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

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

Biotechnology company Novavax, Inc. of Gaithersburg, Maryland recently made public the results of the Phase 1 part of a Phase 1/2 human clinical trial for its experimental NVX-CoV2373 vaccine for COVID-19. According to Novavax, “NVX‑CoV2373 was created using Novavax’s recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax’s patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.”1

The clinical trial involved 131 healthy adults between 18-59 years of age. The results were published in The New England Journal of Medicine (NEJM) on Sept. 2, 2020.2

Novavax COVID-19 Vaccine Contains Strong Saponin-Based Adjuvant

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

Of the remaining trial participants, 25 were given the NVX-CoV2373 vaccine without the Matrix-M1 adjuvant and 23 participants were given a placebo of sterile 0.9 percent normal saline. Each participant received two intrasmuscular injections in the deltoid muscle. The injections were given three weeks apart.2

Trial participants were divided into five group: group A, group B, group C, group D and group E. The 23 participants in group A received two doses of the placebo; 25 participants in group B received 25-μg (microgram) doses of the NVX-CoV2373 vaccine without the Matrix-M1 adjuvant; 29 participants in group C received 5-μg doses of NVX-CoV2373 with Matrix-M1; 28 participants in group D received 25-μg doses of NVX-CoV2373 with Matrix-M1; and 26 participants in group E received a single 25-μg dose of NVX-CoV2373 with Matrix-M1 followed by a single dose of placebo.2

Severe Adverse Events Occurred in Novavax’s COVID-19 Vaccine Clinical Trials

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


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44 Responses to "Novavax’s Adjuvanted COVID-19 Vaccine Caused Severe Adverse Reactions in Clinical Trials"

  1. Brian James   September 14, 2020 at 1:28 pm

    Sep 14, 2020 Community and Countries United! We Say NO!

    Children’s Health Defense is proud to stand with organizations and countries as we work together to pushback on medical mandates, unsafe vaccines, and increasingly totalitarian governments.

    https://youtu.be/bYKGXDm3a00

    Reply
  2. John Doe   September 14, 2020 at 4:43 pm

    typo in paragraph 6 – μg is the symbol for “microgram” but the article says “milligram”.

    1 μg is one millionth of a gram
    1 mg is one one-thousandth of a gram

    1 mg is 1,000x more than 1 μg

    Reply
  3. Marco Caceres   September 14, 2020 at 5:32 pm

    Thank you John. I’ve corrected the mistake.

    Editor, The Vaccine Reaction

    Reply
  4. Marene E. Mayer   September 14, 2020 at 7:03 pm

    to my knowledge – the media is not covering this finding. Maybe because they don’t think these “symptoms” are notable/ important / common with vaccines? They always downplay such things. Very Sad for these people in these trials.

    Reply
  5. Tom   September 14, 2020 at 7:10 pm

    Nano-particle technology should scare the crap out of you. This opens the door to creating human monsters controlled by megalomaniacs to be used for sinister purposes. The adjuvants put into these vaccines sound terrifying. No thanks. There are enough poisons floating around without having them injected into your body…and these can not be filtered by the liver or any other organ.

    Reply
    • Francisco Duarte   September 29, 2020 at 4:38 pm

      FYI, the adjuvants put into this vaccine that sounds “terrifying”, Quillaja Saponins, are the same ingredient you have been drinking your whole life in Slurpees and Root Beers.. Terrifying indeed…

      Reply
      • Chris Ahern   November 4, 2020 at 8:29 pm

        Yes, and by injecting it and getting the immune system to react against it, in the future every time you ingest it in a food or other product containing it, your immune system could react and cause allergic and/or inflammatory reactions.

