After taking a bit of a break my interaction level is very low.

And that's not great because I have a call to action with a very short timetable. So, I'm going to need your help to make sure this information makes it to the people who we need to take action.

VRBPAC (FDA) announced a meeting with almost no leeway to set up a presentation and limited time even to work out a public comment push.

Public comments are due by 11:59 eastern on the 9th.

There are currently only FOUR comments.

The meeting is about vaccines for, among other things, H5N1.

Now, the FDA and CDC are making predictable mistakes regarding H5N1 and that should bother everyone.

We live in the shadow of a pandemic that folks want to ignore while another one is looming...

And me saying "looming" is not me being dramatic, the FDA is already stockpiling millions of H5N1 vaccines...

But their strategy has some big problems.

H5N1 or Bovine Influenza A is creeping its way into the human population but it's doing it only through the immediate workers who handle cows or poultry.

And instead of vaccinating those people and their families with a powerful vaccine that keep this new flu out of the human population...

They are stockpiling millions of doses in anticipation of a nationwide outbreak, it is unclear the level of protection they will provide but based on the FDA's acceptable levels... it's not looking good.

The approach to efficacy in general has been so watered down... they call vaccines with low efficacy "high efficacy" because efficacy as a concept is not on a sliding scale it is simply ANY immunity which is also a broadly defined concept.

This is leaving too much wiggle room for less effective products to be widely used and that makes our response ineffective.

So, we are preparing for the next pandemic by allowing it to first escape into the human population before we act...

This simply feels like an opportunity for pharmaceutical companies to create new markets, with new drugs, and new long term symptoms all based on a neurotropic disease that has completely unknown ramifications but we know it starts in people's brains because the current entry point is the eyes.

We need vaccines that stop transmission at the source and prevent this from entering the human population.

That should be our goal and nothing else should be acceptable.

We are currently preparing millions of vaccines while simultaneously accepting low levels of protection that are sold to the public as "high efficacy" while sitting on our hands in preparation for it to explode in the general population...

A population that has recently been randomly immunocompromised by rampant COVID infections.

This will give the virus opportunities to mutate and we have literally no idea what comes after that...

But it won't be good.

It seems like the purpose of this strategy is to create new treatments for markets with the public, but minimizing will run rampant... their treatments will likely fail... and the public will be left holding the bag with a new list of long term symptoms and a new version of the flu with no way to control it.

I've had sequelae three times in my life and the one I got from the flu in 2009 was completely life changing.

If we are preparing to combine that with Long COVID then we will be left with a suffering population and little room to recover.

We need to demand the FDA reach for more protective vaccines that stop transmission of H5N1.

Hopefully that will be the beginning of a larger trend where stopping transmission is the focus again of our vaccines and then we can put common sense ideas like eradication of these parasites on the table.

I have a larger article with sources that should be out tomorrow.... Hopefully that will help anyone on the fence with writing a quick comment.

But you might think, "Don, this has nothing to do with COVID or Novavax. Why should I care?"

Our problems with handling COVID are part of a larger structural issue on how we are approaching disease from the position of management instead of mitigation.

I have sat through these meetings for a few years now and there is ZERO effort to actually stop transmission while instead they focus on simply making the disease more manageable while ignoring any long term consequence that isn't actual death.

That means everyone's quality of life is on the chopping block...

If we were to use our current influenza shots as the basis for efficacy then we are looking at only a 40-50% protection from hospitalization and that is totally unacceptable.

They imply that this low efficacy is because of our limitations but that isn't true at all, it's the explicit goal.

Novavax has shown that not only is that not our limit, that when we try to go further the FDA actually stops manufactures from offering this level of protection...

AND THIS IS A PROBLEM.

So, like many of the issues surrounding COVID, we have to come at this problem sideways and push for more structural changes that will go on to affect our COVID response instead of trying to change the entire situation from simply our COVID response alone.

We have to meet people where they are and that includes are regulators...

So...

