UCSD/UCLA Get FDA Approval to Study Chinese Herbs to Treat COVID-19

UCSD/UCLA get FDA approval to study Chinese Herbs to Treat COVID-19. The FDA has given study approval to UCSD/UCLA to complete a double-blind study of the formula “Qing Fei Pai Du Tang” to treat acute COVID-19 symptoms.

qing fei pai du tang
Chinese herbs Chinese herbal medicine

This is the formula used in China to treat acute COVID-19 patients, and China sent the formula to Italy and Britain when China went to help these two countries overcome the first wave of COVID-19.

This is an amazing win for Chinese Medicine. For my clients who have been working with me and using Chinese Medicine to overcome their COVID-19 long-haulers or post-viral syndrome, you already know how effective Chinese herbal therapy is with long-haulers. To get more information on what is long-haulers click this link.

What’s great to see is that the government is willing to look at Chinese Medicine as a treatment for the COVID-19 infection! This is an historic event!

Click here to link to the video of the people who worked together to make this study a reality. It goes through the amount of effort and the resources they needed to bring this study to the approval stage. It’s amazing the different specialties and resources needed to consult on this project.

If you work in the Chinese Medicine field, you are probably familiar with Dr. Chen, the herbal consultant. They needed administrative staff, FDA specialist, doctors from different specialties. They had to work with the herbal sourcing to get the specific herbs approved by the FDA. It is incredible the amount of work it took and the number of resources needed to approve this project.

O.k., but that is not everything that this project does for the Chinese Medicine profession.

The critical herbs Ma Huang and Xi Xin remain in the formula. Ma Huang is highly regulated after several serious health concerns using Ma Huang (ephedra) in over-the-counter diet supplements. Practitioners can still get Ma Huang, but since the pandemic started, it is difficult. Xi Xin was banned in about 2010 due to the small amount of alkaloids in the herb.

UCSD/UCLA Get FDA Approval to Study Chinese Herbs to Treat COVID-19

Both of these herbs are incredibly effective in certain types of severe cases of flu, bronchitis, and lung congestion issues. They are so effective; there are no substitutes for them. This study has the opportunity to make Ma Huang easier to access for professional Chinese Medical providers and make Xi Xin available to Chinese Medical providers.

The study also has the opportunity to open a door for Chinese Herbal Medicine in mainstream Western Medicine. In a Western World that has focused on the potential benefits of Western Medicine to treat COVID-19, this is a historical event.

This isn’t regulating Chinese Medicine to supportive therapy. This study is asking for government approval to use Chinese Herbal therapy as a first line treatment for COVID-19. I like this study because it acknowledges a subset of people who are not getting the vaccine and how can they be treated? The current Western treatments are not enough to keep people out of the hospital.

At the beginning of this pandemic, I used a modified version of Qing Fei Pai Du Wan in clinic with great success. To get more information on this formula, check out my episode, “Deep Look Into the Statistics & Understanding Chinese Herbs for COVID-19.”

There are so many things exciting about this study and it’s potential. If you are in San Diego or Los Angeles County, this study is up and running in your area. If you are in the first 7-14 days of being sick with COVID-19, call 858-249-6896 to become a study participant. They will come to you.

What is Post-Covid Syndrome/Long Haulers & are Some People at Greater Risk?

Updated June 18, 2021 with latest research study out of the U.K., “Brain imaging before and after COVID-19 in UK Biobank.”

What is going on with patients and Post-Covid Syndrome also called Long Haulers? I remember getting that horrible flu in February 2020. At that time, there was no testing or any ability to identify if the flu was Covid. Months later, it logically seems like it was Covid.  

ANTIDOTAL VACCINE EXPERIENCE

After my husband and I had recovered from the flu, we both had lingering symptoms. We just never made it back to our pre-flu health. My husband would get “allergies” a lot. We had to stay on top of them to make sure the allergies didn’t sink into his lungs. I was feeling fatigued, had allergies, was experiencing progressing joint pain. Our sleep was crap.

