Should vaccines be adjuvenated with alum?

For a long time vaccines were adjuvenated (made more effective) by adding aluminium salts to them. Eventually, however, sufficient concerns about the practice emerged for the practice to be dropped and Covid vaccines did not contain such adjuvants.

But was something lost by that? Might the Covid vaccines have worked better with adjuvants? The study below used mice to suggest an answer to that. They found that breakthrough infections were much worse with adjuvants.

While COVID-19 vaccines have generally remained effective in stopping more severe illness associated with SARS-CoV-2, the virus behind COVID-19, significant concerns emerge regarding vaccine-associated enhanced respiratory diseases (VAERD) post breakthrough infections. This means even though people get vaccinated, because the COVID-19 vaccines are not of the sterilizing type, they fail to protect against infection, especially over time, less intermittent boosters to bolster protection. Importantly, this recent animal study reveals spike protein subunit vaccines for SARS-CoV-2 induce VAERD in hamsters, where aluminum adjuvants promote a Th2-biased immune response, leading to increased type 2 pulmonary inflammation in animals with breakthrough infections.

Other research such as a study funded by China’s Beijing Science and Technology Plan and Emergency Key Program of Guangzhou Laboratory, found that both novel low-dose and high-dose adjuvanted inactivated SARS-CoV-2 vaccine with CpG and Alum induced high levels of specific IgG antibodies as well as neutralizing antibodies against SARS-CoV-2, and the continuous stability of high-level neutralizing antibody titers over time demonstrates long-lasting immunity.

The prominent study team was represented by Weishan Huang, Ph.D. Department of Pathobiological Sciences, School of Veterinary Medicine, Louisiana State University, as well as Cornell University’s Department of Microbiology and Immunology, College of Veterinary Medicine.

With a focus on virology and immunology, Huang’s lab studies the development and functions ­­of regulatory immunity and immune memory during vaccination, infections, and cancers.

With this infrastructure and expertise in place, plus support in the form of grants by the National Institutes of Health, and a “Big Idea Research Grant” from the Provost’s Fund at Louisiana State University, Huang and colleagues from Louisiana State University sought to gain a more comprehensive understanding of possible risks and the underlying mechanisms of VAERD designed a study involving the immunization of ACE2-humanized mice with SARS-CoV-2 Spike protein adjuvanted with aluminum and CpG-ODN.

After the immunization, the scientists challenged (intentionally infected) the mice with SARS-CoV-2 to establish the breakthrough condition.

What were the findings?

In this case, the authors report that their experimental vaccine A) elicited robust neutralizing antibody responses, B) reduced viral titers and C) enhanced host survival. Yet upon breakthrough infection, the vaccinated animals presented “severe pulmonary immunopathology, characterized by a significant perivascular infiltration of eosinophils and CD4+ T cells, along with increased expression of Th2/Th17 cytokines.”

Th2/Th17 cytokines are groups of signaling molecules produced by specific subsets of T-helped cells (Th cells) that play an important role in the immune system. These cytokines are involved in regulating responses and inflammation, and they are often associated with various immune reactions.

The study team conducted intracellular flow cytometric analysis (a technique used to identify cell types plus analyze signaling and functional responses within cell lines and heterogenous cell samples), revealing a systemic Th17 inflammatory response, especially intense in the subjects’ lungs.

The study authors report in the uploaded preprint server manuscript that the generated data demonstrate that aluminum/CpG adjuvants induce strong antibody and Th1-associated immunity against COVID-19 but also prime a robust Th2/Th17 inflammatory response, which may contribute to the rapid onset of T cell-mediated pulmonary immunopathology post breakthrough infection.

Food for Thought

There are no easy vaccine fixes for SARS-CoV-2, the virus behind COVID-19. These authors reaffirm that especially important principle. They declare in this yet-to-be peer-reviewed paper, “In conclusion, this research underscores the complexity of COVID-19 vaccination and the need for a comprehensive understanding of vaccine-induced immune responses. While vaccines remain a vital tool in combating pandemics, the potential for VAERD highlights the importance of ongoing research, surveillance, and careful vaccine development to achieve broad protection and maximal safety.”