That means we need to demand more protective vaccines that stop transmission of H5N1 so that dairy workers cannot get infected or transmit it to their families where it will then enter the school population and on to circulate among other families as it enters the general population where it becomes much much harder to stop.

We need to cut this off at the source.

We simply do not know what is going to happen but the outlook is grim and we simply don't need that when the pharma corporations who are trying to create this market simply cannot control enough of the people in our environment to make it safe.

We must use the precautionary principle, and assume that long term consequences will be equal to or greater than our worst flu outbreaks, think swine flu instead of seasonal, and that means millions of hurt people.

H5N1 still has a while to go before it infects humans with ease, but it's coming, and that actually makes it easier to cut it off here and protect all people.

The FDA putting a higher expectation on manufacturers to produce more protective vaccines for H5N1 that stop transmission will not only protect the general population, but it also directly protect these workers and their families.

Please take a moment and write a comment to that effect.

The link to comment is in the next tweet. Here's the link to the public comment page.



Please demand that the FDA work with manufactures to create vaccines for H5N1 that stop transmission at the source.

We need to prevent this new pandemic from starting, not see it as part of a profit driven model.regulations.gov/document/FDA-2…

A lot of folks ask me about Novavax timing, and I am still writing a final article, but this seems as good as time as any to explain how this appears to work best.

Again sources will be in the article, or can be found in one of my earlier articles, so this is just the details.

First important part, unless you got a KP.2 updated mRNA then all your mRNA before doesn't matter when thinking about what you are going to do next.

It's not the most popular idea but there is no clinical benefit to mRNA shots you had over six months ago to the response we aim for now.

Some folks will talk about immune memory response and that's true but not the relevant data point for this.

More on immune memory later.

There is a 2 months rule in all these vaccines that we worked hard to get the FDA to accept widely...

IT IS FOR SAFETY.

These vaccines are safe when they are administered properly, please do not plan to get any COVID vaccines more often than two months apart unless you have extreme circumstances or are working with a Doctor.

Also, give our Twitter show a follow before everyone bugs out for the next few months, we have to reach more people so as they say the show must go on.

@BFIshow

Okay, I think I can cover most of the bigger groups.

1. If you are switching to Novavax from mRNA or only got one Novavax last year or only the two the year before that... Then you are effectively starting over.

- You want to get two shots two months apart and then a third at six months after the second shot... so eight months total. The current rules are for any vaccine as long as it is two month since your last but that doesn't mean getting it'll be smooth and we will likely have to help those people on an individual basis when they go to get their second... It should be easier than last year.

2. If you already got 2 or more Novavax of the XBB.1.5... It's been between 6-9 months for almost everyone but if you are closer it's okay. No need to wait to get an update.

- You want to get one Novavax right now and another in six months, the FDA is likely to approve a second vaccine in six months so don't worry about it yet.

3. If you already got three Novavax, last within a year.

- One updated JN.1 is enough but we're likely to see significant mutations over the winter season so we are almost certainly going to want to get a second JN.1 to increase the breath or range of our antibodies. Matrix M overcomes the imprinting issue but it takes multiple shots to help with new variants beyond our current ones. That can happen either after two months or when the second shot is approved.

4. If you are concerned about your memory response.

- Get two as long as they are two months apart, it will still help with antibody range in that shorter time.

5. If you are immunocompromised.

- Get two at least two months apart. Winter is going to be nuts this year and you're going to want to be ahead of the antibody range. The rule for extra shots is literally for you all on paper so use it.

6. You are aiming for persistent virus reduction.

- Three shots two months apart each. Find a Doctor to work with on this and we can provide you information to show them so they are onboard. That way you can also be monitored safely. This is why it's 2 months apart with no clear end for IC folks. This was part of our presentation last year and if you have a doctor involved then getting the additional shots will be no issue.

7. You got KP.2 mRNA a few weeks ago.

- Everyone who gets mRNA will need two vaccines this season because of the imprinting issue Matrix-M overcomes. So, you want to either wait at least two months and get a Novavax or another mRNA or you can wait until the next vaccine is approved in six months or so.

