FDA approves Moderna's next-generation COVID-19 vaccine: Here's what makes it different
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.
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