[Done] Novavax Update/Watch Thread: Finally....FDA, NIH & CDC APPROVES FOR EUA

[WarBoyNux]

https://www.reuters.com/business/healthcare-pharmaceuticals/novavax-covid-19-vaccine-receives-emergency-use-authorization-indonesia-2021-11-01/

Nov 1 (Reuters) - Novavax Inc (NVAX.O) expects regulators in India, the Philippines and elsewhere to make a decision on its COVID-19 vaccine within "weeks," its chief executive told Reuters, after the shot on Monday received its first emergency use authorization (EUA) from Indonesia.
...
He said Novavax is “in dialogue with the U.S. FDA and ... we expect a full submission within the next several weeks.”

Novavax gets first approval in Indonesia.

[WarBoyNux]

https://cbs58.com/news/novavax-to-complete-data-submission-to-fda-by-end-of-the-year-for-authorization-of-its-coronavirus-vaccine

The biotechnology company Novavax plans to submit complete data to the US Food and Drug Administration soon for possible emergency use authorization of its coronavirus vaccine, CEO Stanley Erck told CNN in a phone interview Friday.

"We'll have a file in the US hopefully before the end of the year," Erck said.

If the FDA gives the green light, the first 100 million doses of the protein-based vaccine will be ready to ship following authorization, Erck said.
...
On Thursday, Novavax announced it completed the submission process for emergency use listing of its vaccine to the World Health Organization.

"We've actually filed in nine regulatory agencies just in the past half-dozen weeks," Erck said. "And that resulted in our first one where we got approval."

[choprzrul]

And even if it were, a new shot isn't really needed. Only the Elderly/Sick/Obese have anything to be concerned about - and they should be doing everything possible to avoid falling into the grave anyway.

My healthy 58 year old brother just died from the rona Wednesday night. No underlying conditions, no other illness, just rona. Saying "only" isn't exactly accurate.

.

[choprzrul]

why would Novavax have special interest to us ? It looks like another viral injected genetic type therapy like J&J.

This may help explain how Novavax works:

[HibikiR]

"Immune Activator", I guess that's the new term for adjuvant since that term triggers all the autism/poison conspiracy theorists.

[DGoodale]

My healthy 58 year old brother just died from the rona Wednesday night. No underlying conditions, no other illness, just rona. Saying "only" isn't exactly accurate.

.

I'm very sorry to hear that about your brother, my condolences and prayers.

[WarBoyNux]

My healthy 58 year old brother just died from the rona Wednesday night. No underlying conditions, no other illness, just rona. Saying "only" isn't exactly accurate.

.

Sorry for your loss. Sending prayers

[WarBoyNux]

Novavax is preparing to seek approval of their protein-based vaccine for COVID-19. And, in a user-friendly development, it comes with no major side effects.

That means no headaches, fevers, nausea or chills associated with mRNA vaccines from Moderna and Pfizer.

The journal Nature reports the Maryland company has already filed for use in Australia, Canada, the United Kingdom and the European Union, and Indonesia just awarded emergency use authorization.
...
And, 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.

I didn't know the CDC already approved Novavax for air travel.

https://www.msn.com/en-us/health/medical/novavax-coronavirus-vaccine-simple-and-a-likely-pandemic-game-changer/ar-AAQtkQR

[HibikiR]

Less a statement about the vaccine's effectiveness, but rather a way to prevent people from being singled out just because they volunteered to participate in the trial as mentioned in the last line.

[WarBoyNux]

Less a statement about the vaccine's effectiveness, but rather a way to prevent people from being singled out just because they volunteered to participate in the trial as mentioned in the last line.

Could be... In the UK, Novavax never got approved on the air travel list and the Brits in that trial had to end up getting 2 more shots of another brand on top of the 2-shot Novavax.

[WarBoyNux]

The company is on track to file with the U.S. Food and Drug Administration (FDA) by the end of the year, and has already called for a meeting with the agency to move forward, according to CEO Stanley Erck.

