Can Chyawanprash help prevent or cure coronavirus infection? Benefits and uses of Ayurvedic medicine  |  Photo Credit: iStock Images

New Delhi: Chyavanprash, also spelled Chyawanprash, is an Ayurvedic formulation that is being widely consumed as a dietary supplement in India. The popularity of the herbal remedy has now extended to even post-COVID care management. Touted for its immense health benefits, Chyawanprash has been used by Ayurvedic healers since ancient times to enhance immunity and increase longevity. Recently, the Health Ministry issued post COVID-19 management protocol that includes encouraging the use of Chyawanprash, yoga asanas, breathing exercises, daily morning or evening walk among various other recommendations.

The ministrys guidelines on post-COVID management also recommend eating a balanced nutritious diet, having adequate rest and sleep, looking for early warning signs (like high-grade fever, breathlessness, unexplained chest pain, etc,) taking regular medications as advised for coronavirus disease and also for managing comorbidities, if any. It said a holistic approach is required for follow up care and well-being of all post-COVID recovering patients.

Earlier, the Ministry of AYUSH suggested the use of Chyawanprash in the morning with lukewarm water/milk under the direction of registered Ayurveda physician. But the question here is - does consumingChyawanprash offer protection against COVID-19 infection?

Chyawanprash is fortified with vitamins, minerals and potent antioxidants that may help strengthen the immune system and prevent a range of health problems. It is believed that the high vitamin C content in the Ayurvedic medicine can help boost your immunity, metabolism and prevent various viral and bacterial infections, including common cold and cough. Hence, the idea is that taking this Ayurvedic formulation may help in boosting immunity against infections, including COVID-19 disease. Its important to note that theres no scientific study yet that proves Chyawanprash can prevent or cure COVID-19.

Some of the purported health benefits of Chyawanprash are:

Whats more, Chyawanprash can be consumed by everyone, including children and older people.

Heres how to use Chyawanprash to improve immunity

As per the AYUSH Ministrys recommendation, one should take 1 teaspoonful of Chyawanprash in the morning along with lukewarm water/milk under the supervision of a registered Ayurveda physician.Chyawanprash is believed to be effective in post-recoveryperiod in the clinical practice.

Parents considering giving Chyawanprash to their kids should consult a doctor as the dose largely depends on their digestive strength.

Other natural tips to help improve immunity include:

In the absence of a safe vaccine or specific treatment, taking precautions in all possible may be our best against COVID-19.

Disclaimer: Tips and suggestions mentioned in the article are for general information purpose only and should not be construed as professional medical advice. Always consult your doctor or a dietician before starting any fitness programme or making any changes to your diet.

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Can Chyawanprash help prevent or cure coronavirus infection? Benefits and uses of Ayurvedic medicine - Times Now

I wish to counter many politicians claims that the government seeks to take over our health care system. The specious claims ignore the huge beneficial role government has played, and plays, in improving human health. Our collective good health and longevity derives from a hundred years of federally funded research in public health, human physiology, genetics, surgery, pharmacology, immunology, microbiology, virology and engineering.

Biomedical research at universities, medical schools, hospitals and research laboratories is substantially supported by the government. Few realize that the largest share of funds for training physicians and for postgraduate physician training come directly or indirectly from the government.

Millions of Americans receive health care through Medicare, Medicaid, veterans hospitals, Indian Health Service, Public Health Service, the Uniformed Services (Department of Defense) and others. The government subsidizes health care insurance premiums for thousands of United States civil servants. Without government support, our present health care system would implode. In their polemics, some politicians call this government support socialism or socialized medicine. I call it informed self-interest by a government concerned with the well-being of its citizens.

I practiced government medicine for over 40 years as a United States Air Force pediatrician, biomedical researcher, teacher and administrator. I witnessed massive growth in medical knowledge, the introduction of incredible new technologies and evolution of new medical skills. Hundreds of new drugs, biologics, surgical techniques, vaccines, enhanced genetic knowledge and approaches to improving mental health have revolutionized modern medicine, allowing more accurate diagnosis, real-time health monitoring, and temporary replacement of hearts, lungs and kidneys. Americans now survive cancer more often than ever before.

These new technologies and tools are only possible because the citizens of this country invested in the acquisition of knowledge, tools and services the research enterprise produced. Yet, the United States fails to equitably distribute these advances to all citizens. Health care is rationed based on ability to pay. We often spend large sums to treat patients with complex and life-threatening conditions while basic preventive care is unavailable to many families and children. Unnumbered citizens and families are bankrupted annually by catastrophic illness.

I believe the United States must redress modern health care inequities. There is much debate about how this might be done. It seems to me the fairest solution is a countrywide insurance program, or programs, to provide access to care, education, public health and protection from catastrophic illness for every person and family in the land.

