The Food and Drug Administration has given the green light to a new, lower-dose Covid-19 vaccine from Moderna. This vaccine is specifically for adults aged 65 and older, as well as those between 12 and 64 who have health conditions that put them at higher risk for severe Covid-19. It is important to note that this approval is limited to individuals who have already received a Covid-19 vaccine.

This new vaccine, named mNEXSPIKE, is not a replacement for existing Covid-19 vaccines. It contains just one-fifth of the dose found in Moderna's original vaccine, Spikevax. The goal is to provide an alternative for those who prefer a lower-dose option. However, young, healthy adults will not be eligible to receive it, even though they were included in Moderna's clinical trials.

The FDA's decision comes after Moderna submitted an application in May for the updated formula, which targets the LP. 8. 1 variant. This new vaccine is expected to be available in the U. S. in time for the 2025-26 respiratory virus season, which begins in the fall. The FDA has also imposed similar limitations on Novavax's Covid-19 vaccine, which was approved last month. This marks the first time the FDA has approved a vaccine since the Trump administration called for stricter restrictions on vaccine eligibility and approvals.

The FDA has stated that it will limit its approval of updated Covid-19 shots to older adults and younger people with underlying medical conditions. Health and Human Services Secretary Robert F. Kennedy Jr. announced that the Centers for Disease Control and Prevention would no longer recommend Covid-19 vaccines for healthy children and pregnant women. However, the CDC website suggests that parents can consult with a doctor about vaccinating children aged 6 months and older.

Moderna's new vaccine underwent clinical trials with an active comparator, which means it was tested against the company's original Covid-19 shot, rather than an inert placebo. This method is considered more ethical because it does not withhold the benefit of a vaccine from study participants. In a trial of around 11, 400 participants aged 12 and up, the new vaccine generated higher antibody levels than the original shot. It also had fewer local reactions, such as redness or swelling at the injection site. Systemic reactions, like fever, headaches, or chills, were comparable between the two shots. The main side effects of mNEXSPIKE were injection site pain, fatigue, headache, and muscle pain.

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