FDA reverses course, refuses to review Moderna’s application for new mRNA flu vaccine

[JBTX]

FDA reverses course, refuses to review Moderna’s application for new mRNA flu vaccine

www.cidrap.umn.edu

New MNRA flu shot found to be 50% better than regular flu shots, and faster to adapt, is not going to be reviewed by the FDA. Apparently during testing all FDA protocols were followed and testing plan approved but now FDA has reversed course for no apparent reason.

 

[Teacher Terry]

I’m not surprised at this terrible news(.

 

[Flieger]

Do your own research (NIH, etc), but there are significant SRE and permanent adverse risks associated with mRNA vaccines that came out upon further review to consider.

I don't think it should stop review however. If the sometimes reported 16% increase in SRE is true, it should come out.

Flieger

 

[Fermion]

I am not anti vax at all but mRNA possibly has caused major problems for us and I would like to see less rushed studies (but not stopping a review).

 

[The Cosmic Avenger]

From Weill Cornell medical center's newsletter (emphasis mine):

The risks  associated with the disease itself far outweigh  the  risks of  the  vaccine’s  side effects.  So  say the scientists involved with developing the mRNA COVID-19 vaccine, those who conducted both early and ongoing clinical trials and those tracking the vaccine’s side effects. 

Like all vaccines, the mRNA  COVID  shots have side effects.  These are overwhelmingly mild, such as a sore arm,  fatigue  and a low-grade fever.  Such side effects  show that your immune system is working.  

Extensive studies  conducted  in the U.S. and  other countries  found only a few serious ones. For example, the  new  vaccines can cause  myocarditis (inflammation of the  heart  muscle)  in a small fraction of young men, and one study  reported  seven severe cases of shingles for every million shots administered.  

These rare side effects, while deeply regrettable,  are  in line with  the safety record of most other vaccines.  

Be aware that COVID-19 itself causes myocarditis at much higher rates than the COVID vaccine.  

 

[The Cosmic Avenger]

FDA reverses course, refuses to review Moderna’s application for new mRNA flu vaccine

www.cidrap.umn.edu

New MNRA flu shot found to be 50% better than regular flu shots, and faster to adapt, is not going to be reviewed by the FDA. Apparently during testing all FDA protocols were followed and testing plan approved but now FDA has reversed course for no apparent reason.

It's going to be very hard to answer that without getting Porkied, but I'll pull a quote from the Weill Cornell Medical Center article above, as they cite specific, relevant evidence:

HHS leadership, too, has promoted outright falsehoods with respect to mRNA COVID-19 vaccines, including the following statement: “One mutation and the vaccine  becomes  ineffective.” That is incorrect. SARS-CoV-2 has already accumulated many mutations—also known as variants—and vaccine manufacturers continue to update the vaccines accordingly in the form of boosters. 

 

[Beststash]

I personally think the politicalization of vaccines is not only dangerous but irresponsible. It has eroded public trust in science and our public health organizations.

So now we have a resurgence of once eliminated diseases, which means more deaths and unnecessary suffering.

IMO, the mRNA debate is more about politics than science.

 

[ut2sua]

I personally think the politicalization of vaccines is not only dangerous but irresponsible. It has eroded public trust in science and our public health organizations.

So now we have a resurgence of once eliminated diseases, which means more deaths and unnecessary suffering.

IMO, the mRNA debate is more about politics than science.

Modern medicines are miracles. Sick + miracle = back to health.
Science has created too many miracles. And that is not acceptable to some.

 

[Flieger]

Yes, this will get too political (both sides), so I am out.

Flieger

 

[wolf]

One has to define "risk". In the old days, vaccines were basically made from a "dead virus" Tried and true method. New MRNA vaccine, are "Lab-made genetic instructions". Some MD'S are asking for more
clinical data, to insure safety. Up to us to make up our own minds.

 

[ShokWaveRider]

We had ALL Moderna vaccines up until a year or so ago. Never did us any harm. If some folks have poor immune systems that may be a different story. But they are at a disadvantage even before they start.

 

[thenameiwish]

Good. There needs to be more caution.

 

[Fermion]

"At the time of its approval and widespread use (including as a treatment for morning sickness in pregnant women), thalidomide was promoted as remarkably safe, with very few side effects. Preclinical testing in animals (mostly non-pregnant) showed low toxicity even at high doses, and early human data didn't reveal major problems."

Just saying, there is a reason these things usually take 3 to 5 years or more to study.

 

[Gumby]

Taking a long time to review it, in the interests of safety, is one thing. Refusing to review it at all is another.

 

[The Cosmic Avenger]

"At the time of its approval and widespread use (including as a treatment for morning sickness in pregnant women), thalidomide was promoted as remarkably safe, with very few side effects. Preclinical testing in animals (mostly non-pregnant) showed low toxicity even at high doses, and early human data didn't reveal major problems."

Just saying, there is a reason these things usually take 3 to 5 years or more to study.

Yes, and mRNA vaccines for humans have been in development for over 20 years, 30+ years since mouse studies.

 

[stepford]

Presumably mRNA vaccine development and availability will continue in other countries. May be time to schedule some vaccine tourism.

 

[thenameiwish]

The original post was about one specific mRNA vaccine. Traveling to another country to get a flu shot that may, or may not, treat a future flu strain? That seems riskier than catching the flu.

 

[pb4uski]

Good. There needs to be more caution.

But how do you equate a refusal to review Moderna's new mRNA vaccine with caution. Caution would be if you reviewed it but with healthy professional skepticism.

IMO, refusal to review it is more ignorance than caution.

 

[pb4uski]

The original post was about one specific mRNA vaccine. Traveling to another country to get a flu shot that may, or may not, treat a future flu strain? That seems riskier than catching the flu.

WADR, other than you, who said anything about traveling to another country to get a flu shot?

 

[thenameiwish]

Easy there cowboy. Reference post #16 "May be time to schedule some vaccine tourism".

Hippocratic Oath, "primum non nocere,"

 

[pb4uski]

Ok. Edited the post.

 

[Jerry1]

Taking a long time to review it, in the interests of safety, is one thing. Refusing to review it at all is another.

I agree.

Yes, and mRNA vaccines for humans have been in development for over 20 years, 30+ years since mouse studies.

During COVID, this was my main concern about the vaccine. It had been in development for many years and was never approved until there was a pandemic. It's not a great leap to think that it wasn't ready for use but given the magnitude of what we were dealing with it was found to be the best alternative. That's all well and good, but the immediacy of the pandemic is over and now we should be cautious and proper studies are needed. If from the start, the government said - hey, this is the best we have, take it understanding that it's risky, instead of saying right from the beginning that it's safe and effective, I would feel a lot better about the information we receive from our government and the drug manufacturers. The political nature of this has caused credibility issues that are not likely to be resolved quickly. We need a trusted group that is totally removed from the government and the pharmaceutical industry to evaluate vaccines. Trust needs to be re-earned.

 

[Koolau]

I hope we haven't heard the last of this. Amazing what public pressure can (eventually) accomplish. (Do I have to say it)? Call your congressperson...

 

[JBTX]

It’s one thing to say you don’t want a vaccine forced on you. It’s another when people don’t allow me access to medical treatments on issues that have nothing to do with science or medical research.

 

[frank05]

One has to define "risk". In the old days, vaccines were basically made from a "dead virus" Tried and true method. New MRNA vaccine, are "Lab-made genetic instructions". Some MD'S are asking for more
clinical data, to insure safety. Up to us to make up our own minds.

Not true there are several methods to making vaccines including the live attenuated method.