CORBEVAX, a New Patent-Free COVID-19 Vaccine, Could Be a Pandemic Game Changer Globally

Yves here. While the manufacturing advantages of Corbevax look obvious and are well explained in this article, I’m less clear on what the vaccine mechanics mean for patients. For example, the European medical regulator has warned against frequent boosting as having the potential to overtax the immune system. From Bloomberg:

European Union regulators warned that frequent Covid-19 booster shots could adversely affect the immune response and may not be feasible. Repeat booster doses every four months could eventually weaken the immune response and tire out people, according to the European Medicines Agency.

So key questions are:

1. Is Corbevax as demanding to the immune system as the current mRNA and adenovirus vector vaccines?

2. Will the duration of its initial immunity be at least as long?

3. Will its boosters fare better than the current ones?

Scientist GM recaps where we are now:

BTW, currently nearly everyone is unvaccinated by the definitions according to which the vaccines were approved.

The 3 shots are doing better against severe outcomes than I feared, at least for the first few months.

But the Phase III trial end points were “symptomatic COVID”. And CureVac was rejected because it was at 47% due to being tested against Mu, Lambda, Delta and Beta, not the WT (Pfizer, Moderna, AZ & J&J were quick enough to get in just before the appearance of variants).

Well, guess what? Current VE against “symptomatic COVID” is below 50% for those with 3 Pfizer doses after only 10 weeks.

And those with Pfizer two dozes are below 50% within 6 weeks of the second shot.

Peak VE is at 75% for 3 doses Moderna a month after the 3rd dose, then it goes down too.

So basically we barely have vaccines now — 2-3 months after a third dose, a month after a second.

And data from Israel is coming on 4th shots — while the 3rd shots did improve overall immunity, the 4th shots only bring antibody levels back to those after the 3rd.

So please curb your enthusiasm.

By Maureen Ferran, Associate Professor of Biology, Rochester Institute of Technology. Originally published at The Conversation

The world now has a new COVID-19 vaccine in its arsenal, and at a fraction of the cost per dose.

Two years into the COVID-19 pandemic, the world has seen over 314 million infections and over 5.5 million deaths worldwide. Approximately 60% of the world population has received at least one dose of a COVID-19 vaccine. But there is still a glaring and alarming gap in global access to these vaccines. As a virologistwho has followed this pandemic closely, I contend that this vaccine inequity should be of grave concern to everyone.

If the world has learned anything from this pandemic, it’s that viruses do not need a passport. And yet approximately 72% of vaccine doses were administered in high- and upper-middle-income countries – and only 1% in low-income countries. Wealthy countries are giving boosters, and even fourth doses, while first and second doses are not available to many worldwide.

But there is hope that a new vaccine called CORBEVAX will help close this vaccination gap.

How Does the CORBEVAX Vaccine Work?

All COVID-19 vaccines teach the immune system how to recognize the virus and prepare the body to mount an attack. The CORBEVAX vaccine is a protein subunit vaccine. It uses a harmless piece of the spike protein from the coronavirus that causes COVID-19 to stimulate and prepare the immune system for future encounters with the virus.

Recombinant vaccines commonly use yeast to produce the immune-stimulating proteins of a virus in the lab.

Unlike the three vaccines approved in the U.S. – Pfizer and Moderna’s mRNA vaccines and Johnson & Johnson’s viral vector vaccine, which provide the body instructions on how to produce the spike protein – CORBEVAX delivers the spike protein to the body directly. Like those other approved COVID-19 mRNA vaccines, CORBEVAX also requires two doses.

How Was CORBEVAX Developed?

CORBEVAX was developed by the co-directors of the Texas Children’s Hospital Center for Vaccine Development at Baylor College of Medicine, Drs. Maria Elena Bottazzi and Peter Hotez.

During the 2003 SARS outbreak, these researchers created a similar type of vaccine by inserting the genetic information for a portion of the SARS virus spike protein into yeast to produce large amounts of the protein. After isolating the virus spike protein from the yeast and adding an adjuvant, which helps trigger an immune response, the vaccine was ready for use.

The first SARS epidemic was short-lived, and there was little need for Bottazzi and Hotez’s vaccine – until the virus that causes COVID-19, SARS-CoV-2, emerged in 2019. So they dusted off their vaccine and updated the spike protein to match that of SARS-CoV-2, creating the CORBEVAX vaccine.

CORBEVAX received emergency use authorization in India on December 28, 2021.

A large U.S.-based clinical trial found the vaccine to be safe, well tolerated and over 90% effective at preventing symptomatic infections. The vaccine received emergency use authorization in India, and other developing countries are expected to follow.

Interestingly, the group at Baylor was not able to drum up interest or funding in the U.S. for their vaccine. Instead, newer technologies such as mRNA vaccines raced ahead, even though Bottazzi and Hotez’s vaccine design was more advanced, thanks to their previous work during the 2003 SARS and 2012 MERS outbreaks.

