Novavax COVID-19 vaccine receives FDA emergency authorization

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MiMi
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Novavax COVID-19 vaccine, manufactured in Aggieland, receives FDA emergency authorization

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SILVER SPRING, Md. (KBTX) - A Food and Drug Administration panel voted in favor of emergency use authorization for the Novavax COVID-19 vaccine, the same one that is being manufactured right here in Aggieland.

This vaccine is very different from the Pfizer and Moderna shots, especially in the way it's made.
The Novavax shot is a protein vaccine, which is similar to traditional vaccines used for Hepatitis B and shingles, according to the FDA. The protein the vaccine uses in mass produced in the lab, differing from the other shots which teach the body to make the protein.

"Our vaccine achieved 90% efficacy in the U.S. and Mexico despite the majority of cases being attributed to variants. Anything we can do to get people to be more comfortable and be able to accept these potential life-saving medical products, is something we feel we are compelled to do," said Director of the Mayo Vaccine Research Group, Dr. Gregory Poland, when speaking with CBS.

Novavax is already approved in 41 other countries, but manufacturing problems have held up it's entry into the vaccine market, according to the FDA.
eiggA2002
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Going forward, it's time to stop the emergency use authorization and make all these vaccines go through the normal approval process.
01agtx
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At this point, what emergency justifies bypassing the normal routes for approval?
Old Buffalo
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[Wrong forum. - Staff]
Furlock Bones
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Agreed. The fact that we are still under emergency use is absurd. I have had 3 Moderna shots. So it's not like I am against the vaccine. But it's beyond time these companies are shielded from any liability.
Seersucker Ag 2011
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Dangerous precedent. Emergency use should require an emergency.

Edit: that was supposed to be a thumbs down, but consider it a sarcastic thumbs up instead.
FlyRod
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Great news! Another victory in the fight against this hideous virus, and from Aggieland no less! Whoop!
Capitol Ag
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01agtx said:

At this point, what emergency justifies bypassing the normal routes for approval?
I have to agree with this. Where is the emergency in the US? There isn't one and this virus really has become one that is beyond manageable for the vast majority of people. That said, I do think the addition of a traditional vax will help many to get a covid vaccine who have concerns about the Pfizer and Moderna mRNA vaccines...
Capitol Ag
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FlyRod said:

Great news! Another victory in the fight against this hideous virus, and from Aggieland no less! Whoop!
Is it really "hideous" anymore? I would argue no. Yes, dangerous for a very small few but we can rejoice in the fact that Covid, for now, has morphed into a virus really no dangerous than the common cold...
FlyRod
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The declining death rate/risk, yes, not hideous...genuine good news. The rising long Covid rate and disabilities (which is not a common cold thing), quite hideous.

I will keep cheering on the new vaccines (including Moderna's just announced new Omicorn specific booster), and improved treatments for those affected, along with the good people behind them.
BusterAg
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01agtx said:

At this point, what emergency justifies bypassing the normal routes for approval?
Saving face by granting emergency approval, while still approving it after the pandemic is over.
In the end the Party would announce that two and two made five, and you would have to believe it. It was inevitable that they should make that claim sooner or later: the logic of their position demanded it. Not merely the validity of experience, but the very existence of external reality, was tacitly denied by their philosophy. The heresy of heresies was common sense -George Orwell, 1984, Part 1, Chapter 7
WoMD
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Capitol Ag said:

FlyRod said:

Great news! Another victory in the fight against this hideous virus, and from Aggieland no less! Whoop!
Is it really "hideous" anymore? I would argue no. Yes, dangerous for a very small few but we can rejoice in the fact that Covid, for now, has morphed into a virus really no dangerous than the common cold...

