Moderna to ask FDA for emergency clearance of COVID-19 vaccine



Moderna said it will ask the feds to clear its experimental coronavirus vaccine for emergency use on Monday, adding to hopes that two inoculations could be available by Christmas.

The biotech firm will submit the second request for a so-called emergency use authorization for a COVID-19 vaccine from the US Food and Drug Administration after Pfizer and BioNTech filed their application earlier this month.

Moderna announced the move Monday as it revealed new data showing the vaccine was 94.1 percent effective in its late-stage clinical trial — similar to Pfizer’s efficacy rate of 95 percent — and posed no serious safety concerns. The FDA’s vaccine advisory committee is expected to review data from the Phase 3 study at a Dec. 17 meeting, the company said.

“We believe that our vaccine will provide a new and powerful tool that may change the course of this pandemic and help prevent severe disease, hospitalizations and death,” Moderna CEO Stéphane Bancel said in a statement.

The news sent Moderna’s stock price surging 10 percent in premarket trading Monday to $139.80 as of 7:51 a.m.

The submission will come as US officials and drug companies prepare to distribute coronavirus vaccines to first responders and other vulnerable people around the country as soon as they’re approved.

Massachusetts-based Moderna said it expects to ship its vaccine to distribution points throughout the US “shortly after” the FDA grants the emergency use authorization. The first doses could be administered as soon as Dec. 21 if the process goes as planned, Bancel told The New York Times.

Moderna says it will have about 20 million doses available in the US by the end of the year, enough to inoculate about 10 million people with two doses apiece. Manhattan-based Pfizer, meanwhile, expects to have produced up to 50 million doses of its shot globally by year’s end and has said its shot could be distributed to high-risk populations by mid- to late December. The FDA’s vaccine panel is scheduled to discuss the company’s emergency use authorization at a Dec. 10 meeting.

The FDA did not immediately respond to a request for comment Monday.

Moderna deemed its vaccine highly effective after a new analysis of 196 people who contracted COVID-19 in its clinical trial of more than 30,000 people. Only 11 of those who got sick had received the vaccine while the other 185 had gotten a placebo, the company said.

Some 30 participants came down with severe cases of the coronavirus, none of whom had been vaccinated, Moderna said. One person in the study died of COVID-19-related causes but the patient had received a placebo, according to the company.

Moderna’s latest analysis found no serious safety problems with the shot, though the company noted that patients have reported fatigue, muscle aches, joint pain, headaches, and pain and redness at the injection site.

Moderna also announced that it will seek conditional approval for the vaccine on Monday from the European Medicines Agency, the European Union’s drug regulator. The company said it has already started the approval processes in the UK, Israel and Singapore.

Both Moderna’s and Pfizer’s vaccines use messenger RNA, manufactured genetic material that’s injected into cells to provoke an immune response in the body. That makes them different from another leading candidate from AstraZeneca, which uses a deactivated cold virus to deliver a gene for the coronavirus’ spike proteins into the body. The British drugmaker said last week that its shot was up to 90 percent effective.

Hopefully they get a ton of this out there and distributed before Biden is inaugurated and starts being selective and "fair" with the distribution (and able to use it as a political weapon).

Not impressed...

IMO, they are like wild dogs wanting to prevent Pfizer from hoarding all the profits.

Anyone who takes that rushed up shit deserves whatever side effects that happen for a virus 99.97% will survive just fine.  Lol fuckin doomers

FIFY

This. I can't wait to be first in line to beta test a rushed vaccine for something with a 99 percent survival rate. Its always been my dream.

I have relatives who have come down with Corona more than once.

Weve had a flu vacciene for over 50 years.  People still get the flu.

This vacciene was RUSHED out.  Unless it has been ready for years that is...

The survival rate for this virus is over 99 percent for everyone.

Dont fool yourselves, a vacciene wont do any good for anyone but the folks pushing it.  

Dose't mederna date clear back to the nazis

Once Joe gets his paws in this a working class white man has no chance of getting the vaccine

Hate to be the one that has to tell you this, but the rice rabies has been a political bio-weapon since it's release from wuhan.

Can someone help me understand this?  

1: the virus has infected 13.4 million Americans. This sounds like a lot. It’s around 3%. Even if we had  a ton of people that had it and didn’t get tested, let’s say it’s 5% of the USA.
With a “vaccine” that is 94% effective, what good does it do?  Is the risks from a rushed vaccine worth it?

2: I have seen reports of serious reactions to the vaccine.  Yet they say none occurred?  Here is one article

Covid cranked its way through my family.  We all survived (even though I had a bad case) we will not be taking the vaccine.


Also.  Since the people of color have been so negatively impacted of this virus l, mostly due to systemic racism. I offer someone to take my vaccine.  In fact I say we give it to them first.  Give it to the inner city minorities first.  It’s the right thing to do.

What happened to the right to try? The FDA has been fucking up for years, approving drugs that might be only 1% better than no drugs at all.

I’m not gonna have a choice

A rushed vaccine which is also the first of its kind ever and doesn't work like any other vaccine in history.

I can't wait for the turbo cancer.

I asked someone about this yesterday. This Dr is on the advisory committee for the CEO of Davita, so she's seen a little data. I asked why we should trust this vaccine and her short answer was that more people have received the COVID vaccine in phase 3 trials than the total ppl for some combination of MMR/something/something else (stuff we've all heard off and don;t bat an eye about). She said she would be first in line to get it if she could be.

She is also selectively panicky, but her frame of reference is skewed...if you end up as one of her dialysis patients you're already in trouble and COVID will jack you up.

Is this the version with the chip in it?