Well, then I got the Covid vaccine and got so much better. The really big things went away. To read more about my experience, check out my blog, “My Second COVID 19 Vaccine – the Health Improvements I Experienced.” 

But, how many people besides my husband and I got that flu and felt like they never made it back to their pre-flu health?

HOW MANY PEOPLE GET POST-COVID SYNDROME (LONG HAULERS)?

I was on a call with a doctor out of China last week. The discussion was post-Covid syndrome. Post-Covid syndrome is where the patient still experiences weird symptoms after getting over the infection. It is also called long haulers syndrome. The current research shows that 80%-87% of all infected patients experience post-Covid syndrome to some degree.

Here in the United States, the figures are lower at 33%.

I’m not sure why there are such large differences in numbers. The big difference between the U.S. and other countries is the mRNA vaccines. The U.S. has the largest roll-out of the mRNA vaccine. Other countries are struggling to roll-out a vaccine or are using less effective vaccines.

There are probably other reasons for the large difference in numbers. In the United States, we tend to be a sick society. I think most of us would probably faint if we experienced excellent health. We tend to blow things off especially when it comes to our health. Could that be part of the reduced number of long-haulers?

WHO IS GETTING POST-COVID SYNDROME?

I had been getting some post-Covid syndrome patients. Not a lot of them. Western Medicine was hesitant to prescribed meds for these patients. I thought that was weird because Western Medicine prescribes medications for everything. Later in this article, I’ll highlight why Western Medicine may be hesitant at prescribing drugs. 

It’s not easy to treat. Every one of them is different, which makes treating this a bit scary. It takes some time, a lot more time than most people want to spend. But, probably 80% of them are getting better with Chinese Medicine, which is better than the 0% with Western Medicine.

Either way, the infection rate in the U.S. has dropped from over 200,000 new infections in January to about 20,000. So, 1/10th of the January 2021 infections. The death rate is 1/3rd of what it was at the beginning of the year. Everyone is feeling cozy and comfy, including me, even though these rates are still pretty high.

I had written Covid-19 off and was moving on. I pretty much didn’t think I’d see much more of that nonsense. And what a nightmare of nonsense it’s been.   

And then last week happened, and people started showing up in the office with weird symptoms. Most of them were unvaccinated. One was vaccinated. Not that being unvaccinated is a problem. I’m sharing what I see…antidotal information. I’ve only had one vaccinated client in the clinic with crazy symptoms, and they had a very mild case of Covid followed by a severe, rapidly progressing post-Covid syndrome.

I have a high vaccinated client percentage. About 75% of my clients are vaccinated. Not one of them has shown up with weird symptoms to treat. Pre-vaccination, most of them had that February 2020 flu and were coming in for fatigue, allergies, and stuff. Post vaccine, many of them I haven’t seen. 

That is why I think the vaccine, especially the Moderna vaccine, might positively impact long haulers or post-Covid syndrome. 

WHEN DO PEOPLE EXPERIENCE POST-COVID SYNDROME?

Using inhaler

Now here is the thing with post-Covid syndrome. It doesn’t have to happen right away. It’s not unusual that it waits for months to show up. In the meeting with the doctors from China, they suggested eight months. It could take as long as eight months. I have one client who had mild Covid and had been fine for months. Seven months later, they started experiencing heart issues, wheezing, shortness of breath.

WHAT CAUSES POST-VIRAL SYNDROME

Remember the movie Awakenings with Robin Williams playing the doctor who used the drug L-Dopa to revive the patients. Here is what captured my attention with the movie, the patients were survivors of the 1918 encephalitis lethargica which may be the post-viral syndrome of the 1918 flu. It appeared right after the first wave of the flu. Encephalitis lethargica was a new type of encephalitis that had not been seen before and disappeared around 1926. It attacks the brain, leaving some people in a statue-like condition, speechless and motionless.

