Did the FDA Botch the Review of Moderna’s mRNA Flu Vaccine
The Real Truth About Vaccines
Why do some people think that the FDA botched the review of Moderna’s mRNA flu vaccine?
The usual suspects…
Did the FDA Botch the Review of Moderna’s mRNA Flu Vaccine
And because that’s one of the many anti-vaccine talking points that anti-vaccine influencers are using to try to scare people away from getting vaccinated and protected with this new flu vaccine.
They seem to think that researchers used tricks to hide safety signals and get the vaccine approved.
“In an appendix to its own briefing document, the FDA acknowledged that differences between the trials could produce safety variations “not fully captured by pooled analyses”—but proceeded anyway.”
FDA’s botched review of Moderna’s flu mRNA vaccine
“Hidden tricks” that you can easily read about in the FDA Briefing Document for the vaccine?!?
I mean, if pooling safety data was a “hidden trick,” then why was it mentioned so many times in the FDA Briefing Document?
And why is it considered to be an important way to help provide a more powerful analysis of vaccine safety, providing you with a larger sample size, allowing you to detect rare adverse events?
More importantly, Maryanne Demasi and others hide the simple fact that the overwhelming majority of systemic adverse reactions were not thought to be caused by the vaccine!
Take, for example, the one death that Maryanne Demasi says was “caused by the vaccine.”
It likely was not, in fact, caused by the vaccine!
“One death occurring on Day 2 in Study P303 Part A — in a 76-year-old female with significant cardiac history [prior coronary artery bypass graft (CABG), atrial fibrillation, type 2 diabetes mellitus] — was assessed as vaccine-related by the Investigator based on temporality. FDA considers the participant’s underlying cardiac disease a more plausible alternative etiology, though a contribution from a vaccine-related inflammatory response cannot be fully excluded.”
FDA Briefing Document BLA# 125869/0 Influenza Vaccine, mRNA
Instead, it is much more likely that something in the patient’s significant medical history caused her death.
Basically, the claims of Maryanne Demasi about the new mRNA flu vaccine are simply part of the meltdown from anti-vaccine influencers pushing the idea that it is a “killer shot.”
Claims that you can safely ignore.
What else?
“A phase 3 clinical trial showed that mFLUSIVA provided superior protection compared to a standard-dose shot.”
There’s a New mRNA Flu Shot Coming This Fall
mFlusiva is approved for adults who are at least 50 years old.
It is a great, new option in our fight against getting sick with the flu!