A Vaccine Built for the World

Protein subunit vaccines have an advantage over mRNA vaccines in that they can be readily produced using well-established recombinant DNA technology that is relatively inexpensive and fairly easy to scale up. A similar protein recombinant technology that’s been around for 40 years has been used for the Novavax COVID-19 vaccine, which is available for use in 170 countries, and the recombinant hepatitis B vaccine.

This vaccine can be produced at a much larger scale because appropriate manufacturing facilities are already available. Also key to global access is that CORBEVAX can be stored in a regular refrigerator. Therefore, it is possible to produce millions of doses rapidly and distribute them relatively easily. In comparison, producing mRNA vaccines is more expensive and complicated because they are based on newer technologies, rely on highly skilled workers and often require ultralow temperatures for storage and transport.

Another major difference is that the CORBEVAX vaccine was developed with global vaccine access in mind. The goal was to make a low-cost, easy-to-produce and -transport vaccine using a well-tested and safe method. Key to this, the researchers were not concerned with intellectual property or financial benefit. The vaccine was produced without significant public funding; the US$7 million needed for development was provided by philanthropists.

COBREVAX is currently licensed patent-free to Biological E. Limited (BioE), India’s largest vaccine maker, which plans to manufacture at least 100 million doses per month starting in February 2022. This patent-free arrangement means that other low- and middle-income countries can produce and distribute this cheap, stable and relatively easy-to-scale vaccine locally.

Combined, this means that CORBEVAX is one of the cheapest vaccines currently available. How well it works against the omicron variant is under investigation. However, the CORBEVAX story can be used as a model to address vaccine inequity when it is necessary to vaccinate the world population – against COVID-19 and other diseases on the horizon.

The Necessity of Vaccine Equity

There are many reasons global access to vaccines is inequitable. For example, the governments of wealthy nations purchase vaccines in advance, which limits supply. While developing countries do have vaccine production capacity, low- and middle-income countries in Africa, Asia and Latin America still need to be able to afford the cost of placing orders.

The Indian government has ordered 300 million doses of CORBEVAX, and BioE plans to produce more than 1 billion shotsfor people in developing countries. For context, the U.S. and other G7 nations have pledged to donate over 1.3 billion doses of COVID vaccines, yet only 591 million doses have been shipped. These numbers mean that if BioE is able to produce 1.3 billion doses of CORBEVAX as planned, this vaccine will reach more people than those vaccinated by what’s been donated and shipped by the wealthiest nations.

As the omicron variant has shown, new variants can spread across the world quickly and are much more likely to develop in unvaccinated people and continue to emerge as long as global vaccination rates remain low. It is unlikely that boosters will end this pandemic. Rather, developing globally accessible vaccines like CORBEVAX represent an important first step in vaccinating the world and ending this pandemic.

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  1. TMoney

    Vote for Bottazzi and Hotez. in 2024 !

    We know they don’t want to get rich at our expense.

    What more could we ask from our politicians in the modern world ?

    Doing good for the us and world – yup they do that too !

  2. MP

    Yves, your point is such a good one. Even if we have this pan-covid vaccine, we’re still constrained by diminishing immunity over time. So unless, as has been oft-discussed, we get a vaccine with actual sterilizing immunity, you’re still shooting a moving target. As far as boosters are concerned, we’re back to March 2021 as far as population immunity; it seems we’re just going to be along a 2021-ish axis of population immunity depending on natural infection and boosters. And as we know, the changing of the virus guarantees something like 100K deaths per quarter. I hate to beat a dead horse, but five, ten, etc. more years of something like that does not yield a functional society.

    1. Tom Stone

      ” Does not yield a Functional Society” ?
      850K plus deaths in the USA and counting might be considered an indication that America’s society is not functioning very well at the moment.

    2. Yves Smith Post author

      As we have also stated, infection-induced immunity is not a hot idea.

      It may last longer than vaccine-induced immunity. Stress may. That would be because you acquire some nasal immunity, which you don’t get with vaccines.

      Getting it comes at the cost of getting Covid. That taxes the immune system more than the vaccines, particularly T cells. We’ve pointed out that at the very outset, experts warned that Covid, particularly repeat cases, could cause T cell derangement and exhaustion. T cells are the front line of defense against cancer…..

    3. Joe Well

      I think that given the short duration of immunity against a coronavirus, there would be the second challenge of administering a sterilizing vaccine to everyone, worldwide, at the same time.

      Remember that the prospect of immune fatigue means that boosting the original recipients is not just wasteful, but risky if not impossible.

      Not a scientist here, any correction appreciated.

    4. Glossolalia

      Maybe a dumb question but are there any sterilizing vaccines for non-covid 19 coronaviruses/flus?

