Edible vaccines produced in lettuce – Edible mRNA vaccine in lettuce chloroplasts

The concept of embedding vaccines, particularly mRNA-based vaccines, into everyday foods such as lettuce and tomatoes is a growing research area that, while innovative, poses profound concerns about consumer rights, health safety, and ecological balance.

Emerging Research on Edible Vaccines Recent studies have proposed incorporating mRNA vaccines into the chloroplasts of lettuce and other edible plants, with the aim of creating an easily distributable vaccination method. Researchers argue that this could potentially streamline vaccine distribution, reduce cold storage dependency, and simplify global vaccination efforts (MDPI, 2016; PMC8329267, 2021).

In Mexico, researchers have developed TOMAVAC, a tomato-based edible COVID-19 vaccine intended to produce antibodies against the virus (ResearchGate, 2024). Similarly, initiatives in Tennessee and other regions suggest modifying lettuce for drug delivery, sparking debates on public health ethics and regulatory oversight (Newsweek, 2024).

Potential Risks and Ethical Concerns Despite optimistic claims from proponents, critical analysis highlights alarming potential risks associated with edible mRNA vaccines. Firstly, the long-term health implications of consuming genetically altered foods containing mRNA vaccines remain insufficiently studied. Historically, rushed approvals, as observed with some COVID-19 mRNA vaccines, have raised public distrust due to emerging side effects and limited transparency regarding long-term safety profiles.

Moreover, edible vaccines could unintentionally expose consumers to pharmaceutical interventions without informed consent. Introducing mRNA vaccines into widespread food sources could result in involuntary medical treatments, infringing upon individual rights to bodily autonomy and informed medical consent.

Ecological and Agricultural Risks Embedding mRNA vaccines in plants risks unintended cross-contamination and gene flow into wild ecosystems. These genetically modified plants, if released into open agriculture, could potentially disrupt ecological balance, affecting pollinators, soil microbiology, and non-target plant species. This bioengineering initiative poses profound ecological risks, extending beyond controlled laboratory environments into broader ecosystems.

Transparency and Consumer Rights The move towards edible vaccines embedded in everyday foods raises significant transparency issues. Consumers must retain the unequivocal right to know precisely what they are consuming. If vaccines are embedded in common produce, clear labeling and stringent regulations would be essential, yet enforcing such oversight presents considerable practical challenges.

Regulatory Gaps and Precautionary Principle Currently, regulatory frameworks remain insufficiently equipped to address the rapid advancement and deployment of genetically modified organisms (GMOs) intended for medical consumption. The pace of biotech innovation is often far ahead of existing regulation, potentially placing consumers at risk. Advocates for cautious progression emphasize the precautionary principle: rigorous and comprehensive risk assessments must precede widespread adoption.

Conclusion While edible mRNA vaccines offer a superficially appealing solution to vaccine distribution challenges, the unresolved health, ethical, ecological, and regulatory concerns cannot be overlooked. Protecting consumer rights, ensuring transparent labeling, and thoroughly evaluating ecological and health impacts must be paramount. Without addressing these critical factors comprehensively, altering our fundamental food supply with edible vaccines is an endeavor fraught with significant and lasting risks.

Tennessee Moves to Classify ‘Vaccine Lettuce’ as a Drug

Abill that would classify as a drug certain foods with vaccine materials added to them was passed by the Tennessee Senate and now awaits Governor Bill Lee’s signature into law amid concerns about research on putting immunity boosters into lettuce.

The proposed law, HB 1894, was passed in a 23-6 Senate vote last Thursday after getting the House’s green light in a 73-22 vote in early March.

It would classify any food that “contains a vaccine or vaccine material” as a drug under Tennessee law, meaning the food would have to be labeled accordingly. The bill defines vaccine material as a substance intended to “stimulate the production of antibodies and provide immunity against disease.”

The legislation would not ban vaccine-imbued foods from being sold in the state but would require them to carry the same sort of medical labeling as injectable vaccines or medications.

While proponents of the measure cited ongoing research into this method of conveying vaccines and the need to give people the recommended dose of a vaccine, opponents questioned the bill’s necessity and whether such foodstuffs would ever be sold alongside their unvaccinated counterparts at grocery stores.

During a debate on the bill before Thursday’s vote, state Senator Heidi Campbell, a Democrat, asked for evidence of “any instances of there being food offered in the state of Tennessee that contains vaccines.”

Speaking of the research, she said that “the idea that this would somehow correlate to some kind of a retail offering of vegetables, especially when that vegetable would cost many thousands of dollars, just seems to me [to be] messy to be passing legislation for that reason.”

