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Novavax seeks FDA emergency use authorization of its coronavirus vaccine
CNN via msn.com ^ | January 31, 2022 | Jacqueline Howard

Posted on 01/31/2022 6:58:54 PM PST by fluorescence

Novavax announced Monday that it has formally submitted a request for the US Food and Drug Administration to authorize its coronavirus vaccine for emergency use in the United States.

The request is based on data that includes the results of two large clinical trials that demonstrated an overall efficacy of about 90% and a "reassuring safety profile," according to the company.

"We believe our vaccine offers a differentiated option built on a well-understood protein-based vaccine platform that can be an alternative to the portfolio of available vaccines to help fight the COVID-19 pandemic," Stanley Erck, Novavax's president and chief executive officer, said in the announcement Monday.

Novavax announced in June that its vaccine candidate was found to have an overall efficacy of 90.4% in a Phase 3 trial conducted across the United States and Mexico; the trial took place before the Omicron variant dominated in the United States.

In December, the company said it had finished its final submission package to the FDA for emergency use authorization of the vaccine, called NVX-CoV2373.

The vaccine can be stored at normal refrigeration temperatures, between 2 and 8 degrees Celsius (about 35 to 46 degrees Fahrenheit), and has a shelf life of about nine months, according to the company. Erck told CNN in November that if the FDA gives the green light for the EUA, the first 100 million doses of the protein-based vaccine will be ready to ship.

Novavax's vaccine -- administered as two doses, three weeks apart -- is made using small, laboratory-built pieces of the coronavirus to stimulate immunity, a more traditional approach for vaccine development that some people may be more familiar or comfortable with, compared with the mRNA vaccines made by Moderna and Pfizer/BioNTech.

(Excerpt) Read more at msn.com ...


TOPICS: Culture/Society
KEYWORDS: chat; chatforum; covid19; newsforumabuse; notculture; novavax

1 posted on 01/31/2022 6:58:54 PM PST by fluorescence
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To: fluorescence

Finally... It’s about time.


2 posted on 01/31/2022 7:02:18 PM PST by Tired of Taxes
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To: fluorescence

Why do they HAVE to use human embryos in the testing or development of these vaccines?


3 posted on 01/31/2022 7:03:32 PM PST by frogjerk (I will not do business with fascists)
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To: fluorescence

I’m confused. If Pfizer has full FDA approval, why are the EUAs still in place for Modernia and J&J. I thought EUAs got pulled after approval. How can Novavax get an EUA if Pfizer is approved?

Let me guess, Pfizer FDA approval is a fraud?


4 posted on 01/31/2022 7:06:56 PM PST by OHPatriot (Si vis pacem, para bellum)
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To: fluorescence

Everyone has got to get in to the “market” while the gettin’ is good.


5 posted on 01/31/2022 7:08:16 PM PST by rlmorel (Nothing can foster principles of freedom more effectively than the imposition of tyranny.)
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To: fluorescence

Why is there such a big push to inject the masses with a “vaccine” for a respiratory virus with a 99.98% chance of survival for those under 50, hell for over 70 it’s better than 95%???


6 posted on 01/31/2022 7:09:44 PM PST by eyeamok (founded in cynicism, wrapped in sarcasm)
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To: OHPatriot
FDA grants full approval to Moderna's Covid vaccine

7 posted on 01/31/2022 7:09:56 PM PST by Governor Dinwiddie (LORD, grant thy people grace to withstand the temptations of the world, the flesh, and the devil.)
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To: Governor Dinwiddie

So let me guess, documents will take 50-70 years to release just like Pfizer?


8 posted on 01/31/2022 7:13:18 PM PST by OHPatriot (Si vis pacem, para bellum)
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To: fluorescence

Revelation 16:2 โ€” King James Version (KJV 1900)
2 And the first went, and poured out his vial upon the earth; and there fell a noisome and grievous sore upon the men which had the mark of the beast, and upon them which worshipped his image.


9 posted on 01/31/2022 7:13:49 PM PST by Varsity Flight ( "War by the prophesies set before you." I Timothy 1:18)
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To: OHPatriot

Perhaps because they were all funded by the government? They have definitely been trying to discourage people from getting J&J and I have heard it is becoming harder to find.
J&J was sold at cost, unlike the rest, so they wouldn’t have had much of a budget for bribes and kickbacks (or incentive to bother).


10 posted on 01/31/2022 7:17:10 PM PST by fluorescence
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To: fluorescence

So 3 shots aren’t enuff? Eff the stalinists.


11 posted on 01/31/2022 7:17:20 PM PST by dynachrome ("I will not be reconstructed, and I do not give a damn.")
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To: OHPatriot
Weird, huh? We had all that Pentagon Papers and Watergate etc. etc. shoved down our throats but now those people are in power and fomenting a worse cover-up than Nixon could have ever dreamed of.
12 posted on 01/31/2022 7:29:26 PM PST by Governor Dinwiddie (LORD, grant thy people grace to withstand the temptations of the world, the flesh, and the devil.)
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To: fluorescence

We’re down to Omicron variants now...they’re a “little” late to the ball...


13 posted on 01/31/2022 7:39:50 PM PST by politicket
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To: fluorescence

how many different epitopes will the body develop immune response to from novavax?

if just one, it is pointless. ultimately no matter how many it will mutate around it (or a mutation will be designed around it)


14 posted on 01/31/2022 8:02:31 PM PST by WoofDog123
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To: fluorescence

Meanwhile...

Disclose.tv
@disclosetv

JUST IN - Pfizer-BioNTech is expected to request “emergency use authorization” for the COVID vaccine for children 6 months to 5 years old on Tuesday, WaPo reports.
8:08 PM ยท Jan 31, 2022


15 posted on 01/31/2022 8:20:03 PM PST by mewzilla (God bless Canada's Freedom Truckers!)
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To: Governor Dinwiddie

โฌ†๐Ÿ“Œ
Bkmk. Cover. Darkness. Prince of Darkness. Eden. Eden Leaves.


16 posted on 01/31/2022 8:23:05 PM PST by Varsity Flight ( "War by the prophesies set before you." I Timothy 1:18)
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To: mewzilla

Horrifying. Sounds like a drug for post-birth abortion.


17 posted on 01/31/2022 11:24:40 PM PST by Veto! (Political Correctness offends me)
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To: eyeamok

Exactly. Abortion tainted or not, the whole push to inject all is evil.


18 posted on 02/01/2022 2:42:52 AM PST by piusv (Francis didn't start the Fire)
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To: politicket

Well, at least there is a non rna vaccine which could be tested more thoroughly over a few years.
Semi- Paranoid alert!
Maybe some bad folks have a stockpile of other coronaviruses which they will release from time to time....just to stir things up a bit.


19 posted on 02/01/2022 4:19:39 AM PST by Getready (Wisdom is more valuable than gold and diamonds, and harder to find.)
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