Novavax asks for FDA meeting after first global authorization for its COVID-19 vaccine: CEO

AOL ^ | 11/11/2021 | ANJALEE KHEMLANI

[SeekAndFind]

Novavax (NVAX) is getting some momentum for its two-dose COVID-19 vaccine, starting with a series of emergency use fillings globally and the first authorization in Indonesia this month.

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.

The company has scaled up production and estimates it will have 2 billion doses per year starting next year.

"We're going to go from zero to a very large scale very quickly," Erck said.

Novavax has applied for emergency use with the World Health Organization, the U.K., Canada, Australia, New Zealand and has completed a rolling submission with the European Union. With a majority of the world's population still unvaccinated, Novavax is poised to play a role in areas that are especially hard to reach with mRNA vaccines, which have more demanding storage and shipping requirements.

The company's use of protein-based technology, compared to mRNA, has made it slower to ramp up production and testing. But its efficacy is comparable, boasting 90% efficacy against earlier strains of the virus.

[SeekAndFind]

The company has delayed its timeline for various reasons — including manufacturing and issues with partners — throughout the year. But Erck has said that the recent filings should signal an end to the series of delays.

[cgbg]

Insider tip—dump lots of cash on the Democrats and FDA will give you the green light...

[rktman]

“AUTHORIZATION” for use. Approval? Meh!

[SeekAndFind]

Every time a Novavax Covid Vaccine Thread comes up, the question inevitably arises from some FReepers unfamiliar with its technology — what makes it different from Pfize, Moderna or J&J?

Like other EUA vaccines, The Novavax vaccine contains the spike protein of the coronavirus itself, but is formulated as a nanoparticle, which cannot cause disease, according to published reports.

It is a traditional protein-based vaccine platform used for decades to guard against hepatitis, tetanus and shingles. It also claims that in tens of thousands of tests, it comes with no major side effects. That means no headaches, fevers, nausea or chills associated with mRNA vaccines from Moderna and Pfizer.

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.

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.

[SeekAndFind]

Every time a Novavax Covid Vaccine Thread comes up, the question inevitably arises from some FReepers unfamiliar with its technology — what makes it different from Pfize, Moderna or J&J?

Like other EUA vaccines, The Novavax vaccine contains the spike protein of the coronavirus itself, but is formulated as a nanoparticle, which cannot cause disease, according to published reports.

It is a traditional protein-based vaccine platform used for decades to guard against hepatitis, tetanus and shingles. It also claims that in tens of thousands of tests, it comes with no major side effects. That means no headaches, fevers, nausea or chills associated with mRNA vaccines from Moderna and Pfizer.

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.

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.

[God luvs America]

This is one of the few vaccines i would consider taking.

I know doctors who are against the present vaccines but believe this one to be the best and safest. One doctor, a very liberal doctor who believes this whole this is a scam and being politicized, believes the chinese purposely made their virus and ivermectin works, says he wished this was available before he took pfizer. He told me “Novavax will be approved in the US sometime next year as pfizer and moderna still have millions of dosages they need to sell.”

[SeekAndFind]

RE: This is one of the few vaccines i would consider taking.

So, the issue of testing on already aborted fetal tissues does not concern you?

[PrincessB]

I believe the pfizer and moderna sales are the reason for the December 8 and January 4 deadlines to be fully vaxxed. I’ve been waiting for Novavax.

However,an employer mandate came to me. After a lot of hard thinking, research, running of the finances and prayer, I took the plunge with J&J. I believe my timing has it that Novavax will be here if I need a booster.

[rightwingcrazy]

“Like other EUA vaccines, The Novavax vaccine contains the spike protein”

To clarify further, the Novavax product contains modified spike protein, whereas the others (Pfizer, Moderna, J&J) contain genetic material that trick cells in the body into producing modified spike protein.

[proust]

Don’t care, still not getting it.

[SeekAndFind]

RE: I took the plunge with J&J

So, how’s it working out for you these days? Hope there were no side effects.

[NoLibZone]

Pfizer states of America.
Pfizer will never allow novavax to be authorized for use or available in the US.
Even if it’s available and authorized Pfizer will make sure that no pharmacies carry it.