It's got to be far more than 5% that have already had it with 3% confirmed by a test.  We knew early on from relatively closed populations like cruise ships that there were a ton of people with minimal or no symptoms.  There's studies from back in September that figured it was about 10% of the population and that was back in September.

I don't understand the "It's 94% effective, so what good does it do?".  I mean, isn't the 94% effective number pretty self explanatory?  The candidates who were vaccinated had a dramatically lower rate of COVID infection than the candidates who got the placebo.  What else do you want from a vaccine?

Whether the risks are worth it or not probably boil down to several questions.  First, I think one would have to really understand how an mRNA vaccine works to understand the potential for unknown risks.  Second, you'd have to look at your particular risk group with respect to age and general health.  I would think some fat diabetic 60 year old would be pushing his way to the front of the line risks be damned whereas a healthy 30 year old might want to do some further reading and let the high risk people go first.

The entire basis for FDA emergency use authorization is based on benefits being greater than the risk so watching to see how they respond to the requests for emergency use authorization will be interesting.

Pull random vaccines off the production line and I want to watch the entire executive board take it along with every single governor and member of congress.

11 people...

11 fucking test subjects?

damn.

I am ready and willing to receive it.

Yep government toolbags get it first

They will be in the yearly boosters.

I would very likely survive COVID-19 unscathed, but if I get infected and pass it on to my wife or my mom there is a significant chance of either of both of them dying from it.

For that reason I'll gladly take the a vaccine if it gets approved and if it's available.  The mRNA vaccines are looking very encouraging.

Trillions of nano-chips that will get embedded in your testicles and passed on through your sperm to your future children.

Survival rate varies hugely with age. If you're over ~55 it probably makes more sense to take the vaccine than get COVID.



This vaccine doesn't require cryogenic storage temps like pfizer's does.

It's probably closer to 20% of people who have had it by now. 3% is just the people who have got it and had a positive test with it.

So the "severe adverse reaction" that 1 person out of 50,000 had was "fever of 103" and fully back to normal in a DAY?  

Oh boy.  

Read up on ANY prescription med and see how they have the same or worse records for "adverse reactions".  ANY of them.  Come back and share.

4 out of 45 had a class 3 reaction.

Covered here already

You think that instead of ~13 million cases in the US there have actually been ~65 million?

A company that has had safety issues with prior meds, that has never brought a product to market, never made it past stage 1 trials, that’s the company that we trust to develop a rushed vaccine for a “deadly virus”

Fuck that.

Well, it's a race.  The first to market will make billions more than #2.  Of course they're going to play hardball.

So 10% give or take

Yeah ..my hope is that there will be a possible positive outcome, as many more people will seek out opposing information to the loud, authoritarian narrative that is being force fed to the masses by disgusting communist and globalist superfigures who we all know have our best interests in mind.

Said it before and will again, no vaccine for me or my family. You'll need to take my guns first. And guess what? You can't have them.

Attached File

I would absolutely believe it.  My coworker tested positive after his wife got sick.  He's had zero symptoms the entire time.  He never would have gotten tested if it wasn't for his wife showing symptoms.

I've had symptoms of something 3 times this year.  Could have been colds, could have been COVID.  Never got tested, just stayed home.

Really. Thanks for thinking of me.

My, look at the time.

I'll get it...next week.

Can you not read? There were 30,000 test subjects. 11 got sick

Presumably about 15,000 got the actual vaccine and the rest got a placebo.

My work includes crunching numbers from clinical trials, mainly for implantable cardiac devices.  I've been doing that since 2012.  I have never seen a positive outcome as clear as this one.  It's also consistent with results reported for mRNA vaccines from Pfizer and AstraZenica/Oxford University.

People should be skeptical, of course.  Questions should be asked, and they are.  There have been a few fumbles.  But three entities independently developing mRNA vaccines and all three reporting effectiveness well over 90% is amazing.

+1 Emergency Use Authorization is for Soldiers and CBRN lab workers, who are at an elevated risk and can be required to be vaccinated against emerging threats, not the generation population.

Kharn

Roughly. Infections and cases are different things.

I suspect around ~60m have already had it, and probably ~3m are currently infected.

Is Pfizer not a wild dog also?

There were 11 of the vaccine recipients who later got the virus. There were 10’s of thousands of test participants.

Not just rushed (exponentially), it is a completely new TYPE of vaccine that hasn’t  been approved before.

Yeah those numbers make sense to me as well.

I think it's significantly more prevalent than we realize.

That's not true at all. It's heavily dependent on age.

And the virus has no side effects? Nothing like lung or heart damage?

same, our freezers are ordered and on the way if not already here. I look to get the first dose in about two or three weeks, woohoo.

Pretty much everything on the planet dates back (or forward) to Nazis, but Moderna was founded in 2010.  It has yet to bring a product to market.

Rumors abound concerning a connection between Anthony Fauci and Moderna.  He is not, nor has he ever been, either a board member or part of management in the company.  However, the fact that TinyTony is pushing Moderna’s vaccine over Pfizer’s more effective one tells me that prick stands to benefit from it in some way.

“We researched the safety and efficacy of our own product that we stand to make billions of dollars from, and we found out product to be almost 100% effective and safe.”

Surprise, surprise!

Crazy thing about Moderna is that Bancel and his top couple execs sold almost all of their shares of stock in the company several months ago.  Why bail so early?

Follow the loot

Lol go for it sport....99.97% of all humans will be just fine without it.  This is beyond fucking retarded.  Fuckin doomers and Karens buying the bullshit panic narrative....go take some new, literally never been done before, meds rushed to market.