Senate advocates of the bill said that they did not know of any specific examples of vaccine-imbued foods being sold but that the bill was to ensure regulations are in place if such sales occur. They also noted the relative inexpensiveness of some vaccines and lettuce.

State Representative Scott Cepicky, a Republican who originally sponsored the bill, said in February that lettuces containing vaccines would require a prescription “to make sure that we know how much of the lettuce you have to eat based off of your body type so we don’t under-vaccinate you—which leads to the possibility of the efficacy of the drug being compromised—or we overdose you based off how much lettuce is [eaten],” according to Nashville’s WKRN-TV.

A research project, funded by a $500,000 federal grant, at the University of California is looking into whether pathogen-targeting mRNA, like that used in COVID-19 vaccines, could be implanted in the cells of edible plants to replicate and then be consumed.

“We are testing this approach with spinach and lettuce and have long-term goals of people growing it in their own gardens,” Juan Pablo Giraldo, an associate professor at the university’s Department of Botany and Plant Sciences, who is leading the research, said in 2021. “Farmers could also eventually grow entire fields of it.”

The idea of edible vaccines is not new. A 2013 scientific paper noted attempts to put vaccines against various diseases, such as measles, hepatitis B and cholera, into foodstuffs like potatoes, bananas, corn, soybeans and rice.

Researchers say that successfully placing vaccines in plants would mean they don’t have to be stored at low temperatures, which is the case for many injectable vaccines. source

While large companies and public sector consortiums in the United States, Canada, China and Europe are running at full speed to develop a vaccine grown in genetically modified (GM) tobacco plants, a research group at a Mexican university is working toward the same terrorzing objective, but with a different and innovative strategy. They are using bioinformatics and computational genetic engineering to identify candidate antigens for a vaccine that can be expressed in tomato plants. Eating the fruit from these plants would then confer immunity against COVID-19.

sources

https://pmc.ncbi.nlm.nih.gov/articles/PMC8329267/

https://pubmed.ncbi.nlm.nih.gov/38260078/

https://allianceforscience.org/blog/2020/05/gmo-tomato-as-edible-covid-vaccine-mexican-scientists-work-to-make-it-a-reality/

https://www.sciencedirect.com/science/article/pii/S2590262825000218

http://mdpi.com/1422-0067/17/10/1715

https://www.nature.com/articles/s44222-025-00299-1

https://www.uottawa.ca/faculty-science/please-pass-salad-edible-vaccines-produced-lettuce-protect-against-covid-19

The future of vaccines may look more like eating a salad than getting a shot in the arm. UC Riverside scientists are studying whether they can turn edible plants like lettuce into mRNA vaccine factories.

Messenger RNA or mRNA technology, used in COVID-19 vaccines, works by teaching our cells to recognize and protect us against infectious diseases.

One of the challenges with this new technology is that it must be kept cold to maintain stability during transport and storage. If this new project is successful, plant-based mRNA vaccines — which can be eaten — could overcome this challenge with the ability to be stored at room temperature.

The project’s goals, made possible by a $500,000 grant from the National Science Foundation, are threefold: showing that DNA containing the mRNA vaccines can be successfully delivered into the part of plant cells where it will replicate, demonstrating the plants can produce enough mRNA to rival a traditional shot, and finally, determining the right dosage.

“Ideally, a single plant would produce enough mRNA to vaccinate a single person,” said Juan Pablo Giraldo, an associate professor in UC Riverside’s Department of Botany and Plant Sciences who is leading the research, done in collaboration with scientists from UC San Diego and Carnegie Mellon University.

“We are testing this approach with spinach and lettuce and have long-term goals of people growing it in their own gardens,” Giraldo said. “Farmers could also eventually grow entire fields of it.”

Key to making this work are chloroplasts — small organs in plant cells that convert sunlight into energy the plant can use. “They’re tiny, solar-powered factories that produce sugar and other molecules which allow the plant to grow,” Giraldo said. “They’re also an untapped source for making desirable molecules.”

In the past, Giraldo has shown that it is possible for chloroplasts to express genes that aren’t naturally part of the plant. He and his colleagues did this by sending foreign genetic material into plant cells inside a protective casing. Determining the optimal properties of these casings for delivery into plant cells is a specialty of Giraldo’s laboratory.

For this project Giraldo teamed up with Nicole Steinmetz, a UC San Diego professor of nanoengineering, to utilize nanotechnologies engineered by her team that will deliver genetic material to the chloroplasts.

