ACNEM Members Only – Novavax Vaccine

ACNEM Report By Dr Mark Donohoe, President

Intense immunoreactivity of the current novel coronavirus vaccines (AstraZeneca Vaxzevria, Pfizer Cominarty and Moderna Spikevax vaccines) has created a dilemma for many doctors not only within ACNEM, but outside the College as well. Many patients suffer severe exacerbations of inflammatory conditions following vaccination, and these initial highly immunogenic vaccines would appear to have increased the likelihood of this happening.

One problem is that the choice of vaccine is limited to only the two novel vaccine types (mRNA and chimp adenovirus vector), and there are currently (as of 14-09-21) no “traditional” (i.e. antigen + adjuvant) vaccines available to the public. In addition, there is now both legislation and intense pressure on workers in particular industries and professions to undergo vaccination immediately in order to be able to return to the work, under threat of dismissal should they fail to comply.

One recurring question some of our doctors have raised is the availability of the Novavax vaccine in Australia, and whether it may prove a good alternative to the three vaccines currently available.

This is a summary of my discussion with Karl Herz, the CEO of Biocelect which is the “manufacturer” of the Novavax vaccine in Australia and New Zealand. This document is a short report on the information gleaned from that discussion on 27 August this year. The addendum about possibly delayed availability was conveyed on 13 September.

 

Availability

The Government has purchased over 50 million doses of the Novavax vaccine, and the first shipment was due to land in October 2021. The expected delivery date for the vaccine is now “between October and December 2021”. While the Federal government controls distribution, the expiry date for the vaccine is six months from the date of manufacture, meaning that all vaccines need to be used within that period. Since the government owns and distributes the vaccine at its own discretion, it is not possible to be precise about availability to the public, and how Novavax will be rolled out.

 

Safety, efficacy and adverse affect profiles  

The Novavax vaccine has virtually identical efficacy and effectiveness in phase 3 clinical trial compared to AstraZeneca Vaxzevria, Pfizer Cominarty and Moderna Spikevax vaccines. No safety issues arose in the trials done to date, and because this is a traditional protein + adjuvant technology, no unusual safety issues are considered likely to occur. The adverse affect profile is significantly better than the current vaccines. I attach the report of the phase 3 trial trials, showing adverse reaction similar to placebo.

On the question of sterilising immunity (i.e. preventing infection and transmission), this is as yet untested in humans, and cannot be assumed. This is the same with all current vaccines. The goal of this vaccine is to develop neutralising immunity to prevent clinical disease, and it achieves this at levels that match the current vaccines.

 

Components of the vaccine 

The Novavax vaccine comprises 5μg of full-length spike (S) protein as the antigen, and once manufactured this is put in deep freeze and has no expiry. The adjuvant is “Matrix-M”, a saponin derived from the Chilean soap bark tree. This saponin has the property of stimulation of both B and T lymphocytes, thought to be important in inducing the appropriate immune response to protect against COVID-19 disease.

When the Matrix-M and spike protein are combined, it starts the clock on the 6 month expiry date for the vaccine.

One potential issue for ACNEM is environmental in nature. The Chilean soap bark tree is a limited native environmental resource, and the vaccine has apparently consumed the majority of available plants.

 

Comment

The Novavax vaccine appears to be an effective traditional vaccine with fewer and milder adverse effects and reduced immunogenic (inflammatory) effects after both first and second doses compared to the currently available mRNA and chimp adenovirus DNA vaccines. The adjuvant (Matrix-M) is naturally derived and has effects on both arms of the immune response.

This may become the vaccine of choice for patients who are at risk of strong inflammatory responses after strongly immunogenic vaccines. These may include patients with autoimmune disease, persistent IgM positive viral infections, chronic inflammatory conditions and severe reactions to previous vaccines.

Its likely value is as a choice of a traditional vaccine technology in place of the current limited COVID-19 vaccine options.

I include links to the trial data sheet, and links to articles on the vaccine and the saponin adjuvants from The Atlantic.

 

Addendum

The manufacturer has no discretion on the deployment of the vaccine following delivery to the Federal Government. The Federal Health Minister has absolute discretion on the deployment of the vaccine after delivery.

The Hon. Greg Hunt MP, Minister for Health and Aged Care was interviewed on 2GB Drive by Clinton Maynard on September 2021:

CLINTON MAYNARD:

Novavax; a question from one of our listeners, Roy: when will Novavax be available?

GREG HUNT:

So the latest advice we have is November. That’s a global question. They’re just completing their clinical trials. And so our first doses are due to arrive in November.

We don’t have a schedule from them yet, but I’ve met with senior global leadership recently and that was what they advised me.

So we have 51 million of those. They are what is called a protein vaccine. And if they’re not needed in this year’s round, they make an excellent booster in case we need this next year.

 

Novavax Is Now the Best COVID-19 Vaccine – The Atlantic

A COVID-19 Vaccine Could Rely on Rare Trees in Chile – The Atlantic

Novavax PREVENT-19 Phase 3 Trial Data Factsheet 2021