Expected by many of us with a medical background who aren't gripped by fear or influenced by money and the media…

So is this one an actual vaccine? Additional "vaccines" for something that is harmless for almost 100% of the population is nice, I suppose. But at this point is completely necessary. At least from the medical perspective. Political requirements (I'm looking at you California) are another scenario, obviously. In which case it gives a better option if you truly must do it due to being forced to "vaccinate," even if it doesn't provide any actual benefit, other than being allowed to go to school, eat at restaurants, travel…basically be allowed the privilege of being in society again. Personally, I'd rather move than be controlled politically like that. Oh wait, I did. Idaho would never have this requirement (they tried in some hospitals for a short time but luckily that mess is over and was because of federal requirements, nothing to do with local politics) over a politically driven situation. And somehow, with zero restrictions, people aren't dying left and right compared to back in California. But hey, if a vaccine is required, this is a better option. That said, aside from being forced, most who haven't been vaccinated already won't get a new one now that omicron has proven to be barely a threat.

If it actually works, then I'd rather this be the only option and the others go away. So there's some potential good in this development. An actual effective option would be nice…
And a safe one, if at all possible. But either that won't be known for a long time, or will be ignored (assuming there's enough money in play). Unfortunately, people will remain skeptical after the mess of the past year regardless of the (filtered) data presented. The earned distrust in medicine, a lot having to do with intermixing and influence politically, has made it very difficult to expect otherwise for a long time.

Staff, please don't ban me. Delete if you feel you must.
DadHammer
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I don't know anyone who hasn't had Covid yet so not sure vaccines are even needed.
Capitol Ag
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FlyRod said:

The declining death rate/risk, yes, not hideous...genuine good news. The rising long Covid rate and disabilities (which is not a common cold thing), quite hideous.

I will keep cheering on the new vaccines (including Moderna's just announced new Omicorn specific booster), and improved treatments for those affected, along with the good people behind them.


Still have a long way to go and more study to see how much of the reported long covid actually connected to Covid. It's kinda like all the things being blamed on the vaccines. Some is real, but a lot isn't at all connected but too many are looking for anything that they can blame on long Covid or vaccines when in reality they are both probably very rare and not something that should stir panic (not accusing you of stirring panic).
FlyRod
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I agree it pays to weigh data carefully. But we have a lot…a lot of data, meta-studies etc. on both vaccines and long Covid I think. My own doctor, a pretty conservative guy overall, takes long Covid very seriously and has promised to send me what he considers the best peer reviewed studies on the matter (which I may share here if appropriate).
Inca
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DadHammer said:

I don't know anyone who hasn't had Covid yet so not sure vaccines are even needed.


I know numerous people who haven't had Covid, including my 84 and 86 year old parents. They would certainly prefer to have vaccines available.
Whirligigs
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Inca said:

DadHammer said:

I don't know anyone who hasn't had Covid yet so not sure vaccines are even needed.


I know numerous people who haven't had Covid, including my 84 and 86 year old parents. They would certainly prefer to have vaccines available.


The old folks I know don't want to touch any of this stuff with a 10 foot pole.
Inca
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My parents are as right wing as you can get and they got vaccinated as soon as they could and have gotten boosted. It's good it is available so people who want it can get it.
Charpie
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Inca said:

My parents are as right wing as you can get and they got vaccinated as soon as they could and have gotten boosted. It's good it is available so people who want it can get it.


There are far many more people who don't bring politics into their health decisions than anyone wants to admit. My mom is as far right as they come and got vaxxed, got Covid and got a booster
88planoAg
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My parents are 83 and are vaccinated and boosted. They had covid in January 2021. I think for 80 year olds a vaccine is appropriate. Weird that some wouldn't think that. Much different than mandates, vaccine proof, continued masking, etc.
BCR
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Capitol Ag said:

FlyRod said:

Great news! Another victory in the fight against this hideous virus, and from Aggieland no less! Whoop!
Is it really "hideous" anymore? I would argue no. Yes, dangerous for a very small few but we can rejoice in the fact that Covid, for now, has morphed into a virus really no dangerous than the common cold...
I wish my friend who died at the end of the year from Covid only had a cold. I guess it's not hideous if it doesn't effect you. He was anti vaccine and conspiracy theorist. Thought it was all fake news. To his family it was hideous.
KidDoc
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This is pretty exciting as the current mRNA vaccines have horrible efficacy vs the current variants. This one showed 90% efficacy which is awesome.