Erck told Yahoo Finance Live on Wednesday that the company expects to hear back from the FDA "very soon" and believes Novavax could receive up to five authorizations in the coming 6-8 weeks globally. But a majority of its distribution of actual doses is likely to start at the beginning of 2022.

"We do expect to be able to ship to Indonesia, and perhaps one or two other countries before the end of the year. But the majority of our production is scheduled for the first quarter," Erck said.

https://www.msn.com/en-us/health/medical/novavax-asks-for-fda-meeting-after-first-global-authorization-for-covid-19-vaccine-ceo/ar-AAQymQU

So expected EUA by E.O.Y. 2021, but you really won't see the vaccine here until the beginning of 2022.

[WarBoyNux]

Novavax gets approved in the Philippines.

https://www.chron.com/business/article/Novavax-NVAX-COVID-Jab-Gets-Philippines-Nod-16632591.php

Slapped with some class-action lawsuits by investors.

https://apnews.com/press-release/globe-newswire/business-boston-lawsuits-class-action-lawsuits-a0c69c294533a7a2b4760329c5657c76

https://news.bloomberglaw.com/litigation/novavax-hit-with-derivative-lawsuit-over-covid-19-vaccine-delay

And they will be attending a Health conference and will be talking about Novavax.

https://finance.yahoo.com/news/novavax-participate-evercore-isis-4th-141500154.html

GAITHERSBURG, Md., Nov. 23, 2021 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that it will participate in Evercore ISI's 4th Annual HealthCONx Virtual Conference. Novavax' recombinant nanoparticle protein-based COVID-19 vaccine candidate, NVX-CoV2373, will be a topic of discussion.

Conference Details: Fireside Chat

Date: Thursday, December 2, 2021

Time: 9:15 – 9:35 a.m. Eastern Time (ET)

Moderator: Josh Schimmer

Novavax participants: Gregory M. Glenn, M.D., President, Research and Development and John J. Trizzino, Executive Vice President, Chief Commercial Officer and Chief Business Officer

Conference

Event: Investor meetings

Date: Thursday, December 2, 2021

A replay of the recorded fireside session will be available through the events page of the Company's website at ir.novavax.com for 90 days.

[bruss01]

So, question....

If one of the necessary qualifications for being granted EUA is that there's no other treatment or prophylactic available...

AND

Phizer has an approved vaccine....

Then how does any other vax candidate qualify for EUA?

How can both be true? Answer... they can't.

Someone is not being truthful somewhere.

[Rockglocks]

To answer you correctly and technically Pfizer never had anything approved. If you look up the FDA approved vaccines bioNtech received the approval not Pfizer. Yes they do both work together but they are not the same company

The reason all the other ones can apply for emergency use authorization is because the approved drug does not exist in America and from their own statement they won’t exist till 2023. The only drug that exist in the United States of America is the Pfizer version which is only approved under EUA and it’s not the same thing as the approved FDA drug from bioNtechQUOTE=bruss01;26388172]So, question....

If one of the necessary qualifications for being granted EUA is that there's no other treatment or prophylactic available...

AND

Phizer has an approved vaccine....

Then how does any other vax candidate qualify for EUA?

How can both be true? Answer... they can't.

Someone is not being truthful somewhere.[/QUOTE]

[Libertarian777]

Novavax gets approved in the Philippines.

https://www.chron.com/business/article/Novavax-NVAX-COVID-Jab-Gets-Philippines-Nod-16632591.php

Slapped with some class-action lawsuits by investors.

https://apnews.com/press-release/globe-newswire/business-boston-lawsuits-class-action-lawsuits-a0c69c294533a7a2b4760329c5657c76

https://news.bloomberglaw.com/litigation/novavax-hit-with-derivative-lawsuit-over-covid-19-vaccine-delay

And they will be attending a Health conference and will be talking about Novavax.
https://finance.yahoo.com/news/novav...141500154.html

These types of lawsuits are frivolous. I work at a public Co with very significant vol in our stock, we get sued everytime the stock drops 10% (but never get sued when it rises 10%)