Next Steps

Do these findings underscore the necessity for further research to unravel the complexities of VAERD in COVID-19? Does the study output point to the necessity to enhance vaccine formulations for broad protection and maximum safety? The study authors believe so.

https://www.trialsitenews.com/a/spike-protein-subunit-vaccine-adjuvanted-with-alum-and-cpg-elicits-t-cell-mediated-pulmonary-immunopathology-upon-breakthrough-infection-a8919e13

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DeSantis: Overhaul National Childhood Vaccine Injury Act of 1986 & Impose More Oversight over FDA Staff

In a recent podcast interview, Florida Governor Ron DeSantis went on the record that he supports changing the current vaccine liability laws promulgated by the Reagan administration back in 1986. Those laws have helped spawn a robust vaccine sector targeting more diseases in the name of public health. Or, that’s what the public is told by a wealth-generating vaccine industry. What were at first, pragmatic measures meant to incentivize vaccine manufacturers, according to DeSantis, have turned into a vaccine development free-for-all, a race to generate the next blockbuster not as concerned with safety and quality but for economic return. The Food and Drug Administration (FDA) represents the world’s apex of drug and vaccine regulators. Yet about half of the agency’s budget now derives from Prescription Drug User Fees. This means that the FDA is highly dependent on the very industry it is tasked with regulating. Of the $5.9 billion budget, 45% derives from user fees, and 65% of the funding for human drug regulatory activity comes from user fees.

The National Childhood Vaccine Injury Act. of 1986, or “the Vaccine Act,” offers vaccine manufacturers a form of universal liability providing “no vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine-related injury or death: (1) resulting from unavoidable side effects; or (2) solely due to the manufacturer's failure to provide direct warnings.”

While DeSantis acknowledges at the time the intention was needed to ensure the pharmaceutical companies needed incentives to invest in public health-related vaccines, the politician said on the Shannon Joy podcast, “I think what has happened now it is has shifted incentives actually away from safety.” He takes a controversial stance, markedly opposed to general sentiment from Washington that emphasizes the comprehensive rigor that goes into regulatory approvals.

The Florida Governor continued, “The incentives are now to produce anything you can get to the market and then make money off it because you aren’t going to be held accountable for the safety. So yes, I would support legislation to fix that because I think we want incentives that are going to be positive for the ultimate health outcome.”

While it’s most certainly true that the number of vaccines has exploded since the 1986 Act, it’s likely, not clear if the standards in regulatory oversight have declined generally, and if that is the case, that it’s due to this legislation.

Vaccine opponents believe regulators are “captured” by industry. But that’s a more complex, nuanced issue that DeSantis at least acknowledges.

On the problem of the intertwined nature of the pharmaceutical industry and the regulatory body in the U.S., DeSantis chimed in, “Of course, a lot of the people who work for the FDA end up going to work for Big Pharma after, so we are going to end the revolving door. We are going to put a grace period in there: five to ten years, whatever would be appropriate so that you can't just keep bouncing back and forth.”

Should the revolving door end? This doesn’t sound very pragmatic, given the real-world circumstances—constraints and realities on the ground. After all, an ongoing shortage of the talent needed to run regulatory bodies, industry, academic, and the growing nonprofit research machine, not to mention the private equity firms now investing in drug development, means that placing further constraints on this limited pool of labor likely would lead to a series of other more severe problems. Much legislation, while well-intentioned, often leads to other even worse problems.

Plus, this sounds like substantial federal regulatory oversight of the type that goes well above and beyond what standard Republican and Democrat politicians would be willing to back. Would that truly be a Republican priority should DeSantis be the winner? Or more political talking points to exploit animosity, fear, and anger due to COVID-19-related pandemic government overreach?

Perhaps what’s needed first is solid research into the problem. Have the regulatory standards declined since the 1986 Act? How could evidence be generated to prove that point? Some of the answers may lie in the real-world data.

https://www.trialsitenews.com/a/desantis-overhaul-national-childhood-vaccine-injury-act-of-1986-impose-more-oversight-over-fda-staff-476a9264

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Also see my other blogs. Main ones below:

http://edwatch.blogspot.com (EDUCATION WATCH)

http://antigreen.blogspot.com (GREENIE WATCH)

http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH)

http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)

http://snorphty.blogspot.com (TONGUE-TIED)

https://immigwatch.blogspot.com (IMMIGRATION WATCH)

https://awesternheart.blogspot.com (THE PSYCHOLOGIST)

http://jonjayray.com/blogall.html More blogs

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