      1. Aljay

        Sorry my edit got cut off. Animal coronaviruses appear to only require effective protection/vaccination very shortly after birth. The vaccines that exist are effective and given once early on, but not boosted as it doesn’t matter once they reach maturity. They are also significantly different enough not to have any overlap with human coronaviruses.

  3. Terry Flynn

    Licensed patent free. Apologies for dumb question – I did Google this and expected to see something like the Volvo invention of seat belts which meant they held the patent but allowed everyone to produce them free. But I didn’t.

    So – is the framework here like that? We don’t want some opportunist to find a loophole to patent it and hike up prices.

    1. voislav

      One of the links mentioned the IP was in-licensed, meaning given royalty-free. So there is probably underlying IP involved, meaning people can’t just go on and produce it on their own, you have to contact Baylor and sign an in-licensing contract. It’s a good way to control who is producing it and on what terms, they may include provisions to prevent people from overcharging for it.

    2. Basil Pesto

      I can’t track down the tweet – sorry! – but Hotez says this won’t be an issue, possibly for the same reasons as voislav explains

  4. Louis Fyne

    A vaccine is only as good as the factories that produce it.

    It wouldn’t take much money for Pfizer to buy up the bulk of available contract factory time.

    And of course no American company would ever do such a thing

    1. lordkoos

      I don’t think that would fly in many countries.

      On the other hand, I would not be surprised if Pfizer had something to do with this —

      Interestingly, the group at Baylor was not able to drum up interest or funding in the U.S. for their vaccine. Instead, newer technologies such as mRNA vaccines raced ahead…

    2. Yves Smith Post author

      KLG said pretty much any competent microbiology lab could make the Pfizer/Moderna vaccine, and there were plenty of countries that could produce it at decent scale now and ramp up. So the issue isn’t competence or facilities. It may be the cost of and access to critical components that are a choke point in addition to the patents.

  5. Mikel

    “And yet approximately 72% of vaccine doses were administered in high- and upper-middle-income countries – and only 1% in low-income countries. Wealthy countries are giving boosters, and even fourth doses, while first and second doses are not available to many worldwide.”

    And yet there are “low income countries” doing better with case and/or mortality rates than “higher income countries.”
    It’s worth taking a harder look at and not attributing it all automatically to age.

    1. Soredemos

      Pay no attention to the drug which shall not be named being widely deployed throughout much of Africa. Absolutely nothing to see there, nope.

      1. T_Reg

        In the U.S. here; I did a quick search, and found the liquid injectible version available online. It’s high-priced, coming in at about 30 cents per dose, but I can’t think of a better option when pills require a prescription – which you probably can’t get.

        BTW, it’s not just Africa. Peru, Mexico City, Uttar Pradesh in India, Japan… I stopped tracking progress (or backsliding) in that area a while back, so that’s not up to date.

      2. rowlf

        A recent account of someone I interact with on the rural/suburban border area notes that his family and many he knows had positive results using vitamin I early on recently. No hospitalizations, cold like experiences. Maybe it is a very effective placebo?

        1. Carla

          Be careful. You can destroy your kidneys with regular use of ibuprofen. I know of someone who is on dialysis because of it.

    2. Lvh262

      In “low income countries” there is probably very little testing (cost of PCR test is around the same as vaccine) and record keeping is probably not that great. Additionally many countries have diseases with a higher mortality rate (yellow fever, malaria to name a few) to worry about so COVID is probably not their main concern.

  6. BeliTsari

    Brain-trust question: Had D614g & omicron 21 mos apart. Had 2 Moderna shots, ~six months apart (Aug 23rd). Contingent on further ELISA immuno-survey, should I get this, another Moderna, await Walter Reed or simply get the HECK outa the psycho US of A? Any PASC symptom mitigation expected from any of these?

    1. Yves Smith Post author

      If you are sure you had Omicron, as in a recent Covid case, I don’t see why you’d be thinking about needing to get vaccinated for a while. And by the time you’d need to worry about the Covid-induced immunity having waned, we ought to have better data about any new vaccines and the duration of infection-induced immunity from Omicron.

      1. BeliTsari

        Yep, THANK you! Antigen test was positive. PCR test… sometime soon. Sequencing, I’ll see about. I’d need to travel & go back to dentist (hopefully, not infect anybody in the interim. A conversation with my car insurance folks, in Pittsburgh was SCARY. I’m just happy, we’ve been VERY luck, so far. Thank you! we were going to await the ELISA testing before anything. I’d wait ~3 months, but CURIOUS!

  7. Ignacio

    I think we have obtained from vaccines as much as we can obtain. Only way to improve somehow would be to adapt those more specifically to new variants but yet they wouldn’t work much better and the results could be hampered by previous vaccination efforts.