Some studies have tried to explore the origins of encephalitis lethargica as an autoimmune response to influenza. Science has found a link between the flu and regular encephalitis. Since encephalitis can be a post-viral symptom of the flu, it seems reasonable Encephalitis lethargica could also be a post-viral syndrome to a new flu strain.

If encephalitis lethargica was a post-viral syndrome, its aftermath was damaging.  

“Many surviving patients of the 1915–1926 pandemic seemed to make a complete recovery and return to their normal lives. However, most survivors subsequently developed neurological or psychiatric disorders, often after years or decades of seemingly perfect health. Post-encephalitic syndromes varied widely: sometimes they proceeded rapidly, leading to profound disability or death; sometimes very slowly; sometimes they progressed to a certain point and then stayed at this point for years or decades; and sometimes, following their initial onslaught, they remitted and disappeared.”

Oliver Sacks, Awakenings

Post Covid Syndrome/Long Haulers

Felix Stern was a German neurologist who examined the encephalitis lethargica patients during the 1920s. He documented that encephalitis lethargica became worse with time. The early symptoms would be either sleepiness or being wide awake. Later, the disease would progress to a prolonged, involuntary upward deviation of the eyes. The third phase started with a recovery, later followed by Parkinson-like symptoms.

The U.K. just published a pre-print of a study of brain scans before and after COVID-19. The study has not gone through peer review. The study found a consistent reduction in the grey matter of the brain which the study states could have long-term implications for individuals.

By using automated, objective and quantitative methods, we were able to uncover a consistent spatial pattern of loss of grey matter in limbic brain regions forming an olfactory and gustatory network. Whether these abnormal changes are the hallmark of the spread of the disease (or the virus itself) in the brain, which may prefigure a future vulnerability of the limbic system, including memory, for these patients, remains to be investigated.”

: https://doi.org/10.1101/2021.06.11.21258690

WHAT ARE THE SYMPTOMS OF POST-COVID SYNDROME? 

There is a pre-print study of over 3,700 patients who were sick for more than four weeks. The results were published at the end of December 2020, updated in April 2021 and are waiting for peer review. The study identified over 205 symptoms patients experience post-Covid. 

POST-VIRAL SYNDROME MORE COMMON THAN YOU THINK

Post-Covid Syndrome is a “post-viral syndrome.” A post-viral syndrome is where a person experiences symptoms long after the original viral infection has gone.

I didn’t know post-viral syndromes are fairly common with viruses. Not only did we experience a post-viral syndrome with the Flu of 1918, but we can also experience it today with recovery from strep throat turning into rheumatic fever. Or fatigue and other symptoms after Epstein-Barr, Zika, West Nile, Dengue, and other viruses.

The post-viral syndrome is not studied in Western Medicine. That means it is not well understood. With this Post-Covid Syndrome, the Western medical labs and tests are coming back normal. No issues. But, the person is sick. And when the doctors do try to prescribe medications, the medications don’t work. Sometimes it appears the drugs encourage whatever this is. If the virus produced post-viral syndrome due to damage in the brain, many medications are known to harm brain function.

TREATING POST-COVID SYNDROME WITH CHINESE MEDICINE 

The bottom line is this is all information. We don’t know anything right now. All we have is history and supposition. What we do know is post-Covid syndrome is real. Post-Covid syndrome is a type of post-viral syndrome and post-viral syndromes are not studied in Western Medicine. It’s not unusual for the patient to come back with clean labs. Everything can seem normal for a long-time, and then it shows up. In the clinic, I’m noticing that Chinese herbs can help. It’s a little bit tricky to treat because, just like in Western Medicine, where nothing shows up on the labs, in Chinese Medicine, you have to think beyond Traditional Chinese Medicine and really go into your theory on cold pathogens. If you don’t, you’ll usually treat the wrong thing, and they won’t get better. 

More Resources

How does COVID-19 affect the brain? A troubling picture emerges.

