Thursday, December 07, 2023

Next Generation mRNA COVID-19 Vax Shows Promise in Preclinical Studies

A novel mRNA vaccine developed by GreenLight Biosciences demonstrates significant potential in preclinical animal studies. Does the market need more COVID-19 vaccines? Well, while the market for the existing COVID-19 vaccines have collapsed for now, COVID-19 will likely be around ongoing. As surges may worsen in the future, next generation vaccines will be needed, ones that are more effective, including ones more durable and safer.

This experimental mRNA vaccine encodes for the full-length SARS-CoV-2 Wuhan wild-type spike protein.

What’s the candidate?

GLB-COV2-043, positioned to be a low-cost mRNA vaccine targeting COVID-19.

So how does this early-stage, investigational vaccine differ from say Pfizer-BioNTech’s BNT162b2 or Moderna’s mRNA-1273?

For starters, TrialSite has referred to the above vaccines as version “1.0” or first-generation mRNA vaccines. The current authors concur, however, and not surprisingly, are very careful with their language in the journal entry. Referring to those first mRNA vaccines as “the first-generation mRNA vaccines, encoding for a prefusion stabilized version of the spike (S) protein of SARS-CoV-2 wild-type (Wuhan-Hu-1) strain,” they insert the customary (and likely mandatory) reminder that these current vaccines are considered “safe and highly effective in preventing severe COVID-19 disease, hospitalization, and death in clinical trials,” and therefore authorized for emergency use in humans.

But the authors go on to discuss in pre-clinical research the promise for GLB-COV2-043-driven durability. That is the ability for the vaccine to induce long-term memory responses and durability of binding and neutralizing antibodies against homologous strain and several heterologous variants of SARS-CoV-2.

Also investigating a third booster jab, the data at least thus far suggests GLB-COV2-043 elicits short and long-term potent humoral and cellular immune responses in C57BL/6 mice.

They also point out the success of GLB-COV2-043 in protecting Golden Syrian hamsters in a challenge model against Omicron BA.1 virus.

What about safety?

Thus far tests (cGLP Toxicology study) in Sprague Dawley Rats suggest that GLB-COV2-043 is well-tolerated and effects attributed were consistent with the immunological and inflammatory changes associated with the intramuscular administration of an immunogenic mRNA vaccine.

What’s the delivery technology?

The delivery mechanism involves modified mRNA and lipid-nanoparticle (LNP) technology.

What are pre-clinical results to date?

Studying the vaccine in mice, the researchers from GreenLight finding that GLB-COV2-043 induces robust antigen-specific binding and virus-neutralizing antibody responses targeting both homologous and heterologous SARS-CoV-2 variants and a TH1-biased immune response, as reported by the study authors in a recent entry in the peer-reviewed journal Nature.

The authors point out:

“Boosting mice with monovalent or bivalent mRNA-LNPs provided rapid recall and long-lasting neutralizing antibody titers, an increase in antibody avidity and breadth that was held over time and generation of antigen-specific memory B- and T- cells.”

Further study in hamsters found injecting GLB-COV2-043 led to lower viral loads, reduced incidence of SARS-CoV-2-related microscopic findings in lungs, and protection against weight loss after heterologous challenge with Omicron BA.1 live virus.

What’s the takeaway?

Results show that the “GLB-COV2-043 mRNA-LNP vaccine candidate elicits robust protective humoral and cellular immune responses and establishes our mRNA-LNP platform for subsequent clinical evaluations.”


UK Covid Inquiry Continues with New Testimony, Some Provocative Speakers Show Up

The ongoing Covid Inquiry in the United Kingdom continues this week with former prime minister Boris Johnson finally facing two days of questions about the British government’s actions during the pandemic. The Inquiry is being led by Baroness Heather Hallett in several locations in London. As TrialSite has reported the Inquiry aims to offer a review of the government pandemic response, lessons learned from mistakes with the goal of improving the next pandemic response. Some speakers considered proactive traveled across the pond to discuss problems with the COVID-19 vaccine response at the request of controversial MP Andrew Bridgen. The MP doesn’t trust the formal COVID-19 narrative.

Dealing with the Pandemic

So far, the inquiry has covered topics such as, Resilience and Preparedness, Core UK Decision Making and Political Governance, the impact of Covid-19 on the healthcare system and Vaccines and Therapeutics. On that note, one specific conference led by KC Anne Morris deals with the Vaccine Injured. The vaccine compensation system is a disaster, much like in the United States. According to Morris, the vaccine scheme doesn’t work, it’s not “fit for purpose….”

Apparently, the Inquiry has some influence and can determine if reform to the compensation scheme is necessary. According to the Daily Mail, at least 6,399 claims have been filed with over 500 individuals waiting over a year to get a decision. 166 are “stuck in limbo for more than 18 months,” lawyers told the Inquiry. And as mentioned previously, 127 claims have been approved, state-funded financial support totaling over $18.7 million.

