Moderna announced this weekend that Food and Drug Administration approved its COVVI-19 low-dose vaccine for adults 65 and over, as well as people aged 12 to 64 with at least one medical condition that increases their severe covid risk.
The approval, which is limited to people who have already received a cocovated vaccine, were granted on Friday by the FDA.
Moderna said in a press release on Saturday That the new vaccine should be available in the United States on time for the 2025-26 respiratory virus season, which is starting in the fall. Moderna is also Update of its original vaccine To target the LP.8.1 variant this fall. Business submitted a request in May For the FDA to approve the updated formula.
The newly approved vaccine, MNEXSPIKE, contains a fifth of the Moderna, Spikevax cocodid vaccine dose. It is intended for an alternative for people who prefer a lower dose option, and not to replace existing COVIVS vaccines.
But young healthy adults will not be eligible to receive it, despite their inclusion in Moderna's clinical trial.
The FDA imposed similar limitations on the cocvid vaccine of Novavax when it approved the shot last month. But Friday marks the first time that the FDA has an enlightened Green vaccine since the Trump administration’s call to more strict restrictions on eligibility and approvals to the vaccine.
The FDA said last month that it would limit its approval of the updated coastal plans to move forward to older adults and young people with underlying medical conditions. The Secretary of Health and Social Services, Robert F. Kennedy Jr., also announced last week that the centers for Disease Control and Prevention would no longer recommend vaccines wearing for healthy children and pregnant women. The CDC website seems to soften this recommendation, suggesting that parents can speak with a child with children's vaccination of 6 months and more.
The Trump administration has also said that new coids vaccines should undergo clinical trials with an inert placebo – which means that some participants would receive the new vaccine while others would receive an inactive substance like the saline solution, to compare the results.
Many new vaccines are tested against older and approved versions, a method considered to be more ethical because the use of an inert placebo would mean retaining the benefit of a vaccine against study participants.
The new Moderna vaccine has been tested in this way, using what is known as an “active comparator”. In a trial of approximately 11,400 participants aged 12 and over, the new vaccine has generated higher antibody levels than the firing of the company of the company, according to Moderna.
The company also said that the new vaccine had fewer local reactions, which generally include redness or swelling on the injection site. Systemic reactions, which may include fever, headache or chills, were comparable between shots.
Mnexpike's main side effects were pain, fatigue, headache and muscle pain, Moderna said in her press release.
