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...
How soon after infection should you get vaccinated?
- 3 months is current guidelines but it’s optional, it’s mostly to avoid a type of hives that can happen. It’s like an MCAS reaction.
Using H2 blockers like Pepcid AC can help reduce some of these effects and risk plus it’s an OTC treatment so easy.
AND MAKE SURE YOU ARE HYDRATED BEFORE AND AFTER ANY VACCINATION.
It just makes the whole experience easy on your body and that means fewer AE.
You know I don’t think I made it as clear as I could have that things get really flexible after your third Novavax so there’s less concern about timing at that point.
You want more than that’s fine, just no sooner than two months
You want to wait that’s also fine, probably want a boost or update at least once a year.
It’s just a matter of what type of protection you think you need.
@zonwins @drseanmullen Probably be okay though
Also, it should be made clearer that a single booster of either mRNA or Novavax is about the same in response.
So, when we talk about Novavax timing it's to use the product to its fullest potential not just mRNA levels of protection.
These are two vastly differently places because mRNA treats COVID like a flu but Novavax treats COVID like its own problem unique to be solved.
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1. There are vaccines that expire in April, but most batches expire at the end of this month.
2. There will be no new batches distributed by Novavax for this season.
3. In theory, the FDA could extend the expiration date to nine months, as other countries have done. However, there's been no sign of this happening.
4. Sanofi will be taking over distribution for future vaccine seasons. I am unsure if that will be the Novavax product they distribute or the same product they produced. I think in the US, it will stay Novavax but be distributed by Sanofi.
5. Pediatric expansion can happen now under EUA, but it is expected to happen (according to the previous administration) after the BLA is approved.
That brings us to the problem.
5. Novavax needs the FDA to formally accept their BLA in April, which is tied to their deal with Sanofi.
6. There is significantly concerning chatter that short sellers are plotting to prevent the BLA from going through.
This could mean no more Novavax products or approvals, and it will certainly put their Sanofi deal at risk.
We'll need to put together a focused effort in April to ensure that we can push this BLA through at the new FDA.
And it's three steps.
a) Extend Novavax's expiration date so that the April batch stays on the shelf until new doses are approved.
b) Push through the BLA at the new FDA.
c) Ensure that pediatric access happens for the next vaccine season at the latest.
That's it... Two of those things need to happen in April... Pediatric access will be a few months later.
There will be more updates.
Unfortunately, our next show isn't until April 1st, but that's when we will start the push to take action on this.
Dear everyone who wants a blood test to check for Long COVID...
Red blood cells do not have a nucleus, and though COVID can infect them and form syncytia...
It cannot replicate inside of them without said nucleus.
We remove white blood cells for transfusion, so at your best, you'd probably want to check the white blood cells instead of the red ones...
But you knew that already, right?
Right...?
This whole thing just gives Theranos vibes.
You cannot measure a small amount of blood to find a disease in the cells... We will find it in some cases; some people will have COVID in their blood... this is what creates the catastrophic heart risk...
But, generally speaking, it's just not how it works, except in rare cases.
There are a number of excellent documentaries that cover this idea.
However, they are all about Elizabeth Holmes.
We do, on the other hand, have scanners that can detect COVID in your body by seeing the damage that it is causing but not the virus itself, though we don't have many of them.
It's sorta like how we measure black holes, in that we can't measure the black hole itself, but we can measure its effect on its surroundings
And I wonder why no one ever talks about these scanners and processes.
Fun fact: About 14 years ago, I helped a team working on black hole theory with this concept, which led to several advances in how we measure black holes.
It wasn't anything fancy; it was just an ask for help on Reddit, but they used the theory I gave them to get past what they were stuck on.
We cannot measure a black hole with standard diagnostics, but we can measure the impact of the gravitational waves it creates on the things around it.
Finding persistence is the same thing.
We don't do great at measuring individual viruses in cells, but we can easily measure the damage that we would expect to see if the virus were persistent.
But in order to do that, you have to understand syncytial theory because it creates the damage we would detect.
That is why I explain these things together: they are all required to understand to solve the problem.
Most don't seem to understand a single part, let alone the whole thing.
This has been in my Long COVID article the entire time.
There is just no excuse for us not to understand this.
I HAVE LITERALLY HAD IT IN MY LONG COVID ARTICLE FOR THREE YEARS.