A Different Narrative: COVID-19 Vax Critics Contribute
Yesterday, a panel of experts well known to openly question governments’ top down, rigid response to COVID-19—some even attacked and branded as “conspiracy theorists” testified in front of over twenty members of parliament.

The panel of experts included Dr David E. Martin, Dr Robert Malone, Dr Ryan Cole, Dr Pierre Kory, Professor Angus Dalgleish and Steve Kirsch, the latter being a particularly extreme anti-COVID-19 vaccine advocate. Steve Kirsch has gone on the record that far more people have been killed by the vaccines than saved. While the mainstream medical establishment evades Kirsch, the wealthy Silicon Valley entrepreneur continuously seeks to find smoking gun evidence to shut down the countermeasure program.

Dr. Robert Malone became relatively famous, or infamous, when he went on the Joe Rogan show, and is associated with at least one of the types of research workstreams involved in early mRNA laboratory work. Malone has branded himself as “the inventor of mRNA technology” and has established a substantial platform to call out and question governments’ responses to the pandemic.

Malone, who is now branded an anti-vaxxer by elements within the U.S. said about the Covid vaccine, “What we have here is a rushed product. A rushed technology. A failure to provide respect for humans in not allowing them to have informed consent. And furthermore, actively deploying the most massive propaganda campaign in the history of the modern world, to suppress the ability of the public to gain access-merely to have the knowledge- of what the adverse event risks are. I come to you with one request- open the books! Let’s see the data and let’s allow the data to be examined so we can actually get to the bottom of the most important question the world is facing: were these products actually safe and effective?”

They also mentioned the question of the origin of the Covid virus, and the cover up of early treatments for the disease. Malone also brought up the side effects of the Covid vaccine including myocarditis and the possibility of reproductive damage to women. While there is some peer -reviewed evidence for at least temporary altering of menstrual cycles, there is no direct evidence that the vaccines permanently damage the reproductive system. Malone also emphasized the importance of transparency and the need to access COVID-19 vaccine injury data.

Boris Johnson Expected

The British mainstream media acknowledges members of their Government are under examination and should be treated as severely as how Britons were treated by the Government during what is being referred to as “the Great Panic of 2020-21.” Boris Johnson, the former prime minister, is expected to appear at the inquiry and will be questioned.

The questioning will be a rare opportunity for Johnson to face close scrutiny about the decisions he made during the pandemic, a time when he breached the lockdown rules which he was urging others to follow. The ex-PM is also expected to apologize to the Covid Inquiry because he didn’t get everything right during the pandemic, but he was correct on the “big calls”. Apparently, Johnson has to do some reputation management.

Johnson’s Skill Set

According to Johnson’s former director of communications, Lee Cain, the pandemic was the wrong crisis for Johnson’s skill set, with Cain saying there was “dithering and delay”. This is not the only criticism coming from people who served in the UK government with Johnson. The former chief scientific officer, Sir Patrick Vallance claims Johnson was "bamboozled" by scientific data. Vallance has contradicted himself by also saying “we should have "Locked down harder, earlier.”

The chief scientific adviser to the government did a complete U-turn on what he said to start with! Vallance also revealed he was “reprimanded” by a couple of civil servants when calling for the lock down action by mid-March 2020. While Boris Johnson announced the Covid-19 response by March 23, Vallance shared he privately thought the lockdowns should commence on March 14 or 15. Another former advisor, Dominic Cummings, described the former prime minister as “the trolley” due to his tendency to veer around and constantly change his mind. Johnson’s sister, Sarah, claims the inquiry is just a “show trial” to scapegoat those who were in government during Covid.

Boris Johnson is expected to make an apology on behalf of the government over his early handling of the pandemic, but he’ll defend his personal behavior, obviously over the “party gate” scandal when the PM didn’t adhere to the rules he set for others. Ironically, in Sir Patrick Vallance’s diaries, he claims Johnson, when he was prime minister, pushed to “punish people who aren’t doing the right thing” and for “massive fines” when it came to lockdown rules.

Former Prime Minister to Face Tough Questions

Johnson may be asked specific questions like, “Was the UK too slow to impose lockdowns?” “Did the former PM really say, “let the bodies pile high?” and other similar statements when discussing the idea of a lockdown in 2020. It’s also claimed Johnson said, “Covid is nature’s way of dealing with old people.”

Families of Covid victims are expected to confront Johnson at the inquiry. The former prime minister will be quizzed under oath, and reportedly, Johnson is uncomfortable taking questions so much so, supposedly he once hid in a refrigerator in order not answer inquiries. However, as uncomfortable as Johnson is, the British public may finally get some answers.




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