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Novavax files COVID-19 vaccine data with FDA Clearing the Way for Emergency Authorization in 2022
The Hill ^ | 12/31/2021 | Brad Dress

Posted on 12/31/2021 1:52:10 PM PST by SeekAndFind

Novavax on Friday filed final data with the Food and Drug Administration (FDA) for its COVID-19 vaccine, clearing the way for a potential emergency approval next year.

The move was the last step for the Maryland-based biotechnology company to fulfill prerequisites for its protein-based vaccine, which is different than the other three vaccines approved in the U.S. from Pfizer, Moderna and Johnson & Johnson.

If all goes well, Novavax could seek emergency approval next month as the U.S. continues to prioritize booster shots amid a spike in confirmed coronavirus cases driven by the highly transmissible omicron variant.

"Novavax is committed to delivering our protein-based vaccine in the United States, where the COVID-19 pandemic continues to evolve with the emergence of new variants," said Stanley Erck, the president and CEO of Novavax, in a statement.

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


TOPICS: Culture/Society; Government; News/Current Events
KEYWORDS: chinavirusvaccine; covid; fda; novavax; vaccine
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1 posted on 12/31/2021 1:52:10 PM PST by SeekAndFind
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To: SeekAndFind

Novavax is partnering with the Serum Institute of India Pvt. Ltd, one of the largest vaccine manufacturers in the world, to deliver NVX-CoV2373.

The vaccine is derived from the spike protein pulled from the very first strain of the novel coronavirus, and is bolstered by an adjuvant, or an ingredient that enhances the immune system’s response.

A phase three trial in the U.S. and Mexico, with more than 25,000 participants, proved a vaccine efficacy of above 90 percent for the vaccine.


2 posted on 12/31/2021 1:53:10 PM PST by SeekAndFind
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To: SeekAndFind

as usual, will the FDA seal
the test files for 70 years,
while the CDC will seal
the morbidities and deaths for 70 yrs.

nothing to see here, because it is corrupt sealed,
and the deaths are covered up for
the profits of Pelosi and Congress
and the gain of the CCP through genocide.


3 posted on 12/31/2021 1:54:15 PM PST by Diogenesis (Si vis pacem, para bellum)
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To: SeekAndFind

Just give us Ivermectin.


4 posted on 12/31/2021 1:57:02 PM PST by stars & stripes forever (Blessed is the nation whose God is the Lord. (Psalm 33:12))
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To: SeekAndFind
Italian pharmacist shows reality of percentage of testing positive to covid vaccinated
5 posted on 12/31/2021 1:59:33 PM PST by Trillian
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To: SeekAndFind
NFW.

Recommended reading: The Real Anthony Fauci, by Robert F. Kennedy, Jr.

Number 1 on the NYT bestseller list

$3 on Kindle

https://www.amazon.com/Real-Anthony-Fauci-Democracy-Childrens/dp/1510766804

6 posted on 12/31/2021 2:01:04 PM PST by OKSooner (All thinking people should read "The Real Anthony Fauci" by RFK Jr.)
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To: SeekAndFind

Novavax uses protein subunit technology that’s been approved, and used, since the 1980s. Hepatitis and Shingles vaccines use it. This might make some difference for those who have refused to take the new-fangled mRNA vaccines.


7 posted on 12/31/2021 2:06:00 PM PST by LuxAerterna (/)
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To: LuxAerterna

Interesting.


8 posted on 12/31/2021 2:09:38 PM PST by BenLurkin (The above is not a statement of fact. It is either opinion, or satire. Or both.)
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To: SeekAndFind

Tested on HEK aborted fetal cells

https://cogforlife.org/wp-content/uploads/CovidCompareMoralImmoral.pdf


9 posted on 12/31/2021 2:13:34 PM PST by roving
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To: SeekAndFind

Been watching and waiting for Novavax to be approved. Many are thinking of taking that vaccine as opposed to the others.


10 posted on 12/31/2021 2:13:42 PM PST by ducttape45
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To: BenLurkin

They can review and approve the data in no time flat. However to make it public takes 55 years. Also, if Cormidity is approved why allow any more EUA’s.


11 posted on 12/31/2021 2:15:21 PM PST by RBW in PA
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To: LuxAerterna

Still used an aborted baby. Pass


12 posted on 12/31/2021 2:16:08 PM PST by roving
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To: stars & stripes forever

It’s funny how Nigeria had something like 16 deaths per million from Covid while America had 2200 per million. Might have something to do with Nigerians taking ivermectin weekly to combat both malaria and river blindness. But what’s a few thousand needless deaths if it means BigPharma and ppl like Fauci, Collins, and Gates make billions of dollars? That wouldn’t have happened if ivermectin and hydroxychloroquine were made easily available to us since day 1. Heads should roll when ppl finally realize what The Masters of the Universe®️ have done to us.


13 posted on 12/31/2021 2:27:26 PM PST by Prince of Space ( Let’s go, Brandon! )
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To: RBW in PA

Comirnaty licensing was approved in August by the FDA. However, testing won’t be finished until 2023 at the earliest. You cannot get a Comirnaty shot in America yet. Once it’s available, then EUA goes away and so does BigPharma’s shield from liability. That’s why they’re dragging their feet on actual approval, while the media does their part by falsely proclaiming that “the vaccine has been approved!” They think they’re so clever. 🤬


14 posted on 12/31/2021 2:33:46 PM PST by Prince of Space ( Let’s go, Brandon! )
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To: LuxAerterna

The Netherlands health minister authorized Novavax for those who don’t want the other shots recently.


15 posted on 12/31/2021 2:33:59 PM PST by Nextrush (FREEDOM IS EVERYBODYS BUSINESS, REMEMBER PASTOR NIEMOLLER)
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To: SeekAndFind

I thought there can’t be an EUA if there is an approved option, which there is now?


16 posted on 12/31/2021 2:36:21 PM PST by nickcarraway
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To: SeekAndFind

“protein-based vaccine”

yep,that would be the SPIKE protein:

“The Novavax vaccine uses a telltale piece of the coronavirus: the notorious spike protein.”

AND great news for anyone who wants to be injected with covid spike proteins PLUS their secret, propriety adjuvant, Matrix-M, a chemical designed to cause your immune system to go bonkers because their vax is so weak it won’t work without something to cause your immune system to hyper-react ... can anyone say: “I wonder if hyper-stimulating my immune system will trigger auto-immune disease or add new ones to my existing auto-immune diseases?”


17 posted on 12/31/2021 2:42:04 PM PST by catnipman (Cat Nipman: Vote Republican in 2012 and only be called racist one more time!)
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To: catnipman
In other words it's a typical vaccine.
18 posted on 12/31/2021 2:50:25 PM PST by palmer (Democracy Dies Six Ways from Sunday)
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To: ducttape45

Still not 100% crazy about this vaccine, but I would choose it over the others easily.


19 posted on 12/31/2021 2:56:59 PM PST by Paradox (Don't call them mainstream, there is nothing mainstream about the MSM.)
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To: nickcarraway

Novavax was grandfathered, as their application process started well before there was an approved vaccine. It wasn’t a “first approved wins” or Pfizer would be the only option.

There seems to be some foot dragging on Moderna’s approval and I wouldn’t be shocked if it doesn’t get approved. Same with J&J. Not that I’m predicting denial, but there are some safety signals with Moderna in people under 40 and myocarditis that need to be addressed. Same for J&J with thrombocytopenia.


20 posted on 12/31/2021 3:02:12 PM PST by ETCM
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