I have Moderna x2 and have never had COVID despite directly caring for COVID patients. I did not get a booster as it does not make a lot of medical sense to get a booster for a virus that has dramatically changed. I would be interested in getting Novavax once more data comes out and/or the next wave gets cooking- assuming we get another significant wave which I don't think is going to happen. I think we have enough community immunity where it can't really get to critical mass and explode like it did at the beginning of 2022.
No material on this site is intended to be a substitute for professional medical advice, diagnosis or treatment. See full Medical Disclaimer.
Capitol Ag
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BCR said:

Capitol Ag said:

FlyRod said:

Great news! Another victory in the fight against this hideous virus, and from Aggieland no less! Whoop!
Is it really "hideous" anymore? I would argue no. Yes, dangerous for a very small few but we can rejoice in the fact that Covid, for now, has morphed into a virus really no dangerous than the common cold...
I wish my friend who died at the end of the year from Covid only had a cold. I guess it's not hideous if it doesn't effect you. He was anti vaccine and conspiracy theorist. Thought it was all fake news. To his family it was hideous.
Which is something I am not. I do believe the vaccine works to limit the severity of the virus. I also believe that the vaccine is not dangerous in any way. I am 2x vaxxed. But I fully believe that it should NOT have at all been mandated and the government overreached in do that and too many lost their jobs and livelihoods not wanting to be forced to get the vaccine.

As to your friend, people die from viruses. A very sad and unfortunate reality. But for the vast majority of unvaccinated, omicron is nothing but a cold. An upper respiratory cold. A lot less unvaccinated were severely effected by the omicron strains. And with all we have today to combat the virus and severe infections, it is a shame your friend did not vaccinate.

So again, is this thing "hideous" if there are remedies to prevent deaths or severe illness, even when some refuse to take those remedies? What was more hideous was the choice your friend made not to try to prevent what eventually did happen. .I am not trying to be disrespectful in any way. Just my honest opinion. This whole thing was handled so damn poorly by the powers that be. Mandates, closures, government overreach, terrible messaging. When idiots like Fauci and the rest get paraded around by the media and misinformation is allowed to try to encourage vaccination, its no wonder your friend was compelled to avoid vaccination. This has been a cluster from the very beginning and if anything, your friend died due to how this virus and the vaccine were handled and messaged by the people that were supposed to help us understand the best way to proceed through all of this. I took the vax not b/c I trusted the government stance on this. I knew a slight risk was being taken by being one of the first to vaccinate. But i viewed it as a chance to see what will happen. To be a Guinee pig so to speak. But I chose to do it, which I feel is the best way to handle this. almost a year and a half later I am fine. And, shockingly (being sarcastic here) I have had Omicron at least once if not twice since. Hence, I do not need a booster. Both were so mild that I continued very intense weight training through it and lived my life as normal. The vaccine won't prevent one from getting new variants of the virus but, again, does what it's supposed to do, limit severity. And that is always how it was sold if you listened to the right people.
Capitol Ag
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BCR said:

Capitol Ag said:

FlyRod said:

Great news! Another victory in the fight against this hideous virus, and from Aggieland no less! Whoop!
Is it really "hideous" anymore? I would argue no. Yes, dangerous for a very small few but we can rejoice in the fact that Covid, for now, has morphed into a virus really no dangerous than the common cold...
I wish my friend who died at the end of the year from Covid only had a cold. I guess it's not hideous if it doesn't effect you. He was anti vaccine and conspiracy theorist. Thought it was all fake news. To his family it was hideous.


One more side note here. This whole "tell that to the guy who died" argument doesn't work. It's an anecdote at best. We have no idea of the patient's health history, we don't know if there were underlying issues that had yet to be discovered that would have indicated that getting Covid would be more dangerous to them. There's just too much that isn't understood or known even by you unless you were this person's doctor or caregiver. Just because a person dies doesn't change that Covid, at this point, is probably no worse than the flu for more people than it ever has been before. I never said it wasn't still dangerous to some. But the number of people that this virus truly is dangerous to has lessened significantly. Even to the unvaccinated. So can we stop using anecdotal yet obviously tragic situations to try to make an argument that this is still the same threat level it was in 2020? It just isn't anymore. Again, there are ways to prevent severe disease and infection. I am blown away anyone masks or stays in nowadays. But it is what it is.
Inca
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Totally agree the overall danger from Covid is much reduced from 2020 or even last year.