This is not government takeover. It is the responsibility of government to provide life, liberty and the pursuit of happiness for all Americans, not only those who can pay. I urge all to consider voting with an eye to making our wealth of health care resources accessible to all citizens of our great country.

Val G. Hemming is the 2015 recipient of the distinguished alumni award from the University of Utah College of Medicine. He is the emeritus dean of the F. Edward Hbert School of Medicine at the Uniformed Services University of the Health Sciences in Bethesda, Md.

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Guest opinion: Why accessible health care is not government takeover - Deseret News

Creating a vaccine that would be injected into the arms of millions of people is a usually a years-long endeavor. Not only is the process slowed by trial and error and first-time failures, it's also traditionally restricted by rigorous clinical trials that in their final stages can give public health authorities a reasonable idea of whether a vaccine is safe and effective.

But not even a full year after the first infection from the novel coronavirus in China was documented, the White House is now saying a vaccine could be fast-trackedas soon as early November.

A safe, effective shot produced so rapidly would be unprecedented. It could also save tens of millions of Americans from falling ill with Covid-19 and prevent countless deaths. And the U.S. could desperately use a shot in the arm in its losing fight against the outbreak: As of Sunday, nearly 6.5 million Americans have been diagnosed with the virus -- with some severely sickened-- and nearly 200,000 have been killed.

But what if a hastily rolled out vaccine that skips the final stages of study turns out to have unforeseen problems -- either with safety or efficacy? What happens, for example, if millions of vials are distributed of a prematurely OK'd vaccine and then it turns out to be inferior to a better one that completes all trials months later? What if fading antibodies mean a vaccine's protection wears off after only a short time -- a possibility that can't be known with trials only carried out over several months? Would your own physician even recommend a fast-tracked vaccine if it lacked key data that would be typically expected for review?

In addition, many observers are increasingly skepticalof the Food and Drug Administration's leadership, after giving misleading statements on the promise of plasma therapy for Covid-19 and on an apparent willingness to OK a vaccine so close to the presidential election.

Some worry a fast-tracked vaccine could be seen as the result of unnecessary political pressure on the FDA. But, what if the bet pays off and saves lives?

To sort through these questions, we asked Dr. Otto O. Yang, a veteraninfectious disease expert and medical doctor at the David Geffen School of Medicine at UCLA. Yang specializes in clinical infectious diseases, and his laboratory focuses on T-cell immunology in HIV infection, as it relates to developing immune therapies and vaccines for HIV and other diseases and infections.

While it would be impossible to predict which of the dozens of vaccine candidates might be most likely to see early approval, said Yang, the two leading candidates could be themRNA nanoparticle vaccine byModerna (MRNA) - Get Reportand therecombinant adenovirus one byOxford University and AstraZeneca (AZN) - Get Report.

"From the limited amount of data Ive seen" that's publicly available, said Yang, "it looks like both vaccine candidates generate the right types of antibodies that we would expect to be effective at preventing infection. And, they both generate T-cell responses, which could be effective in more than one way."

But there are many other factors at play in creating a Covid shot -- and there could be unexpected consequences of speeding through vaccine approvals or just running with the first one that looks acceptable.

Yang was reached by phone this week by TheStreetto discuss these vaccine projects, the possibility for a fast-track OK and potential pitfalls. The following is an edited version of the interview.

TheStreet: Specifically, looking at the vaccine project by Oxford University and AstraZeneca, Ive heard some concern that it might prevent the development of full-blown disease in patients, but might not prevent the spread of the virus from one person to another. What are your thoughts?

Yang: Its a theoretical possibility. So, if a vaccine doesnt fully protect somebody from getting infected, its possible they could get a milder infection. Even with the flu vaccine that we get annually, in some cases it appears to make infection milder, even if it doesnt protect you from getting infected. But I think its most likely that even if somebody did get infected, the immune responses that would be put in place by the vaccine would probably reduce symptoms and reduce severity. If so, it would most likely reduce the degree to which somebody is contagious. Its a theoretical concern, but not something that I would be that worried about.

TheStreet: In a general sense, weve seen reports about, and youve researched, the potential for fading of antibodies. Is there a concern that there could be a vaccine that is safe and it seems to work and then, say six months down the road, somebody gets infected, though they were vaccinated?

Yang: Its definitely a possible scenario. Potentially dropping antibodies might mean that immunity will wane, but its not entirely clear that thats true. The fact is that immunology is kind of a black box and we dont know for sure that antibodies are the whole story for protecting somebody from infection. The data are worrisome that protection will be short-lived for natural infection. And there recently have been increasing news reports of people getting reinfected. That does raise concerns for the longevity of protection from a vaccine, and, of course, short-term vaccine trials are not going to be able to tell us about longevity.

That does raise concerns for the longevity of protection from a vaccine, and, of course, short-term vaccine trials are not going to be able to tell us about longevity.