8. You got KP.2 and you want to switch completely.

- Technically, having mRNA for the start of your new Novavax series is not ideal but it gets pretty close in most easily measurable ways. When we talk about vaccine exposure after multiple shots a lot more is about the adjuvant than the antigen though both play a role of course. So, you would get the second shot as Novavax at least two months after your KP.2 then another Novavax at six months. Then you would update like normal and after your third Novavax you are basically caught up. It takes a bit longer but you are consistently protected while you make the change.

9. So the basic timing?

- Two shots two months apart with a third at six months.

Then it's a booster no sooner than six months, you just don't need it, and by the 8-10th month some of the more complex protection starts to wane. So, if you are high risk in any way then you probably want to stick with that timing but you can technically go longer between shots.

If you go longer than 18 months between Novavax then it's likely you want to start over but two six months apart should catch you up... looking for more data on that as we go forward.

I am currently one year from my last Novavax and I will get one now and likely a second in six months or in Dec if COVID is really bad.

Then I should be good for a while even if we have big mutational jumps. We would need another event like JN.1 which we saw coming for a year to need an update.

But should we need an update you can get it as soon as it is available and restart your timing from that as if it was your third shot in the three shot series.

I hope this helps.

While this is helpful for Twix, in order to convince your family members and such to get vaccinated again to protect themselves this winter it will take the more convincing sourced article.

It's my priority item so it should be done in time to still help folks convince our loved ones to better protect themselves and any work we can do to lessen this winter wave that is coming.

Oh, and don't forget... we have to push for the pediatric vaccine and now Japan has approved it for 6 years and older... so they are ahead of us in pediatric applications.

Americans paid for Novavax as part of Operation Warp Speed...

Plus, we have to keep up the pressure at the FDA so we don't have to keep going through this. Especially with looming expiration dates already because of the new single dose shots. If you want to follow my substack, one of my other social medias, or make a contribution to the work...

You can find all that on my linktree --->linktr.ee/donford

So a few months ago we hatched a wild plan thanks to @tkweeks01…

The only way to get COVID protections in hospitals is to make it so COVID is added to the list of hospital acquired infections that stop Medicare and Medicaid from paying out…

And we were all writing in a bit ago…

Well, I got an update… it’s working.

Also, they have to report COVID infections starting in Nov…

That’s what winning looks like. This is all stuff we work out live on our show twice a week.

Join us sometime. It could save your life.

x.com/bfishow?s=21&t…

I need folks to help put a ton of pressure on the FDA.

Basically, Novavax is not like mRNA... while mRNA has a short protective window that cannot be stacked on previous vaccines...

Novavax can build on previous vaccination and does not have a short window in the same way.

Well, great news... the @US_FDA plans to mislead the American public and limit access to all COVID vaccines on the basis of the limited real world effectiveness of mRNA....

That means no updated Novavax until Sept. while it should be ready by the end of the month...

Leaving all the folks who need Novavax in the dust.

We need folks to start calling the FDA... literally every day.

Until they release the current JN.1 Novavax because no other versions of the vaccine will be available until then.

There are at least a half dozen other reasons why this is a good idea but we need to push EXTREMELY hard on the FDA to approve it for release ASAP.

We're probably going to have to be super annoying about this... make it personal.

Also, reminder that the pediatric Novavax that they are playing games with is the EXACT SAME SHOT that you are hoping to get.

I think it really screams Novavax is actually better when they withhold it without any due cause...

Get creative but the petition and the FDA contact info is in the first comment. Call the FDA at 1-888-463-6332

Being obnoxious is technically legal.

actionnetwork.org/petitions/dema…

Fun Fact: Releasing Novavax's JN.1 now won't actually hurt anyone or the ability to sell KP.2 vaccines in Sept.

But not letting Novavax release it's JN.1 vaccine as soon as possible will create harm when no Novavax is currently available and folks can't take mRNA.