    I have made some back-of-the-envelope calculations on current Covid 19 mortality in a context of highly vaccinated population such as Denmark. According to these, and given flaws in numbers plus biases in sampling and more problems I estimated that by late November case mortality was about 0,2%, for Delta. Following changes in variant compositions and yet with little data it seems that case mortality with Omicron would be around 0,1%, though I think that in this case, real mortality against total cases is lower since I believe that total real cases are way many more than those reported. In a few weeks I expect to obtain better numbers on Omicron case mortality once Christmas effects are passed.

    Going like crazy with repeated shots wouldn’t improve the situation and might be counterproductive if we are causing immune fatigue and other side effects kicking up. In some countries, further shots are reserved for the vulnerable and I wonder if this could be even more counterproductive if their immune systems are more prone to immune fatigue.

    You may have noticed that now more attention is paid to the ways this might evolve in the future. So far Covid 19 has followed the manual in the sense that early in the pandemic more infectious variants are selected and as this proceeds immune escape variants tend to prevail. Omicron looks very much this type and immune escape here is achieved not only by antigenic changes but other biological changes than come with changes in pathogenicity still not well characterized. Now it seems difficult even to imagine something that is even more transmissible than Omicron but let us wait to the next turn in the evolutionary road to see what it brings. In this sense I am positive and believe that immune escape also means strains increasingly restricted to where the immune system is less effective, but we will see what time brings. To be sure evolution is unpredictable or hardly predictable and prone to surprises because we don’t understand all forces behind. When I think backwards it is astounding to see how short has been the duration of Delta as a leading variant.

    Time to close those not very well thought vaccine certificate schemes. It seems now authorities do not have much weaponry left against the progress of the pandemic when nobody wants further restrictions. It is up to you and your mask usage and willingness to make “normal” life again.

    For those hospitalized it will all depend on treatment and there is where things could improve to reduce case mortality.

    1. Joe Well

      How well established is the risk of immune fatigue?

      Has there ever been a vaccine where the fourth dose was given so close to the first three?

      For example, the Hepatitis A&B vaccine was boosted after the initial series of three (I believe this is no longer recommended). But that was ten years after the last shot.

      1. Ignacio

        Barely established. It has been seen in annual flu campaigns but yet net benefits are seen in the elder. There is no previous experience that resembles what we are seeing now: repeated vaccinations in short times combined in many cases with previous and breakthrough infections. Even the term is confuse. Could it be related with autoimmune reactions? Could be. Could it be related with specific types of cellular responses? Could be.

        In this sense there is room for improvement on vaccine design but it seems years ahead.

        1. Yves Smith Post author

          But we do have evidence even with flu shots. Getting vaccinated every five years produces better immune protection than annual shots.

          The evidence, which is confounding some researchers, suggests that getting flu shots repeatedly can gradually reduce the effectiveness of the vaccines under some circumstances…

          Dr. Edward Belongia is among the scientists who have seen the picture coming into focus. He and some colleagues at Wisconsin’s Marshfield Clinic Research Foundation reported recently that children who had been vaccinated annually over a number of years were more likely to contract the flu than kids who were only vaccinated in the season in which they were studied.

          “The vaccine was significantly more effective … if they had not been vaccinated in the previous five years,” Belongia, an epidemiologist, recounted in a recent interview with STAT.

          So the elderly needing a shot 4x as strong as younger people may not be entirely the result of age.

          1. Ignacio

            Indeed. Also, among the many unknowns about repeated shot schemes is how the incidence of other adverse reactions could rise compared with a standard of two shots: hypersensitivity reactions, autoimmune reactions. T-Cell exhaustion has been linked with Covid Infection and cancer vaccines but to my knowledge not with virus vaccines. But this would apply to questioning about the results of vaccination after severe Covid episodes. Then there is the question of vaccine memory and how this might have an effect on infections with new variants (Would the immune response against the new variant be less effective after repeated shots?)
            These are too many questions to be answered before running wild with multi-shot schemes.

    2. Dean

      You can find recent data on hospitalization rates in vaccinated, previously infected vs unvaccinated here:

      The time frame is during the Delta surge but there is no info on time post vaccination in the above. The risk for severe outcome after vaccination is shown here:

      If you look closely at the table the risk for individuals between 60 and 120 days post vaccination is slightly less than those <60 days post vaccination. Individuals .120 days post vaccination had even less risk. The study covers Dec 2020 – Oct 2021 so includes some Delta data but no Omicron.

  8. Robin Kash

    I saw Hotez interview by Amy Goodman on Democracy Now! two or three weeks ago. He said then that India has embraced it. India has, or has had, immense pharma manufacturing capabilities.
    I’ve read or heard little since then. Clues on why MSM is so slow on the uptake?
    Are Pfizer, etc and the administration keeping news of the Baylor vax quiet?