        Reply
      • Chris   February 25, 2022 at 12:58 am

        I wish more people realized that there’s a significant difference between ingesting something and having something injected. Also, not everyone consumes the junk you listed 🤷🏻‍♀️

        Reply
  6. Rick   September 14, 2020 at 8:43 pm

    I just read the NEJM study and i cant find anywhere where it says there “Severe Adverse Reactions”. When i read it I see it says that “No serious adverse events or adverse events of special interest were reported”.
    I am no fan of vaccinations but i want to better understand your article. Can you direct me to the study that shows there were actually any Adverse reactions?
    thanks

    Reply
    • Marco Caceres   September 15, 2020 at 7:06 pm

      Rick, read the following paragraph from the NEJM report…

      << Overall reactogenicity was largely absent or mild, and second vaccinations were neither withheld nor delayed due to reactogenicity. After the first vaccination, local and systemic reactogenicity was absent or mild in the majority of participants (local: 100%, 96%, 89%, 84%, and 88% of participants in groups A, B, C, D, and E, respectively; systemic: 91%, 92%, 96%, 68%, and 89%) who were unaware of treatment assignment (Figure 2 and Table S7). Two participants (2%), one each in groups D and E, had severe adverse events (headache, fatigue, and malaise). Two participants, one each in groups A and E, had reactogenicity events (fatigue, malaise, and tenderness) that extended 2 days after day 7. After the second vaccination, local and systemic reactogenicity were absent or mild in the majority of participants in the five groups (local: 100%, 100%, 65%, 67%, and 100% of participants, respectively; systemic: 86%, 84%, 73%, 58%, and 96%) who were unaware of treatment assignment. One participant, in group D, had a severe local event (tenderness), and eight participants, one or two participants in each group, had severe systemic events; the most common severe systemic events were joint pain and fatigue. Only one participant, in group D, had fever (temperature, 38.1°C) after the second vaccination, on day 1 only. No adverse event extended beyond 7 days after the second vaccination. Of note, the mean duration of reactogenicity events was 2 days or less for both the first vaccination and second vaccination periods. >>

      Editor, The Vaccine Reaction

      Reply
  7. FAN GU   September 14, 2020 at 11:57 pm

    “One participant in group D developed a fever of 100.58°F.”

    Where did you find this information. I checked paper and its appendix and could not find the data?

    Reply
  8. Greg Cantin   September 15, 2020 at 1:14 pm

    WTF is in the “Placebo” if it gave a serious reaction?

    Reply
    • Maverick   September 16, 2020 at 9:30 am

      Usually, the placebo is just another vaccine, sometimes a full vaccine but mostly just the main vaccine ingredients without the viruses that they put in them. They will never use an inert placebo like saline because they know if they did that the gap of injuries for their reports will be massively different so they couldn’t ‘cook’ the results easily and it would be plain to see that vaccines cause damage and are dangerous.

      Reply
      • Clark Coleman   August 5, 2021 at 8:28 pm

        Baloney. The article states that the placebo was 0.9% saline. Try reading before spouting conspiratorial nonsense.

        The adverse events are being overstated in severity (“tenderness” is a severe reaction?) and of the two patients who had reactions extending 2 days beyond day 7, one was from the 0.9% saline placebo group. How do we know that the second one wasn’t psychosomatic or unrelated, as the placebo reaction certainly was?

        Reply
      • Leanne Bsc   May 7, 2022 at 9:01 pm

        It was saline solution… placebo should do nothing… should highlight the underlying random events/ mental belief that you have received something that is having an effect on you … ie the placebo effect… so it should not have any active effect on the body….

        Reply
  9. Lisa Stienster   September 17, 2020 at 2:56 am

    Wheres the evidence that: these injections wont cause other side-effects later in life; these injections will prevent whatever sickness may occur caused by the “virus”?

    Reply
  10. Frank Good   September 18, 2020 at 9:31 am

    Marco Caceres,

    38.1°C is classified as mild reaction. Why do you write as Severe Adverse Events?

