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Friesein Profile picture
@Friesein
Jun 12 • 7 tweets • 3 min read • Read on X
Novavax Availability Update 📢

Costco in Little Rock, AR has reportedly confirmed that they'll have Novavax stock in place by September.

My gut feeling is that this is much closer to the timeline we'll end up seeing for most stores instead of July/August.

Here's why. 🧵
In 2024, the first CVS I heard of that had received their stock was in Pittsfield, MA on September 9.

For Costco, it was in Limerick/Sanatoga, PA on September 13.

Prior to that, the national Costco distribution center had received their stock on September 10, and they began shipping to stores shortly afterwards.

There's been confusion on the distribution timeline of Novavax this year. This is the first year Sanofi will handle distribution, so there may be hiccups.

Or, perhaps Sanofi will handle distribution even better than Novavax. The bar is fairly low.

There's one thing that has to happen before any pharmacy in the US can administer Novavax:

For each batch manufactured, the FDA still performs lot release. This is a quality assurance step.

This process can add an estimated 2-4 days of delay.

fda.gov/vaccines-blood…Image
By the way, you can have a pharmacy check lot release status by looking up Novavax's NDC (National Drug Code) on their supplier's website (e.g., via the McKesson Connect web interface).

If the lot is "on hold" wait a few days; if it shows “FDA-released,” it can be administered.
Long story short, in 2024 pharmacies began scheduling Novavax appointments in early September and administering it mid-September.

Sanofi being in control of distribution is an additional variable this year, but they've got more experience with distribution than Novavax ever had.

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More from @Friesein

Friesein Profile picture
Jun 11
Novavax Availability Update 📢

I've heard several reports that some Costco pharmacies are expecting Novavax supply between July and the end of August.

I recommend checking with Costco via their web app to find out when you'll be getting it in your area (instructions below). 🧵
Here's how to contact Costco corporate for pharmacy inquiries.

I recommend doing this over talking to your local pharmacy because stores are not always in the loop on shipping status.

Doing this also sends a demand signal to Costco for ordering stock.

Image
This will be the first time Novavax is available outside of Emergency Use Authorization.

Getting access to it this year may require a bit of extra effort, since the new license stipulates that most must have an underlying condition to access the vaccine.

Read 10 tweets
Friesein Profile picture
May 29
This is NB.1.8.1.
So is this.

And some of the symptoms like intense throat pain and fatigue seem to kick in a week or so after the first appearance of symptoms.

Read 11 tweets
Friesein Profile picture
May 23
SARS-CoV-2 is known to bind with mitochondrial proteins in humans.

Mitochondrial dysfunction caused by COVID persists past the acute phase.

Evidence of ongoing mitochondrial and metabolic dysfunction has been found in the heart, kidneys, liver, and lymph nodes, for example. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral proteins bind to host mitochondrial proteins, likely inhibiting oxidative phosphorylation (OXPHOS) and stimulating glycolysis.
These data suggest that when the viral titer first peaks, there is a systemic host response followed by viral suppression of mitochondrial gene transcription and induction of glycolysis leading to the deployment of antiviral immune defenses. Even when the virus was cleared and lung mitochondrial function had recovered, mitochondrial function in the heart, kidney, liver, and lymph nodes remained impaired, potentially leading to severe COVID-19 pathology.
In the case of SARS-CoV-2, it was shown that mitochondria appear swollen and damaged in skin biopsies from patients, and that depletion of mtDNA in endothelial cells significantly reduced the type I IFN response62. In SARS-Cov-2 infected cells, viral RNA was found to be associated with mitochondria using fluorescence and electron microscopy31. Several reports have suggested the colocalization of mitochondrial-SARS-CoV-2 RNA in infected human tissue.
According to recent studies, SARS-CoV-2 infection causes prolonged disruptions in mitochondrial function, significantly altering cellular energy metabolism. Our research employed transmission electron microscopy to reveal distinct mitochondrial structural abnormalities in Long COVID patients, notably including significant swelling, disrupted cristae, and an overall irregular morphology, which collectively indicates severe mitochondrial distress.
There seems to be an inverse relationship between viral load and the expression of mitochondrial genes during the acute phase.

Could the same be true of the chronic phase? Could persistent virus be causing ongoing mitochondrial dysfunction? Mitochondrial gene expression was reduced in autopsy tissues from patients admitted to the hospital with high compared with low viral loads, which confirmed that the extent of altered mitochondrial gene expression may be regulated by viral load (fig. S5). Down-regulation of mitochondrial pathways in response to virus in human autopsy samples was most extensive in hearts followed in decreasing order by the kidneys, livers, and lymph nodes (fig. S5). This inhibition of mitochondrial gene expression in visceral autopsy tissues parallels that seen in the nasopharyngeal samples with high viral t...
Overall, autopsy heart tissue from patients with SARS-CoV-2 infection showed a systematic down-regulation of genes involved in multiple mitochondrial functions; this was also found, to a lesser extent, in kidneys and livers and, to the least extent, in nasopharyngeal samples and lymph node autopsy samples. The lung autopsy samples showed down-regulation of CoQ synthesis and mtFASII but up-regulation of genes involved in the TCA cycle and cytosolic protein import (Fig. 3A).
It is clear is that SARS-CoV-2 is capable of causing mitochondrial damage that persists for months or even years.