      1. Robin Kash

        Hotel indicated they were not patenting the vax and not staffing those who wanted to make it–which can be done by anyone who is equipt to make a vaccine by convential methods.

  9. Lee

    I have absolutely no idea as to the validity of the claims made in this article. It showed up on the Google News page, so I’m putting it out here. Remarkably good news if true; perhaps too good to be true. The proposed cure described in the article consists of a combination of Benadryl and lactoferrin. Curiously, these findings run contrary to current therapeutic regimes wherein the administration of an immune suppressing drug during the initial phase of the Covid disease process has been strongly contraindicated and should be reserved for the later inflammatory stage.

    Scientist surprised by discovery of ‘99%’ effective, cheap COVID treatment Clark County Today

  10. Synoia

    I wish there were a Vaccine against the worst scourge in the world: Greed.

    Especially the strain of Greed which infects our beloved leaders.

  11. Kris Alman

    Interestingly, the group at Baylor was not able to drum up interest or funding in the U.S. for their vaccine.

    Not entirely accurate. Indeed, we can invoke the ghosts of Bernie Madoff’s Ponzi schemers on some of the funding.
    Texas Children’s Hospital CVD received philanthropic support for developing this vaccine from many generous donors across the country, including a significant contribution from The JPB Foundation in May 2020.

    1. Kris Alman

      Who, pray tell, is the The JPB Foundation?
      The JPB Foundation, created in 2011 with an endowment bequeathed by Jeffry M. Picower, and led by Barbara Picower as President and Chair, sustains the philanthropic spirit that animated Jeffry and Barbara’s history of giving.

      As CBS reported in October, 2009:
      As Bernie Madoff’s victims drown in debt, it appears one of the men that actually made money off of the $65 billion Ponzi scheme, Jeffry Picower, has drowned in his own pool.
      Operating out of one of Manhattan’s most exclusive office towers, Picower has set up The JPB Foundation, which is now one of the nation’s biggest philanthropic organizations. The JPB Foundation had $1.1 billion in assets as of the end of 2012, tax records show. Picower’s new foundation has since doubled in size, according to a person familiar with its activities, and currently has more than $2 billion of assets. That makes it one of the top 40 foundations by asset size in the nation, according to Foundation Center’s list of the largest grant-making foundations. On the surface, it seems like the JPB Foundation is bigger than the Walton Family Foundation, the Ewing Marion Kauffman Foundation and the Alfred P. Sloan Foundation. The JPB Foundation could still grow much larger soon.

  12. Kris Alman

    Regardless, the technology used to create this biologic is no different than the nearly 4 decade technology used to create human insulin and its synthetic analogs. A much simpler way of injecting a specific dosage–unlike mRNA which requires our body to manufacture the spike.

    The amount of spike antigen we are able to manufacture with mRNA vaccines is dependent on how many ACE2 receptors we have. Individual response would vary with mRNA vaccines because ACE2 receptors increase with age and certain diseases. Kiddos simply don’t express as much ACE2 on their cells. That includes nasal epithelium ACE2.
    Among a cohort of 305 patients aged 4 to 60 years, older children (10-17 years old; n = 185), young adults (18-24 years old; n = 46), and adults (≥25 years old; n = 29) all had higher expression of ACE2 in the nasal epithelium compared with younger children (4-9 years old; n = 45), and ACE2 expression was higher with each subsequent age group after adjusting for sex and asthma.

    This recombinant vaccine takes the same approach of using just one antigen, the spike protein (which has undergone significant mutation), to tickle the immune system. Never mind that our natural immune system identifies multiple antigens to ward off pathogens in the future with a more robust immune response.

    Also, this vaccine adsorbs the receptor binding domain to the adjuvant Alhydrogel (Alum), in combination with another approved adjuvant, CpG 1018.

    What do we know about Alhydrogel?

    Consider this recent press release:

    The adjuvant used in COVAXIN, Alhydroxiquim-II, was discovered and tested in the laboratory by the biotech company ViroVax LLC of Lawrence, Kansas with support exclusively from the NIAID Adjuvant Development Program. The adjuvant comprises a small molecule attached in a unique way to Alhydrogel, a substance frequently called alum that is the most commonly used adjuvant in vaccines for people. Alhydroxiquim-II travels to lymph nodes, where the small molecule detaches from alum and activates two cellular receptors. These receptors, TLR7 and TLR8, play a vital role in the immune response to viruses. Alhydroxiquim-II is the first adjuvant in an authorized vaccine against an infectious disease to activate TLR7 and TLR8. In addition, the alum in Alhydroxiquim-II stimulates the immune system to search for an invading pathogen.

    The global elite can hold up this grand experiment as a benevolent gesture because the poor of developing countries are far more disposable than the poor in Western Countries. How well are we going to learn about adverse effects from this new adjuvant after Corbevax is introduced?

