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

May 31, 2024

Moderna, 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.

Stéphane Bancel, Chief Executive Officer of Moderna.

The FDA approval of our second product, mRESVIA, builds on the strength and versatility of our mRNA platform

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.

Moderna races ahead in flu and Covid-19 combo vaccine race with Phase III win

Moderna injection mRNA-1083

Comprises a seasonal influenza vaccine candidate, mRNA-1010,

and a next-generation Covid-19 vaccine prospect called mRNA-1283.

Moderna announces positive data from a Phase III trial of its mRNA vaccine candidate.

Now, in a Phase III trial (NCT06097273) for mRNA-1083

Moderna

“statistically significantly higher immune responses” compared to existing vaccines on the market.

The trial met its primary endpoints, Moderna said in a 10 June press release.

Immune response was seen across three influenza virus strains (H1N1, H3N2, and B/Victoria) and against SARS-CoV-2.

Although Moderna has not published the full dataset from the Phase III trial,

it plans to present the results in more detail at an upcoming medical conference,

in addition to a submission for publication.

The company said it “will engage with regulators on next steps”.

Other mRNA vaccines in development

Moderna Advances Multiple Vaccine Programs to Late-Stage Clinical Trials

Cytomegalovirus (CMV)

CMVictory is a pivotal Phase 3 trial evaluating mRNA-1647 against primary CMV infection in women 16 to 40 years of age.

Epstein-Barr virus (EBV)

mRNA-1189

The randomized, observer-blind, placebo-controlled study is fully enrolled.

Herpes simplex virus (HSV)

mRNA-1608

Phase 1/2 trial

The randomized 1:1:1:1, observer-blind, controlled study is fully enrolled with 300 participants in the U.S.

Varicella-Zoster virus (VZV)

Moderna's VZV vaccine candidate mRNA-1468 has initial data available from a Phase 1/2 trial

Norovirus

The Company is advancing mRNA-1403 toward a pivotal Phase 3 trial.
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I won't be going anywhere near any new "Medical interventions" Who else feels the same?

ThomasKing
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I'm 77 and I just received a letter from the NHS asking me to book my spring covid vaccine. There was an opt out option which I ticked. I then got a message asking me why I was opting out. Here was my reply " I have lost half of my family to vaccine injury and death, and I don't have a suicide wish."

CJR
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All MRNA vaccines should be tried first by the people producing them and then on the government agencies approving them .Solman

marchadwick
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Congress and Senate need to be first in line.

johngalt
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We all need to boycott any mRNA therapy’s

Seek.YouWillFind
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These people are insane..
Who on earth would dare approve ANY mRNA medication??

joseevaniersel
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If you don't PROSECUTE criminals, they continue to offend

timmyterd
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Thank you Dr. Campbell for all you do, stay-safe everyone.

sabrinapeterson
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Is anyone still gullible enough to fall for pharma's bs?

GingerPeacenik
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All these people need to be put in prison for what they’re doing

Nana
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WE NEED TO BOYCOTT IT IN LIVESTOCK TOO !

antheablackmore
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This is July 3, 2024 in Southern California. Once again, thank you, Dr. Campbell for your consistent integrity and untiring service in the face of pharmaceutical dishonesty and global greed.

UrsulaPainter
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These days an approval from the FDA immediately raises a red flag.

alexo
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Don't give up Dr Campbell we need you here to keep us informed ❤

Flowerpot
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As a physician, I will never take an RNA vaccine and will dissuade anyone and my patients, who ask my advice from doing so! God bless you!

rubensneto
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I have lost all faith in all medical interventions

lisyloulouedwards
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Why is this still happening. They all need to go to jail. So sick. People need to

darleneharrington
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My wife and I retired from nursing some years ago. We were wary of mRNA technology because of their history in animal trials. After watching the insane overreaction of the medical establishment to the covid situation, we have lost confidence in the system in which we spent our careers. We can no longer trust them to any degree.

michaeleastes
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The alarm bells were ringing as soon as the Pharmaceutical companies got indemnity “If you have to be persuaded, reminded, pressured, lied to, incentivized, forced, bullied, socially shamed, guilt-tripped, threatened, punished and criminalized ... If all of this is considered necessary to gain your compliance -- you can be absolutely certain that what is being promoted is not in your best interest ” - Ian Watson

ebutuoy
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It's really weird how they keep pushing this.

TUCOtheratt
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