    What is a Serious Adverse Event?
    Death. …
    Life-threatening. …
    Hospitalization (initial or prolonged) …
    Disability or Permanent Damage. …
    Congenital Anomaly/Birth Defect. …
    Required Intervention to Prevent Permanent Impairment or Damage (Devices) …
    Other Serious (Important Medical Events)

    Reply
    • Marco Caceres   September 22, 2020 at 11:40 am

      I didn’t write that a fever of 38.1°C (100.58°F) represented a severe adverse event.

      I wrote: << 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. >>

      Reply
  11. Francisco Duarte   September 29, 2020 at 4:38 pm

    FYI, the adjuvants put into this vaccine that sounds “terrifying”, Quillaja Saponins, are the same ingredient you have been drinking your whole life in Slurpees and Root Beers.. Terrifying indeed…

    Reply
    • Nathan   December 16, 2020 at 11:13 am

      Try injecting and emulsifier into your arm and let me know how that goes.

      Reply
  12. David Andrews   April 17, 2021 at 10:23 pm

    It sounds as if the adjuvant issue needs to be resolved. The main idea of the protein-based vaccine seems like a step forward. Mercury and aluminum-based adjuvants obviously pose permanent health threats. I would expect to prefer a soap-like one, personally, if forced to vaccinate.

    Reply
    • Dawn   June 2, 2021 at 2:34 pm

      The overall problem with this is the induced auto-immunity. My daughter developed a severe milk protein allergy after the dtap, which happens to contain bovine serum (milk protein). She was a perfect baby before, slept through the night, within hours of the injection she had a chest and face rash and explosive diarrhea. It took me weeks to figure it out and eliminate milk and soy from my diet, and it resolved. You see, when you put something in your body it doesn’t recognize (like injecting milk protein) it triggers your body that it’s foreign and your immune system reacts. Now the body recognizes milk protein as foreign and creates an inflammatory response. No, not everyone will react, but some will. In Africa, the accusation is that injections (from the Gates foundation, and tested) were laced with HCG, which is a pregnancy hormone, and then when women got pregnant, the hormone was attacked and miscarriage occurred. It’s always tricky science introducing something into your body in an artificial way, to create an artificial reaction….there are always consequences.

      Reply
      • April   August 5, 2021 at 9:38 pm

        Bovine serum is made from the separated blood of cattle (cows) – not the milk. However, someone predisposed to a beef allergy could react to a vaccine containing Bovine Serum. The whole point of an adjuvant is to make the body overreact to the vaccine – it is probably impossible to find a material that no one would ever be allergic to. Any use of medicine involves weighing up the risk created by the illness vs the risk of the cure.

        More on beef allergies at this site:
        https://stopallergyguide.com/beef-allergy/

        Reply
        • MN   September 27, 2021 at 8:25 pm

          April says, “Any use of medicine involves weighing up the risk created by the illness vs the risk of the cure.” I agree, as long as *I* am the one weighing the risk for myself and making the decisions. I should not be forced to take a risk by my employer or any civil authority.

          Reply
  13. Kim K Aubry   June 22, 2021 at 4:26 pm

    This is a genuine question. To me, severe adverse reactions are more permanent or causing more damage than a fever or a really sore arm or fatigue for a few days or even a week. I know the top 3 vaccines are having extreme adverse reactions. Other than long term issues which we don’t know, these seem pretty mild comparatively to the other top 3 Covid vaccines. Is someone wanted to get the vaccine that was doing the less harm (short term wise) wouldn’t this be better than the other three? What am I missing here?

    Reply
    • April   August 5, 2021 at 9:53 pm

      I agree with you. I find the information regarding Novavax adverse reactions far more reassuring than the other vaccines for Covid. A vaccine induces an immune response. If it doesn’t then it is not working. So you would expect to have a sore and achey arm after receiving a vaccination.
      I am wondering if the descriptions of responses are on a sliding scale – so if reports of reactions went from some people having practically no adverse reaction and some people feeling off colour for a few days, then the people who were off colour for a few days/got a temperature, had a more severe adverse reaction than the person who had a hot arm for an hour or so. I imagine if people had suffered blood clots etc then these would have changed the scale?