My Second COVID 19 Vaccine – the Health Improvements I Experienced

If you’ve watched my Youtube episode on my first Moderna shot, I mentioned that there were some weird positive things that happened with the first shot. But, I wanted to wait until after the second shot to verify it wasn’t a figment of my imagination.

Well, it’s been over a month since my second vaccine shot, and by now, you’ve probably heard about the positive side effects of the Pfizer and Moderna vaccine. Well, for my clients who have been able to obtain one of these shots and me, it seems to be true.

Getting the vaccine is a personal decision. Yet, if you got sick over the last year and a half, you may want to assess if getting one of the mRNA vaccines might be an option for you. Most importantly, the Pfizer and Moderna are mRNA technologies. The Johnson and Johnson and the AstraZeneca vaccine are different technologies and use an adenovirus to transport the vaccine into the body. The positive effects I experienced with the mRNA vaccines may not be experienced with the adenovirus vaccines. In fact, there is no guarantee you’ll get any positive effects with any of the vaccines. But, here is my anecdotal story of how the Moderna mRNA vaccine impacted my life.

If you want to understand why I chose the mRNA over any of the other technologies, check out my Youtube “Genetically Engineering Vaccines to Fight COVID-19

So, I’m going to go over three things. First, did I have COVID last year, and did you have COVID? There wasn’t any testing available. Well, the second part talks about long-haulers. If you think you had COVID, long-haulers syndrome is a very real complication of COVID. Lastly, the impact of the vaccine on me. I’ve got each section labeled so you can pick any section.

DID I HAVE COVID LAST YEAR?

O.k., why do I say, “If you got sick over the last year and a half, you may want to consider getting the vaccine.” Well, because the flu hasn’t been around. The flu season from Oct 2020 to Jan 2021 has had 132 hospitalizations and 292 deaths. The 2019 flu season had 35 million people getting influenza. There were 404,646 hospitalizations and 21,909 deaths. So, if you ever wanted to know what you could do to reduce your chances of the flu, wash your hands and wear a mask.

So, if the flu hasn’t been around and you got sick, you got to wonder what it was? That was the question I was asking myself when my husband and I got so deathly sick beginning of last year – before the pandemic was called.

At that time, there wasn’t any testing available. And by the time the COVID antibody test became available, it was five months after I was sick. With the lack of available science, I resorted to logic to determine if I had COVID-19.

I know my immune system. I don’t get the flu unless there has been a mutation in the flu virus – not a drift. A drift is a minor change in the virus. A mutation is a significant change making it a different virus. This was the H1N1, and I already went through that party and wasn’t expecting to be sick. So, I can’t tell you the surprise I experienced when I did get sick. It made no sense, and I had a hard time believing it was just H1N1.

But that wasn’t enough. I needed more information. I watched that mutated strain of the U.K. COVID-19 virus. It took that virus three weeks to transmit to 22 U.S. states even though the U.S. had travel restrictions.

Well, the first documented case of COVID-19 was something like December 1, 2019. The first ban on travel from China came eight weeks later, on the last day of January 2020. So, it had a much easier time transmitting.

And, in the middle of December 2019 the second wave of the flu started hitting the U.S. It was a very virulent, highly contagious H1N1 strain that hung on for weeks or months and had people flat on their backs. Now, COVID-19 likes other coronaviruses and the flu is a coronavirus.

And I’ve always wondered about the death rates. Well, this is just a hypothesis that myself and some of my Western medical friends have been kicking around. It could be that COVID-19 is dose dependant. The larger the dose, the more virulent the virus. And population matters when it comes to dose. China commonly has large cities of over 11 million. Bejing has 20 million people. New York is our largest city with a population of 8 million. In these cities, the virus can quickly shoot out of control. In our more spacious regions, the virus can get out of control, it seems to take more effort.

O.k., based on all that, it may be reasonable to assume if you got sick last year, it was COVID.

