Posted on 06/01/2021 9:28:46 AM PDT by Pollard
COVID-19 vaccine maker Moderna has petitioned the Food and Drug Administration for full approval of its shots for use for adults 18 and older.
“We are pleased to announce this important step in the U.S. regulatory process for a Biologics License Application (BLA) of our COVID-19 vaccine,” said Moderna CEO Stephane Bancel. “We look forward to working with the FDA and will continue to submit data from our Phase 3 study and complete the rolling submission.”
The company will supply the FDA with additional safety data on a rolling basis over the coming weeks. It is only the second vaccine maker, behind Pfizer, to file for a biologics license application, or full approval, for its shots. The licensing process relies on the availability of six months worth of additional safety and efficacy data.
(Excerpt) Read more at washingtonexaminer.com ...
Next phase will be this vaccine will be required for everyone.
I expect FDA to wave a magic wand and just say “Approved”.
Once the vaccines get that rubber stamp, then it becomes easier to mandate the no-longer-experimental medicine.
It shouldn’t be like that, but I think it will be.
Wanna bet this means they’ve been lying to us about uptake stats...
They must really, really suck.
Since it normally takes 10 years to get this approval then they can only get through using a corrupt system.
Good thing for Deep State then that it overthrew our republic, eh?
Corruption?
Deep State has it covered.
They had not even applied yet?
And people are pushing this? Pushing, coercing, sequestering, they have not even applied for approval?
We are living in a dangerous idiocracy. What is this?
“ I expect FDA to wave a magic wand and just say “Approved”.”
I don’t. This... this has only just now been applied for? No
This is pretend
Moderna does not want approval any more than Harris wants to or can do the job of president they do not want the liability. No
Couldn’t see that one coming.
Pfizer-BioNTech has already applied to the FDA for full approval.
First they have to confirm that there is no other viable treatment for COVID19, such as Ivermectin, which is saving India’s and Mexico’s butt right now.
Moderna to have an FDA Approved Grenade?
Wanna bet?
https://www.modernatx.com/sites/default/files/mRNA-1273-P301-Protocol.pdf
Moderna’s trial protocol, dated Aug 2020, says Phase 1 to run for 24 months and here we are at 9 months. The world must be spinning faster these days.
>>for use for adults 18 and older.
So the doctors who are administering it to minors are going “off label”?
Wasn’t “off label” use something governors were cracking down on while Trump was president?
Yes.
One of the defense claims by those in the medical industry (who themselves are avoiding these shots) is that they are still only “experimental” and not yet approved. They claim that they can not be mandated to take part in such an experiment.
I don’t use quotes for *experimental*.
I use them for *vaccine* and it’s not for scare but because the definition is wrong.
It’s not a vaccine by the classic definition of the word and I won’t give the impression of legitimizing it by calling it such.
Off label was bad when it was for HCQ and Ivermectin.
It all depends on what you’re pushing and how much money there is to be had in it.
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