An outlier in the U.S. pharmaceutical industry’s vaccine wars, one which uses a totally different technology than the current gene therapy vaccines sold by Moderna, Pfizer, and Johnson & Johnson, says it will have a vaccine ready for testing and manufacturing ready in the next several weeks, according to reports.
Novavax was paraphrased by Reuters on Nov. 26 amid the emerging hype around the B. 1.1.529 Omicron variant of SARS-CoV-2, the virus that causes Coronavirus Disease 2019 (COVID-19), as announcing “it had started working on a version of its COVID-19 vaccine to target the variant detected in South Africa and would have the shot ready for testing and manufacturing in the next few weeks.”
The timing is significant considering that the Government of Botswana revealed on Nov. 25 that it had first discovered Omicron in four fully vaccinated diplomats from an undisclosed country who tested positive on Nov. 11.
The diplomats entered Botswana on Nov. 7 and have “since left the country,” according to a Nov. 26 statement by the Ministry of Health & Wellness. The Ministry said genomic sequencing of the positive test was not completed until Nov. 24.
A difference maker
Novavax is a protein subunit vaccine. On the company’s website, it describes its COVID-19 vaccine as a “recombinant nanoparticle technology” used “to generate antigen derived from the coronavirus spike protein.”
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The company also says it uses a “proprietary Matrix-M™ adjuvant.”
The CDC says, “An adjuvant is an ingredient used in some vaccines that helps create a stronger immune response in people receiving the vaccine. In other words, adjuvants help vaccines work better.”
While the messenger RNA types sold by Pfizer-BioNTech and Moderna deploy a genetic instruction to your cells to forcibly grow the SARS-CoV-2 spike protein inside your body in order to elicit an immune response, and the J&J adenovirus vector uses a neutralized adenovirus genetically engineered to carry a double stranded DNA instruction to perform the same function, Novavax’s protein subunit vaccine works by directly injecting cultured spike proteins into the human body.
A June 25 article published by Nebraska Medicine explains this variety of vaccine was created by using spike proteins cultured from moth cells and says the proprietary Matrix-M adjuvant is “made from tree bark.”
The spike proteins are created in a method very similar to how an adenovirus vector vaccine works, but in moths instead of humans. The spikes are manufactured by genetically engineering an insect virus called baculovirus with the genetic instructions required to grow the SARS-CoV-2 spike protein.
“The baculovirus infects moth cells and replicates inside them…These moth cells create lots of spike proteins….Researchers extract and purify the spike proteins,” explains the article, which adds that some influenza vaccines already use a similar technology.
NebraskaMed also adds that the proprietary adjuvant is “based on a saponin extracted from the soapbark tree (Quillaja saponaria).”
“The soapbark extract encourages immune cells to activate, generating a more potent immune response.”
Novavax’s offering is already in phase 3 clinical trials in the United Kingdom, with the U.S. trial beginning in December of 2020.
Foreshadowing
Non-believers of an outlier vaccine candidate may be wise to take notice. The company says it was chosen to participate in Operation Warp Speed in July of 2020, where it was disbursed a substantial $1.6 billion USD.
Between March and May of the same year, Novavax received $458 million in funding from the Department of Defense and the Coalition for Epidemic Preparedness Innovations.
In a Nov. 4 press release, Novavax announced it had applied to the WHO for an emergency use listing, touting its partnership with the Serum Institute of India Pvt. Ltd., described as “the world’s largest vaccine manufacturer by volume.”
The presser claimed it had achieved “100% protection against moderate and severe disease and 90.4% efficacy overall” in its U.S. and Mexico phase 3 trials so far.
The company’s wares have been approved for distribution in Indonesia and the Philippines, and applications are underway in the UK, Australia, Singapore, New Zealand, Canada, and the European Union.
The writing has been on the wall around Novavax’s offering for some time. In June of this year, a puff piece in The Atlantic titled The mRNA Vaccines Are Extraordinary, but Novavax Is Even Better used clever paragraph construction to promote vaccine acceptance as it described messenger RNA injections as “the most effective ones you could get” and “better, sleeker, even cooler than any other vaccines could ever be,” as it set the stage to laud Novavax.
The article said Novavax was pushed to the background while Pfizer and Modera led the foray only “because of superior trial management, not secret vaccine sauce,” and although discussion of how the company’s protein subunit offering worked was buried in the later third of the article, and discussed only very briefly, it was nonetheless described as “more familiar technology that more people may be inclined to trust” than mRNA.
An April article by Politico dubbed The Most Promising Coronavirus Vaccine You’ve Never Heard of may have demonstrated clairvoyance when it stated, “The Novavax shot could serve as an insurance policy in case supplies of the two mRNA vaccines — the workhorses of the country’s vaccination push — or the J&J shot falter.”
Big Pharma’s workhorses appear lethargic in comparison to Novavax. On Nov. 27, Pfizer said it would need “approximately 100 days” to craft a new version of its mRNA injection to account for Omicron’s highly mutated spike protein.
For Moderna, in a Nov. 27 press release titled Moderna Announces Strategy to Address Omicron (B.1.1.529) SARS-CoV-2 Variant, the company could do little more than push booster injections of its existing mRNA-1273 injection as its only path forward when it said “A booster dose of an authorized vaccine represents the only currently available strategy for boosting waning immunity.”
While J&J offered no updates at its Media Center, a spokesperson commented to some outlets only that the company is “closely monitoring newly emerging” variants and that it is “already testing the effectiveness of our vaccine against the new and rapidly spreading variant first detected in southern Africa.”
Like a key
The spike protein, which a coronavirus uses like a pass card to enter human cells to begin the process of infection, is a key issue as humanity fights the pandemic with measures and medicine. The Omicron variant is reported by CNN to have “about 50 overall” mutations, noting “more than 30 of the mutations were found in the spike protein.”
In early October, investigative journalist team Project Veritas captured Pfizer scientist Nick Karl on hidden camera in a personal, after hours setting, explaining the significance of mRNA generated immune responses versus that from natural exposure, “When somebody is naturally immune, like, they got COVID, they probably have better… Like, not better, but probably more antibodies against the virus.”
“Because what the vaccine is, is like I said that [spike] protein, that’s just on the outside [of a coronavirus].”
Karl continued, “So it’s just one antibody against one specific part of the virus. When you actually get the virus, you’re going to start producing antibodies against, like, multiple pieces of virus, and not only just like that outside portion, like the inside portion. The actual virus.”
“So your antibodies at that point are probably better at that point than the vaccination.”
Karl’s impromptu immunology lesson may explain why a September preprint study from researchers in Israel who examined anonymized health records held at one of the nation’s four mandatory healthcare providers found that those who had accepted Pfizer’s vaccination, but had not been naturally exposed to SARS-CoV-2, were at significantly greater risk of symptomatic breakthrough COVID than those with natural immunity were at risk of reinfection.
Moreover, an October study published in Viruses by two Chinese scientists working at the Department of Clinical Microbiology, Virology at Umea University in Sweden found that the full length SARS-CoV-2 spike protein, which is also the same spike that mRNA and adenovirus vector vaccines force the human body to synthesize, tended to concentrate in cellular nuclei, significantly inhibiting the DNA repair mechanism utilized by the body after the immune system forges antibodies in response to exposure to pathogenic antigens.