But one of the big unknowns is whether the vaccine could actually do a better job at making antibodies or T-cell responses than natural infection itself. The study that we did on dropping antibodies was on people who were naturally infected and had fairly mild disease. It is clear that people with more severe infection have fairly high antibody levels, so a vaccine could look more like that like a person who has a more severe infection and fairly high levels of antibodies.

The other thing is, we dont know if the virus actually has mechanisms to interfere with immune response. Many viruses have evolved to have ways to blunt the immune response to enhance their survival. From an evolutionary standpoint, if the immune system is trying to do something to reduce the virus, then the virus can evolve to counter that. If thats the case with this virus if immune response is short-lived because the virus is actively doing something to the immune system to cause that a vaccine could theoretically do better, because the vaccine is not the whole live virus. It might not have that negative impact on the immune system. Well have to just wait and see.

TheStreet: Do you think fast-tracking a vaccine by, say, skipping or shortening the final clinical trials, would be warranted? Hong Kong, Taiwan, New Zealand, China and many other countries have proven that the spread of Covid-19 can be mostly controlled with public health measures.

Yang: So, theres the ideal, theoretical answer, and theres the practical answer. Unfortunately, we are much less like Taiwan or New Zealand, than we are like Brazil. From the standpoint that this country has been unable to implement effective public health measures, for whatever reason, that makes the urgency for a vaccine higher. Ideally, we would be able to get the pandemic under control to an acceptable level and take our time with the vaccine. But theres added urgency, because, for various reasons, were unable to do that theres not enough public buy-in, theres not enough political leadership. Whatever the reasons, were unable to contain it, and the pandemic is just burning on and lives are being lost, so that adds greater urgency for a vaccine

TheStreet: Would you take a fast-tracked vaccine would you recommend it to friends or family?

Yang: It would really depend on what data were available ... safety data being No. 1., and, of course efficacy. I would say that I would certainly be cautious and hesitant, because I feel that the Food and Drug Administration has lost a lot of its credibility, because of its bowing to political pressures. Its already made major fumbles during this pandemic. So I would go with what experts say, and if there is not enough available data to make me feel comfortable to recommend it, then I would say dont take it. Because, as you pointed out, with the right measures, you can prevent spread and you can(potentially)protect yourself from getting infected. So, until its clear that a vaccine is safe and effective, we can each protect ourselves.

TheStreet:That brings up another question. Lets say a vaccine is fast-tracked and millions of doses are produced, and, then, say, several months later, a problem is discovered with the vaccine. At the same, lets say, another vaccine that finishes all its trials comes along and it looks great. Would that pose a logistical problem for distributing the latter, better vaccine could it cause a vaccine production traffic jam?

Yang: Yes, in more ways than one. Lets, for argument, say one vaccine is 50% effective and the other is 75% effective, what do you do? What do you do with all these 50% effective vaccine vials you have sitting around? Is there going to be motivation to get them out and get them used? It raises all sorts of questions about what would happen. What would be the threshold for saying you just throw out the first vaccine which would be at a huge cost? Another point to raise is potentially the first vaccine could interfere with the second. The first vaccine might steer your immune responses in ways that are less effective than the second would have. To some extent, the immune system tends to be trained in a certain way, and once its trained, its hard to get it to change. Theoretically, there could be interference.

Potentially the first vaccine could interfere with the second.

Theres a concept in immunology called original antigenic sin. The concept is that the immune system tends to want to react to something the same way every time, so if you challenge it with something that looks very similar, but is not exactly the same, it will still stick to the original way that it responded. That is the explanation for Dengue fever. Dengue fever is a disease where you get very mild illness the first time you are exposed, and if you get exposed again, to a second strain, then you can get hemorrhagic Dengue fever, which is a very severe, life-threatening infection, and that is because the immune system is still stuck on the first strain and unable to adapt to the second strain. So, you can see something like that happening, as well. Its not that straightforward.

This story has been updated.

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Fast-Tracking Covid Vaccine 'Is Not That Straightforward' - TheStreet

Depiction of SARS-CoV-2, the coronavirus that causes COVID-19. The spike proteins are in red. (Image courtesy of the Centers for Disease Control and Prevention)

More than 100 companies have rushed into vaccine development against COVID-19 as the U.S. government pushes for a vaccine rollout at warp speed possibly by the end of the year but the bar set for an effective, long-lasting vaccine is far too low and may prove dangerous, according to Marc Hellerstein of the University of California, Berkeley.

Most vaccine developers are shooting for a robust antibody response to neutralize the virus and are focusing on a single protein, called the spike protein, as the immunizing antigen. Yet, compelling evidence shows that both of these approaches are problematic, said Hellerstein, a UC Berkeley professor of nutritional sciences and toxicology.

A better strategy is to take a lesson from one of the worlds best vaccines, the 82-year-old yellow fever vaccine, which stimulates a long-lasting, protective T-cell response. T-cells are immune cells that surveil the body continuously for decades, ready to react quickly if the yellow fever virus is detected again.