And we independently know the virus persists in some form, chronically.

For patients, this means that new symptoms can appear after acute COVID infections. Image
We have observed an interesting phenomenon in the mitochondria, the swollen and vacuolated mitochondria, distorted and broken cristae, all indicated severe damage to this important cellular organelle. This damage is highly likely caused by the SARS-CoV-2 Infection, as we have found an almost identical mitochondria disorganization in the mice that were infected with SARS-CoV-2. Our findings are consistent with a recent study in which mitochondrial gene expression was analyzed in autopsy tissues from patients with COVID-19, and core mitochondrial gene expression were suppressed in the hearts,...
Image
Highlights: - SARS-CoV-2 spike protein persists in the skull- meninges-brain axis in COVID-19 patients. - Spike protein is sufficient to induce brain pathological and behavioral changes in mice. - Spike protein enhances brain vulnerability and exacerbates neurological damage in mice. - mRNA vaccines reduce, but do not eliminate, the spike burden
Read 6 tweets
Friesein Profile picture
May 21
I can appreciate skepticism of long COVID as a concept. After all, it may instinctually seem like an epistemological overreach to assign a singular cause to such a heterogeneous disease presentation.

On the other hand, consider the localization of ACE2 throughout your body. Consider the reach of your blood vessels. Couple that with imaging studies that demonstrate spike persistence in areas such as the brain and skull. Consider also that viral persistence has been identified in the gut with replication competent virus.

In the last few years, I've interacted with tons of people on this platform, both vaccinated and unvaccinated, who have lost a significant amount of mobility after having had COVID infections. Healthy and unhealthy, comorbidities or not. People in their 40s are also dying of rare cancers. Athletes and soldiers are having a decrease in functional performance after a single COVID infection, let alone reinfections.

The deeper you look into viral persistence (look at the work Polybio and Erturk Lab are doing on imaging, for example), the more you'll find yourself willing to consider that COVID might play a role in it.

The key is in recognizing that the microvascular changes COVID causes are difficult to detect with off-the-shelf diagnostics. Once research develops more readily commoditized diagnostics, perhaps the condition will gain wider recognition. In the meantime we have a large segment of young, middle-aged, and previously healthy athletes succumbing to unusually debilitating chronic illness after COVID infections. That illness is real despite misgivings some may have. And so too is the underlying damage COVID causes, even if it's not straightforward to detect in all instances. Whatever you want to call the disease, those patients deserve medical treatment despite limitations in the diagnostic tools conventionally available.Image
Where in the body is it found? ACE2 is present in many cell types and tissues including the lungs, heart, blood vessels, kidneys, liver and gastrointestinal tract. It is present in epithelial cells, which line certain tissues and create protective barriers. The exchange of oxygen and carbon dioxide between the lungs and blood vessels occurs across this epithelial lining in the lung. ACE2 is present in epithelium in the nose, mouth and lungs. In the lungs, ACE2 is highly abundant on type 2 pneumocytes, an important cell type present in chambers within the lung called alveoli, where oxygen i...
Image
Image
Long COVID in young Marines.

thelancet.com/journals/lanam…
Evidence of viral persistence from COVID.

ucsf.edu/news/2024/03/4…
Read 6 tweets
Friesein Profile picture
May 11
The NB.1.8.1 variant seems to have originated in Hong Kong, then spread to several other countries in the region (including Singapore & Australia).

It's now spreading to Western US states such as California, which currently has the highest proportion of NB.1.8.1 across the US.🧵 Image
Image
For the month of March, NB.1.8.1 went from having single digit prevalence in Hong Kong to 80%.

It achieved 100% dominance in HK by late April. Image
NB.1.8.1 has also been spreading to Thailand, South Korea, Taiwan, and Japan (which saw a 30% prevalence of the variant at the beginning of April to 70% prevalence by the end of the month).

Read 10 tweets
Friesein Profile picture
May 8
On the Novavax earnings call today, the head of R&D made an interesting claim.

She said that the Novavax COVID vaccine is capable of inducing mucosal antibodies that could protect against infection.

This lines up with previous data that has been published on the vaccine. 🧵 "Additional exploratory data in the context of our COVID vaccine have shown that our technology platform can induce mucosal antibodies. Mucosal protection is important not only for the person receiving the vaccine, but for instance for reducing virus transmission." —Ruxandra Draghia-Akli, MD, PhD, Head of Research & Development at Novavax
Multiple non-human primate studies and human studies have supported the finding that Novavax reduces viral load in upper and lower respiratory tracts.

Some of this data was published as early as 2020. I've covered these findings over the last few years.

In 2022, Novavax stated in a FDA VRBPAC meeting that they had seen evidence of sterilizing immunity against SARS-CoV-2 through to the presence of IgA and IgG antibodies in mucosa of challenged primates.

They also saw prevention of infection from clinical evidence in humans. Image
Read 11 tweets

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