New Non-mRNA 'Emergency' Vaccine Authorized for COVID
September 11, 2023, the U.S. Food and Drug Administration announced1 it had approved reformulated monovalent COVID shots by Pfizer and Moderna for use in individuals 12 years of age and older. They also issued emergency use authorization (EUA) for use of the reformulated jabs in children aged 6 months to 11 years.2
The updated mRNA injections contain a single modified RNA said to correspond to the Omicron variant XBB.1.5., which was the dominant variant in the U.S. for most of 2023, but which has since been replaced by other variants.
According to authorities, however, this strain is different enough from the strains in any of the previous shots to recommend everyone take it, regardless of your previous COVID jab history.3
Fortunately, most Americans are not falling for the same lies this time around. Most have realized that the shots are ineffective and can cause all sorts of health problems, including heart damage and immune system deregulation. Most people are also tired of the never-ending boosters.
In all, high-risk individuals (such as the elderly and/or immunocompromised of all ages) who were recommended to get additional doses will have received as many as six mRNA injections at this point — a three-dose primary series in 2021,4 two boosters to the primary series during 2021/2022,5 and one bivalent booster in the fall of 2022.6 The latest reformulation for XBB.1.5 will be the seventh in just three years.7
Non-mRNA Shot Authorized as Public Rejects mRNA
Uptake of the new monovalent shots has been disappointing, however. As of October 12, 2023, only 7 million Americans had rolled up their sleeves. For comparison, by October 12, 2022, more than 18 million had received the bivalent booster released that September, and by May 2023, 17% of the population — 56.5 million people — had received it.8
Assuming the U.S. population is 340.47 million people,9 7 million is only about 2.06%. According to CIDRAP News,10 booster uptake is being "hindered by prior infections" and "fear of side effects." That’s what an October 2023 study11 found. As noted in that paper:"The most commonly reported reason for not having been boosted was a prior SARS-CoV-2 infection (39.5%), followed by concern about vaccine side effects (31.5%), believing that the booster would not provide additional protection over the vaccines already received (28.6%), and concern about booster safety (23.4%) or that it would not protect from SARS-CoV-2 infection (23.1%).
For themes related to reasons for not having been boosted, those 60 years of age or older were less likely to select items related to knowledge or logistical concerns about the vaccine; while those reporting Hispanic ethnicity were more likely to convey concerns about logistics than those reporting non-Hispanic ethnicity.
Finally, compared to college graduates, those with some college or technical school were significantly more likely to select items related to the risks and benefits of the bivalent vaccine not being clear as reasons for not having been boosted."
Note how they downplayed people’s concern about vaccine side effects. They separated "concern about vaccine side effects" (31.5%) and "concern about booster safety" (23.4%), which is the exact same thing. Add them together, and 54.9% are skipping further boosters due to fears about their safety.
To Allay Fears, FDA Grants EUA to Non-mRNA COVID Vaccine
The FDA’s authorization12 of an updated non-mRNA COVID vaccine — Nuvaxovid, a subunit protein vaccine made by Novavax — is reportedly part of the strategy to encourage uptake among those who are "hesitant about the mRNA vaccines."13
The updated Novavax vaccine was authorized by the FDA in early October 2023 for ages 12 and older, regardless of previous COVID jab status. Like Pfizer’s and Moderna’s new shots, the updated Nuvaxovid targets the SARS-CoV-2 variant XBB.1.5, and the FDA is encouraging people to select whichever shot they prefer (mRNA or non-mRNA).14
Novavax Is Not Using Well-Tested Technology Either
While Novavax isn’t using the mRNA platform, it’s not using entirely tried and true vaccine technology either. Rather than growing the viral protein in eggs or mammalian cells, as has been done for decades, the company is producing the SARS-CoV-2 spike protein in moth cells.15 As explained by NebraskaMed.com:16"The Novavax method uses moth cells to make spike proteins:
1.Researchers select the desired genes that create certain SARS-CoV-2 antigens (spike protein).
2.Researchers put the genes into a baculovirus, an insect virus.
3.The baculovirus infects moth cells and replicates inside them.
4.These moth cells create lots of spike proteins.
5.Researchers extract and purify the spike proteins.
