CHENNAI: The US Food and Drug Administration (FDA) on Saturday officially approved Moderna’s next-generation COVID-19 vaccine for use in key high-risk populations. This marks the first FDA endorsement of a COVID-19 vaccine since the agency revised its regulatory guidelines to tighten standards for safety and efficacy reviews.
The US drug regulator had recently announced that it will limit the use of the COVID-19 vaccine to certain groups. This follows updated guidance from the Centers for Disease Control and Prevention (CDC)—the agency responsible for monitoring disease trends and vaccine safety—which no longer recommends the vaccine for several categories of individuals, including pregnant people and healthy children.
According to an FDA note reviewed by The New Indian Express, the vaccine is approved for Adults aged 65 and older — blanket approval for all individuals in this age group, Individuals aged 12 to 64 with underlying risk factors — approval applies to those who have at least one or more underlying health conditions, including chronic respiratory conditions such as asthma, COPD, cardiovascular disease, diabetes and obesity.
The vaccine is also approved for use in individuals below 65 years old if they are in immunocompromised states like cancer and undergoing cancer treatment.
Why Next-Generation Vaccine
This vaccine is designed using an updated mRNA platform aimed at offering broader protection against currently circulating SARS-CoV-2 variants. The vaccine formulation includes enhanced stability, improved immune response targeting, and better protection duration over previous iterations.
Its virus variant-adapted composition targets dominant sublineages of the Omicron variant. The FDA also state that the new vaccine has a reduced side-effect profile compared to earlier versions. And, a single-dose regimen is recommended for previously vaccinated individuals.
Regulatory Background
This approval follows the FDA’s updated review framework established in early 2025, which introduced more stringent requirements for COVID-19 vaccine modifications, particularly around proven or demonstrated efficacy against new variants.
The FDA has also reviewed it considering strong real-world evidence of benefit for high-risk groups and reinforced post-market safety surveillance.
Moderna had submitted Phase 3 data (final human trial) earlier this year showing strong neutralising antibody responses and a favorable safety profile in both seniors and individuals with comorbidities.
Public Health Implications
According to medical experts, this approval is a key milestone in the ongoing COVID-19 mitigation strategy in the US, particularly for vulnerable populations. As community transmission continues to fluctuate, ensuring protection for high-risk individuals remains a public health priority.
However, the CDC is expected to issue formal recommendations regarding rollout logistics and prioritisation in the coming days.
Moderna had in a statement on Saturday said that following the FDA approval, that it remain committed to protecting the most vulnerable populations. "This milestone reflects the strong efficacy and safety data behind our updated platform and reaffirms our role in fighting COVID-19 as it evolves,” it said.
The US vaccine maker also said it is coordinating with federal and state agencies to begin immediate distribution to authorised providers and pharmacies, and the individuals in the approved categories are advised to consult their healthcare provider for eligibility and availability.
Impact in India
As India braces for a potential new epidemic due to the rising number of cases detected across several regions, next-generation vaccines could be particularly relevant in terms of their safety profiles and effectiveness against emerging virus variants.