FDA Reverses Decision and Agrees To Review Moderna's Flu Vaccine
Source: Slashdot
Overview
The Food and Drug Administration has reversed its earlier decision on Moderna’s flu vaccine and agreed to review it for possible approval, Moderna announced on Wednesday.
Application Details
Moderna split its application for the flu vaccine by age groups:
- Traditional approval for people aged 50 to 64 years.
- Accelerated approval for those 65 years and older.
The company also committed to conducting an additional study among the 65‑plus group once the vaccine reaches the market.
Regulatory Timeline
- The FDA set a deadline of August to decide whether to approve the vaccine.
- If authorized, the vaccine would become available to older adults during the flu season that begins later this year.
mRNA Technology
The vaccine uses messenger RNA (mRNA) technology. While Health Secretary Robert F. Kennedy Jr. has repeatedly criticized mRNA as unsafe and ineffective, the approach— which instructs the body to produce a fragment of a virus to trigger an immune response—was widely successful in COVID‑19 vaccines and is considered generally safe by public‑health experts and scientists.
Source: Slashdot