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Novavax Covid Vaccine getting ready to apply for full approval
WDEF ^ | 09/07/2021 | Joeli Poole

Posted on 09/11/2021 5:25:06 PM PDT by SeekAndFind

The Novavax Covid vaccine has undergone months of clinical trials against not only the original coronavirus strain but also the new variants.

The Maryland based biotech company says it’s 2 dose vaccine is around 90 percent effective and is safe – after being tested on nearly 30 thousand trial participants.

“Where we are currently as investigators reviewing data with the sponsor. The FDA is looking at safety data and following up with patients who were vaccinated early this year to see if any of them have breakthrough cases and then trying to give efficacy results to the public so we can have another option out there for Covid,” says Dr. Mark McKenzie, Regional Medical Director for ClinSearch.

Recently The CDC announced that participants in the Novavax PREVENT-19 Phase 3 clinical trial are considered fully vaccinated two weeks after they have completed the vaccine series.

Chattanooga resident Brooke Marsh was one of these participants.

“I was really glad to hear that they considered it fully vaccinated. It’s a more traditional vaccine. I have had nothing but good experiences from it. I didn’t have any side effects from either set of shots. I think they are very trustworthy,” says Marsh.

The company says they plan to seek full authorization to distribute the vaccine within the next few months- with the focus being on low to middle income countries.

“It’s a different type of vaccine though. Moderna and Pfizer are mRNA vaccines. This one is a protein subunit vaccine. It’s a type of vaccine that we have used for flu, hepatitis, and HPV in the past. But this one is targeting the world. It will be available to people around the world in addition to what’s out there. Hopefully it will be at a lower cost for some countries that don’t have the resources like the United States has,” says Dr. McKenzie.

Dr. Mark McKenzie is hoping that with this fourth vaccine being a more familiar type of vaccine – those who have felt uneasy, will finally feel comfortable with getting vaccinated.

On Tuesday, Japan secured 150 million doses of the Novavax vaccine.


TOPICS: Culture/Society; News/Current Events
KEYWORDS: approval; covid; novava; vaccine
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1 posted on 09/11/2021 5:25:06 PM PDT by SeekAndFind
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To: SeekAndFind

It’s about freekin’ time.


2 posted on 09/11/2021 5:27:10 PM PDT by Paladin2 (Critical Marx Theory is The SOLUTION....)
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To: SeekAndFind
"It’s a different type of vaccine though. Moderna and Pfizer are mRNA vaccines. This one is a protein subunit vaccine. It’s a type of vaccine that we have used for flu, hepatitis, and HPV in the past."

Isn't the J&J COVID vaccine similar to the flu shots also?

3 posted on 09/11/2021 5:28:53 PM PDT by CatOwner (Don't expect anyone, even conservatives, to have your back when the SHTF in 2021)
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To: Paladin2

RE: It’s about freekin’ time.

The title says FULL APPROVAL. I understand this to mean that it will not be simply the Emergency Use Authorization (EUA) like the FDA gave the other three vaccines, but FULL APPROVAL.


4 posted on 09/11/2021 5:29:19 PM PDT by SeekAndFind
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To: SeekAndFind

Later


5 posted on 09/11/2021 5:29:30 PM PDT by servantboy777
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To: SeekAndFind

No abortion-derived cell lines.


6 posted on 09/11/2021 5:32:07 PM PDT by Jeff Chandler (THE ISSUE IS NEVER THE ISSUE. THE REVOLUTION IS THE ISSUE.)
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To: SeekAndFind

Really hoping for this one. Doesn’t have the blood clots, GB syndrome and not mRNA.


7 posted on 09/11/2021 5:36:28 PM PDT by Tuxedo (We have become China… the destroyer of worlds…)
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To: SeekAndFind

It’s the pure antigen, not instructions for your ribosomes to produce it. Less than the mRNA vaxxes produce because it comes with an adjuvant to enhance immune system response. They found a way to trick an immortal moth cell line into producing the spike protein instead of making your own cells do it. The adjuvant is an extract from tree bark. It’s really interesting stuff, but it’s still focused on a single protein.


8 posted on 09/11/2021 5:38:28 PM PDT by Billthedrill
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To: SeekAndFind

My wife was part of the trial, and she came down with it over the labor day weekend. She was pretty sick, but has mostly gotten over it. She has now tested covid negative.

Now I’m sick with a sinus thing that isn’t covid. I am not vaccinated. Four tests, all of them negative. FWIW


9 posted on 09/11/2021 5:41:00 PM PDT by ecomcon
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To: SeekAndFind

Let’s all sing happy days are here again!!!!!!


10 posted on 09/11/2021 5:42:55 PM PDT by shanover (...To disarm the people is the best and most effectual way to enslave them.-S.Adams)
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To: SeekAndFind

Well, hurry up, Novavax.

This is a US company, and other countries have the vaccine before we do.


11 posted on 09/11/2021 5:44:12 PM PDT by Tired of Taxes
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To: SeekAndFind

Thanks for posting this.


12 posted on 09/11/2021 5:44:51 PM PDT by Fury
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To: SeekAndFind

This vaccine trial study reads just like the others…
1. Reduces “laboratory confirmed symptomatic COVID-19”, i.e. reduces symptoms but doesn’t stop transmission.
2. Uses relative reduction instead of absolute reduction. Relative reduction is 90% or whatever. Actual reduction from vaccine to placebo is less than 1% (because less than 1% of placebo participants got “laboratory confirmed symptomatic COVID-19 “. Go figure.


13 posted on 09/11/2021 5:51:39 PM PDT by Meah (The terrain is everything. ~Louis Pasteur )
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To: Billthedrill
Fascinating paper here....

The impact of immuno-aging on SARS-CoV-2 vaccine development

Scroll down to vaccine strategies for the scary ****. Includes a brief mention of that saponin-based adjuvant you mentioned.

14 posted on 09/11/2021 5:53:41 PM PDT by mewzilla (Those aren't masks. They're muzzles. )
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To: CatOwner
Isn't the J&J COVID vaccine similar to the flu shots also?

No, it's an adenovirus vector. Not traditional like deactivated viruses. But not as new as the RNA vaccines from Pfizer and Moderna.

15 posted on 09/11/2021 5:55:05 PM PDT by palmer (Democracy Dies Six Ways from Sunday)
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To: SeekAndFind

I would get this vaccine.


16 posted on 09/11/2021 5:55:16 PM PDT by Recovering_Democrat
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To: Jeff Chandler

Not used in production, but HEK lines were used in testing, so it’s not totally free of the use of aborted fetal cells. I had high hopes for this one so was disappointed to read that testing involved fetal cells.


17 posted on 09/11/2021 5:55:24 PM PDT by kalee
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To: Meah
Relative risk reduction means the vaccine works. Absolute risk reduction means that nobody is exposed to COVID, vaccinated or not.
18 posted on 09/11/2021 5:56:58 PM PDT by palmer (Democracy Dies Six Ways from Sunday)
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To: SeekAndFind

So if this is approved, will the regime stop it from being used in US?


19 posted on 09/11/2021 5:57:58 PM PDT by JstABrdPstr
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To: JstABrdPstr

RE: So if this is approved, will the regime stop it from being used in US?

The answer is — we don’t know. My bet is it will be approved for use in Europe, Australia, New Zealand and many Asian Countries first before it gets approved here because of FDA bureaucracy.


20 posted on 09/11/2021 6:02:08 PM PDT by SeekAndFind
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