‘The Novavax vaccine has no genetic material, only proteins,’ says Dr. Florescu. ‘The vaccine technology is more traditional, and it's very similar to a protein-based influenza vaccine.’"
Nuvaxovid also contains a proprietary adjuvant called Matrix-M, which is based on saponin extracted from the bark of the Chilean soapbark tree. Like other adjuvants, it boosts your body’s immune reaction to the viral protein, which allows a smaller dose of spike protein to be used. According to published studies, Matrix-M has an excellent safety profile, but where have we heard that before? I, for one, will wait for independent corroboration before making such claims.
Effectiveness and Safety of Novavax
Novavax is said to have the same degree of effectiveness as the other COVID shots. According to a study17 published in early October 2023, the Novavax vaccine released in late 2021 was 31% effective against diagnosed SARS-CoV-2 infection and 50% effective against symptomatic COVID-19 during the first four months. Like the mRNA shots, effectiveness against infection waned from there.
As for safety, Novavax appears to be less risky than the mRNA shots when it comes to myocarditis and other heart-related damage, but serious side effects do occur, as evidenced in data18 from the Centers for Disease Control and Prevention.
Out of a cohort of 1,148 teens aged 12 to 17, 52 (3.6%) experienced a severe systemic event after the first dose of Novavax, and 304 (21.9%) had a severe systemic event after the second dose. One teen boy was diagnosed with myocarditis after his second dose, and the FDA officially concluded that his condition was "related to the vaccine."19
Among adults, ages 18 to 64, 2.4% experienced a serious systemic adverse event after the first dose and 13% had a serious event after the second dose. Among the elderly (65 and older), 1.6% had a serious event after the first dose and 4.4% after the second.20 So, clearly, Novavax appears to be far riskier for younger people than older ones.
Curiously, at the last minute, the European Medicines Agency (EMA) decided to push back its authorization of the updated Novavax shot, and is asking the company for additional information. In August 2022, the EMA recommended Novavax add a warning about the possibility of heart inflammation to its vaccine.21
So, what is the EMA concerned about now that the FDA isn’t? "FDA did authorize it — but don’t take it, as there must be a significant problem," Dr. Meryl Nass warned in an October 16, 2023, Substack post.22
Where’s the Emergency?
As mentioned, the FDA has only authorized Novavax for emergency use. It does not have full approval. But wait a second. Wasn’t the COVID emergency declaration officially ended May 11, 2023? It sure was, so, how can the FDA issue Emergency Use Authorization (EUA) for Novavax when there’s no emergency?
Short answer: the FDA made up new rules on the fly. Again. As noted in the FDA’s letter to Novavax, dated October 3, 2023:23"On February 4, 2020, as amended on March 15, 2023, pursuant to Section 564(b)(1)(C) of the Federal Food, Drug, and Cosmetic Act ... the Secretary of the Department of Health and Human Services (HHS) determined that there is a public health emergency, or a significant potential for a public health emergency, that affects, or has a significant potential to affect national security or the health and security of United States citizens living abroad, and that involves the virus that causes Coronavirus Disease 2019 (COVID-19) ...
On July 13, 2022, the Food and Drug Administration (FDA or the Agency) issued an Emergency Use Authorization (EUA) for emergency use of the Novavax COVID-19 Vaccine ... pursuant to Section 564 of the Act ... On October 3, 2023, having concluded that revising this EUA is appropriate to protect the public health or safety under section 564(g)(2) of the Act, FDA is reissuing the May 11, 2023 letter of authorization ..."
The emphasis in the above paragraph is mine. There are several curious things going on here. For starters, according to this letter, the FDA authorized Novavax based on the POTENTIAL for a public health emergency, not an actual emergency.
Secondly, it specifies that this potential public health emergency must affect either national security or the health of Americans "living abroad." Isn’t that curious? Why is there no mention of U.S. citizens who live in the United States? To reiterate, the potential emergency only covers two things: threats to national security and citizens who live abroad.
In reading the amendment in the Federal Register,24 the reason for this oddity becomes clear. That’s the only justification the secretary could use to declare an "possible emergency" that would authorize the FDA to issue the EUA.
There are only four situations under which the HHS secretary can justify EUA and the other three require us to be under attack from a chemical, biological, radiological or nuclear weapon.
