Moderna announced this weekend that the U.S. Food and Drug Administration (FDA) has granted approval for its lower-dose COVID-19 vaccine, mNEXSPIKE. This approval is specifically for adults aged 65 and older, as well as individuals between 12 and 64 who have at least one medical condition that elevates their risk of severe COVID-19.
The FDA’s decision, made on Friday, applies only to individuals who have previously received a COVID-19 vaccine. Moderna stated in a press release on Saturday that the new vaccine is expected to be available in the U.S. in time for the 2025-26 respiratory virus season, which commences in the fall. Additionally, Moderna is updating its original vaccine formula to target the LP.8.1 variant, with an application for FDA approval submitted in May.
The newly approved mNEXSPIKE vaccine contains one-fifth of the dosage found in Moderna’s original Spikevax COVID-19 vaccine. It is designed as an alternative for individuals who prefer a lower-dose option and is not intended to replace existing COVID-19 vaccines. Notably, healthy adults under the age of 65 will not be eligible to receive this lower-dose vaccine, despite their participation in Moderna’s clinical trials.
This approval follows similar limitations imposed by the FDA on Novavax’s COVID-19 vaccine last month. However, Moderna’s approval marks the first vaccine authorization since the Trump administration reportedly called for stricter criteria regarding vaccine eligibility and approvals.
The FDA announced last month its intention to limit future approvals of updated COVID-19 shots to older adults and younger individuals with underlying health conditions. Furthermore, Health and Human Services Secretary Robert F. Kennedy Jr. indicated last week that the Centers for Disease Control and Prevention (CDC) would no longer recommend COVID-19 vaccines for healthy children and pregnant women. However, the CDC website appears to present a more nuanced recommendation, suggesting that parents can discuss COVID-19 vaccination for children aged six months and older with a healthcare provider.
The Trump administration has also stated that new COVID-19 vaccines must undergo clinical trials using an inert placebo, where some participants receive the vaccine and others receive an inactive substance like saline for comparison. This contrasts with the practice of testing many new vaccines against older, already-approved versions, a method often considered more ethical as it does not withhold potential benefits from study participants.
Moderna’s mNEXSPIKE vaccine was tested using an “active comparator,” meaning it was compared against the company’s original COVID-19 vaccine. In a trial involving approximately 11,400 participants aged 12 and older, the new lower-dose vaccine demonstrated higher antibody levels than the original shot, according to Moderna. The company also reported fewer local reactions, such as redness or swelling at the injection site, with the new vaccine, while systemic reactions like fever, headaches, or chills were comparable between the two shots. Moderna stated that the main side effects of mNEXSPIKE were injection site pain, fatigue, headache, and muscle pain.
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