LONG-HAULERS

Wow, all the stories on long-haulers, right? Creepy, yet distant from you. Long haulers have debilitating, lasting effects of COVID that seem to be progressive and can end in death. It’s like it turns on an aging switch consuming your resources until you pass away. If your normal life expectancy is 80 years, COVID will help shave off 10 to 20 years.

The focus on long-haulers has been on those who have debilitating symptoms, and it started with those who had post COVID heart issues and died months later from some significant heart event. But, what if long-haulers is for everyone? My clients, including myself, have mentioned that they never got back to their pre-illness health.

My husband and I were on Chinese formulas for eight months. Our immune system was weak. Something out of thin air would attack us. It always felt like allergies where the sinuses would plug up, the head would feel heavy, and we felt tired. Overall, we would get tired easier. Our digestive issues became much worse. The body aches increased and begin to seem unmanageable.

My clients, my friends, and my colleagues, all were saying the same thing. No one had returned to their peak, pre-illness, health, and everyone was feeling just a little off or a little tired or a little something. And it had a progressive nature to it. Given more time, it would get worse.

I got the COVID testing. I got the antibody test, and everything came back negative. Yet, something didn’t seem right…

This was when I started to hypothesize that many people received some form of long-haulers.

THE VACCINE

So, with that background, my husband and I rumbled on down to the nearest vaccine administration site that would let us get the vaccine and got our shots.

The day I was headed down to get my first vaccine my body aches were going into overdrive. I could feel knots in my back forming. Getting the shot was easy, and I just remember the indifference of the person administering my shot. It wasn’t like she was for or against the shot. I knew she got the shot. But she had an interesting detachment to whether or not I got the shot.

In a universe that currently has an opinion on everything, I found her response interesting and unexpected.

Well, a half-hour later, I was all shot up and on my way home. I had been noticing since about 15 minutes after the administration of that shot my body aches were reducing. In the car, I turned and looked at my husband and said, “You know, all those body aches and knots I had coming down here…they are reducing.” I could actually palpate the knots and felt they had reduced by about half. My husband’s comment was, “Makes you wonder what you had.”

Sure does…

Over the next week, my body aches subsided and disappeared. That was weird because I had the aging and personal sports abuse body aches. My feet were a problem due to decades of riding Dressage and Jumping. I hadn’t been able to run for years. But, I could now.

My stomach problems reduced significantly and I took that opportunity to wander over to my favorite fast food joint…that I hadn’t visited in three years because of my stomach pains…and get a burger and fries. I could eat more crap again. I started sleeping again and wasn’t so wiped out and fatigued.

Of course, I wasn’t going to skip the second shot. The first shot was such a surprising shot of vitality both my husband and I raced to our second shot. The second shot reaffirmed the first shot. It wasn’t near as amazing because I wasn’t near as messed up.

O.k., in Chinese Medicine, if you have a physical change, you have to have an emotional or mental change, and I did. It wasn’t even a subtle change. It was just a change. I saw things differently. The world became less black and white and more shades of grey.

Remember the health care worker who administered my first shot? I was interested in her expression. I was interested in her indifference to whether I got the shot or not. I think that is part of the shades of grey because I feel her indifference. This shot really worked for me, but I don’t really have a buy-in to whether you get the shot or not. I think that indifference is why it’s taken me so long to even talk about my second experience with the mRNA vaccines. I wouldn’t have talked about it at all except in my episode, “My First Covid Shot,” I promised to talk about it.

So, there it is – my second COVID vaccine. What a wild ride! Good-luck to you and your decisions.

Thanksgiving – What Do I Have to be Thankful For?

What a year. I reflected on the year because I’m not sure how I ended up at the end of the year. It seems like January was just an hour ago, which is weird because every day seems to last three days.  

The last time I remember feeling like days lasted forever while the year seemed to race by was when I was a kid. I remember waiting for Christmas. The Christmas tree would go up. My elementary school would have us practice for the Christmas program. Each day seemed like an eternity, and Christmas seemed so far away. But, the year, well, the year was just fine.