  13. deplorado

    Forget MSM keeping quiet about the Baylor vaccine:

    All four Cuban vaccines are protein subunit vaccines and have been available for a while now:

    I remember reading that Cuba provides them abroad in “the 3rd world” at very low cost, and shares the technology and assists with setting up production. Im sure lots of data is compiled about their effectiveness.

    But not a word about that from prof. Maureen Ferran, while trumpeting “The world now has a new COVID-19 vaccine in its arsenal”…. Stealing thunder, promoting a benevolence example to temper public suspicion of unabashed pharma greed, or flexing JPB and the donor class? Probably all 3.

    It is nauseating that ideology and greed trump everything.

  14. Kris Alman

    Alhydrogel, a substance frequently called alum, is an adjuvant in Corbevax.

    As Wikipedia notes: An alum (/ˈæləm/) is a type of chemical compound, usually a hydrated double sulfate salt of aluminium with the general formula X Al(SO4)2·12 H2O, where X is a monovalent cation such as potassium or ammonium.

    Vaccine Adjuvants: from 1920 to 2015 and Beyond
    by Alberta Di Pasquale 1,*,Scott Preiss 1,Fernanda Tavares Da Silva 1 and Nathalie Garçon
    1 GSK Vaccines, Avenue Fleming, 1300 Wavre, Belgium

    Vaccines act by initiating the innate immune response and activating antigen presenting cells (APCs), thereby inducing a protective adaptive immune response to a pathogen antigen. Adjuvants are substances added to vaccines to enhance the immunogenicity of highly purified antigens that have insufficient immunostimulatory capabilities, and have been used in human vaccines for more than 90 years. While early adjuvants (aluminum, oil-in-water emulsions) were used empirically, rapidly increasing knowledge on how the immune system interacts with pathogens means that there is increased understanding of the role of adjuvants and how the formulation of modern vaccines can be better tailored towards the desired clinical benefit. Continuing safety evaluation of licensed vaccines containing adjuvants/adjuvant systems suggests that their individual benefit-risk profile remains favorable.

    Figure 3 of the above article shows historical trends of the use of adjuvants in vaccines. The vast majority have not required adjuvants.

    So is the benefit-risk profile favorable with aluminum adjuvants? The verdict is not out on this question.

    Efficacy and safety of immunological adjuvants. Where is the cut-off?

    Biomedicine & Pharmacotherapy
    Volume 105, September 2018, Pages 616-624

    •The limits of adjuvants immunostimulation/immunotoxicity is imprecise.

    •Adjuvant immunotoxicity can be acute or delayed.

    •A reductionist analysis of efficacy/toxicity is not possible.

    •The efficacy/toxicity analysis of adjuvants must be done case by case.

    •Reliable biomodels and biomarkers to predict efficacy/toxicity are necessary.

    Evidences suggest that several mechanisms that are responsible for the immunostimulating effects are, at the same time, responsible of the adverse effects. In this context, it is often very difficult to establish the boundaries between immunostimulation and immunotoxicity to reach the ideal balance of efficacy/safety.

    1. Dean

      Pure proteins alone are poorly immunogenic. Immune responses can be significantly boosted by various adjuvants. Looking at figure 3 it appears that most non-adjuvanted vaccines are complete microorganisms. These typically require no adjuvants as they often react with TLR’s to initiate strong immune responses.

      Corbevax is adjuvanted to Aluminum hydroxides (maybe Alhydrogel) and CpG ( Aluminum hydroxides may increase immunity by release of uric acid which leads to local inflammation. The CpG is commonly used to increase immunity because it binds to TLR 9.

  15. John

    I seldom see any reference to the J&J vaccine. It is as if it does not exist. My first shot was J&J, because that was what was available. I would be interested in followup as seems to be everywhere for the mRNA vaccines. Is it being willfully ignored, or should I start thinking conspiracy on the part of competitors?

    1. JoeC100

      J&J remains available here in Maine, if a bit hard to find. I got my J&J booster about two weeks ago in Portland.

      Maine was operating a mobile vaccination clinic some time ago when I was initially vaccinated and they were offering only J&J at these clinics because it did not require very low temperature refrigeration.

      The pharmacist where I had my J&J booster went way out of his way to make sure I could get Fizer or Moderna instead if I preferred.. This left me suspicious that the pharmacy could benefit financially if I shifted to F or M..

    2. katiebird

      In NE Kansas, I didn’t have any trouble getting my original shot last April and the same pharmacy had it in November when we went in for our booster shots.

    3. rowlf

      I got J&J at a small family run independent pharmacy in September 2021. I am wary of the mRNA vaccines as the certification process and approval seems rushed and I work in a safety sensitive field.

    4. Jack

      I received my first J and J and a small independent pharmacy last May. I received a J and J booster at the VA last November. I elected to get the J and J because it used an adenovirus and not the mRna technology.

