Novavax: “Are we there yet?”

“I’m STILL waiting for Novavax” and its Relative Safety

Ok, Novavax has been in the news lately and with results of the Phase Three trial published I thought I would take a closer look at the safety of this thing.

But first, I want to make it very clear, I personally have no intention at all of injecting myself with any Covid “vaccine”.

Whatever the societal price there is to pay for this stance, I am able and willing to pay it. As my 22 year old son wisely said yesterday after recently finishing Robert Kennedy Jnr’s book (The Real Anthony Fauci), “Now that I know Bill Gates is behind Novavax, I’m definitely not putting it into my body”.

But that’s us. I know that there are millions of people that do not have the ability or luxury of paying the societal price put to them. It is for them that I have been writing about Novavax and the “I’m waiting for Novavax” strategy. Strategy: “I’m waiting for Novavax”

The foundation of the strategy has been the assumption that it is relatively safer than the other 3 jabs available in Australia (Pfizer, Astra Zeneca and Moderna). Well, we now have some actual data to look at to test that assumption.

There is talk of it being available in Australia in Jan 2022

Health Minister Greg Hunt says Novavax vaccine could be approved by January 2022

It will be called Nuvaxovid in Australia. The government has ordered 51 million doses and it is a two dose jab.

WHO recently issued it with an Emergency Use Listing

WHO lists 10th COVID-19 vaccine for emergency use : Nuvaxovid

But first, this from Sept 2020

Novavax’s Adjuvanted COVID-19 Vaccine Caused Severe Adverse Reactions in Clinical Trials – The Vaccine Reaction

What seems to make this jab “special” is their Matrix-M1 ingredient (adjuvant as they like to call it)

Of the 131 participants in the clinical trial…which began on May 26, 2020, 83 were given the NVX-CoV2373 vaccine containing the Matrix-M1 adjuvant to help stimulate an immune response to produce a strong antibody response.

Matrix-M1 contains nm (nanometers) of nanoparticles composed of Quillaja saponins, cholesterol and phospholipid. Quillaja saponins are chemical compounds extracted from the soapbox tree. They are used by the food industry as “emulsifiers in beverages and food additives.”2 3 4 5 6

In the cosmetics industry, Quillaja saponins (from the Latin “sapo,” meaning soap) are used as “antidandruff, cleansing, emulsifying, foaming, masking, moisturizing, skin conditioning, and surfactant agents.”6

The article has exaggerated the risks of the Phase One trial by calling them Severe Adverse Reactions but in reality:

According to the results of the clinical trial, two of the 83 participants (one each in groups D and E) suffered “severe adverse events” (headache, fatigue and malaise) after the first dose. Two participants—one each in groups A and E—had “reactogenicity events” (fatigue, malaise and tenderness). A reactogenicity event is an “expected” adverse event following vaccination.7 8

Following administration of the second dose, one participant in group D had a “severe local event” (tenderness) and eight participants—one or two in each group—had “severe systemic events.” The most common of these severe systemic events were joint pain and fatigue. One participant in group D developed a fever of 100.58°F.2

So, not great but not the end of the world either.

Now onto their Phase Three results announced 15 Dec 2021.

Novavax Investor Relations - Press Releases & Statements

Novavax Statement on PREVENT-19 Phase 3 Clinical Trial Results Publication in the New England Journal of Medicine

Dec 15, 2021

Today, the full results from PREVENT-19, Novavax’ pivotal Phase 3 clinical trial of NVX-CoV2373, a recombinant protein nanoparticle vaccine against COVID-19, were published in the New England Journal of Medicine. The paper, ‘Efficacy and Safety of NVX-CoV2373 in Adults in the U.S. and Mexico,’ may be accessed here.

PREVENT-19 achieved its endpoint of efficacy in preventing polymerase chain reaction (PCR)-confirmed, symptomatic mild, moderate or severe COVID-19 with onset at least 7 days after the second dose. The trial demonstrated 100% protection against moderate and severe disease, 93.2% efficacy against the predominantly circulating variants of concern and variants of interest, and 90.4% efficacy against COVID-19 of any severity during the time period evaluated. Solicited adverse events were predominantly mild-to-moderate and transient. Severe reactions were infrequent and there were no safety concerns related to vaccination.

PREVENT-19 evaluated the efficacy, safety and immunogenicity of NVX-CoV2373 with Matrix-M™ adjuvant in nearly 30,000 participants 18 years of age and older at 119 locations in the United States and Mexico. The trial included a blinded ‘crossover,’ ensuring all participants received NVX-CoV2373 without compromising Food and Drug Administration (FDA)-required safety follow-up. 

Novavax expects to submit its complete CMC package to FDA for review by the end of 2021.

The manuscript was previously posted to the medRxiv preprint server in October 2021. Initial findings from the study were shared in June.

Effectiveness

They are saying all the right things about effectiveness. Nice high numbers that the TGA can promote.

Efficacy and Safety of NVX-CoV2373 in Adults in the United States and Mexico | NEJM

The media release makes this point

93.2% efficacy against the predominantly circulating variants of concern and variants of interest

But, only two mentions of Delta in the published study and no mention on Omicron.