This reminds me a word but I can't put my finger on it... It's not like everyone knows that folks will take the first vaccine available no matter which one it is...

Right?

It's not like that data is presented at these vaccines hearings or anything.

Since folks are still trying to prove how little they know about COVID and how the variants work...

JN.1 and KP.2 are two mutations different on the RBD.

It's essentially the same variant.

mRNA is using KP.2 because benefits from being slightly closer because it's an INFERIOR PRODUCT.

So, now we see people trying to lie to you and trick you about what is best...

But we got the receipts... and participated in the meeting.

A lot of people are proving to all of us that after all this they still do not understand the subject better or how to make a decision that is best for the public.

But don't worry... we got you. What everyone is missing is that we all need two shots to update imprinting and Novavax is the ONLY vaccine that increases range of your antibodies.

So, while mRNA will get stuck at KP.2... even if you get two.

You get two Novavax and it rises to meet the variants we can't see yet.

I mean, this is a complete checkmate and they don't even understand why.

And I got 2.5 months to explain it.

This won't even be hard.

American college students are demanding a ceasefire...

So, what does Biden do?

Has cops show up to fire at them.

"You want a ceasefire? How about some non lethal rounds..?"

Which are not only toxic but are supposed to be shot at the ground so they ricochet but instead they are pointing them in people's faces...

Guess what? They are just lethal rounds when used that way.

At least Biden said to just shoot them in the leg, an actual quote... but naturally the police mocked him for suggesting anywhere but the face like the Zionists taught them.

Make no mistake, the point is to scar these students so they are easier to spot in the future just like they do to Palestinians.

The point is to maim them.

If this is what "protecting democracy" looks like then I don't want it. BTW... that part about the leg and the cops is 100% real.

fox13news.com/news/police-ri…

Every single person who doesn't care about COVID is a person who will care about COVID in the future...

But for most it will happen in the hospital bed when it's too late to do anything for them.

They've made their bed, we should simply prepare for the fallout...

And all the room they'll make for activities.

I'm not even sad anymore, I just feel nothing for these folks.

I wish it weren't like that but we have to start protecting ourselves emotionally in ways that we are not prepared for.

Their indifference toward the death of others has made me indifferent about their eventual premature passing. I used to care... but I just don't anymore.

I've seen so many dead children with 100s of people defending their slaughter.

And I think I am prepared to do what is necessary now.

We have to let them go... and prepare for what's next.

This is what Long COVID cognitive dysfunction looks like.

I know folks are always going on about Bob's takes...

But this is the sign of a legit disability and shift in his perception of risk.

We think he's lying for the corps... but he's not... his brain is damaged and his risk appetite is shifted.

This is cognitive Long COVID, it's subtle... but kills. It's likely he had asymptomatic brain invasion because his upper respiratory protection was limited without proper respirators.

So, we're seeing the negative outcomes of the risk appetite shift that occurs when the brain is damaged.

This is NOT cytokine damage... this is more permanent CTE like damage that has occurred...

I wonder if he finds himself raging in private lately.

Mass infection for immunity to SARS2 does not work.

And I'd like to explain to you why.

The thing that folks don't realize about SARS2 is the incredible quantity of viral particles in an infection... back during Delta it was understood that during peak infection there were more viral particles than your own cells.

It is understood as having a higher volume now but is less concentrated in your lungs... this is not actually a good thing.

Don't worry though, you aren't more SARS2 than human because SARS2 is very small so by volume it's still substantially less. *laughs nervously*

But when it comes to mutational capability in a certain amount of time... this is not what we want to see.

There is an old joke about an unlimited amount of monkeys typing on an unlimited amount of typewriters. google typewriter if you aren't sure what that is... and how eventually given enough time one of them will write out the entire collected works of Shakespeare...

Or at least the works attributed to him, more likely a them as were learning it's likely more than one person... you know what? I'm off subject... And technically if it's infinite it would do it instantly... but I'm not rewriting it.