The HHS is not going to admit SARS-CoV-2 is a bioweapon, so the HHS Secretary chose the only justification available, which is a "potential" public health emergency "that affects, or has a significant potential to affect, national security or the health and security of United States citizens living abroad."
That determination authorized the FDA to issue an EUA to Novavax even though no emergency exists, and even though Americans living in the U.S. are not even covered by the potential emergency. It’s ridiculous, but that’s where we are.
mRNA-Related Deaths Is the Real Emergency
If there’s an emergency, it’s that children and young adults are dying in record numbers and people are linking those deaths to the mRNA shots, hence the dramatic drop in booster uptake.
As reported by Dr. William Makis25 and the Ethical Skeptic,26 the excess mortality for birth to 24-year-olds is now at 41.7% — an historical high, and massively higher than 2020, when excess mortality for this age group remained well within historical norms.
They Used COVID to Get Untested Vaccines to Market
Importantly, just like the updated mRNA shots, the updated Novavax vaccine has not undergone additional testing. It’s safety is entirely based on the original formula, investigational monovalent and bivalent vaccines that didn’t make it to market, and postmarketing data.
According to the FDA,27 "The data accrued ... are relevant to Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) as the vaccines are manufactured using a similar process." However, it’s not the manufacturing process alone that determines how risky an mRNA shot might be. The antigen used, and other ingredients that may or may not have changed, likely play a far more important role.
Considering the spike is the most pathogenic part of the virus, and the reformulated shots contain an entirely different spike, how can we assume that the safety will be identical to that of the original shots that were based on the Wuhan spike? We can’t.
What we have now is a brand new paradigm where vaccines are allowed to be brought to market without testing, which no doubt is a vaccine maker’s dream come true. They’re also blatantly ignoring clear EUA rules and misusing authority to declare emergency when none exists.
Also, recall the FDA licensed Comirnaty while simultaneously extending EUA for the Pfizer-BioNTech jab. It was a classic bait and switch, as people were told to get the now "fully licensed" jab, when in fact the shots they received were not licensed at all, but still the experimental and unlicensed EUA product.
According to the law, EUA can only be given when there’s no approved alternative, so once Comirnaty was approved, the FDA lost its legal ability to preserve ANY of the EUAs, even if there was an actual emergency.
Got the Jab? Take Action to Safeguard Your Health
When it comes to treatment, it seems like many of the treatments that worked against severe COVID-19 infection also help ameliorate adverse effects from the jab. This makes sense, as the toxic, most damaging part of the virus is the spike protein, and that’s what your whole body is producing if you got the jab.
- 1 FDA September 11, 2023
- 2, 28 The Defender September 12, 2023
- 3 Scientific American September 1, 2023
- 4 Ardent Health COVID Vaccine Primary Series
- 5 AARP Guide to COVID Boosters March 20, 2022
- 6 Johns Hopkins Bivalent COVID Booster Updates October 3, 2022
- 7 CDC People Who Got Previous COVID Vaccines
- 8 CNN October 12, 2023
- 9 US Population Live
- 10 CIDRAP News October 3, 2023
- 11 Vaccine October 6, 2023; 41(42): 6221-6226
- 12, 27 FDA October 3, 2023
- 13 Scientific American October 16, 2023
- 14 CDC, Interim Clinical Considerations for Use of COVID-19 Vaccines in the United States, October 6, 2023
- 15 WUSA9 June 14, 2021
- 16 Nebraska Med July 21, 2022
- 17 JAMA Network Open October 4, 2023; 6(10): e2336854
- 18, 19, 20 CDC Novavax COVID-19 Vaccine Local Reactions, Systemic Reactions, Adverse Events, and Serious Adverse Events
- 21 The Jerusalem Post August 3, 2022
- 22 Meryl Nass Substack October 16, 2023
- 23 Letter from FDA to Novavax October 3, 2023
- 24 Federal Registster COVID 19 Emergency Use Authorization Declaration
- 25 Twitter William Makis October 3, 2023
- 26 Twitter Ethical Skeptic October 3, 2023
- 29 HHS.gov Fact Sheet April 14, 2023
- 30 Covid19criticalcare.com