Because case accrual for this analysis occurred during the first half of 2021, when the delta variant of concern had not been widely established throughout the United States or Mexico,14 no Covid-19 efficacy end-point cases due to this variant were accrued, and thus the vaccine efficacy against delta and other newer variants could not be established.

They know that if the agencies want to sabotage its approval, this is what will be used against it.

Understanding this weakness in there Phase Three data they have quickly come out with some follow up data suggesting it is effective against Omicron.

Novavax Announces Initial Omicron Cross-Reactivity Data from COVID-19 Vaccine Booster and Adolescent Studies - Dec 22, 2021

Good News for Novavax as Vaccine Works on Omicron | Nasdaq

Safety

Now back to safety, that’s the only thing that matters. The tiny Phase One trial seems harmless enough, but too small.

But the “Safety” assessment of the Phase Three trial is a sham:

The trial was designed to evaluate efficacy on the basis of the number of events expected to be required in order to achieve significance with respect to the primary end point, originally estimated to be 144 cases meeting the definition of the primary end point. However, to maintain the viability of the trial and retain participants in the face of nationwide availability of vaccines under emergency use authorization, a blinded crossover (i.e., participants who had originally been randomly assigned to receive placebo were administered NVX-CoV2373 and vice versa) was implemented.

This coincided with the accumulation of a median of 2 months of safety follow-up and ensured that all participants received active vaccine at the earliest possible time without compromising FDA-required placebo-controlled safety follow-up.

Blinded Crossover

This is such a clever and wonderful scam. Here is how it works.

Crossover trials: what are they and what are their advantages and limitations? - Students 4 Best Evidence (cochrane.org)

This type of trial is typically used for chronic disease

Crossover trials can only be conducted when the disease persists for a longer period of time, hence, crossover trials are mostly used in studying chronic diseases. There are some short-term illnesses or acute conditions that might be cured once they are treated and there are treatments that will have a permanent effect (i.e. surgery) on the patient. It is usually not possible to perform crossover trials in such cases.

What they did in the Phase Three trial is give Novavax to about 20,000 and Placebo to about 10,000 and then after about 2 months gave the placebo group Novavax (!).

The bottom line outcome of this is to destroy the placebo group, you cannot now see longer term problem differences between the two groups. There is no control group anymore to compare longer terms problems.

On a more positive note:

The frequencies of medically attended adverse events, serious adverse events, severe adverse events, adverse events of special interest related to Covid-19, and potential immune-mediated medical conditions were balanced between the two groups (Table S9).

No episodes of anaphylaxis, no evidence of vaccine-associated enhanced Covid-19, and no events that triggered prespecified pause rules were observed. No episodes of the Guillain–Barré syndrome20 and no imbalance in myocarditis or pericarditis21 or in vaccine-induced immune thrombosis with thrombocytopenia22 were observed during the relatively short safety follow-up period reported here (Tables S14 through S16).

All-cause mortality was balanced: nine deaths occurred among NVX-CoV2373 recipients (0.5%), and five occurred among placebo recipients (0.5%).

So, it certainly seems safer than the other junk (in the short term), no incidence of myocarditis and ACM (all cause mortality) looks good.

But, the bottom line is, that we don’t know because of their “blinded crossover” BS.

So, if anyone does decide to take it, because a gun has been put to our head, then the best course of action, based on the current available info is to wait a few months and track the real world reports on injury. If there is nothing significant to worry about, then you are good to go.

But, to conclude, from everything that has come out recently, it does seem that it is significantly safer than the other jabs in the short term.

Kirsch wrote on this recently, yesterday, 26 Dec 2021

WHO approves Novavax and COVAXIN (substack.com)

The basis for the “relatively safer” claim has always been an understanding of its simpler and more “traditional” mechanism of action. Kirsch confirms this again:

This is good news because this vaccine is a “traditional” vaccine that does not transfect your existing cells, so it “should” have a much better safety profile than any of the three vaccines now available in the US for two major reasons:

1.    No transfection. All of the existing vaccines basically invade your cells and them to express a spike protein; your immune system may then start attacking your own organs and kill you as explained here. This doesn’t happen with Novavax because you are injected with the antigen.

2.    A controlled amount of antigen. The other major safety benefit is that a controlled amount of antigen is injected. With the mRNA vaccines, the amount of antigen that is ultimately expressed is a complete crap shoot.

Kirsch similarly to me cautious about its “safety”.

Does this mean that Novavax is “safe.” No, it just means it has the potential to be safer assuming they didn’t screw up anything else. And even if they got everything right, simply injecting particles with the spike protein could be dangerous. In short, it’s possible that there may not be a safe vaccine for this virus.

Certainly Dr. Richard Fleming doesn’t think the Novavax vaccine is safe. One of my followers wrote: “it’s viral like particles (spikes) adhered to plastic inner core, mixed with proprietary saponin adjuvant called Matrix M1.”

Kirsch is suspicious of the FDA as I am of our TGA. I think there is the real possibility of sabotaging is availability in Australia, or of making it available as a booster only, and out of reach of all the jab hesitant.

At this point there is no reason to believe there is any goodwill within the decision making class.

To conclude: Does the Fact Pattern of all currently available data suggest that Novavax is Relatively Safer?

The answer is Yes.