We know what really good vaccines look like for viral infections, Hellerstein said. While we are doing phase 2 trials, we need to look at the detailed response of T-cells, not just antibodies, and correlate these responses with who does well or not over the next several months. Then, I think, we will have a good sense of the laboratory features of vaccines that work. If we do that, we should be able to pick good ones.

Using a technique Hellersteins laboratory developed and perfected over the past 20 years that assesses the lifespan of T-cells, it is now possible to tell within three or four months whether a specific vaccine will provide long-lasting cells and durable T-cell-mediated protection.

Hellerstein laid out his arguments in a review article published today in the journal Vaccine.

There isnt a lot of room for major error here, Hellerstein said. We cant just go headfirst down a less than optimal or even dangerous avenue. The last thing we want is for immunized people to get sick in a few months or a year, or get sicker than they would have. Whoever is paying for or approving the vaccine trials has the obligation to make sure that we look at the quality and durability of the T-cell response. And this would not delay the licensing process.

Hellerstein points out that antibodies are not the primary protective response to infection by coronaviruses, the family of viruses that includes SARS-CoV-2. Indeed, high antibody levels to these viruses are associated with worse disease symptoms, and antibodies to coronaviruses, including SARS-CoV-2, dont appear to last very long.

Most vaccines under development are aiming for a robust antibody response to neutralize the coronavirus, as depicted in this cartoon. A UC Berkeley scientist argues that a robust T-cell response should be the goal of a good, long-lasting vaccine against SARS-CoV-2. (iStock image)

This was noted in people infected by the first SARS virus, SARS-CoV-1, in 2003. SARS patients who subsequently died had higher antibody levels during acute infection and worse clinical lung injury compared to SARS patients who went on to recover. In MERS, which is also a coronavirus infection, survivors with higher antibody levels experienced longer intensive care unit stays and required more ventilator support, compared to subjects with no detectable antibodies.

In contrast, strong T-cell levels in SARS and MERS patients correlated with better outcomes. The same has also played out, so far, in COVID-19 patients.

A strong antibody response correlates with more severe clinical disease in COVID-19, while a strong T-cell response is correlated with less severe disease. And antibodies have been short-lived, compared to virus-reactive T-cells in recovered SARS patients, Hellerstein said.

The most worrisome part, he said, is that antibodies also can make subsequent infections worse, creating so-called antibody-dependent enhancement. Two vaccines one against a coronavirus in cats and another against dengue, a flavivirus that affects humans had to be withdrawn because the antibodies they induced caused potentially fatal reactions. If an antibody binds weakly against these viruses or falls to low levels, it can fail to neutralize the virus, but instead help it get into cells.

Antibody-dependent enhancement is well known in diseases such as dengue and Zika. A recent UC Berkeley study in Nicaragua showed that antibodies produced after infection with Zika can cause severe disease, including deadly hemorrhagic fever, in those later infected by dengue, a related viral disease. This dangerous cross-reaction may also occur with antibodies produced by a vaccine. Hellerstein noted that a robust T-cell response is key to maintaining high levels of antibodies and may prevent or counteract antibody-dependent enhancement.

Hellerstein primarily studies the dynamics of metabolic systems, tagging the bodys proteins and cells with a non-radioactive isotope of hydrogen, deuterium and tracking them through the living body. He began to study the birth and death rates of T-cells in HIV/AIDS patients over 20 years ago, using sophisticated mass spectrometric techniques designed by his laboratory.

The immune system mounts several types of attacks against invading viruses, including the production of antibodies (Ab) to neutralize the virus, B-cells that ramp up antibody production, and CD4 and CD8 T-cells to kill virus-infected cells. In coronaviruses like the COVID-19 virus, T-cells seem to produce the most lasting protection against infection. (Image courtesy of Marc Hellerstein)

Then, three years ago, he teamed up with immunologist Rafi Ahmed and his colleagues at Emory University to determine how long T-cells induced by the yellow fever vaccine stick around in the blood. Surprisingly, he said, the same T-cells that were created to attack the yellow fever virus during the first few weeks after a live virus vaccination were still in the blood and reactive to the virus years later, revealing a remarkably long lifespan. He and the team estimated that the anti-yellow fever T-cells lasted at least 10 years and probably much longer, providing lasting protection from just one shot. Their long lifespan allows these cells to develop into a unique type of protective immune cell.

They (the T-cells) are a kind of adult stem cell, sitting silently in very small numbers for years or decades, but when they see viral antigen they go wild divide like crazy, put out cytokines and do other things that help to neutralize the virus, he said. They are like seasoned old soldiers resting quietly in the field, ready to explode into action at the first sign of trouble.

The same deuterium-labeling technique could be employed to measure the durability of a COVID-19 vaccines T-cell response, helping to pinpoint the best vaccine candidates while trials are ongoing, he said.

