> Novavax covid vaccine FINALLY approved by the FDA for Emergency Use.Previous | First | 1 | Last | Next
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anon user #3Novavax covid vaccine FINALLY approved by the FDA for Emergency Use.
Better late than never. This is the one I received for my first two doses. So now I officially have had 5 FDA authorized vaccine doses. I'm glad I decided to switch to Pfizer and left the trial. Otherwise I would just now be getting an FDA approved card AFAIK.
Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the Novavax COVID-19 Vaccine, Adjuvanted for the prevention of COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older.
“Authorizing an additional COVID-19 vaccine expands the available vaccine options for the prevention of COVID-19, including the most severe outcomes that can occur such as hospitalization and death,” said FDA Commissioner Robert M. Califf, M.D. “Today’s authorization offers adults in the United States who have not yet received a COVID-19 vaccine another option that meets the FDA’s rigorous standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization. COVID-19 vaccines remain the best preventive measure against severe disease caused by COVID-19 and I encourage anyone who is eligible for, but has not yet received a COVID-19 vaccine, to consider doing so.”
The FDA has determined that the Novavax COVID-19 Vaccine, Adjuvanted has met the statutory criteria for issuance of an EUA. The data support that the known and potential benefits of the vaccine outweigh its known and potential risks in people 18 years of age and older, and that this vaccine may be effective in preventing COVID-19. In making this determination, the FDA can assure the public and medical community that a thorough analysis and evaluation of the available safety and effectiveness data and manufacturing information have been conducted.
The Novavax COVID-19 Vaccine, Adjuvanted is administered as a two-dose primary series, three weeks apart. The vaccine contains the SARS-CoV-2 spike protein and Matrix-M adjuvant. Adjuvants are incorporated into some vaccines to enhance the immune response of the vaccinated individual. The spike protein in this vaccine is produced in insect cells; the Matrix M-adjuvant contains saponin extracts from the bark of the Soapbark tree that is native to Chile.
“After a comprehensive analysis and evaluation of the data, and assessment of the manufacturing processes and information, as well as input from the FDA’s committee of external independent advisors, the FDA’s medical and scientific experts have determined that the vaccine meets the FDA’s high standards for safety and effectiveness for emergency use authorization,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “Novavax COVID-19 Vaccine, Adjuvanted provides another alternative for adults and adds another vaccine to the COVID-19 vaccine supply for the United States. The American public can trust that this vaccine, like all vaccines that are used in the United States, has undergone the FDA’s rigorous and comprehensive scientific and regulatory review.”
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anon user #3Re: Novavax covid vaccine FINALLY approved by the FDA for Emergency Use.
Note that this is NOT an mRNA vaccine. So if any of you are afraid of the mRNA technology for whatever reason then this is another option for you.
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RockHardConservativeRe: Novavax covid vaccine FINALLY approved by the FDA for Emergency Use.
anon user #3 wrote:
Note that this is NOT an mRNA vaccine. So if any of you are afraid of the mRNA technology for whatever reason then this is another option for you.
I would assume people are afraid of this vaxx because it causes myocarditis.
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anon user #3Re: Novavax covid vaccine FINALLY approved by the FDA for Emergency Use.
RockHardConservative wrote:
I would assume people are afraid of this vaxx because it causes myocarditis.
Novavax? Really? I had not seen that. Of course I haven't been paying much attention to this stuff lately.
Can you post a legitimate source for this?
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TesticularFortitudeRe: Novavax covid vaccine FINALLY approved by the FDA for Emergency Use.
You guys still pushing Vaxxes? 
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Re: Novavax covid vaccine FINALLY approved by the FDA for Emergency Use.
TesticularFortitude wrote:
You guys still pushing Vaxxes?
No shyt. Are they really using the same playbook from 2020?
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RockHardConservativeRe: Novavax covid vaccine FINALLY approved by the FDA for Emergency Use.
anon user #3 wrote:
Novavax? Really? I had not seen that. Of course I haven't been paying much attention to this stuff lately.
Can you post a legitimate source for this?
Sure.
https://www.science.org/content/blog-po … ne-finally
So how well does it work, and how safe is it? That's what the advisory committee is hashing out today, and if you want live updates, I would suggest following Helen Branswell on Twitter. There has already been controversy about indicidents of myocarditis during the trials, which is quite interesting, because that's been an issue to some degree with several other vaccines as well. It seems that it's not something to do with the mRNA or the adenovirus platforms per se, since we're seeing it here (edited because there has been far less sign of it in the adenovirus vaccines). What's in common is the Spike protein. Novavax, it must be said, disputes that there is a relationship with its vaccine, saying that there is not enough data, but the signals seem stronger than were seen with the other vaccines, so we'll see how that argument flies. Expect that to be a big topic of discussion as the day goes on! The age dependence will be much scrutinized - other vaccines have shown that younger patients (teenagers) seem at most risk, and several of the Novavax cases were in young men. But for this vaccine and the others, the myocarditis has been much milder than "regular" viral myocarditis infections, which is good
It only gives you a little bit of myocarditis. 
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anon user #3Re: Novavax covid vaccine FINALLY approved by the FDA for Emergency Use.
RockHardConservative wrote:
Sure.
https://www.science.org/content/blog-po … ne-finally
So how well does it work, and how safe is it? That's what the advisory committee is hashing out today, and if you want live updates, I would suggest following Helen Branswell on Twitter. There has already been controversy about indicidents of myocarditis during the trials, which is quite interesting, because that's been an issue to some degree with several other vaccines as well. It seems that it's not something to do with the mRNA or the adenovirus platforms per se, since we're seeing it here (edited because there has been far less sign of it in the adenovirus vaccines). What's in common is the Spike protein. Novavax, it must be said, disputes that there is a relationship with its vaccine, saying that there is not enough data, but the signals seem stronger than were seen with the other vaccines, so we'll see how that argument flies. Expect that to be a big topic of discussion as the day goes on! The age dependence will be much scrutinized - other vaccines have shown that younger patients (teenagers) seem at most risk, and several of the Novavax cases were in young men. But for this vaccine and the others, the myocarditis has been much milder than "regular" viral myocarditis infections, which is good
It only gives you a little bit of myocarditis.