    5. Bridget

      I got the JNJ vaccine in April 2021. I subsequently made the decision to take my chances with the disease rather than get another vaccine. I laid in an arsenal of home remedies which were deployed in the wee hours of January 4 when symptoms that had begun to develop the evening of the 3rd began to worsen. (Sore throat and fever) The symptoms reversed course on the 4th and by the 5th I was symptom free although continuing to test positive. Part of the home remedy regimen was baby aspirin every 6 hours, (for blood clots) which probably did help with the abatement of all symptoms.

    1. Brian Beijer

      Okay, I’ll bite. Are you suggesting that Moderna patented the genome for Covid-19 before the pandemic? If so; this would be huge news. Like, revolutionary news. I can’t imagine that an assertion such as this wouldn’t get any feedback by the commentors on NC.

      1. Gumnut

        I also thought it was mad, but search for that 19 Nt sequence yourself on blast = 100s of covid virs genomes + when you select patents, you get that one. Not the whole covid genom btw, just seems to be partial evidence that the 1st covid genome was manipulated by humans. That the same humans have links to Moderna, yep, totally nuts.

  16. harrybothered

    Again, only the spike protein is used? Wouldn’t it be more efficacious if it was more like a killed virus vaccine and used multiple proteins? I know the whole organism has been sequenced multiple times. Surely they have the ability to produce many of the proteins in vitro by now.

  17. Kris Alman

    Corbevax uses Alhydrogel as an adjuvant.

    Interesting findings here, comparing Alhydrogel with CoVaccine HT™ as adjuvant for Covid vaccine.

    The former is a proprietary adjuvant and the latter is an FDA approved adjuvant used in several FDA licensed vaccines. CoVaccine HT™ is an oil-in-water (O/W) emulsion of hydrophobic, negatively-charged sucrose fatty acid sulphate esters with the addition of squalane (8, 9) whereas Alhydrogel is a colloid of aluminium hydroxide which binds protein to facilitate antigen recognition and thus, improve the immune response (10).

    Overall, we observed the most potent humoral and cellular immune responses, including neutralizing antibody responses in the CoVaccine HT™ study group. Day 14 titres (post-dose 1) indicate that this formulation may even be efficacious after administration of a single dose, however, this was not investigated in the current study. Neither antigen alone nor the combination with Alum was able to induce detectable neutralizing antibodies with the model antigen utilized in this study.

    Concerns have been raised regarding antibody dependent enhancement (ADE) with SARS-CoV-2 infection or immunization. This phenomenon occurs when non-neutralizing or poorly binding antibodies interact with Fc receptors on antigen presenting cells and facilitate infection. This interaction increases pro-inflammatory cytokine production which exacerbates immunopathology (42). ADE was previously observed with SARS-CoV infection caused by anti-Spike antibodies through the FcγR and FcγRII pathways (43, 44). In respiratory syncytial virus infections, a Th2 response alone can lead to aberrant immune responses associated with ADE caused by either a prior infection or immunization (45, 46). For these reasons, caution may be warranted when using Alum as an adjuvant for SARS-CoV-2, at least for the subunit protein used in this study. Additionally, our data suggest that antigen alone may also drive a predominantly Th2 type response with recombinant S1 antigen immunization in mice. In contrast, the subunit protein with CoVaccine HT™ produces neutralizing antibodies while boosting Th1 responses which may increase durability, vaccine safety, and efficacy.

    One might think that with a name like CoVaccine HT™ that it was developed specifically for a Covid-19 Vaccine.

    While CoVaccine HT is a novel vaccine adjuvant, licensed by BTG Specialty Pharmaceuticals (“BTG”), a division of Boston Scientific Corporation (NYSE: BSX), for the fields of SARS-CoV-2, the cause of COVID-19 and pandemic flu, it’s been around for a while.

    Here’s research going back to 2005.
    Sucrose fatty acid sulphate esters as novel vaccine adjuvant

    We concluded that CoVaccine™ HT is a promising adjuvant as it combines the efficacy of strong adjuvants with the safety of mild ones, is effective towards various types of antigens in large non-rodent mammals and is a chemically defined, stable, aqueous formulation.

    Adjuvants play a huge role in vaccine technology. There is the scant regulation regarding adjuvants.

    An adjuvant shall not be introduced into a product unless there is satisfactory evidence that it does not affect adversely the safety or potency of the product. The amount of aluminum in the recommended individual dose of a biological product shall not exceed:

    (1) 0.85 milligrams if determined by assay;

    (2) 1.14 milligrams if determined by calculation on the basis of the amount of aluminum compound added; or

    (3) 1.25 milligrams determined by assay provided that data demonstrating that the amount of aluminum used is safe and necessary to produce the intended effect are submitted to and approved by the Director, Center for Biologics Evaluation and Research or the Director, Center for Drug Evaluation and Research (see mailing addresses in § 600.2(a) or (b) of this chapter).

