Posted on 01/03/2022 11:24:24 AM PST by SeekAndFind
In June 2021, MedPage Today wrote about whether Novavax and its "tried-and-true" subunit protein approach to a COVID-19 vaccine could potentially ease vaccine hesitancy. In this story, we explore what's known about the vaccine and why it still isn't on the market.
Pfizer, Moderna, and Johnson & Johnson: Ask any American, and they'll likely be able to rattle off the trio of COVID-19 vaccines available in the U.S.
But what about Novavax's "tried and true" protein subunit vaccine?
Early this year, public health experts told MedPage Today that Novavax -- whose vaccine strategy is used in other vaccines on the market today -- could provide another option to reach the vaccine hesitant.
The recombinant nanoparticle technology used in Novavax's protein subunit vaccine candidate (known as NVX-CoV2373) generates full spike protein, and the vaccine is formulated with an adjuvant to enhance immune response and stimulate high levels of neutralizing antibodies, according to the company.
The technology is the same as that used in the Flublok influenza vaccine, and is similar to other vaccines that have been around for a long time, like the hepatitis B, diptheria or tetanus vaccines.
However, nearly a year later, the Novavax vaccine still isn't available in the U.S. In August, Novavax announced that it was delaying submission of an emergency use authorization (EUA) to the FDA until the fourth quarter.
On December 15, full results from PREVENT-19, Novavax's pivotal phase III trial of its vaccine, were published in the New England Journal of Medicine.
The company said in an announcement that the trial achieved its primary endpoint of preventing infection at least 7 days after the second dose. Overall efficacy was 90.4% and efficacy against moderate-to-severe disease was 100%. Adverse events were mostly mild to moderate and transient. Severe reactions were infrequent, and there were no safety concerns related to vaccination.
Novavax did not immediately make a member of leadership available for an interview following the publication of the study. However, a spokesperson told MedPage Today in an email that it expects to submit its complete chemistry, manufacturing, and controls data package to the FDA by the end of 2021.
"We still anticipate a significant market need in the U.S. and globally," the spokesperson said.
At the same time, with the mRNA vaccines already saturating the market, it's not entirely clear how the Novavax vaccine will be rolled out or how it will resonate with consumers in the U.S., should it be granted an EUA from the FDA.
Mayank Mamtani, MSc, a senior biotech analyst and head of healthcare research at B. Riley Securities, told MedPage Today that the way to think about the vaccine is as an alternative to the mRNA vaccines. It is a "very strong vaccine," and while it may come late in the game, it has been differentiated, he noted.
"This is a very attractive option to have," he added.
In a December 16 research note, Mamtani wrote that NVX-CoV2373 is "well-suited for COVID's likely evolution into a relatively benign flu-like paradigm," adding that prior NEJM publications included datasets clinically validating that the Novavax platform "maintain[ed] high efficacy despite antigenic drifts, including via the adjuvant-specific effect."
"We view tolerability profile of a vaccine candidate to be a key consideration for use in a post-pandemic environment, where [Novavax] continues to stand out as the least reactogenic vaccine," he wrote.
The Novavax vaccine has made significant strides in other countries.
On December 20, the company announced that the European Commission had granted the vaccine conditional marketing authorization in people 18 and older. They noted that it had recently received an EUA in Indonesia and the Philippines, where it will be commercialized under the trade name Covovax. Covovax also received an emergency use listing from the WHO.
One day later, Novavax said it had initiated a booster study.
The vaccine's extended stability and simple storage requirements of up to 6 months at refrigerator temperatures make it "well suited for global deployment," according to the authors of the NEJM study.
"The efficacy of NVX-CoV2373 in preventing moderate-to-severe COVID-19 as well as any symptomatic COVID-19 in people at high risk for acquisition and complications of COVID-19 will make this vaccine a valuable tool in controlling the pandemic and its most serious health and economic consequences," they wrote.
Even with the trial's promising results, the question remains as to whether the Novavax vaccine will reach more of the vaccine hesitant in the U.S.
When the word “paradigm” is used it is time to watch out. It usually signals World Class BS.
Oravax is also in clinical trials and is also protein based. The major difference is that it targets 3 different proteins and is expected to provide better protection against variants.
I’d read they applied for EUA in the US on December 30 or 31 and hope to get it this month.
This looks like the safest vaccine but the protein nanoparticle uses the original amino acid sequence from the 2019 virus. Question is would it still work as the virus continues to mutate? Does anyone know?
