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European Regulator Starts Assessing Novavax’s Covid Vaccine—Stock Jumps 8%; Green Light Could Come "Within Weeks"
Forbes ^ | 11/17/2021 | Robert Hart

Posted on 11/17/2021 10:14:12 AM PST by SeekAndFind

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The company has already filed for emergency authorization in India, the World Health Organization, Canada, the U.K. and Australia.


1 posted on 11/17/2021 10:14:12 AM PST by SeekAndFind
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To: SeekAndFind

I remember when it took more than “weeks” to get a new medicine approved.


2 posted on 11/17/2021 10:18:28 AM PST by ClearCase_guy (Alec Baldwin has killed more people than the Jan 6 protesters. And he will serve less jail time.)
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To: ClearCase_guy

yeah but now they grease the skids or palms and voila...


3 posted on 11/17/2021 10:19:52 AM PST by rolling_stone
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To: SeekAndFind
And I am not taking this one either.
4 posted on 11/17/2021 10:21:22 AM PST by Harmless Teddy Bear (add a dab of lavender in milk, leave town with an orange and pretend you're laughing with it)
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To: rolling_stone

Maybe it’s too bad that some of the Regulators aren’t grown up Thalidomide babies — no palms to grease.


5 posted on 11/17/2021 10:22:06 AM PST by ClearCase_guy (Alec Baldwin has killed more people than the Jan 6 protesters. And he will serve less jail time.)
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To: SeekAndFind

SOME Q&A about the Novavax Covid vaccine:

SOURCE:

https://www.mercurynews.com/2021/11/15/novavax-coronavirus-vaccine-when-can-i-get-it-and-how-does-it-work/

Q: When can I get a Novavax coronavirus vaccine?

A: The vaccine, called NVX-CoV2373, is not currently available in the United States. The company expects to submit data to the Food and Drug Administration by the end of the year. Once authorization is requested, a rigorous review process will take place before the shot is cleared for use in the general public.

Q: What makes this coronavirus vaccine different from the ones we already have?

A: The Novavax vaccine is protein-based and uses the same platform as shots for shingles and hepatitis. The proteins deliver immune stimulation directly into a person’s cells as opposed to a fragment of genetic code. It is not an mRNA as is the case with Moderna and Pfizer, or an adenovirus vector, such as the Johnson & Johnson vax.

Q: How does it work?

A: The Novavax coronavirus vaccine is engineered from the genetic sequence of coronavirus with nanoparticle technology. The technology binds with human receptors targeted by virus which is critical for effective protection. When the vaccine is injected, it stimulates the immune system to produce antibodies.

Q: Is it safe and effective?

A: Clinical trials for the Novavax shot have shown an overall 90% efficacy against coronavirus and 100% protection against moderate and severe disease. Most common side effects include injection site pain and tenderness, fatigue, headache and muscle pain. No single adverse reaction was reported by more than 1% of trial participants.

Q: Can foreign travelers show proof of the Novavax vaccine to enter the United States?

A: Yes. Novavax clinical trial participants from sites outside the U.S. are considered fully vaccinated if they received the same product that was administered in the U.S. clinical trials. It is one of the vaccines already approved by the Centers for Disease Control and Prevention for air travel in the U.S., giving the 30,000 in the trial for the jab a passport to move around, whereas other shots haven’t made the cut.

Q: Could children get this vaccine?

A: The vaccine is not yet authorized for use in the United States, but Novavax initiated a pediatric expansion of a phase 3 clinical trial in May 2021 for children ages 12-17. The company intends to pursue authorization in that age group and younger age groups.

Q: How is it administered?

A: Two doses are given three weeks apart.


6 posted on 11/17/2021 10:24:03 AM PST by SeekAndFind
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To: ClearCase_guy

excellent point!


7 posted on 11/17/2021 10:32:40 AM PST by rolling_stone
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