“Our idea is to repurpose naturally occurring nanoparticles, namely plant viruses, for gene delivery to plants,” Steinmetz said. “Some engineering goes into this to make the nanoparticles go to the chloroplasts and also to render them non-infectious toward the plants.”

For Giraldo, the chance to develop this idea with mRNA is the culmination of a dream. “One of the reasons I started working in nanotechnology was so I could apply it to plants and create new technology solutions. Not just for food, but for high-value products as well, like pharmaceuticals,” Giraldo said.

Giraldo is also co-leading a related project using nanomaterials to deliver nitrogen, a fertilizer, directly to chloroplasts, where plants need it most.

Nitrogen is limited in the environment, but plants need it to grow. Most farmers apply nitrogen to the soil. As a result, roughly half of it ends up in groundwater, contaminating waterways, causing algae blooms, and interacting with other organisms. It also produces nitrous oxide, another pollutant.

This alternative approach would get nitrogen into the chloroplasts through the leaves and control its release, a much more efficient mode of application that could help farmers and improve the environment.

The National Science Foundation has granted Giraldo and his colleagues $1.6 million to develop this targeted nitrogen delivery technology.

“I’m very excited about all of this research,” Giraldo said. “I think it could have a huge impact on peoples’ lives.”

The University of California opened its doors in 1869 with just 10 faculty members and 40 students. Today, the UC system has more than 280,000 students and 227,000 faculty and staff, with 2.0 million alumni living and working around the world. Source

Tennessee lawmaker wants rules in place for the possibility of vaccines in produce

Tennessee House Bill HB1894

On 21 February 2024, the Tennessee House of Representatives passed a bill (HB1894) on food labeling sponsored by lawmaker Scott Cepicky. The bill “prohibits the manufacture, sale, or delivery, holding, or offering for sale of any food that contains a vaccine or vaccine material unless the food labeling contains a conspicuous notification of the presence of the vaccine or vaccine material in the food”.

NASHVILLE, Tenn. (WTVF — Some Tennessee lawmakers are wanting rules in place to prevent vaccines from possibly being put in fruits and vegetables.

There are no vaccines in your lettuce or tomatoes when you go grocery shopping right now, but Representative Scott Cepicky believes it could happen since researchers in California have “perfected putting vaccines into certain foods.”

The representative crafted what he calls a consumer protection bill to make sure you know whether you’re picking up a tomato with a vaccine in it or not in the event vaccines are admitted in your favorite foods.

He says there need to be safety measures in place.

“If you go to buy tomatoes, and there’s a polio vaccine in there, that you’re aware of what you’re buying as a polio vaccine,” said Rep. Cepicky. “The problem we have is if it’s not treated as a pharmaceutical… How many tomatoes do I have to eat to get the proper dosage versus how many tomatoes do you have to eat? And if you eat too many, do you get an overdose?”

Representative John Ray Clemmons questioned whether having vaccines in fruits and vegetables is legal in TN and if not, is the legislation to protect Tennesseans necessary. Cepicky says having something in place is better than not.

The protection bill passed its latest House committee vote just last week. source

A review of oral vaccination with transgenic vegetables by the US GOVERNMENT

PubMed Disclaimer

HOPO 14-1  :Drug product for removing radioactive contaminants from the body.

Researchers begin human trials for oral drug to protect against dirty bomb exposure

LOS ANGELES – Researchers have begun the first-in-human clinical trial of an experimental oral drug that will hopefully be able to remove radioactive contaminants from inside the body has begun, the National Institutes of Health reported on Monday.

HOPO 14-1 will hopefully be able to be given to people in tablet form and will work against elements that can be used to make dirty bombs.

Dirty bombs are commonly known as explosive devices that are laced with radioactive substances.

If the trials prove optimistic, HOPO 14-1 could be used rather than intravenous methods in the event of an emergency.

The trial will consist of 42 healthy adults, aged 18 to 65, all of whom will be given varying doses of the experimental tablet.

Results from the trial are expected to be published next year.

What is a dirty bomb?

Technically known as radiological dispersion devices, dirty bombs are relatively primitive, imprecise weapons. They are much easier and cheaper to build than a nuclear device and also far less dangerous.

Dirty bombs use conventional explosives, such as dynamite, placed alongside radioactive material, which is then flung outward by the force of the blast. The amount of radioactive material dispersed, while dangerous, is not necessarily lethal.

The material used in the bomb could have been obtained from radioactive sources used in medicine and industry or from research facilities.