      Anyway, from my reading so far, Novavax seems to have the least worrying adverse reactions. Some people will be against vaccinations, no matter what, some people will be trying to balance the risks caused by the disease vs the risk caused by the medication. Life is never perfect and we just have to do the best we can but we do need to keep an open mind.

      Reply
  14. Sally   August 9, 2021 at 7:57 pm

    Is the adjuvent necessary

    Reply
    • DT   November 18, 2021 at 6:32 pm

      Yes. Purified protein in low doses do not always stimulate the adaptive arm of the immune system. Adjuvants help kick start that pathway to provide longer lasting immune response which is the point of the vaccines.

      Reply
      • Lilly   December 31, 2021 at 1:12 am

        But then the immune response is to the adjuvant, not to the pathogen the vaccine is supposed to protect the individual from. Hence the severe immune response when exposed to the adjuvant in the future. The vaccine may not be protective against the pathogen at all.

        Reply
  15. Peter Donnelly   August 24, 2021 at 8:33 pm

    The trials didn’t test against the Delta strain from what I read. https://mvec.mcri.edu.au/references/novavax-covid-19-vaccine/ Can anyone verify this? The efficacy seems lower than previous vaccines as well.
    My doctor said this is the safest one yet but I’m still not convinced.

    Reply
  16. DeSelby   October 12, 2021 at 9:19 am

    I still don’t undestand why the IM route is preferred for vaccination when the route of infection is through the air passages. Surely they should be targetting mucosal immunity not basal immunity.

    Reply
  17. Maria Donna Solano   November 8, 2021 at 10:10 am

    These adverse reactions sound more bearable than other vax reactions some people with my illness have endured such as neuro inflammation causing weak body/legs, burning, 60percent taking 3 months to recover from side effects (Health Rising), some longer.
    The ingredients sound quite salty which is better than ingredients that cause natal defects and cancer in mice. But I wasn’t sure about polysorbate 80 as a safe ingredient. I know it’s used in chemo.

    Reply
    • Lilly   December 31, 2021 at 1:15 am

      Polysorbate 80 allows substances to cross the blood/brain barrier.

      Reply
    • lilly   January 5, 2022 at 4:02 am

      https://pubmed.ncbi.nlm.nih.gov/4026903/ on polysorbate:

      Polyoxyethylene (20) sorbitan monooleate (polysorbate 80, Tween 80), a surfactant, has been widely used as a solvent for pharmacological experiments. In the present study, polysorbate 80 was found to have toxicity of a low order in both the mice and rats when given by i.p. and p.o. routes. It produced mild to moderate depression of the central nervous system with a marked reduction in locomotor activity and rectal temperature, exhibited ataxia and paralytic activity and potentiated the pentobarbital sleeping time. On intravenous administration in dogs, it had a dose-dependent hypotensive effect. Polysorbate 80 did not have a direct stimulant or relaxant effect on either guinea pig ileum or rat uterus, however, it antagonised the contractions induced by acetylcholine, histamine, barium, 5-hydroxytryptamine and carbachol in a dose-dependent manner. A direct relaxant effect was observed on rabbit jejunum. A dose-dependent myocardial depressant effect was observed on guinea pig and rabbit paired atrial preparations. On the electrically-driven guinea pig left atrial preparation, polysorbate 80 exhibited a dose-dependent negative inotropic action. Polysorbate 80 did not induce diuresis in rats upto a dose of 2.5 ml/kg. The results of the present study indicate that polysorbate 80 can neither be used as a solvent for isolated tissue experiments nor when considered for intravenous administration. However, polysorbate 80 can be employed safely as a vehicle for neuropsychopharmacological experiments in doses not exceeding 1 ml/kg.

