the recommendations the U.S. CDC’s vaccine advisory board made at its June meeting, the first one Health and Human Services Secretary Robert Kennedy signed off on would essentially remove thimerosal from influenza vaccines in the U.S. What is surprising is the time it took for him to do so, given his long-held position on the preservative used in multidose vials and his insistence that a thimerosal presentation and vote be added to the agenda.
With the June 9 U.S. Senate Health, Education, Labor and Pensions (HELP) Committee party-line vote of 12-11, Susan Monarez’s nomination is headed to the Senate floor where she could become the first CDC director to go through the confirmation process. That’s thanks to a provision in the bipartisan PREVENT Pandemics Act that was signed into law in 2022.
Led by the American Academy of Pediatrics, several medical groups went to court July 7 to force Health and Human Services Secretary Robert Kennedy to restore the CDC’s COVID-19 vaccine recommendations for pregnant women and healthy children ages 6 months to 17 years.
With no U.S. CDC director in place yet, Health and Human Services Secretary Robert Kennedy recently adopted two vaccine recommendations from the April meeting of the Advisory Committee for Immunization Practices (ACIP), making them official CDC recommendations and ensuring coverage of the vaccines for the specified populations.
