Novavax surges on the news European nod for COVID-19 shot is imminent

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• Novavax (NVAX +21.9%) shares have spiked after Reuters reported that European Medicines Agency (EMA) could soon clear the COVID-19 vaccine developed by the company.
• At a meeting in Brussels, Emma Cooke, the head of EMA, told EU health ministers on Tuesday: "The vaccine from Novavax could be authorised in the very near future."
• The company’s protein subunit vaccine named NVX-CoV2373 has already been greenlighted in both Indonesia and the Philippines.

• In a Phase 3 trial conducted in the U.S. and Mexico, NVX-CoV2373 has demonstrated 100% protection against moderate and severe COVID-19 with 90.4% in efficacy. In another pivotal trial conducted in the U.K., the vaccine has shown a 96.4% efficacy against the original virus with an overall efficacy of 89.7%.

• Read more on data from a mix-and-match study that involved NVX-CoV2373.

Comments

[Mijjoey]

FDA will NOT approve anytime soon because that will greatly reduce the royalties that NIH and Dem politicians receive from Moderna and Pfizer mRNA vaccines.

[Dr. LouX]

@Mijjoey Unfortunately you may have a point. Politics and $$$ tend to cloud vision.

[Doc 224899]

A falling (sector) tide lowers all boats.

and

Vaccine companies, prior to product approval, routinely have brief spikes and then sag, and then fluctuate in response to multiple factors. It's the common pattern.

[CitronSource]

You have to wonder, if EVERYONE is already CONVINCED of EMA approval next week, WHY would it rally upon the actual announcement. Certainly, market action since this headline hasn't been encouraging.

[27717033]

@CitronSource I read the SEC has launched an investigation into short sellers. Have you heard anything about it?

[CitronSource]

@27717033 "Have you heard anything about it?"???

Nope! But you have to wonder why would anyone short into a presumed approval announcement unless they were pretty confident that everyone interested had ALREADY bought into the stock, leaving nothing but potential sellers behind.

[BBwetrust]

Dropped like a rock in the after-hour. Why?

[Rhmassing]

@BBwetrust NVAX was up over $40 and MRNA up $17 today. Both dropped after market about the same at -$7, so a mere 4% drop after a glorious day is not dropping like stone, but profit takers making a easy 28% today. Sellers will regret with the EU and UK announcement soon enough .

[CitronSource]

Come to think of it -- who cares? Omicron is CLEARLY rapidly pushing covid-19 and all its other variants off of the map and, so far, it's looking like omicron is so mild that doesn't really NEED a vaccine.

[CitronSource]

Can you imagine what will happen to the stock price if the EMA requests more information?

[WWG1_WGA_Q]

@CitronSource only in your dreams?
Cheers and enjoy the ride much, much higher by eoy my friend.

SuperNova

[cchpgc]

@CitronSource - That is a real possibility so be prepared for it.

[dsPragmaticInvestor]

The study on efficacy has been published months ago. Approval was likely. Strange the market did not put that in the price already.

[Dr. LouX]

@dsPragmaticInvestor Not priced in already? There have been many false starts.

[StrawberryDream]

Tolle Nachricht.Zuletzt…Lass uns gehen Leute!

Finally the pieces of the puzzle….perhaps!?!I’m in!;);p

[eduso]

I really wonder why this one has not filled application yet with FDA in the USA. Opinions?

[sKibi]

@eduso because it is using US production sites to make that filing is my speculation while all the others it could use Serum as the manufacturing for initial license since the plant already previously certified by EMA, MHRA, and WHO.

We shall see whether FDA gets filed by Q4 (December 31st) as the company has been saying ever since May. So not sure why there is that much wondering.

[eduso]

@sKibi Thanks for you views. To me this company is a huge question mark. So far, little to be proud of, but maybe will shine someday.

[sKibi]

@eduso nothing in life is risk-free. I merely addressed your question and “wondering” if you hadn’t been keeping up with its history and disclosures about the FDA.

[khlim115]

Is this not unusual for the head of the EMA to make an announcement like this? What if the committee does not come through? He will look like a idiot. Strange times.

[sKibi]

@khlim115 EMA has many leaks from its public sessions (and private sessions) as the agency has to continually update the health ministries of EU members. She didn’t make an “announcement” per se but was quoted on her public briefing session to the other health ministers.

[cchpgc]

It might see $200 again if it gets EU approval. US approval still in doubt.

[MICHAELSONG]

@cchpgc after EU approval UK and common wealth approvals will follow very shortly.. also India, as they clearly said they wait these approvals..

then fda "politicians" will not be able to drag their feet..

[cchpgc]

@MICHAELSONG - The US has no reason to approve NVAX. It does not need it and there is no upside for the FDA to approve.

[StrawberryDream]

@cchpgc Nvax doesn’t need fda approval if the fda want to be political and stubborn for some odd reason.It needs WHO.

Its edge so to say is the still huge chronically under vaccinated lower and middle income countries of the world (never mind boosters yet) ie. most of the worlds population.

The ‘developed’ world is surely coming to its senses that variant rates won’t be potentially slowed down until these folks get fully vaccinated.

Worldwide travel, flying and tourism are at risk.We are living in a globalised society nowadays after all.

[Lodge66]

I bought shares yesterday believing the stock was close or at its bottom, so I got lucky. However, the other shoe often slams down on this stock. Hopefully, NVAX is closing in on delivering their promises...........

[FiscalResp]

Is this also an mrna "vaccine" or a traditional?

[MICHAELSONG]

@FiscalResp traditional and will be suitable even for kids..and works well in cross vaccinations as well..

[J D R]

Too late, the pandemic is over, if it ever was one. Omicron seems harmless.

[Carlos08]

@UUII too late!!! 22% Up

[Captain Jakob Schwanz]

@UUII Please update yourself/read more news, especially in regards to need for booster shots, and vaccine rates in non-EU, non-US countries.

Long $NVAX

[Ishi Kenjo]

@UUII False... it will take years to wind down this epic scam. Rhe third world thinks they need vax too. Billions will be served up vax... at least NVAX is better & safer because it is time proven method/not mrna, not unknown effects, and it has natural soother for immune system. Not to mention much more affordable for poor countries. God forbid if smaller fush compete with PFE! Go NVAX!!!😊

[AlieGee]

Impressive move today.

[Dr. LouX]

@AlieGee Hey Al, what do you think? Finally for real? My best guess is it is, but I have been fooled before! Lou

[billygoatsgruff]

@Dr. LouX I hope so, my quote for Novavax so far has been "fool me once, shame on you, fool me twice and thrice, well I'm still around."

[Dr. LouX]

@billygoatsgruff Same here! LOL

[Doc 224899]

The EMA asked the company about not having an approval from the FDA, taking into account that it's an American company.

I guess the EMA accepted the explanation that our FDA is kind of retarded and bogged down with political conflicts and failures of administrative and bureaucratic leadership, which is apparently being recognized internationally.

[billygoatsgruff]

@Doc 224899 ok this is hysterical...and absolutely true i'm afraid!

[Dr. LouX]

@Doc 224899 FDA motto "No decision is the best decision."

[thesavvyinvester]

@Doc 224899 I am imaging Dan Akroyd reading that in his newscaster voice, back in the day when he was doing the news with Jane you ignorant ***t. I dare you S.A posters/readers to tell me that isn't funny...

[Jianguo Xin]

Go $NVAX, babe!