I guess I’m waiting again. I guess me and the rest of the country are waiting. Each day feels like an eternity, while the year feels like a flash.

So, I decided to think about why I was thankful. I have much to be grateful for. I am grateful for my husband and our life together. I’m grateful that where I’m weak, he is strong. 

He has better survival instincts than I do. We had planned to spend Thanksgiving in a rented apartment on the beach. He didn’t think it was a good idea. I just canceled. He has excellent survival instincts.

That brought up the pain of the pandemic. This pandemic is going to last as long as it is going to last. My husband and I have spent the last eight months at home. We’ve done take-out food a couple of times. But, other than the grocery stores, we haven’t been out. No vacations to the beach or the desert or the mountains. No splurges on clothes we don’t need. No expensive restaurants – our absolute favorite. And no movies.

I’m pretty proud of us. We’ve done it. We’ve learned a lot about ourselves. Who we were before the pandemic and who we are today are different people. I think we’re better. 

Before the pandemic, we were pathological consumers. Before the pandemic, I was always busy with nonsense. I had no time because I wasted time doing nonsense things. And, everything had to be so wonderful. I had lost pleasure with the simple things in life. 

The pandemic has forced time on me. It’s been painful, but my expectation of life has been returning to “normal” where I can see and appreciate the simple things in life. I stopped my pathological spending. I spent time reaching even deeper into Chinese Medicine. I’ve stepped up my meditation. All this means self-discovery is on overdrive. The simple living experience and the pleasure of a chilly fall morning or a crisp winter day have been reawakened.   

I don’t think I would have ever gone this deep into the medicine or myself without the pandemic. And sure, now it feels like I accidentally stepped on a slide and am on a wild ride. Yet, the ride is impressive.

Do you know what else happened? The pandemic gave all of us permission to wear face masks and make it normal. When this is over, I’m wearing a face mask during flu season because the flu has become so virulent and difficult to overcome. 

We may have gained another positive from the pandemic. When you are feeling sick, you might feel justified in staying home. Remember how frustrated you would get that a co-worker came in snotting and coughing all over everything. Two days later, you would have the flu, and it lasted for eight weeks. 

People may be more willing to stay home. And with the advent of work-at-home, businesses may be more supportive of keeping the sick home.

In Australia, this year, with masks and social distancing, Australia’s flu season was a tenth of the 2019 season, and total deaths from the flu were 34.   

I have to thank my clients. Without them, I wouldn’t have a business. With them, they have made a problematic year survivable. So, thank you for being there for me. And I got to meet new clients this year who were terrific and filled with new stories and new lives. 

Most importantly, my husband and I have managed to keep ourselves and our friends safe. I’m incredibly grateful for that. 

What I’ve come to realize is this year is not a normal Thanksgiving. It is a significant season marked by thanks and grace. This is a year where I’ve been introduced to heroes every day. Every essential worker, the grocery worker, the food processor, healthcare worker, and the civil servants that worked so others can stay home and safe, I am grateful to you. This year has reawakened my midwestern values of family and community. And this year has made me aware that nothing can be taken for granted, and I’m so grateful my family is safe.

There is still a road ahead of us. From the past eight months, my husband and I know we can make the next six months.

My wish and prayer for you is that you can keep yourself, your family, and your friends safe. Have a safe and wonderful Thanksgiving.

Genetically engineering vaccines to fight COVID19 – the mRNA vaccine

Want to listen to the audio?

With the prospect of either Moderna or Pfizer bringing their mRNA vaccine to market, I’ve had clients question me on what is this technology? In my episode on “The biggest healthcare challenge facing you today,” I talked to why it is so important to be or have a patient advocate. One of the functions which a patient advocate is able to complete is the initial research so you can start to figure out what works best for you and to allow you to have a more in-depth conversation with your medical provider.  

