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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26 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
  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
  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
  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
  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

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