Concerns over potential vaccine-associated enhanced respiratory disease lead to a pause in pediatric mRNA-based RSV vaccine trials in the United States.
The United States has paused enrollment in pediatric trials for Moderna’s experimental mRNA-1345 and mRNA-1365 respiratory syncytial virus (RSV) vaccines following alarming safety signals observed in a Phase 1 study. The trial, conducted in July 2024, flagged a troubling imbalance in severe respiratory illnesses among vaccinated children compared to those receiving a placebo.
The most concerning outcome was the identification of a potential vaccine-associated enhanced respiratory disease (VAERD) linked to the vaccine candidates. Of the six cases of severe lower respiratory tract illness (sLRTI) recorded, five occurred in the vaccinated groups, compared to just one in the placebo group. Notably, five of these children required hospitalisation, with one infant needing “mechanical ventilation”.
The paused trial aimed to evaluate the safety, tolerability, and immunogenicity of the vaccine candidates in RSV-naïve children aged under five. It involved three phases:
- Part A: Testing 30 µg doses of mRNA-1345, mRNA-1365, or a placebo in children aged 8 to 24 months.
- Part B: Evaluating two dose levels in infants aged 5 to 8 months.
- Part C: Administering three doses to children aged 8 to 12 months, stratified by prior receipt of another RSV antibody, nirsevimab.
Participants were randomised in a 1:1:1 ratio across groups.
The pause was triggered after meeting the protocol’s predefined criterion: two or more cases of RSV-associated sLRTI confirmed by polymerase chain reaction (PCR) testing. The adverse outcomes have raised questions about the safety of the mRNA platform for RSV vaccines in vulnerable pediatric populations.
What Is VAERD?
VAERD is a phenomenon where an immune response generated by a vaccine leads to worsened outcomes upon exposure to the virus. In this case, the observed imbalance in severe RSV cases suggests that the vaccines may have inadvertently increased the risk of severe illness in young recipients.
The Vaccines and Related Biological Products Advisory Committee (VRBPAC) is currently reviewing the data to determine the conditions under which the trial might safely resume. This scrutiny will likely focus on revising dosage levels, adjusting participant criteria, or implementing stricter monitoring protocols.
This development is the latest in a series of controversies surrounding the safety of mRNA technology in vaccine development.
Image credit: Getty Images
Imagine my shock!! “Alarming safety signals”!! But, but experimental mRNA were sold as “safe and effective”. Must be a mistake, surely?
Bill Gates knew this, he is a murderer.
I hope this gets the publicity it deserves.
Very similar to the covid injection, those who had them seem to catch it more. I was not injected and have never contracted it. Say no more.
Seriously, what kind of parent would consent to their child undergoing an mRNA trial? And with a company with a reputation like Moderna??? Crazy! Are these poor kids trafficked from Ukraine?
All over MSM of course
Well fancy that…what a surprise……
Hold some crystals in your hands, remember these mantras and meditate upon them:
“Safe and effective.”
“Trust the science.”
After your meditation upon the “great ones”, reflect upon how they have a great life snorting cocaine off naked women (or spirit cooking) and then go for a drive in their brand-new Ferrari F50 whilst their staff attend to their multi-million-dollar mansion. What a life: Inventing “nasties” using “gain of function” and then making “vaccines” to “cure” the nasties, the “vaccines” that make you more ill, so you end up paying for their cocaine, Ferrari F50’s and mansions for the rest of your life for your medical “treatments”. Who would believe it? It sounds like some unhinged conspiracy theory.
Why would parents allow their own children to be used to test some “vaccine” that could damage them for life? Were they paid a lot of money? What’s wrong with them? Are these the same type of parents that allow their children to have sex change operations before they are legal adults?
If the parents cannot or will not protect their own children from dangers, then our society has a real problem: In the animal world, when parents do not protect the children, then the number of children that survives is reduced significantly, sometimes to nothing with the result of extinction.