The U.S. Food and Drug Administration (FDA) has approved Moderna’s mRNA-based respiratory syncytial virus (RSV) ‘vaccine’ for adults age 60 and older.

“Moderna, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved mRESVIA (mRNA-1345), an mRNA respiratory syncytial virus (RSV) vaccine, to protect adults aged 60 years and older from lower respiratory tract disease caused by RSV infection. The approval was granted under a breakthrough therapy designation and marks the second approved mRNA product from Moderna,” Moderna announced in a press release.

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

“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. This approval is also the first time an mRNA vaccine has been approved for a disease other than COVID-19. With mRESVIA, we continue to deliver for patients by addressing global public health threats related to infectious diseases,” he added.

“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,” Vigilant News noted.

Per Moderna:

The FDA’s approval of mRESVIA is based on positive data from the Phase 3 clinical trial ConquerRSV, a global study conducted in approximately 37,000 adults ages 60 years or older in 22 countries. The primary analysis with 3.7 months of median follow-up found a vaccine efficacy against RSV lower respiratory tract disease (LRTD) of 83.7% (95.88% CI 66.0%, 92.2%). These results were published in The New England Journal of Medicine. A follow-up analysis of the primary endpoint was performed during FDA review, including cases that started before the primary analysis cut-off date but were not confirmed until afterward. The results were consistent with the primary analysis [VE 78.7% (CI 62.9%, 87.8%)] and were included in the U.S. package insert. An additional longer-term analysis showed continued protection against RSV LRTD over 8.6 months median follow-up.

No serious safety concerns were identified in the Phase 3 trial. The most commonly reported solicited adverse reactions were injection site pain, fatigue, headache, myalgia and arthralgia.

Moderna expects to have mRESVIA available for eligible populations in the U.S. by the 2024/2025 respiratory virus season.

Moderna has filed for mRNA-1345 approval with regulators in multiple markets around the world.

“mRESVIA®is an RSV vaccine that consists of an mRNA sequence encoding a stabilized prefusion F glycoprotein. The F glycoprotein is expressed on the surface of the virus and is required for infection by helping the virus to enter host cells. The prefusion conformation of the F protein is a significant target of potent neutralizing antibodies and is highly conserved across both RSV-A and RSV-B subtypes. The vaccine uses the same lipid nanoparticles (LNPs) as the Moderna COVID-19 vaccines,” Moderna stated.

Dr. Peter McCullough stated:

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 significant outcomes was far below 1%, meaning this product will not have a significant clinical impact. Consumers should know that at the bare minimum, the following safety concerns exists for any pseudouridinated, synthetic mRNA product including mRESVIA(R):

1) Myocarditis because mRNA of all types targets the heart as shown by Krauson et al

2) Auto-immunity because of the generation of foreign RSV proteins and frameshifted peptides as shown by Boros et al

3) Genomic integration as shown by Alden et al

4) Oncogenicity as shown by Seneff et al

The Defender reports:

The FDA approved the drug without input from the agency’s independent vaccine advisory committee, which typically makes recommendations about such drugs, because the FDA didn’t see any “concerns or controversial issues” that would make input necessary to the approval process, the agency said in its approval letter.

Moderna is running at least 11 clinical trials for its new mRNA RSV drug on several other demographic groups, including young children, adolescents and healthy adults.

The vaccine, marketed under the name mResvia, is Moderna’s second-ever FDA-approved drug. It uses the same mRNA platform as its COVID-19 Spikevax vaccine.

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

The Centers for Disease Control and Prevention (CDC) must recommend the drug before it can be used. The CDC’s advisory committee will discuss and vote on the vaccine at its meeting next month.

If approved, the vaccine will provide a second revenue stream for Moderna, whose first-quarter sales fell 91% compared with same-quarter sales in 2023.

The company said it expects to launch the vaccine in time for the 2024 fall vaccination season.

The FDA’s approval of Moderna’s mRNA RSV vaccine comes a year after the agency approved GSK’s Arexvy and Pfizer’s Abrysvo RSV vaccines for the same age group.

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