The coronavirus is insanely risky.  In the last two weeks, more and more people are comfortable talking about their infection and the lasting ramifications of the virus. Twitter is probably one of the more vocal platforms. As celebrities and influencers talk about their positive test for Covid19, more and more people are tweeting about some of the lasting health impacts of the disease. Asthma or some other impaired lung function is the most popular post I read about. But, I’m also reading about issues with brain function and dementia, post viral heart attacks, and just a slew of other things. 

And pre-election, it was really hard for me to find this information. I really wanted to understand what my risk was if I survived an infection and prior to two weeks ago no one was comfortable talking about it. Nor were they posting pictures of their loved ones who had passed. The weird thing is the pictures I’m seeing are not 80 year old seniors in a healthcare facility. These people look like they are in their 40’s or 50’s, healthy and vibrant. These people were me. 

That pushed me to produce the episode on “Coronavirus Update, 4 medications in Your Medicine Cabinet” and their positive impact on Covid 19.  

But now we are going to have another decision facing us. What do we do when the vaccine becomes available? Right now, Moderna and Pfizer are leading the pack with their mRNA technology. Johnson and Johnson was working on an adenoviral vector vaccine that was pulled in the last few weeks due to an adverse incident. 

So, what are these technologies? mRNA vaccine technology is one of three genetically engineered vaccine technologies. The three technologies are: 1. DNA vaccines, 2. mRNA vaccines and 3. adenoviral vector vaccines. There are over 200 hundred vaccine candidates worldwide. There are companies in each of these categories. Inovio has a DNA vaccine in clinical trials. Pfizer and Moderna have mRNA vaccines.  Johnson and Johnson has an adenoviral vector vaccine.

And this is just focusing on the genetically engineered vaccines. 

Let me tell you, in concept, I like the concept of genetically engineered vaccines because it takes out the variability of life in vaccines created through naturally occurring processes. And this risk really came to light back in 2009 with our flu vaccines. We’ve used chicken eggs to create the flu vaccine for over 70 years. So, it’s a stable platform with a hitch. Every vaccine would have a mutation. These mutations didn’t pose a concern because the vaccine was really about making our immune system sensitive to one protein on the virus – the only protein our immune system could target. In 2009, the mutation happened on that protein hiding it from our immune system. Back in 2019, I produced an episode on this phenomenon “Research Updates Flu Vaccine 2019.”

The episode goes over the research that was happening and some of the short term solutions of addressing the problem. Now, none of the short term solutions fixed what caused the problem in the first place. In fact, they had the potential for making that problem even worse because the problem was diversity in nature coupled with non-human DNA and injecting it into humans. I’ve been really curious how science was going to address the problem with the random nature of life. Out of the three genetically engineered vaccines, it appears that mRNA may have the potential to address this problem. 

All three of the technologies have been around for 20 to 30 years. None of the technologies have an approved vaccine for human use. So, let’s look at what each of the technologies does have approved. First, DNA vaccines have two approved veterinary vaccines in the US. The West Nile Virus vaccine for horses and melanoma vaccine for dogs. Second, the mRNA technology has no approved vaccines for humans or animals. The third technology, the adenovirus vaccine has one vaccine approved for rabies in wild animals. 

I would highly support reading the Chemical and Engineering article, “Adenoviral vectors are the new COVID-19 vaccine front-runners. Can they overcome their checkered past?” Well written and explains the adenoviral vaccines in clear, easy to understand language. It highlights the risks with these vaccines. It sounds like the concept is valid, but when you try to implement it, you can’t. 

With the DNA vaccines, I hesitate when you inject something into our DNA. I just don’t think that is a good idea. And the  West Nile virus vaccine was causing so many adverse events in horses, that I stopped using it. I stopped following this vaccine when I stopped using it. Although, I can say I don’t hear the same outrage that I heard with the initial vaccine where birth mutations were common, sudden death, reproduction concerns – just all sorts of weird DNA issues. That’s just me, and I’m sure science would be more than willing to help me understand how naive my position is. 

