Moderna COVID Vaccine Approved: Lower Dose for Some
- the Food and Drug Management has approved Moderna's mNexspike, a lower-dose COVID-19 vaccine, for individuals 65 and older and those aged 12 to 64 who face a high...
- Moderna CEO Stéphane Bancel said the approval provides a crucial tool to protect those at high risk.He noted that COVID-19 remains a significant public health concern, causing over...
- The FDA's approval letter,dated May 30,specifies that mNexspike is for individuals who have previously received a COVID-19 vaccine and meet the age or risk criteria.
The FDA has greenlit Moderna’s mNexspike—a new, low-dose COVID-19 vaccine—specifically for adults 65 and older, plus those aged 12-64 at high risk. This strategic move, using the low-dose vaccine, directly addresses the latest guidelines, aiming to heighten protection where it’s needed most. The authorization comes after Moderna showcased strong clinical trial results, revealing higher efficacy in some groups compared to the original shot.The new vaccine—one-fifth the strength of the previous version—demonstrates similar safety, with an availability projection for later this year. The news, covered in News Directory 3, reflects a shift towards more targeted vaccination approaches. what are the next steps in combating the virus? Discover what’s next …
Moderna Low-Dose COVID Vaccine Approved for High-risk Groups
the Food and Drug Management has approved Moderna’s mNexspike, a lower-dose COVID-19 vaccine, for individuals 65 and older and those aged 12 to 64 who face a high risk of severe illness. This aligns with the agency’s updated guidelines for COVID-19 shots. The low-dose vaccine is one-fifth the size of Moderna’s original shot and is anticipated to be available this fall.
Moderna CEO Stéphane Bancel said the approval provides a crucial tool to protect those at high risk.He noted that COVID-19 remains a significant public health concern, causing over 47,000 American deaths last year. The company welcomed the FDA’s prompt review.
The FDA’s approval letter,dated May 30,specifies that mNexspike is for individuals who have previously received a COVID-19 vaccine and meet the age or risk criteria.
Moderna stated that the approval is based on phase 3 clinical trial data involving approximately 11,400 participants aged 12 and older. Results showed that a 10 µg dose of the new vaccine had a 9.3% higher relative efficacy than a 50 µg dose of Moderna’s original vaccine in people 12 and older. Among those 65 and older, the low-dose vaccine demonstrated a 13.5% higher relative efficacy.
The company reported a similar safety profile between the new and original vaccines, with fewer local reactions and a comparable number of systemic reactions. Common side effects included injection site pain, fatigue, headache, and muscle pain.
this action mirrors the FDA’s recent restrictions on Novavax’s COVID-19 vaccine, limiting it to similar groups. The FDA has indicated that future COVID-19 vaccines will be restricted based on age and risk factors, moving away from universal recommendations.
The Department of Health and Human Services also announced that the Centers for Disease Control and Prevention will cease recommending COVID-19 shots for healthy children and pregnant women, instead suggesting decisions be made in consultation with a doctor.
In May, the FDA’s advisory committee recommended that COVID-19 vaccines for the 2025-2026 season target viral variants descended from the JN.1 sublineage, including the predominant LP.8.1 strain.
Moderna has submitted its LP.8.1-focused vaccine formulation to the FDA for approval and anticipates the newly approved COVID-19 vaccine to be available this fall.