We can, in my view, tell you the quality and durability or longevity of your T-cell response within a few months, he said. These tests can be used to judge vaccines: Is a candidate vaccine reproducing the benchmarks that we see in highly effective vaccines, like the ones against smallpox and yellow fever?

Hellerstein said that he was motivated to write a review on the role of antibodies versus T-cells in protective immunity against SARS-Cov-2 when he heard from experts in vaccine development that companies would likely not be interested in testing anything beyond the antibody response. The reason given was that it would slow down the approval process or could even turn up problems with a vaccine.

That is why I wrote this review, honestly, because I was so upset by this response, he said. At this moment in history, how can we not want to know anything that might help us? We need to get beyond the narrow focus on antibodies and look at the breadth and durability of T-cells.

Hellerstein was also alarmed that most vaccines under development are focusing exclusively on inducing an antibody response against only one protein, or antigen, in the COVID-19 virus: the spike protein, which sits on the surface of the virus and unlocks the door into cells. But important new studies have shown that natural infection by SARS-CoV-2 stimulates a broad T-cell response against several viral proteins, not just against the spike protein.

A profile of COVID-19 vaccine projects by antigen target, as of September 7, 2020. Bars 2 through 6 encompassing 132 candidate vaccines in all represent vaccines that target some part of the spike protein (S) or the receptor binding domain (RBD) to which spike binds. Some vaccines (Multiple) target more than one antigen. Data courtesy of Nature.

T-cells produced after natural infection in SARS patients are also very long-lived, he said. A recent study showed that patients who recovered from SARS-CoV-1 infection in 2003 produced CD4 and CD8 T-cells that are still present 17 years later. These T-cells also react to proteins in todays SARS-CoV-2, which the patients were never exposed to, indicating that T-cells are cross-reactive against different coronaviruses including coronaviruses that cause common colds.

These findings all call into question whether limiting a vaccine to one protein, rather than the complement of viral proteins that the body is exposed to in natural infection, will induce the same broad and long-lasting T-cell protection that is seen after natural infection.

In contrast, vaccines like the yellow fever vaccine that employ attenuated viruses viruses that divide, but are crippled and cant cause damage to the body tend to generate a robust, long-lasting and broad immune response.

If you are going to approve a vaccine based on a laboratory marker, the key issue is, What is its relationship to protective immunity? My view is that T-cells have correlated much better than antibodies with protective immunity against coronaviruses, including this coronavirus. And T- cells havent shown a parallel in COVID-19 to antibody-dependent enhancement that could make things worse, not better, he said.

The effectiveness and durability of the first COVID-19 vaccines could impact, for years, the publics already questioning attitude toward vaccines, he warned.

It would be a public health and trust-in-medicine nightmare, with potential repercussions for years including a boost to anti-vaccine forces if immune protection wears off or antibody-dependent enhancement develops and we face recurrent threats from COVID-19 among the immunized, he wrote in his review article.

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For an effective COVID vaccine, look beyond antibodies to T-cells - UC Berkeley

Peter H. Diamandis, PhD, Vice Chairman, COVAXX

Peter H. Diamandis, PhD, calls himself a data-driven optimist, which is a necessary quality for an entrepreneur who relishes tackling grand challenges.

His XPRIZE Foundation has created $10-million incentive competitions focused on the life sciences and other areas, while his venture capital fund, BOLD Capital Partners, has invested $250 million in innovative or exponential technologies. His Abundance 360 summits have brought together entrepreneurs, executives, and investors to apply those technologies toward transforming their businesses. His Singularity University focuses on solving global problems through educational programs, partnerships, and a startup accelerator. Diamandis companies also specialize in cellular therapeutics (Celularity), personalized machine learning (Futureloop), and longevity health (Fountain Life and Human Longevity).

Another Diamandis company, United Neuroscience, combats animal and human diseases by discovering, developing, and commercializing vaccines and monoclonal antibody treatments. Earlier this year, United Biomedical created a subsidiary called COVAXX focused on tackling COVID-19 through a vaccine as well as through antibody diagnostics deployed in China, Taiwan, and several U.S. states. The companys serology test is designed to complement RT-PCR testing by helping identify asymptomatic COVID-19 patients and those who were infected and have recovered.

COVAXXs UB-612 program focuses on developing its Multitope Peptide-based Vaccine against SARS-CoV-2, constructed from a peptide-based platform first deployed by United Biomedical. The vaccine platform has been commercialized successfully in more than 500 million doses annually and 5 billion doses cumulatively in animal health indications for infectious disease.

Designed to activate B-cells and T-cellsboth arms of patient humoral and cellular immune responsesUB-612 consists of amino acid sequences of the SARS-CoV-2 Receptor Binding Domain (RBD) formulated with designer Th and CTL epitope peptides derived from the S2 subunit, membrane and nucleoprotein regions of SARS-CoV-2 structural proteins for induction of memory recall, T-cell activation and effector functions against the virus.