Obviously there have been improvements in the technology. Back in 2003, there was a review on DNA vaccines. One of the problems was reaching enough cells. According to a review initiated in 2015 and finalized in 2017, that is still the problem in humans. I’ll be curious to see how Inovio is going to overcome this obstacle. 

Which leaves us with mRNA vaccines. What I liked about this concept is it is synthetic. So, the risks involved in using chicken eggs to grow the virus and injecting the virus into the body are avoided. What I also like is the limited function of mRNA in the body.  mRNA is a recipe or instructions our cells read to make a protein. And this vaccine is only delivering instructions to create one protein and has no other instructions.  What I also like is mRNA degrades overtime so it won’t be floating around your body. It has a natural termination date. 

On the other side, the biggest concern with the Pfizer mRNA vaccines is the need to keep them cold…really cold until use. That will create a logistics problem. Moderna does not need to be kept cold. That alone would make it a natural front runner over Pfizer. The other thing that is going to be tough with these vaccines is it is new technology.  I know there was some concern that the data wasn’t available before the elections. There weren’t enough infections before the elections to open the data. And I still question whether 90 some infections is enough to make a determination in a population of 30,000 to 45,000 because we just don’t know what we don’t know. And that article in Chemical and Engineering news highlights what we learned about the adenovirus technology as we started trying to use it. It was identified that people who have immunity to the adenovirus used in the vaccine had no protection. In some people, this technology caused a significant inflammation response that could cause death. The researchers also found that after the first injection,  the body mounts an immune response to the adenovirus vaccine. So, you couldn’t use it a second time. 

So, right now, I like the concept of genetically engineered and I like the mRNA technology the most of the three available. But this is really preliminary. I thought I had read somewhere that Pfizer will open their trial data towards the end of November to allow researchers to peer into the data, but I can’t find that information anywhere. If you want to see the study design here is a link to it. https://www.pfizer.com/science/coronavirus

CNBC did a great overview of the process of getting a COVID-19 vaccine to market and mRNA vaccines called, “ What is an mRNA coronavirus vaccine.” It goes into more depth on the speed these are coming to mark, the phases of the trial, and emergency use approvals. 

O.k. that is the introduction to the genetically engineered vaccines. Good-luck you guys and stay safe. 

FOOTNOTES

Erman, Michael Mishras, Manas (2020, October 27). Pfizer says no COVID-19 vaccine data yet, could be a week or more before it reports. Reuters. Retrieved on November 15, 2020 from https://www.reuters.com/article/us-pfizer-results-idUSKBN27C1GT

Cross, Ryan (2020, May 12). Adenoviral vectors are the new COVID-19 vaccine front-runners. Can they overcome their checkered past? Chemical & Engineering News. Retrieved on November 15 2020 from https://cen.acs.org/pharmaceuticals/vaccines/Adenoviral-vectors-new-COVID-19/98/i19

 Cuffari, Benedette. (2020, September 25). What is a DNA-based vaccine?. News-Medical. Retrieved on November 15, 2020 from https://www.news-medical.net/health/What-is-a-DNA-based-vaccine.aspx.

Liu, M.A. (2003, March 21). DNA vaccines: a review. Journal of Internal Medicine. Retrieved on November 15, 2020 from https://onlinelibrary.wiley.com/doi/full/10.1046/j.1365-2796.2003.01140.x

Li L, Petrovsky N. Molecular mechanisms for enhanced DNA vaccine immunogenicity. Expert Rev Vaccines. 2016;15(3):313-329. doi:10.1586/14760584.2016.1124762

Beasley, Deena (2020, November 9). Inovio expects FDA decision on COVID-19 trial start this month. Reuters. Retrieved on November 15 2020 from https://www.reuters.com/article/us-health-coronavirus-inovio-pharma-idINKBN27P2UW