FDA Approves New mRNA Vaccine

The FDA has just approved Moderna’s new RSV mRNA vaccine.

The new vaccine by Moderna is for adults over the age of 60.

Moderna CEO Stephane Bancel said in a press release, “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,” added Bancel.

BREAKING–Moderna Receives U.S. FDA Approval for mRNA RSV Vaccine mRESVIA(R)

Approval of Synthetic mRNA Product for Public Use with No Genotoxicity, Oncogenicity, or Long-Term Safety Studies

The press release does not tell the public the absolute risk reduction for clinically… pic.twitter.com/YSjfYDTsKB

— Peter A. McCullough, MD, MPH® (@P_McCulloughMD) June 3, 2024

The FDA approves another MRNA vaccine without adequate safety research. Several levels of decision-makers at the FDA need to be replaced with actual humans.https://t.co/DpVI6Bw34G

— zJack (@z_watching) June 4, 2024

The Hill got the scoop too:

The Food and Drug Administration (FDA) has approved Moderna’s RSV mRNA vaccine for adults older than 60 years.

The approval makes RSV the second disease for which an mRNA vaccine has been greenlighted. There are two other RSV vaccines approved for adults older than 60: Arexvy by GSK and Abrysvo by Pfizer. Moderna’s mRESVIA is now the third shot added to the arsenal against RSV.

“The FDA approval of our second product, mRESVIA, builds on the strength and versatility of our mRNA platform,” Moderna CEO Stéphane Bancel said in a statement.

“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.”

According to Moderna’s announcement, the FDA approval was based off a multinational study involving around 37,000 adults older than 60 across 22 countries. The study found that mRESVIA had an efficacy against RSV lower respiratory tract disease of 83.7 percent.

FDA Approves Moderna’s mRNA RSV Vaccine Without Any Long-Term Safety Data

The mRNA product was approved for public use without genotoxicity, oncogenicity, or long-term safety studies.https://t.co/tOSyeH19RG

— Vigilant News (@VigilantNews) June 3, 2024

Here’s what Medscape reported:

The US Food and Drug Administration (FDA) approved mRESVIA (mRNA-1345, Moderna), a vaccine for respiratory syncytial virus (RSV).

The mRNA vaccine is approved for adults aged 60 years or older to prevent lower respiratory tract disease caused by RSV. It is the third vaccine to be approved for RSV in the past year after Arexvy from GSK and Abrysvo by Pfizer.

“The FDA approval of our second product, mRESVIA, builds on the strength and versatility of our mRNA platform,” Stéphane Bancel, chief executive officer of Moderna, said in a news release. “mRESVIA protects older adults from the severe outcomes of RSV infection. This approval is also the first time an mRNA vaccine has been approved for a disease other than COVID-19.”

mRESVIA is a single-dose vaccine available in prefilled syringes, which the company says are designed to maximize ease of administration, saving vaccinators’ time, and reducing the risk for administrative errors.