      Reply
  18. JL   November 11, 2021 at 11:09 am

    If push comes to shove and the illegal mandates persist, this is the only non-mRNA vaccine available. I went from prepared to quit my jobs (healthcare and higher education) to considering this more traditional option. Hoping it is approved by WHO before Dec 2021 so that it will be an option to comply with the illegal Nuremberg violating, but seemingly society acceptable “mandates”. In the US this option may require you fly to UK or Indonesia but hey, beats mRNA at this point.

    Reply
    • DT   November 18, 2021 at 6:35 pm

      You are not alone. Would be nice if there were options for people who just don’t want to get an mRNA or viral vector DNA vaccine. Novavax is coming and perhaps mandates might be placed on the back burner until more options are available. Not everyone who is hesitant for the newer vaccines are anti-vax and shouldn’t be labeled so.

      Reply
    • lilly   January 5, 2022 at 4:07 am

      consider this then for non-mRNA vaccine with less side effects than Novovax – made in australia and already in use In Iran:
      https://www.clinicaltrialsarena.com/analysis/vaxine-australia-approval-covid-19-vaccine/
      Vaxine to file for Australian approval of protein subunit Covid-19 vaccine
      Vaxine chairman and research director Nikolai Petrovsky. An ongoing GoFundMe raise for SpikoGen to be made available in Australia has exceeded its A$400,000 goal. Credit: Vaxine
      Vaxine is looking to bring its Australia-developed Covid-19 vaccine home. The Adelaide-based company is aiming to file for provisional approval of its protein subunit Covid-19 vaccine SpikoGen to the Australian Therapeutic Goods Administration (TGA) this week, vaccine developer Nikolai Petrovsky says. The application will be based on Phase III data collected in Iran.

      The submission would start a TGA rolling review, which could run for a maximum of six months, says Petrovsky, who is also the company chairman. There is an ongoing GoFundMe raise for SpikoGen to be made available in Australia, drawing A$ 414,700 at the time of writing, exceeding its A$400,000 target.

      Vaccine passes 60% efficacy bar
      The Australian application will be based on interim data from a Phase III SpikoGen trial that recruited 16,876 volunteers. Interim data shows that SpikoGen exceeded the 60% efficacy bar in the primary endpoint of preventing symptomatic Covid-19 disease, based on a prespecified 88 PCR-confirmed infection events, Petrovsky explains. Participants received either SpikoGen or placebo in a 3:1 ratio.

      SpikoGen has a favourable safety profile, Petrovsky says. While rarer side effects may not appear in a relatively small trial, adverse events like heart inflammation are not expected with this vaccine technology, he explains. “The trial is unlikely to see an adverse event that is in one out of 12,000 people.”

      Petrovsky declines to add further detail on efficacy data as the manuscript is currently being translated from Farsi to English. There were no death events in either placebo or vaccine arms, he notes. Nonetheless, participants will still be monitored in the coming months for safety and efficacy, with the possibility of unblinding the trial for placebo recipients to also be vaccinated, he adds.

      In Australia, there are four Covid-19 vaccines with provisional approval: the mRNA vaccines by Moderna and Pfizer/BioNTech, and the adenovirus-vectored vaccines by AstraZeneca and Johnson & Johnson.

      SpikoGen authorised in Iran
      Based on Phase III data, Vaxine’s Iran collaborator CinnaGen secured an emergency permit for SpikoGen from the Iranian Food and Drug Administration on 6 October. Petrovsky notes that the local regulatory authority set the bar at 60% – which is 10 points higher than benchmarks by the World Health Organization (WHO), the US FDA and EMA. The vaccine still passed this higher bar despite the Delta variant being prevalent in Iran, he adds.

      CinnaGen is now in talks with the Iranian government on vaccine orders, with CinnaGen to manufacture the vaccine in the country, Petrovsky says. Locally made vaccines assist in cutting through any import delays. The vaccine does not have rigorous cold chain requirements as it is stable between 2–8 °C, he adds.