The spike protein is what causes the damage. No thanks, no matter how you flood my body with them. Go away.
What vaccine? None of these are vaccines. They don’t work.
NO.
All of our politicians are invested financially to either Pfizer or Moderna, thank you very much..
They will NOT have any competition.
Where communists went wrong
The first communist revolutions , after coming to power, shot their revolutionists
.
Their useful idiots were untrustworthy and shot.
This created the unintended consequence of establishing an historical fact and thus became a detriment to future attempted revolutions.
I guess they thought their current revolution would succeed in global rule. Otherwise they would have foreseen creating this detriment.
That is where the communists went wrong.
They have found a way to circumvent this detriment.
Bioweapons, Mass psychosis and fraudici vaccinations.
They created the external threat of pandemic , then stampeded the useful idiot portion of the human herd that didn’t die of the bioweapon part 1 into the bioweapon 2 , the vaccinations .
Now, instead of eliminating the useful idiots after the revolution with lead shots, they have the surviving useful idiots eliminating them selves during the revolution with a vaccination shot.
Highly ironic and highly effective.
Highly evil.
They aim to win this time around.
/\
This ‘ shot’ would supercharge the destructive degradation of the immune system, expedite death ?
Well sign me up Scotty !/ s
.
We need to address HCQ hesitancy and Ivermectin hesitancy.
RE: The spike protein is what causes the damage. No thanks, no matter how you flood my body with them. Go away.
OK, should God forbid, you get Covid or have recovered from Covid, would you not have the spike protein anyway?
What’s the major difference?
“This looks like the safest vaccine but the protein nanoparticle uses the original amino acid sequence from the 2019 virus. Question is would it still work as the virus continues to mutate? Does anyone know?”
Yes I know. The other answer is yes. The number of mutations and the effect on immunity are greatly exaggerated in the press.
Thing about these vaccines also is that they can easily be modified to be specific for a new mutant strain if mutations were to confer attenuated immunosureillance.
And they still will not work. There are approximately 2000 variants noted in the Database.
The “money” quote...
“The company said in an announcement that the trial achieved its primary endpoint of preventing infection at least 7 days after the second dose. Overall efficacy was 90.4% and efficacy against moderate-to-severe disease was 100%. Adverse events were mostly mild to moderate and transient. Severe reactions were infrequent, and there were no safety concerns related to vaccination.”
Let me repeat that
“...Overall efficacy was 90.4% and efficacy against moderate-to-severe disease was 100%....”
Medical dictionary:
“efficacy An index of the potency of a drug or disease treatment; for a vaccine, efficacy is the percentage of persons who are protected by the vaccine”
“... simple storage requirements of up to 6 months at refrigerator temperatures”
NO HYDRA!
“And they still will not work. There are approximately 2000 variants noted in the Database.”
You know nothing about molecular biology.
You’re not a moron because of that.
You’re a moron because you say ludicrous things you know nothing about but think you do.
Interestingly I think it’s possible that “they still will not work,” as you say, but not because “There are approximately 2000 variants noted in the Database.”
You should have stopped at “And they still will not work.”
My family (wife, daughter, me) have been avoiding the mRNA vaccines and waiting for the Novavax to be approved in Japan, which is supposed to happen early this year.
“However, nearly a year later, the Novavax vaccine still isn’t available in the U.S. “
Can you say Hydroxychloroquine or Ivermectin?
Don’t expect to find ANY of these at your Walmart pharmacy anytime soon.
Hi, we’re from Big Pharma, and we are here to “hep you”.
(actually were are really here to FORCE you to take our vaxxines so we can make BILLIONS)
We get RICH whether you live or die. If you do survive, even if you get REAL sick, that’s even better! We will “booster” you FOREVER! Ka-CHING! (a little Chinese lingo there)
Big difference between putting a trace of spike protein into you body to induce an antibody response... vs using RNA coding to program your cells to produce trillions of spike proteins for weeks or months. The RNA vax does not inject you with spike protein. It programs your body to produce spike proteins,
What could possibly go wrong
I believe the answer is that there is too much money to be made by continuing the perpetual emergency, because as soon as a fully approved drug hits the American market the rest of the EUA drugs must be recalled.
Pfizer and Moderna will not allow that to happen until both have approved products ready to ship.
Meanwhile, Democrats are accusing Big Oil of market collusion.
-PJ
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