COVAXX has launched a Phase I trial of UB-612 in Taiwan, with a U.S. Phase I trial and a readout of data in non-human primates planned this fall. Last week, COVAXX said it will advance UB-612 into a Phase II/III trial in Brazil, through a collaboration with that countrys largest diagnostic medicine company, Diagnsticos da Amrica S/A (Dasa) and vaccine distributor Mafra. They are funding clinical research along with three Brazilian companies: Real estate developer MRV, car/fleet rental business Localiza, and Banco Inter.

Diamandis and COVAXX co-founder and co-CEO Mei Mei Hu recently discussed COVAXXs approach to fighting COVID-19, and its vaccine development plans withGEN Edge, in a joint interview (lightly edited for length and clarity).

GEN EDGE: How and why was COVAXX established?

DIAMANDIS: There is a parent company called United Biomedical that Mei Meis parents built nearly 35 years ago. Mei Meis mother [United Biomedical chairwoman ChangYi Wang, PhD] is a very brilliant scientist who developed this concept of synthetic peptides that would be used for vaccines, blood anybody tests, and not only how to construct those, but how to construct them in a way that were safe and were immunogenic, and were really low cost to manufacture. This is a body of work that spans three decades. Out of that work came a series of companies.

The core technology, the core manufacturing was being used to go after different targets. The most prolific and advanced is the work theyve done with a company that went after foot in mouth disease. Here you have a virulent virus that mutates rapidly. They went after that, in a company thats now public on the Shanghai Star Market called Shanghai Shen Lian Biomedical.

On a critically important biological product theyre getting this vaccine for their food security, and going from an unknown player to capturing the majority of the marketplace. I think they captured 55% of the market for foot and mouth disease, for vaccinating whats now over 5 billion pigs. So theyve manufactured 5 billion vaccines. I think thats importantits the same exact platform.

The important thing here is a platform that is easier to manufacture, low cost to manufacture a vaccine, has been produced at half a billion doses per year or 5 billion doses over time. And is distributed into the rural areas of China. What you should take away from that is, a robust and dependent manufacturing base with a simple distribution network. The other thing is that they manufacture that vaccine for about 70 cents a dose with a very significant margin, so low cost as well.

How and why did United Biomedical shift from animal to human health?

HU: When Lou [Reese], my husband and I, joined over a decade ago, we focused on partnering those animal health assets and moving towards human health. We saw the opportunity to make the broadest impact in human diseases, so we moved Alzheimers forward, we just brought it in Parkinsonswe basically expanded the portfolio, and weve conducted four clinical trials off the platform. To our delight, we see a lot of translatability from animals into humans. So the vaccine does everything we want the vaccine to doit safely generates very high antibodies that are super specific with an excellent profile.

Fast forward to the first quarter of 2020. The world is changing, the landscape is shifting, and it reminded us of the first SARS epidemic where, because of our footprint in Taiwan and China, we were one of the first responders. We actually worked with the NIH to develop an antibody test and vaccine back then.

Starting in December, we were actually one of the first to respond with an antibody test just into the field and ground zero. And we called Peter [Diamandis]. I said, I think we should respond to COVID-19, we should stand up an effort. What do you think? That is how, essentially with a phone call, COVAXX was born. We decided to stand up a company that is just dedicated to fight COVID-19. We had no idea how long it would last, or what would be the extent of it. We thought one thing in SARS, and thankfully, that never spread. But COVID-19 seemed like it was different. It has proven to be different.

How has COVAXX gone about developing its vaccine?

HU: We spent a good part of the second quarter basically testing dozensover 30 constructsfor different properties, and we came down to our lead, which were very confident in. Its based on the same platform. In animals we see really good immunogenicity, very good titers, really good neutralizing ability of these titers. It was designed and culled for B and T cell responses. We wanted to make sure that it hit neutralizing antibodies. We wanted to make sure that it got broad immunogenicity, so were not just hitting the Spike (S) protein, but were hitting different parts of SARS-CoV-2. We have seen the super heterogeneous response from serology samples, both in the field and our own. We know that people respond very differently. And there are different parts of the virus, not just the S protein, that are responsible for an immune response. So we wanted to make sure we hit all of those.

How does it go beyond just hitting a spike protein, which a lot of the different treatments and vaccines do?

HU: Its a super rational target. Thats where a lot of the neutralizing antibodies target Its the RBD portion of the spike protein. What we also noticed, though, was that a lot of T cell responses, theyre very important epitopes on different parts of the virus.

So, if you look at recovered patient serum, theres a lot of response to that. So what we did was we selected some important other epitopes on those, because we wanted a balanced response. So we wanted a balanced T-cell response as well. So does it hit it all the same time? In some ways, yes, because the vaccine is introduced to the body at the same time, but they do different things. So we want not just neutralizing antibodies, but we also want T-cell activation, because in our experience weve seen neutralizing antibodies are great, but you need both in order to offer full protection.