However, as a very healthy person who recently had Covid, it is not just a cold either. I've never had a cold that made me completely non functional for a full day and took 4 days to resume all my normal activities.

Life threatening to healthy people? Not in most cases. But definitely a lot worse than a cold in many cases also.
BCR
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Capitol Ag said:

BCR said:

Capitol Ag said:

FlyRod said:

Great news! Another victory in the fight against this hideous virus, and from Aggieland no less! Whoop!
Is it really "hideous" anymore? I would argue no. Yes, dangerous for a very small few but we can rejoice in the fact that Covid, for now, has morphed into a virus really no dangerous than the common cold...
I wish my friend who died at the end of the year from Covid only had a cold. I guess it's not hideous if it doesn't effect you. He was anti vaccine and conspiracy theorist. Thought it was all fake news. To his family it was hideous.


One more side note here. This whole "tell that to the guy who died" argument doesn't work. It's an anecdote at best. We have no idea of the patient's health history, we don't know if there were underlying issues that had yet to be discovered that would have indicated that getting Covid would be more dangerous to them. There's just too much that isn't understood or known even by you unless you were this person's doctor or caregiver. Just because a person dies doesn't change that Covid, at this point, is probably no worse than the flu for more people than it ever has been before. I never said it wasn't still dangerous to some. But the number of people that this virus truly is dangerous to has lessened significantly. Even to the unvaccinated. So can we stop using anecdotal yet obviously tragic situations to try to make an argument that this is still the same threat level it was in 2020? It just isn't anymore. Again, there are ways to prevent severe disease and infection. I am blown away anyone masks or stays in nowadays. But it is what it is.


Sorry I pressed your buttons. Never said tell it to the guy who died. You did for dramatic effect. All I basically said was it depends on how and who it affects wether or not it's "hideous".
One thing this has brought out is an unusual anger from people. On both sides it's I'm right and your the idiot.
Capitol Ag
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Inca said:

Totally agree the overall danger from Covid is much reduced from 2020 or even last year.

However, as a very healthy person who recently had Covid, it is not just a cold either. I've never had a cold that made me completely non functional for a full day and took 4 days to resume all my normal activities.

Life threatening to healthy people? Not in most cases. But definitely a lot worse than a cold in many cases also.
I have had viruses that have knock the **** out of me, yet covid never did. Everyone is different. I had something in 2019 that was bad. Out 4 days. had the flu in 2003 or 4. and that kicked my ass (and yes, I had the flu shot). Some people experience worse infections from certain viruses and a lot may be determined my genetics, current health conditions, overall immunity at the time (say those who have had a lack of sleep, a lot of stress etc). It could be that you handle colds fine and the covid virus not as much while I can hit a PR deadlifting while battling covid and not miss a beat. Yet I get the same cold you had and am in bed for 3 days.
88planoAg
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Inca said:

Totally agree the overall danger from Covid is much reduced from 2020 or even last year.

However, as a very healthy person who recently had Covid, it is not just a cold either. I've never had a cold that made me completely non functional for a full day and took 4 days to resume all my normal activities.

Life threatening to healthy people? Not in most cases. But definitely a lot worse than a cold in many cases also.
So then...the flu?
Capitol Ag
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BCR said:

Capitol Ag said:

BCR said:

Capitol Ag said:

FlyRod said:

Great news! Another victory in the fight against this hideous virus, and from Aggieland no less! Whoop!
Is it really "hideous" anymore? I would argue no. Yes, dangerous for a very small few but we can rejoice in the fact that Covid, for now, has morphed into a virus really no dangerous than the common cold...
I wish my friend who died at the end of the year from Covid only had a cold. I guess it's not hideous if it doesn't effect you. He was anti vaccine and conspiracy theorist. Thought it was all fake news. To his family it was hideous.