“A dirty bomb is really easy to make,” says Scott Roecker, vice president for the nuclear materials security program at The Nuclear Threat Initiative, a nonprofit based in Washington. “It’s a crude device.”

What damage can a dirty bomb cause?

The number of casualties and the extent of damage from a dirty bomb depends on many variables.

A key factor is the amount and type of conventional explosives that are used, which determine the magnitude of the blast.

The quantity and type of radioactive materials released are other factors, as are weather conditions — and especially the wind — at the time of the blast. A potentially wide area could be contaminated.

Most dirty bombs would not discharge enough radiation to cause death or even severe illness.

Low levels of radiation exposure usually do not cause any symptoms. People may not know whether they have been exposed because radiation cannot be seen, smelled or tasted.

How dangerous is a dirty bomb?

A dirty bomb would likely cause a limited number of deaths. Its main impact is psychological, which is why such devices are often referred to as “weapons of mass disruption.”

Dirty bombs are not for battlefield use, being deployed more obviously in urban areas, Roecker said.

“They’re more of a psychological weapon. When you’re trying to scare people, intimidate people, you’d use a weapon like this,” he said.

The radioactive dust and smoke can spread far and are dangerous if inhaled near the blast’s epicenter. The radioactive cloud would likely spread over several blocks, according to Roecker. But as radioactive material spreads through the atmosphere, it becomes less concentrated and less harmful.

Key factors in radiation exposure are what type of radiation it is, how long someone is exposed to it, and whether the radiation was absorbed through the skin, inhaled or consumed orally.

Specialized equipment is required to detect radiation. Contaminated homes, businesses and public services could be placed off-limits for months and need an expensive clean-up operation. source

HOPO 14-1 is an investigational drug product for removing radioactive contaminants from the body. It is an oral capsule designed to act as a defence against radioactive threats such as nuclear power plant accidents or dirty bomb attacks.^[1][2] The active ingredient is the hydroxypyridinone ligand 3,4,3-LI(1,2-HOPO), which is a powerful chelating agent.^[1][3] HOPO 14-1 works by selectively binding to heavy metals in the body and forming a complex that the body can naturally excrete.^[4] The drug is also being studied as a treatment for other forms of heavy metal toxicity, including lead poisoning and exposure to gadolinium from MRI contrast agents.^[5][6][7][8] HOPO 14-1 was developed at Lawrence Berkeley National Laboratory by actinide chemist Rebecca Abergel. Abergel and former postdoc Julian Avery Rees co-founded HOPO Therapeutics, a company commercializing HOPO 14-1 and other treatments for heavy metal poisoning.

References

Now that you know how much these vibrations affect us, look at your life. Are you stressed or burnt out? Don’t you want to feel positive and light, to channel the energy of the world and make your dreams come true?

Then, join me. These are some practices that help me raise my vibrations! Make sure to follow them with great discipline. You’re putting in all this hard work for your higher self, who will thank you in the future.

1. Practice gratitude

I cannot say this enough. Offer thanks to the world, and it will give you more reasons to be thankful. Half the time, in our daily rush of hustling and whatnot, we forget how much we have that other people do not. The universe has brought you gift after gift, be it in the form of your loved ones or pets. Open your eyes and be grateful for that. Take a few minutes every day to remember all that you’re thankful for, and thank others too! It can make such a difference to a person’s day.

2. Practice meditation

Yes, meditation. I know, you’ve heard it time and time again, but it is that powerful.

It is such an efficient way to raise your vibrational energy; I cannot stress how vital it is. Even taking five minutes out of your day to meditate will cause a shift in a negative mindset. Your body functions on neurotransmitters like endorphins, dopamine, serotonin, and oxytocin. And it has been scientifically proven that meditation triggers the brain to release these neurotransmitters.

Meditation brings you peace, and more importantly, it gives you space to reflect on yourself and your actions, which helps you avoid low vibrational actions.

3. Get in touch with nature

Look, we all love vacations for a reason. Get out of these concrete jungles we live in, and pluck a few daisies. Swim in the ocean, bask in the sunlight, but let yourself feel the natural world around you. The universe loves you, for you are its child. It made this world for you, like a home. Recharge and cleanse your energy in nature, and feel at home in Mother Nature’s womb.

4. Find a way to laugh

There is an old saying—laughter is the best medicine. And it’s been around for a reason. Learn to laugh at yourself and with others. Enjoy the one life you have with humor!