Could you elaborate on how you go beyond the neutralizing antibodies, what the virus attacks? I noticed that you look at B and T cells?

HU: Yes, its B and T cells. So we want to hit T helper cell sites as well as CTL sites. Thats the hallmark of our platform technology, whereas we have these peptide carriers and they help generate immunogenicity. The way they do it is they mimic highly promiscuous T-cell sites.

So they attract all these T cells and then the T helper cells, basically, signal to nearby B cells to produce antibodies. So we do thatits a similar thing with our vaccine, whereas we hit both the important antibody sites and the T cell sites. And we do that simultaneously. But what we found is that some of the important T cell sites arent just on the S protein. So theyre across the virus. And its evidenced in real life data that there are other sites that are important, and that actually induce an immune response that are not just on a spike protein.

You had a platform in place. How much variation from that platform was needed to in order to fight COVID?

HU: The platform consists of manufacturing technology, design technology, screening. We have a different assay group, and then basically just the development engine that drives everything for a new disease indication.

I think of them like our platform is like Legos, or an operating system, and each new disease indication is like an app or a new Lego box. Everything is designed from scratch, but theyre using the same types of building blocks. So, for COVID-19, we were actually fortunate because we had worked on SARS before. So we actually knew a lot about this type of coronavirus, and thats why were able to rapidly put together something in just a couple months.

Its doing the same technology. And the good news is, now that were entering the clinic, the manufacturability, the downstream process in drug development, thats leveraging the same infrastructure as all the other vaccine programs, which is important, which also gives us confidence in our ability to actually deliver these vaccines.

Is COVAXX still looking at ramping up production to 100 million doses by the first quarter of 2021, and a billion by the end of 2021?

HU: Were still targeting 100 million doses by the end of the first quarter, and of course wed like a billion. It depends on the dosing, right? Thats what were going to find out. So 500 million to 1 billion doses in 2021.

We manufacture almost all the components internally. So for the fill-and-finishing, these are are going to require collaborations for a variety of reasons: Geography, capacity. But thats our target and this isnt theoretical. Weve manufactured vaccines before, so thats what were aiming for.

What manufacturing will you do on your own? And where are you reaching out? Are there collaborations in place with other partners yet?

HU: We are manufacturing mostly in our facilities in Taiwan right nowreally in New York and Taiwan, but the majority is being done in in Taiwan at the moment. We have peptide, vaccine fill-and-finishso theyre all part of the group there. And were in discussions now for certain areas, developing partnerships for the final process.

The company has launched a Phase I/II trial in Taiwan. What is the timing for launching that study in the United States?

HU: Our plan is to actually start a trial with the University of Nebraska Medical Center at the National Quarantine Center later this fall.

DIAMANDIS: Ive been involved in running a bunch of companies at a timeXPRIZE, Singularity University, my venture fund, Abundance 360. Ive got typically 5-6 projects going. When Lou and Mei Mei called me at the beginning of March, and I helped them bring in team members and capitalize this and stand it up, I took on a role as a co-founder and vice chairman. This has become my dominant focus, near 90% of my time. And its because the opportunity is so massive.

When I look at this, what I see is a vaccine that, number one has high immunogenicitywe do blood antibody testing. So were very clear about convalescent plasma levelsWere seeing immunogenicity that in the lab comes out to 400-fold higher than convalescent plasma.

Can you put that figure in perspective?

DIAMANDIS: So thats huge. We really do light up the immune system to manufacture antibodies at high rates. The second thing is, are those antibodies functional? Do they work and they neutralize the virus?

When we look at the titer for neutralization and we compare it in preclinical to preclinical head to head against other vaccines out there, we see the Oxford/AstraZeneca vaccine with neutralizing factor of 40. We see Moderna ranging from 500 to 1,000 as comparison. And were not at 40, or 500 to 1,000. Were at greater than 32,000. Were talking about orders of magnitude higher in terms of neutralizing titer.

If you have high immunogenicity and super high neutralizing titers, this is because of the rational designwe have six epitopes. The multitope design doesnt just attack COVID-19 and stop it from one angle, one protein. Its coming at it from multiple angles.

How manufacturable is the vaccine?

DIAMANDIS: The answer is, not only yes but hell yes! Because the platform has been manufactured at scale. The team has made a decision to put everything else on hold, and spin up manufacturing to support getting to 100 million doses in Q1 of 2021 and to a target of a billion doses by the end of 2021. So, its manufacturable.

Is it transportable? Can you get it to the end patient? You know, does it require negative 80 degrees nitrogen, like you do in RNA vaccines? No, this is a vaccine that can be transported easily into the rural areas like it does in China, because its the same platform. It doesnt require anything special. It uses the existing distribution channels, so its immunogenic, its neutralizing, its manufacturable.