One more side note here. This whole "tell that to the guy who died" argument doesn't work. It's an anecdote at best. We have no idea of the patient's health history, we don't know if there were underlying issues that had yet to be discovered that would have indicated that getting Covid would be more dangerous to them. There's just too much that isn't understood or known even by you unless you were this person's doctor or caregiver. Just because a person dies doesn't change that Covid, at this point, is probably no worse than the flu for more people than it ever has been before. I never said it wasn't still dangerous to some. But the number of people that this virus truly is dangerous to has lessened significantly. Even to the unvaccinated. So can we stop using anecdotal yet obviously tragic situations to try to make an argument that this is still the same threat level it was in 2020? It just isn't anymore. Again, there are ways to prevent severe disease and infection. I am blown away anyone masks or stays in nowadays. But it is what it is.


Sorry I pressed your buttons. Never said tell it to the guy who died. You did for dramatic effect. All I basically said was it depends on how and who it affects wether or not it's "hideous".
One thing this has brought out is an unusual anger from people. On both sides it's I'm right and your the idiot.
Sorry if you misunderstood my reply as angry. I am not at all. I agree, this thing has become a very divided/politcal issue. I don't blame folks like us. I blame the media, the powers that were supposed to navigate this and have failed and the politicians that use this for their own gain on both sides. It's lead to situations where people won't get a vaccine b/c many just can't trust anyone and then they die. I have seen it too. It's a damn shame for something that is preventable. I guess what makes me mad is your friend died b/c, in my estimation, the idiots that are supposed to run this thing did a ****ty job. Message this better and your friend may be alive today....
Charpie
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How about everyone experiences things differently? My thin, physically fit marketing girl had it last week. She was down for the count for the entire week. She had big time brain fog, had massive headaches and nasal congestion. She was coughing and couldn't function. She does yoga everyday and goes for runs 4 times a week. She was way worse off than I ever was.

And as someone who has had the flu and covid, they couldn't be anymore different than one another.
Loyalty
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Unlike the other "vaccines", will Novavax actually work to keep you from getting Covid? We'll see.
88planoAg
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Charpie said:

How about everyone experiences things differently? My thin, physically fit marketing girl had it last week. She was down for the count for the entire week. She had big time brain fog, had massive headaches and nasal congestion. She was coughing and couldn't function. She does yoga everyday and goes for runs 4 times a week. She was way worse off than I ever was.

And as someone who has had the flu and covid, they couldn't be anymore different than one another.
I meant flu in terms of severity and duration. I, too, have had both, and found them roughly equivalent. Really covid was worse in terms of how anxious I was, but in the end they were similar.
KidDoc
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Loyalty said:

Unlike the other "vaccines", will Novavax actually work to keep you from getting Covid? We'll see.
The current data says that it does-- but yes time will tell hopefully.

Quote:


How well it works: 90% effective against lab-confirmed, symptomatic infection and 100% against moderate and severe disease in Phase 3 trial results published in The New England Journal of Medicine in December 2021.

Comparing the COVID-19 Vaccines: How Are They Different? > News > Yale Medicine
No material on this site is intended to be a substitute for professional medical advice, diagnosis or treatment. See full Medical Disclaimer.
Loyalty
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KidDoc said:

Loyalty said:

Unlike the other "vaccines", will Novavax actually work to keep you from getting Covid? We'll see.
The current data says that it does-- but yes time will tell hopefully.

Quote:


How well it works: 90% effective against lab-confirmed, symptomatic infection and 100% against moderate and severe disease in Phase 3 trial results published in The New England Journal of Medicine in December 2021.

Comparing the COVID-19 Vaccines: How Are They Different? > News > Yale Medicine


Thank you for the data. The fact that it's more of a traditional true vaccine using tried and true vaccine technology gives me hope.
aggieduke
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Kid Doc....can I get novavax if I have already had moderna x3?

Thanks for all your help.
Philippians 4:13
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