      Reply
      • J G   February 28, 2022 at 8:10 pm

        I’m with you on this one, Lilly, it seems a much safer bet than an mRNA vaccine or one with nano particles of a Matrix-M adjuvant in it.

        The fact that Professor Petrovski was the first person to receive a dose of his vaccine says a lot.

        Unlike the head of Pfizer who refused to take his own vaccine saying it was more important for his workers to be injected!

        Reply
  19. lee thai   November 14, 2021 at 9:36 am

    As more knowledge on the mRNA spike injected circulating and attaching to ACE2 receptors, then second shot is given with the same adjuvant , then required booster of the same, the overloading of spike seems to me to be obvious when even after 2 jabs and then infection with the virus more over load for the body,
    Pathology shows the spikes block the platelets and cause micro clotting that can not be picked up with MRI or CT, The rush to Market the Current crop of prototype vaccines has been their down fall, for many reluctant to take (never buy the first model of car) as we see the high rate of adverse effects for double jabbed &infected,
    I too am hoping the size of the spike is reduced, is stopped from entering the cell, the natural and localised in situ site has way more merit and more time to develop better outcomes, I keep using preventative ivermectin until peer review published

    Reply
  20. Linda   November 16, 2021 at 9:13 am

    That’s why references are listed at the end, so you can look at the actual texts used to write an article. It enables the reader to continue reading and researching if they want further information.
    In school they used to call it a bibliography.
    It’s sad, people today don’t even know how to research properly and or are too lazy to look further.
    It’s no wonder fake news spreads so easily.

    Reply
  21. The Dile   December 8, 2021 at 4:05 am

    I don’t get the purpose of this article., the way the headline is worded.

    The reactions listed may be considered “severe” on some list or form, however, I think when we compare them to the insane and terrifying ones from mRNA vaccines like heart inflammation, bells palsy, strokes, et c. we can say that this one doesn’t sound so terrifying.

    Dr. Robert Malone, a prominent co-inventor of mRNA vaccine technology, has promoted this vaccine (Novavax), again, remember he has been speaking out about the potential dangers of the mRNA and viral vector versions of the covid vaccine, due to the fact that they cause your body to produce a spike protein that *can* be toxic (isn’t toxic in small amounts while localised, but can be if it gets produced in large amounts or spreads through the body it can be, Malone argues.)

    I’m certainly no scientist or doctor, but to me, if I were absolutely forced to take a covid vaccine, (another story altogether – I think it’s unnecessary for most people given the low death rate of covid (0.23-0.27 IFR), plus mandating medical treatments is just insane tyranny) … if I were given the choice between a vaccine that causes your body’s cells to produce the spike proteins, or one that contains a set amount of spike proteins, I’d pick the one that you know will eventually be cleared – and that’s Novavax. Not saying I want it – but if it means being able to put food on the table for my kids, I’d take it. (And I’d be bitter about it – sabotage and other property crimes would be committed in retribution, targeting Government assets!)

    Reply
  22. Alice   March 6, 2022 at 8:11 pm

    Another potential vaccine approved in Canada.
    Medicago produces it.. in Canada the Medicago is called
    Covifenz. Two doses required. 21 days apart.
    Less harmful adjuvant, Ithink.
    A

    Reply
  23. Leo   March 23, 2022 at 5:44 am

    Hmmm, I didn’t see any sums here (unless I missed it), but amid the less than crystal-clear report here’s is a quick calculation result I get:
    Of 83 participants 13? had significant reactions.
    83 x 15.66% = 13 (approx.).
    Multiply any population by approx. 15.5% and the result will be a LOT of people!
    Not a great trial result to roll out mass vaccinations, as I see it.
    Am I thinking too logically? Apologies – it just comes with the territory: vaccine-free human.

    THANK you Vaccine Reaction Team for all your great work. 🙂

    Reply

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