Is it affordable? The answer again is yes. Now, its not going to be as cheap as the animal viruses, because theres an additional level of quality control and safety. But to remind you, the platform manufactures the foot and mouth disease vaccine at scale for less than $1/dose with significant margins.

So, we have a belief that we can manufacture something that really is extraordinary. It goes into human trials the last week of this month in Taiwan, Phase I/II. The Taiwanese government has been very closely overseeing this and so theyre covering 90% of the cost of those trials as part of their investment.

What, if any, U.S. partners is COVAXX working with?

DIAMANDIS: We have also partnered with the University of Nebraska Medical Center, which specializes in pandemics. Its really the national jewel for treating pandemics. Within the medical center the Global Center for Health Security, within which is the 20-bed National Quarantine Center, the nations only federal quarantine unit. Were going to be doing our US trials phase I and II with them. Were lining up a series of other additional trials that I cant mention right now. Were pushing as rapidly as we can.

And then theres one last factor: Is this vaccine safe? I would normally say, Well, well find out. And we will. But what we do know is that this vaccine platformeffectively the majority of the structure, the mechanism and all of that, other than the selected short chain amino acids, the peptidesthat this vaccine platform has been in four human clinical trials right, in the Alzheimers and Parkinsons efforts that go back to what our sister company has done.

In those trials, it has been absolutely safe with only minimal irritation. It has been a platform that has proven to be very safe in humans. And in those trials as wellwhich took place in elderly because Alzheimers is a disease of the elderly, like to some degree COVID-19 is a disease of the elderlyin those trials, it proved to have immunogenicity in 98% of the elderly in which it was introduced. Again, the science will prove it out, but we have a predominance of evidence that here we have a vaccine thats immunogenic, super high neutralizing, low cost to manufacture, that is manufacturable, transportable, safe and effective in the elderly. We have super strong evidence to support that. And thats what gets us all excited, and thats whats, from my own personal standpoint, gotten me to put to put everything else aside and prioritize COVAXX.

HU: Then, well be aiming to start the Phase II/III efficacy trial the end of this year, which will require at least four months of safety data. So itll run into mid 2021 if not late 2021.

How big of a population are you looking at? Some of the leading COVID-19 vaccine developers companies have been recruiting 10,000 participants, or 30,000, or even 60,000.

HU: Were actually doing powering estimates right now to make sure that were well powered for the efficacy trials. But, you know, depending on the prevalence of these, you know, it does look like its a large trial and the thousands of patients will probably do it in multiple sites, not just in the U.S. And one of the reasons is because you want to make sure you get high-quality recruitment, fast recruitment, and that youre basically chasing where the outbreaks go.

Is COVAXX quantifying its investment in COVID-19? Is it $X million in capital raised, for example, or you can give a figure?

HU: This platform has been developed over the last couple of decades. Weve invested over about a quarter of a billion dollars into the technology and the underlying infrastructure. So, we have been able to leverage all that for COVID-19.

You said your team went into China very early in the run of the virus. Is there still testing in China right now?

HU: No. What I meant was that when we were developing our antibody tests, we basically sent them early on to ground zero of the outbreak, both in China and Taiwan. Were doing most of our stuff actually in Taiwan right now.

How does your companys antibody test come into play here?

HU: As vaccines roll out, antibody tests are going to become increasingly more important. So I think were well positioned to offer a complimentary product after the vaccines come on. Now, the question of, do you have antibodies is increasingly important and you want to know if you respond to the vaccine. You want to know if youve got antibodies from the vaccine or from natural infection. These are things that our antibody tests can actually differentiate and provide information on.

DIAMANDIS: A lot of theseeven natural immunity, we dont know how long it will remain. And if you get immunized, did you develop a sufficient antibody level? And at six months or a year later, are you still immune? Thats a question which is going to start to be asked in the middle of next year, end of next year. And thats when the antibody tests will actually be the most useful.

Theres the issue of how long you stay immune once you get this. At least one patient made headlines worldwide as having been infected twice with COVID-19.

DIAMANDIS: Yes, especially when you start to see some mutations in the virus.

Now, whats with those mutations? How will this vaccine be able to keep up with mutations?

HU: Thats something everyone is concerned about. From a scientific standpoint, its still early to tell. We just have to wait and see. Thats actually one of the major advantages with our foot and mouth disease platform: We actually saw a mutation, and we were able to quickly adapt and get out a new vaccine to cover this new mutated strain, and we did thatwe basically designed and manufactured in about 60 days, and had it out in the field in the quarter. So this is an opportunity for us to actually shine and create and capture more market share, in the case of animal health.

One of the primary features of our platform is the vast ability to develop and manufacture and adapt to potential mutations down the way. Its something that we actually are very conscientious about, and feel very well suited to tackle if it comes down the pike.

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Beyond the Spike: The COVAXX Approach to a COVID-19 Vaccine - Genetic Engineering & Biotechnology News