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

[WarBoyNux]

Novavax applies to WHO for emergency listing of COVID-19 vaccine

https://www.reuters.com/business/healthcare-pharmaceuticals/novavax-applies-who-emergency-listing-covid-19-vaccine-2021-09-23/

Sept 23 (Reuters) - Novavax Inc (NVAX.O) and its partner Serum Institute of India have applied to the World Health Organization for an emergency use listing of Novavax's COVID-19 vaccine, potentially clearing the way for the shot to ship to many poorer countries, the company said on Thursday.

Novavax has been prioritizing regulatory submissions to low- and middle-income countries after falling behind in the race for authorization in the United States and Europe, which have already vaccinated most of their residents

[stonefly-2]

How bout them Nics huh?

[SPUTTER]

You mean Knicks

[stonefly-2]

You mean Knicks

You're right,

never seen it written before.

[Foothills]

It works great so far.

[WarBoyNux]

How bout them Nics huh?

No, this is CAL-Guns....so how bout them Dodgers?

[Sgt. J Beezy]

[Dan_Eastvale]

Not applying to FDA for approval may mean that it IS much more effective than their current 3 cash cows.

[CheapBloke]

No, this is CAL-Guns....so how bout them Dodgers?

So how bout them cheerleaders?

Sent from my SM-N960U using Tapatalk

[stonefly-2]

So how bout them cheerleaders?

Sent from my SM-N960U using Tapatalk

As long as they aren't "vaxxed" no violation of the "no other "vax" talk" rule.

[WarBoyNux]

Today is the last day of the 3rd quarter.....more delays?

https://www.fool.com/investing/2021/09/30/should-you-buy-novavax-on-the-dip/

Now, let's consider the Novavax situation. The biotech company was a favorite since the start of the vaccine race. Novavax has proven its vaccine expertise. It's brought a flu candidate -- NanoFlu -- successfully through trials. The next step is regulatory authorization. The U.S. government last year invested a whopping $1.6 billion in Novavax's nascent COVID-19 vaccine program.

And Novavax followed up on those wins with strong clinical trial data from the vaccine candidate. In the U.S. phase 3 trial, the vaccine candidate was 90.4% effective in preventing mild, moderate, and severe disease. It showed 100% efficacy against moderate and severe disease.

So why isn't this potential product on the market right now? When companies apply for vaccine authorization, they must submit manufacturing information. They have to show they can actually produce doses at scale. Novavax has built a supply chain network spanning 10 countries. But the company has struggled with raw material shortages and related manufacturing issues. This has held up its progress toward an EUA.

...

But what if Novavax announces another delay and doesn't make it to market this winter? That's the biggest risk right now. This would be problematic for a few reasons. First, it would delay vaccine revenue. Second, it puts Novavax in danger of missing the EUA window. Once the pandemic is over, the FDA won't evaluate vaccine candidates for rapid authorization. This process only exists during public health emergencies. After the pandemic, the FDA would review applicants for full approval. That usually takes six to 10 months. And third, another delay would further damage investors' confidence in Novavax's ability to actually produce its vaccine for a global population. So, if a delay happens, I would expect the shares to extend declines.

[WarBoyNux]

-No new news on the Novavax U.S. front except for some upper management new-hires and a promotion.

-WHO still hasn't gave their authorization approval.

-Australia expects the Novavax to be out in November for them.

https://www.abc.net.au/news/2021-10-13/when-is-the-novavax-vaccine-coming-to-australia-/100532184

When is Novavax coming to Australia?
The federal government has said it expects Novavax to begin arriving in Australia in November.

But before it starts being used it will have to be approved by the Therapeutic Goods Administration, which currently lists the vaccine as "under evaluation".

-Seems to be a logistics/mfg delay that is really holding things up.

[Libertarian777]

-No new news on the Novavax U.S. front except for some upper management new-hires and a promotion.

-WHO still hasn't gave their authorization approval.

-Australia expects the Novavax to be out in November for them.

https://www.abc.net.au/news/2021-10-13/when-is-the-novavax-vaccine-coming-to-australia-/100532184

-Seems to be a logistics/mfg delay that is really holding things up.

This is literally how it works (approval relates to logistics not science).
So Pfizers approval had nothing to do with the vaccines efficacy. Approval hinges on the ability of the company to safely manufacture at scale (plus documented tracked etc).

Pfizers been in the game a long time so they could get this approved easily, they know how to fill the paperwork.

Novavax being new hasn't scaled manufacturing and doesn't have as many ex FDA / CDC folks working for them. They haven't been able to scale or file the paperwork, hence the delay. It has nothing to do with the vaccines efficacy or safety. That's done in phase 1 through 3

[WarBoyNux]

Investor fraud?

https://apnews.com/press-release/globe-newswire/coronavirus-pandemic-business-health-2433cdc9df66b3384c3d3326a8d81a64

[LBDamned]

How bout them Nics huh?

You mean Knicks

No, this is CAL-Guns....so how bout them Dodgers?

Are these badminton teams?