Point is that SARS2 follows a similar idea... it's a vast amount of monkeys on a vast amount of typewriters IN EVERY INFECTION.

It's not infinite but it sure can feel like it...

And it is likely to find an immune evasive combination in that sheer overwhelming volume of mutation possibilities.

When it does that, this version of the virus will proliferate better without challenge from your immune system becoming the new dominant variant in your infection.

This process is very straight forward...

Basically, SARS2 hijacks our cells then it uses ribosomes to print spike protein, same way the mRNA vaccines work, and that means that occasionally the ribosomes misprint the amino acids and you end up with different mutations.

This process is very similar to the "Frame Skipping" that we were discussing regarding the mRNA vaccines but instead of code being read wrong... it's more like a printer error that can be linked to a specific printer.

But ribosomes themselves only have so many possibilities so you end up with the same misprints across a broad spectrum of people.

Those mutations can be total shit... they can be... basically whatever... but occasionally they gain immune evasion and that can become persistent virus, hiding out invisible to your immune system... actively creating more virus and more mutations...

But occasionally it can gain immune evasion AND fitness...

And that's how you get new variants of concern.

The problem we are currently learning about is that BA.2.86 only needs a small ribosome misprint to end up at JN.1 which is an extremely immune evasive variant to ... everything ... vaccines will hold up, for now, and to avoid this turning into a Novavax commercial, I'll leave it there.

Point is that infection based immunity is a total clusterfuck... With any reinfection you are almost immediately seeing a new variant with immune evasion to your previous antibodies or memory response...

Because that's why this new variants exists at all.

(We're not even going to bring IgG4 up here but it makes it even more confusing... and don't even get me started on asymptomatic responses...anywho...)

It gained misprints/mutations that equate to immune evasion and that allowed it to be passed on to someone who already had infection based immunity.

That's just how this works, that is how this will always work.

It's just that sometimes SARS2 gets itself backed into a corner where it can't stack mutations well enough and it is has a harder time finding that right combination...

And this gives folks a false sense of security.

But with this many active hosts and cryptic lineages there are more than enough recombinant possibilities that eventually it will find a way if left to its own devices...

Because given enough time, those monkeys are going to write out the collected works of Shakespeare simply due to the sheer quantity of viral particles in an infection and every single individual one has the capability to start the process I am describing.

Simply put... mass infection for immunity will NEVER work.

And don't let anyone gaslight you into thinking that means "herd immunity"... Herd immunity is when you vaccinate enough people with a non leaky vaccine that those who the vaccine does not work on will still be protected.

We've barely even tried to make that happen...

But were going to have to because...

Mass infection for immunity to SARS2 does not work.

It will only shorten people's lives. BTW regarding herd immunity... Twitter has a gif for that.

I am deeply disturbed that I am the only person on the planet discussing the actual mechanics of the damage COVID is causing and how it's altering the internalized concept of risk in the infected.

COVID is shifting folks' risk appetite making people do more and more dangerous things and most folks don't realize it.

While the world burns. Keep in mind, everyone focuses on just the damage the virus does... which also no one else explains the syncytial mechanics.

But it's actually our organic mammal response to infection that causes most of the effect.

It's a mammal's response to infection that triggers it.

And no one on the planet is talking about this effect.

We need to figure out how to get the @US_FDA to approve Novavax but now everything is up to @DrCaliff_FDA...

And he's a bit of a road block for progress.

So, my suggestion is a brute force style attack... find any @fda email and start emailing them about Novavax approval. @US_FDA @DrCaliff_FDA @FDA It might seem like a bit of a broad stroke...

but let's get honest... this is a digital protest.

Our best shot is for the internal members of the FDA and CDC be so annoyed with us mucking up their communication that they just give us what we want.

