Posted on 05/27/2022 10:00:49 AM PDT by SeekAndFind
CORONAVIRUS UPDATE
Novavax Inc. is still waiting for U.S. regulators to decide whether to authorize its COVID-19 vaccine, which some experts believe could serve as an alternative option for people who are hesitant to get a mRNA vaccine.
Novavax’s vaccine, called Nuvaxovid, is a recombinant protein-based shot that is similar in design to a flu shot that’s been available in the U.S. since 2013.
This type of vaccine has a different makeup than the mRNA vaccines developed by Moderna Inc. BioNTech SE and Pfizer Inc. as well as the adenovirus shot from Johnson & Johnson
“I do think there is a minority group who would take a protein vaccine over an mRNA vaccine,” Dr. Kathleen Neuzil, director of the Center for Vaccine Development and Global Health at the University of Maryland, told Kaiser Health News. (Nuezil is a researcher for one of the Novavax vaccine trials.)
The Food and Drug Administration is expected to make a decision after the regulator’s vaccines advisory committee meets June 7 to discuss the risks and benefits of the investigational two-dose shot.
Nuvaxovid has been authorized as a vaccine or booster in several countries, including Australia, Europe, Japan, the U.K., and Singapore, where rollouts of the shot is currently underway. The company said Wednesday it is participating in a new Phase 2 trial in the U.K. that gives Novavax booster to teens who were vaccinated with the BioNTech SE and Pfizer Inc. vaccine. The company also applied for authorization of a booster for teens in the U.K. earlier this month.
That said, investor interest in Novavax has largely waned at the same time that the intensity of the pandemic has lessened. The stock hit an all-time high of $319.93 on Feb. 8, 2021, but has since tumbled 86% since through Wednesday’s closing price of $46.13.
(Excerpt) Read more at msn.com ...
The company’s COVID-19 vaccine is awaiting FDA authorization. But is there a need for it?
https://www.phillyvoice.com/novavax-covid-19-vaccine-fda-authorization-mrna-alternative/
[EXCERPT]
Although the U.S. commitment eventually expanded to $1.8 billion, hardly any Novavax shots have found arms due to manufacturing issues, and most of the world has moved on. Novavax stock has plummeted from $290 a share in February 2021 to around $50 recently.
The FDA finally appears poised to authorize the company’s vaccine, however. If it does, Novavax would target the tens of millions of Americans who are not vaccinated against COVID-19 or would benefit from boosters but have avoided mRNA vaccines because of health concerns or conspiracy theories about their dangers.
In clinical trials, Novavax’s two-dose vaccine has worked well and had few safety problems. It appears to cause fewer unpleasant reactions — fever, chills and exhaustion — associated with mRNA vaccines produced by Moderna and Pfizer-BioNTech.
Novavax also relies on a more time-tested technology, using recombinant proteins grown in cell cultures. An influenza vaccine produced much the same way as Novavax’s shot has been on the market in the United States for nearly a decade.
“I do think there is a minority group who would take a protein vaccine over an mRNA vaccine,” said Dr. Kathleen Neuzil, director of the Center for Vaccine Development and Global Health at the University of Maryland. She was a researcher in a major U.S. trial of the Novavax vaccine, which found it 100% effective at preventing anything worse than mild COVID-19.
With the FDA’s authorization, Novavax’s product would be the first vaccine produced in India for U.S. consumption. Novavax turned to the Serum Institute of India, a seasoned manufacturer that makes vaccines for poor countries, when its subcontractor in Texas, Fujifilm Diosynth Biotechnologies, stopped producing the vaccine last summer after it was dinged by FDA inspectors for inadequate contamination control, missing records and other problems.
MORE HERE:
https://www.phillyvoice.com/novavax-covid-19-vaccine-fda-authorization-mrna-alternative/
Even with FDA authorization, Novavax may be too late. While its vaccine is licensed in 41 countries and at least 42 million doses have been distributed, the world is overstocked with COVID-19 vaccine.
“They are applying for an emergency authorization” from the FDA, said Manon Cox, a vaccine industry consultant and the former CEO of Protein Sciences Corp., which made a similar vaccine. “What’s the emergency?”
Demand for COVID-19 vaccines is sluggish everywhere. About 13 million doses of the Novavax vaccine had been distributed in European Union countries as of mid-April, but fewer than 200,000 were administered. Distribution of the vaccine has been negligible since then.
Gavi, a nongovernmental organization, has suspended a 2021 agreement to buy at least 350 million Novavax doses for the COVAX program, which distributes vaccines at a deep discount to poor countries.
The U.S. market, however, shows promise for Novavax’s shot as an alternative to mRNA vaccines, especially now that the FDA has limited the use of a fourth vaccine, made by Johnson & Johnson, because of a serious though rare safety risk.
This is the one that I was waiting for, but have had Covid twice a little over a year apart... so probably won’t bother.
Seems to me that it’s devolving into a mild cold.
I am traveling to Italy in September. To get a “super green pass” (to travel on public transportation, go to tourist spots) I either have to get Covid (again) or get a jab. I would take this one. No MRNA for me.
What’s the adjuvant?
Cuz I’m betting there is one...
The Nuvaxovid™ (NVX-CoV2373) Novavax vaccine is a recombinant spike (S) protein nanoparticle vaccine combined with the Matrix-M adjuvant. On December 20, 2021, the European Commission of the European Union (EU) granted conditional marketing authorization for the Nuvaxovid™ (NVX-CoV2373) Novavax vaccine, following recommendations from the European Medicines Agency (EMA)...
Keep reading.
On a cold day in Hades, Deep State.
Nice try, though.
I got the CCP-Coronavirus at the end of March. It was much more like a flu than a cold. Because I refused the shots, I was required to quarantine for two weeks. It was not fun, a bit of a fever and sore throat and sneezing but the worst was a headache, severe body aches and even my skin ached to the touch. And extreme exhaustion! Even going to the bathroom exhausted me! No water for four days nor food for five.
After a week or ten days, I felt like I could return, but had to remain at home because of the quarantine. I did still feel weak after the two weeks.
As ‘flu’ and ‘colds’ that I’ve had in the past go, it was not the worst, though the ‘shingles’ like symptoms and body aches were a little nerve racking.
I only had mild fever both times. I fasted and drank chicken broth and coffee through both bouts. I also used Zicam nasal swabs and zinc lozenges which I keep on hand for colds anyway and they worked on covid. I had symptom relief for about 3-4 hours after each swabbing. I think they also prevented it from going down into my lungs in any great degree.
I practice extended fasting for both weight control and autophagy and always fast with broth for any illness.
Ditto here- this was the only one i would’ve considered taking. At this point i see no need for any of them
For Dr. Neuzil, the only reason why people would choose the mRNA vaccine over the Novavaxx product is that the mRNA vaccine was the only one approved and available. They would not be a minority group like she opines.
That's the rub.
My prediction is that the FDA will not approve Novovax, not because it doesn't work but because it does.
By approving Novovax, it will immediately put an end to the oversupplied, but still EUA-approved drugs by Pfizer and Moderna, because Novovax will make it available in the United States (unlike Pfizer which withheld Comirnaty until the experimental stock was used up).
So, the FDA will protect the profits of Big Pharma instead of the health of Americans by not approving the vaccine that does work in order to protect the profits of the drugs that don't work.
-PJ
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