Modern announced this weekend that the Food and Drug Administration approved its lowest COVID-19 vaccine for adults 65 years or older, as well as people aged 12 to 64 with at least one medical condition that increases its risk of severe COVID.
The FDA granted the approval, which is limited to people who previously received a Covid vaccine, on Friday granted on Friday.
Modern 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 begins in autumn. Modern is also updating its original vaccine to aim at the LP variant. 8.1 This fall. The company submitted an application in May for the FDA to approve the updated formula.
The newly approved vaccine, MNEXSPike, contains a fifth of the original Modern Covid vaccine dose, Spikevax. It is intended as an alternative for people who prefer a lower dose option, not as a replacement for existing COVID vaccines.
But young and healthy adults will not be eligible to receive it, despite their inclusion in the modern clinical trial.
The FDA imposed limitations similar to the NOVAVAX COVID vaccine when it approved the shot last month. But on Friday marks the first time that the FDA has a green vaccine from the Trump administration call for stricter restrictions on eligibility and vaccine approvals.
The FDA said last month that it would limit its approval of the updated covid shots that move forward to older adults and younger people with underlying medical conditions. The Secretary of Health and Human Services, Robert F. Kennedy Jr., also announced last week that the centers for disease control and prevention would no longer recommend COVID vaccines for healthy children and pregnant women. The CDC website seems to soften that recommendation, suggesting that parents can talk to a doctor about the vaccination of children 6 months or more.
The Trump administration also said that the new COVID vaccines must undergo clinical trials with an inert placebo, which means that some participants would receive the new vaccine, while others would receive an inactive substance as the saline solution, to compare the results.
Many new vaccines are tested with previous and approved versions, a method considered more ethical since using an inert placebo would mean retaining the benefit of a vaccine of the study participants.
The new modern vaccine was tested in this way, using what is known as an “active comparator.” In a test of around 11,400 participants from 12 years and older, the new vaccine generated higher antibodies levels than the company’s original covid, according to modern.
The company also said that the new vaccine had less local reactions, which generally include redness or swelling on the injection site. Systemic reactions, which may include fever, headaches or chills, were comparable between the shots.
The main side effects of MNEXSPike were injection pain, fatigue, headache and muscle pain, said modern in his press release.