[olivia3boys]

Me too—I chose J&J (so I can travel overseas) and will choose Norovax if I have to take a booster.

[NoLibZone]

The use of aborted fetal cells doesn’t bother anyone.
There has been no pushback by patriots in the US.
I have more respect for antifa than I do patriots.
Antifa is willing to fight for their beliefs.
Patriots or not

[PMAS]

Thanks for this

[ransomnote]

SeekAndFind wrote:

Every time a Novavax Covid Vaccine Thread comes up, the question inevitably arises from some FReepers unfamiliar with its technology — what makes it different from Pfize, Moderna or J&J?

In a way, they are all the same. They are all bioweapons launched in response to the Covid-19 hoax. No one needs any of these toxic vaccines. The same people who are fabricating a 'plandemic' are forcing people to get 'vaccinated' for the fake plandemic. Why?

Covid is highly survivable, even when denied Ivermectin and HCQ. Why be experimented on with Deep State vaccinse courtesy of Wuhan Fauci?

There are prophylatic steps to take to reduce risk - some as simple as Vitamin D3. There are safe and effective treatments with existing medications that cut the risk of hospitalization and death by 85%.

Like other EUA vaccines, The Novavax vaccine contains the spike protein of the coronavirus itself, but is formulated as a nanoparticle, which cannot cause disease, according to published reports.

Disease? It can't cause Covid? But what about adverse events? Sanofi is also a Covid 'vaccine' formulated using the same technology as Novavax and even though Sanofi is not offered formally in the US, VAERS has records of vaccine harm from Sanofi's Covid vaccine using that technology:

All those published reports lied to us about all the other safety hazards from all the other 'vaccines'. Firm, confident statements presented as facts which were just empty promotional content. One researcher phrased it as "chose to believe" as in  "the manufacturer (e.g., PFizer) chose to believe the vaccine would remain in the arm muscle" when in fact it was circulating places it should not go, depositing mRNA to generate spike proteins in vital organs.

It is a traditional protein-based vaccine platform used for decades to guard against hepatitis, tetanus and shingles. It also claims that in tens of thousands of tests, it comes with no major side effects. That means no headaches, fevers, nausea or chills associated with mRNA vaccines from Moderna and Pfizer.

Well, Sanofi usess the same technology as Novavax, and VAERS reports for Sanofi's Covid 'vaccine' includes headaches, nausea, chills, in the top 10 symptoms reported. 

Pfizer, Moderna and J&J claimed tens of thousands of tests there were no major side effects. They lied. Wuhan Fauci and the CDC want to thin the population - there's simply no reason for these vaccinse otherwise. So why believe them now.

The company, Novavax, doesn't exactly inspire confidence:

"....despite a nearly 30-year history making vaccines, Novavax has never won regulatory approval for one of its candidates, and whether the pandemic will finally change that remains to be seen."

Novavax launches pivotal U.S. trial of dark horse COVID-19 vaccine after manufacturing delays | Science | AAAS

Moderna was a failed company, too, before the influx of cash from the NIH to rush production on a new type of 'vaccine'.

If the CDC/NIH/FAUCI/FDA really thought Covid was like ebola, as they often pretend it is, would they really task failed companies Moderna and NOvavax to make them in a rush?

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.

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.

We shouldn't fall to fascism so easily. We don't need to show 'papers' to move around. The vaccinated are infecting and being infected. No vaccine for coronaviruses has ever existed to date, and some experts say none ever will. Moderna and PFizer are built on 20 years of failed attempts to create a Coronavirus 'vaccine'.

We don't need fake vaccines, fake plandemics or papers the government will use to tell us if we can travel, socialize, work, buy food, fuel or see a doctor.

[Tired of Taxes]

Bookmark

[Arcadian Empire]

The Baric-Daszak-Fauci spike protein, by itself, is deadly.

[PrincessB]

I felt like I was surviving a cold with DayQuil for an afternoon and that was it. I have been using every homeopathic prevention (sleep, exercise, vitamin d, etc.) for some time and I think that helped.