    Also of interest:

    U.S., licensed vaccines still contain primarily aluminum-containing compounds as adjuvants. Only one vaccine with a “novel adjuvant” has been licensed, and that is Cervarix, an HPV vaccine that contains AS04 adjuvant.* Also, please be aware
    that in the U.S., vaccine adjuvants are not licensed on their own. Instead, each
    specific antigen plus adjuvant combination or formulation is licensed.
    It is
    possible that this may change in the future, but for now, that is the current

    *Currently, the list of adjuvants (besides aluminum) in approved vaccines (and besides ASO4) is relatively small. ASO4 is no longer being used. Both CoVaccine HT™ and Alhydrogel are not on this list published at the CDC.

    All of this information is to point out that there are different regulations regarding Corbevax as it will be using a novel adjuvant.

    Surely novel adjuvant manufacturers like BTG and InvivoGen, which manufactures Alhydrogel® adjuvant 2%, are chomping at the bit to get a piece of the Covid-19 pie. Better to unleash this experiment in India, where there aren’t as many regulatory hurdles.

  18. Hayek's Heelbiter

    Surprised no one has mentioned the the Army’s SPFn pan-corona virus vaccine (although the economics of its distribution and licensing don’t seem to have been dealt with yet).

    The Army’s SpFN vaccine is shaped like a soccer ball with 24 faces. Scientists can attach the spikes of multiple coronavirus strains to each of the different faces, allowing them to customize the vaccine for any new COVID variants that arise.

    I.e., a buckyball! Buckminster Fuller must be chortling in his grave. I love the technology, which seems to me to make it First-in-Class.
    Currently undergoing Phase 1 trials.

  19. CoryP

    Random vaccine related thought.

    I wonder if/how many people have squirted one of the existing vaccines up their nose… There certainly are enough wasted doses around.

    1. Hayek's Heelbiter

      CoryyP, you’re absolutely right!
      It’s so obvious to the most casual observer, you have to wonder why it hasn’t been tried yet.
      Close to 100% of Covid cases have been proven to be transmitted by aerosolized virions locking onto nasal ACE2 receptors. As has been made increasingly obvious by breakthrough infections, vaccines deal with the issue AFTER infection. It would seem that the optimum strategy would be to prevent the virus from locking onto nasal ACE2 receptors in the first place.
      The compound-that-shall-not-be-named has some benefit in this direction, and nasal sprays are in development that would be even better, probably with fewer side effects.
      But current vaccines are already here and have already had their clinical trials. I’m sure willing ACE2 receptors are there. Why hasn’t anybody tried this experiment?
      I look forward to the clinical trials, when I can say, “I first read about this it in NC.”

  20. tindrum

    Results of a FOI request UK – How many people died OF covid alone…..

    Please see below for death registrations for 2020 and 2021 (provisional) that were due to COVID-19 and were recorded without any pre-existing conditions, England and Wales.

    2020: 9400 (0-64: 1549 / 65 and over: 7851)

    2021 Q1: 6483 (0-64: 1560/ 65 and over: 4923)

    2021 Q2: 346 (0-64: 153/ 65 and over: 193)

    2021 Q3: 1142 (0-64: 512/ 65 and over: 630)

    We have not yet finalised analysis for 2021 Q4. This is currently scheduled for release on 23 February 2022.

    So , hardly anyone actualy died of Covid alone in the UK and most of them werer over 82 years old – why is no one reporting this? (rhetorical question)

      1. tindrum

        I will answer anyway. It seems that Covid is killing 82 year-old healthy people and very sick people, and these groups tend to have a rather short life expectancy anyway. Long covid is a thing, but so are the after effects of Mono. My daughter has had both and mono was much worse, and I don|t see any world wide panic regarding the Epstein-Barr virus. So, I am wondering why exactly we are having such a hissy-fit with covid.

        1. sharron

          My 78 year old husband has diabetes, heart disease, parkinson’s, and slow growing prostate cancer all presumed to be caused by exposure to agent orange. He still travels, works around the house, boats, fishes and enjoys himself and our family. His life expectancy is 5 to 8 years average. He is one that may not have a good outcome if he contracts covid. Evidently 800,000 other folks didn’t do well. I had mono and didn’t die from it.

          1. tindrum

            I wish your husband all the very best, hopefully he can continue boating and fishing for many yeras to come. Maybe though we have to start re-learning that old people eventualy die, and that the deaths of the old and infirmed are not a reason to inject young healthy people with experimental drugs.

        2. skippy

          The focus on death and not morbidities is unscientific, not to mention the legacy issues which will drag on for generations.

          Its the bad maths and physics approach which policy is administrated via game theory as noted by McNamara, Nash, Von Newman, et al … humans are reduced to numerical symbology.

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