Last week, Moderna announced that it has received approval from the Food and Drug Administration (FDA) for the development of an mRNA vaccine for respiratory syncytial virus (RSV).
The vaccine is designed for those aged 60 and older.
Moderna CEO Stéphane Bancel said, “The FDA approval of our second product, mRESVIA, builds on the strength and versatility of our mRNA platform.”
“mRESVIA protects older adults from the severe outcomes of RSV infection, and it is the only RSV vaccine available in a pre-filled syringe designed to maximize ease of administration, saving vaccinators’ time and reducing the risk of administrative errors,” he continued. “This approval is also the first time an mRNA vaccine has been approved for a disease other than COVID-19.”
According to Bancel, mRESVIA helps to address “global public health threats.”
Dr. Peter McCullough wrote on his Substack that the FDA approval was granted without standard observation policies.
“Moderna’s approval marks a clear inflection point for the US FDA—synthetic mRNA will not have to meet safety standards previously put forth by the agency,” he wrote.
The vaccine’s “absolute risk reduction for clinically significant outcomes was far below 1%, meaning this product will not have a significant clinical impact,” McCullough added.
Earlier this year, Moderna announced that it was developing mRNA vaccines targeting Epstein-Barr virus (EBV), Varicella-zoster virus (VZV), and Norovirus.
“Moderna has demonstrated a remarkable ability to impact human health through mRNA vaccines targeting respiratory illnesses. This landmark collaboration is another example of our long-standing strategy to partner with the world’s leading life science companies to advance their critical path vaccines, medicines and medical technologies to patients,” Nicholas Galakatos, Ph.D., Global Head of Blackstone Life Sciences, said in a press release.
