Novavax & Covax – Safe & Effective ?

There have been many questions in recents weeks within our private QHPA Health Practitioners chat group about the Novavax and Covax.   How dose this vaccines compare to the existing mRNA and adenoviral vector vaccines of Pfizer, Moderna & Astrazeneca.

We thank the QHPA members who investigated this topic and shared the findings below.

Editors Note:   Everyone has there own opinion and philosophy of health, and many of our members at QHPA are not supportive of the need for any covid vaccines, especially in light of covid-19 being something that the vast majority of people make a full recovery from with no treatment. Our natural immune system is something that we can support with nutritional supplements, healthy diet, sunshine, stress management and sleep.

However, some people are interested in potentially using a more traditional vaccine if they were deemed safer, and many of our patients have questions about the new vaccines on the block. We hope this article gives some background information for QHPA members. Please note in providing this summary information below we at QHPA are not suggesting that these vaccines should be used or are indeed necessary for covid-19 prevention. We fundamentally believe in freedom of choice and medical rights and are opposed to all vaccination mandates.

Recombinant Protein-based Vaccines

Novavax and Covax are recombinant protein-based rather than the mRNA or DNA adenoviral vector vaccines currently on offer.

This means the modified spike protein sequence has been synthesised based on a computer model of the virus, and then the spike protein (insect derived) is injected along with an adjuvant, rather than the genetic instructions for your own cells to produce the spike protein as currently happens with the mRNA vaccines. In many respects, these new vaccines are closer to what would be called a traditional vaccine.

Australian Approval of the Protein-based Vaccines

NOVAVAX
Novavax has now been provisionally approved by the TGA and is thought to be available February.

TGA website states 20/1/22: “Novavax and the Australian government announced an advance purchase agreement for 51 million doses of Novavax’s COVID-19 vaccine in January 2021. The first shipment to Australia of the Novavax vaccine is expected in the coming month.”

https://www.tga.gov.au/media-release/tga-provisionally-approves-novavax-biocelect-pty-ltds-covid-19-vaccine-nuvaxovid

COVAX-19
Covax-19 (Now called Spikogen) has not yet been provisionally approved by the TGA, however clinical trials most likely will be happening soon here in Australia.

Covax has been been given a “provisional determination” when assessed (pre-approval) by TGA. The granting of a provisional determination means that the TGA has made a decision that Vaxine Pty Ltd is now eligible to apply for provisional registration for the vaccine in the Australian Register of Therapeutic Goods (ARTG).

https://www.tga.gov.au/tga-grants-provisional-determination-vaxine-pty-ltd-its-covid-19-recombinant-protein-vaccine

Efficacy  

Both new vaccines use spike protein sequence from original strain and show good efficiency against original strains. Both claim effectiveness against Delta, but figures are hard to find as Covax-19 trials have not been published, but meet criteria for approval according to Dr Petrovsky (60-65%).

To design a recombinant protein-based COVID-19 vaccine, companies use computer models of the spike protein and its human receptor, ACE2, to identify how the virus infects human cells. Based on this, the COVAX-19 vaccine is synthesized and it theoretically does reduce not only COVID-19 disease but they claim it also blocks virus shedding and transmission.

What About Omicron?

There is no real data against omicron but both claim to be producing omicron specific versions suggesting they are potentially concerned.

Adjuvents

Adjuvants are often the cause of adverse events with vaccination, being an additive that is intentionally irritating to the body to increase immune reactivity. Both novavax and covax use insect derived spike protein for their antigen source, which is considered fairly harmless, but they have different adjuvants.

Novavax uses a Nanoparticle to bind the spike protein and it is then combined with a powerful saponin derived from Soap Tree bark detergent (Matrix-M). Matrix-M has been used in other vaccines and has been thought to be a component that can cause side effects.

Alternately, Covax-19 uses an inulin adjuvant, which has a history of safe use. The “Advax inulin” in Covax-19, is thought to also be an anti-inflammatory agent and the manufacturer claims it should reduce inflammatory reactions such as fever, fatigue and muscle aches.

The spike protein structure has been modified in both from the native form, to improve results, but full details are not available.

Inulin is a naturally derived polysaccharide found in root vegetables.

Adverse Events

Phase III trial of both vaccines show generally low risk of adverse events. Novavax is in Phase IV in Indonesia and Covax-19 in Phase IV in Iran but no formally published results as yet for Covax-19 (2 million doses have been given in Iran).

  • Covax-19 (Spikogen): Claims that no death/thrombosis/myocarditis has been seen
  • Novavax: The adverse event profile appears slightly higher, but not dissimilar to placebo in trials.

Any vaccine that has not undergone long term clinical safety trials has potentially unknown risks of harm and side effects that were not found in the smaller clinical trial phase. Until we have a larger scale roll out, the full safety profile will be unknown. It is a case of watch and wait.

Comment

These vaccines are more traditional, being protein based, rather than using gene based antigen production in the body. The early trials were similar in size, or smaller than the original vaccines and it is claimed that there were minimal adverse effects and no deaths, but there is still a need for larger numbers to exclude rarer side effects. The efficacy on Omicron is not clear at this stage, but one might suspect that it may not work very well due to viral mutations. The occurrence of ADE (Antibody dependant enhancement) is still possible with future variants and these vaccines still only include the spike antigen, which is the highly variable region of the virus.

These vaccines as a booster, or primary vaccination would appear to be a safer option, but that is based to some extent on hope and small trials rather than data from extensive use.  If having the vaccine to satisfy a mandate we will still open the door to future mandates, rather than address the primary issue of free choice of medical treatments. It is still coercion, and yet as we know many people feel they have little choice, when faced with the potential financial impacts and distress from job loss. QHPA still advocates for the removal of any mandate, but some people may feel more comfortable with the protein based vaccine and the potential higher safety profile expected.  Though, of course, it remains to be seen whether these vaccines will even have the same utility against omicron, as there is no data at this time.

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Queensland Health Practitioner Alliance is an official coalition partner of the World Council for Health.