We're going to repeat this...

mRNA vaccines are rolling out... W/ Novavax being held back

- Topol is only expecting 1-2 months protection
- There is a big gap in protection when it wears off
- You won't be able to get a new vaccine
- Imprinting is a giant issue and you can't get 2x shots

Novavax fixed these Basically you are going to rush out to get an already known ineffective product and then be prevented from getting the effective product for an unknown amount of time.

Changing the antigenic mix of mRNA does not change it's efficacy.

mRNA efficacy is against the flu.. not COVID

*EMERGENCY CALL TO ACTION*

The CDC wants to play games with Novavax approval again... And the trolls are out pushing literal lies about why.

So, I put together an article that has all your sources, data, and clarity... AND WE HAVE ONE SINGLE DAY TO CONTACT COMMITTEE MEMBERS... It's easy to just give up and throw your hands in the air with news like this... but that's not the response we should have when there is still time...

Take a moment and contact the committee members at their PERSONAL EMAILS...

https://twitter.com/DonEford/status/1701223583048216722?s=20

The Novavax fight is coming to a bit of a culmination.

In a few days, the US gov will decide if you can access Nova after mRNA.

After months of build up this is where the big decision is made.

And public comment closes in 3 days...

We need as many people as we can to comment. Even if you don't necessarily agree that Novavax is a better vaccine, we all should agree that we need as many tools as possible to fight COVID.

And Novavax is the only non mRNA COVID vaccine available...

That alone should make it something worth fighting for.

The normal parrots are claiming EG.5 isn't causing more clinical disease...

And this time they are outright lying.

Severity is defined by COVID's ability to make syncytia in the lungs and we are seeing in uptick in hospitalization via lower resp tract.

So, EG.5 is more severe. Now this is their definition, not mine.

All COVID variants are of equal severity because we are beyond the safe threshold for interaction with the virus.

But in this case, THEIR LANGUAGE defines severity very specifically allowing them to call Omicron mild.

EG.5 is more severe

More amazing Novavax news...

"Researchers report that a mixed schedule using a full dose of Pfizer followed by a full dose of Novavax led to fewer break-through infections & generated higher antibody & Tcell responses than two Pfizer"

We need access now
ox.ac.uk/news/2023-07-0… https://t.co/s9Ag95yYm4journalofinfection.com/article/S0163-…

Most folks don't understand imprinting as a concept including many of our "leading experts."

The reason we know this is that imprinting is the reason hybrid immunity is not effective, while it does reduce the risk of death during acute...it does nothing for the 200+ LC symptoms. We look at antibodies in most hybrid immunity studies very broadly as a concept...

When in reality antibodies are very specific to each variant... so while you might have high antibodies to COVID it does not mean it is protective against new variants.

This has been demonstrated

A lot of people have been confused about my statements about normally COVID conscious influencers minimzing the risk of Long COVID...

And someone pointed out that maybe we have different definitions of what Long COVID is.

It hit me like a truck, that's the whole issue... You spend so long in the weeds on a subject that you forget how to communicate things and definitions are everything in this explanation.

Normally, we had established the definition of risk in regards to "damage to quality of life" and that risk was self diagnosed at 30%.

If you notice the anti Democratic Party propaganda kicked up super hard at the same time Bidens re-election campaign started…

That’s because they are the same thing, the anti DNC stuff before the primary is to protect the establishment.

It’ll all stop once the primary is over. Just to be clear, the first voting that happens is the primary and if you want to replace Biden it happens there.

It can be done because we got rid of super delegates, but it cannot happen if we all feed the anti-democratic party trolls.

Neolibs hold control with a tiny group.

Emergency call to action...

VRBPAC went well, but were not don

Making changes in vaccines requires two steps...

First the FDA meets for VRBPAC...

Then the CDC meets for ACIP...

This is the June 21-23rd Comments for ACIP close tonight at midnight Est
regulations.gov/commenton/CDC- There are only 167 comments currently.

And it seems like we can do better than that.

If you want Novavax approval to change than this is your portal to create pressure at the next important meeting....

And the door is open for us... but how many are ready to take action?