Thanks!
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RockHardConservativeRe: Novavax covid vaccine FINALLY approved by the FDA for Emergency Use.
anon user #3 wrote:
Thanks!
No problem enjoy the heart damage!
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anon user #3Re: Novavax covid vaccine FINALLY approved by the FDA for Emergency Use.
I will say as a Novavax trial participant at my location it was a total clusterfuq. I mostly kept my mouth shut about that because I did not want to discourage people from trusting the vaccine but honestly the trial was horribly ran at my location. On the first day I got the vaccine and that night had a fever. Instructions said to call a number and leave a message. Someone was then supposed to call back in 10 minutes or so. They NEVER did and no one ever had any record of this. Also when I was weighing whether to leave the trial to get the Pfizer vaccine (as I didn't know if I had the placebo or not) I called MANY times and left many messages. It took many weeks for anyone to ever return my calls and by then I had already got the vaccine. From investigating further there were many complaints of this sort of thing at my location and several others in Florida.
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anon user #3Re: Novavax covid vaccine FINALLY approved by the FDA for Emergency Use.
RockHardConservative wrote:
No problem enjoy the heart damage!
Well it has been about 1.5 years so....
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RockHardConservativeRe: Novavax covid vaccine FINALLY approved by the FDA for Emergency Use.
anon user #3 wrote:
I will say as a Novavax trial participant at my location it was a total clusterfuq. I mostly kept my mouth shut about that because I did not want to discourage people from trusting the vaccine but honestly the trial was horribly ran at my location. On the first day I got the vaccine and that night had a fever. Instructions said to call a number and leave a message. Someone was then supposed to call back in 10 minutes or so. They NEVER did and no one ever had any record of this. Also when I was weighing whether to leave the trial to get the Pfizer vaccine (as I didn't know if I had the placebo or not) I called MANY times and left many messages. It took many weeks for anyone to ever return my calls and by then I had already got the vaccine. From investigating further there were many complaints of this sort of thing at my location and several others in Florida.
Jesus.
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Phillip_McCavityRe: Novavax covid vaccine FINALLY approved by the FDA for Emergency Use.
The Novavax sounds like an early Unix machine. 
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anon user #3Re: Novavax covid vaccine FINALLY approved by the FDA for Emergency Use.
RockHardConservative wrote:
Jesus.
To be fair they still collected all the data in a special app. We had to report temperature and any symptoms daily in a special app. And I think actually the reason for wanting us to call that number and leave a message if we had a fever was because they were trying to get positive cases (if you had symptoms they would instruct you to come in for a blood test - they needed the positive cases in the control group to give to the FDA). So when I called the night of getting the shot they really didn't want that. But they should have communicated that somewhere and someone still should have called me back.
Still it was my first clinical trial and it did not leave me with much confidence in them. That was part of the reason why I left the trial and just got the Pfizer doses. I felt I could no longer trust them. All the same though I actually was given two Novavax doses and it was not the placebo. I didn't find that out until much later though.
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anon user #3Re: Novavax covid vaccine FINALLY approved by the FDA for Emergency Use.
Phillip_McCavity wrote:
The Novavax sounds like an early Unix machine.
The company really dropped the ball. If they had their shyt together and got authorized around the same time as Pfizer they would have made many billions more.
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anon user #8647Re: Novavax covid vaccine FINALLY approved by the FDA for Emergency Use.
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anon user #8647Re: Novavax covid vaccine FINALLY approved by the FDA for Emergency Use.
anon user #3 wrote:
I will say as a Novavax trial participant at my location it was a total clusterfuq. I mostly kept my mouth shut about that because I did not want to discourage people from trusting the vaccine but honestly the trial was horribly ran at my location. On the first day I got the vaccine and that night had a fever. Instructions said to call a number and leave a message. Someone was then supposed to call back in 10 minutes or so. They NEVER did and no one ever had any record of this. Also when I was weighing whether to leave the trial to get the Pfizer vaccine (as I didn't know if I had the placebo or not) I called MANY times and left many messages. It took many weeks for anyone to ever return my calls and by then I had already got the vaccine. From investigating further there were many complaints of this sort of thing at my location and several others in Florida.
Bumping again.
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Re: Novavax covid vaccine FINALLY approved by the FDA for Emergency Use.
That race car guy that died last week probably destroyed his immune system with too many lettuce vaxxes, then when an infection hit him, what was left of his damaged immune system went ballistic into sepsis and he was done.
May you die in agony gasping and coughing up blood like him. Vaxfascist filth.
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anon user #8647Re: Novavax covid vaccine FINALLY approved by the FDA for Emergency Use.
wrote:
That race car guy that died last week probably destroyed his immune system with too many lettuce vaxxes, then when an infection hit him, what was left of his damaged immune system went ballistic into sepsis and he was done.
I don't think he was the vaccine type. I'd be surprised if he got one. Then again, who knows?
May you die in agony gasping and coughing up blood like him. Vaxfascist filth.
Wow. Please link me to the post of mine which pissed you off that much that you would wish this. I am genuinely just curious.
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Re: Novavax covid vaccine FINALLY approved by the FDA for Emergency Use.
anon user #8647 wrote:
Wow. Please link me to the post of mine which pissed you off that much that you would wish this. I am genuinely just curious.
All of them. Fuq you, fascist.
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