5. Move your body

Whether it’s going to the gym, yoga, or running, move your body. Stop hunching over your screens and let your body feel light, let it move, and revel. Isn’t it divine to have a body that is capable of housing your soul? Enjoy the body you have and let it cleanse your vibrational energy.

6. Clean your space

Clean that mess up. If there are obstacles in its way, light cannot shine. The same thing goes for vibrations. Get rid of the things that no longer serve you–especially that ex who keeps resurfacing during every retrograde. They’re no good for you!

7. Practice generosity and kindness

Generosity and acts of kindness are simple ways we can spread love and positivity. No act of kindness is ever too small. If you witness someone being kind, or if you are a recipient of such an act, be sure to thank the other person and express gratitude. This creates a “feel-good circle of positivity”. Volunteering with a local charity, helping a loved one with a simple favor, or giving a thoughtful gift are some simple ways we can practice kindness. Do not have expectations of receiving anything in return.

8. Listen to uplifting music

Listening to cheerful, uplifting music is an instant way to raise your vibration. While you’re at it, try moving your body and dancing to the beat. You can also listen to different sound frequencies, nature sounds, or meditation music.

9. Unplug for a while

Technology, screens, and social media now consume us at an alarming rate. Not everything we see in the media is good for our energy. This is why it’s important to turn off those devices and take a digital detox.

10. Write in a journal

Put down your worries and organize your thoughts in a journal. When you experience an emotion strongly, you can draw a picture or express yourself with colored pencils. There is no “right” or “wrong” way to keep a journal. That’s the beauty of it!

11. Get creative

That’s right, get back to those hobbies you loved. Whether it was learning an instrument, dancing, or singing, let art consume you. When we focus on something creative, our vibrations are automatically raised.

12. Notice the beauty around you

Did you notice how beautiful the sky can be, at different times of the day? Or the perfect golden hue of sunlight as it flows through your room at sunset? No matter where you are, take a few minutes to notice the beauty that surrounds you everywhere!

13. Eat high-vibration foods and stay hydrated

Everything you consume is prana, or life force energy. If you eat a lot of “dead” energy (in the form of meat, fried, or processed food), you will lower your vibration. By eating nutrient-dense, prana-rich foods, like local and organic fruits and vegetables, your body absorbs these things, making you more light, vibrant, and alive. High-vibration food makes a person’s vibration higher. Here is a list of high-vibration foods to get you started.

Recommended for you: What is Prana & how to enhance yours

14. Surround yourself with positivity

The environment we spend our time in affects our vibrational energy. Surround yourself with inspirational books, pretty crystals, houseplants, beautiful artwork, and soothing objects. Choose your objects carefully, though—you don’t want to become a hoarder!

15. Love!

And finally, all you need is love! Love yourself, your partner, your environment, and the people around you. Turn your anger, hate, and other negative emotions into positive ones and share them with everyone you meet. Write your words of love on a water bottle, napkin, journal, and other places where you’ll see them through the day! Make a positive affirmation of love to yourself in front of the mirror every morning. Tell people you love them at every opportunity. As you learn to love, your vibration will increase, and you will be loved in return.

If you want to learn more about how to change your vibrations, you can check out my podcast or my blog post about different ways to raise your vibrational energy!

Pursuing your spirituality isn’t easy at all, but the deep joy and satisfaction of living a life that is so enriched by all that the universe has to offer? That is a feeling of unparalleled joy. source

How to Raise Your Emotional & Spiritual Vibration

The time has come for us to raise our vibrational forces! Read about these powerful ways to manifest your own positivity, light, and love.

A vibration is a state of being, the atmosphere, or the energetic quality of a person, place, thought, or thing. Much of reading “vibes” is intuitive—you can tell a person’s energy when they walk into a room, for example.

While some people draw you closer, others make you want to keep your distance. You see a depressing and violent news story, you get a heavy feeling in your gut. You witness a puppy cuddling with an infant, and you feel a warmth inside.

— One surveillance system detects potential link in seniors, yet multiple others show none

An early signal of stroke risk was detected in older adults who received Pfizer-BioNTech’s bivalent COVID-19 vaccine, the FDA opens in a new tab or window and CDC opens in a new tab or window announced in a joint statement late on Friday, yet the agencies found no link in further analyses and are not recommending a change in COVID-19 vaccination practice.

According to the agencies, incidence of ischemic stroke in CDC’s Vaccine Safety Datalink (VSD) among individuals 65 and up in the 21 days following vaccination with Pfizer’s bivalent booster “met the statistical criteria to prompt additional investigation” when compared with the 22-44 days thereafter.

However, subsequent analyses of the Vaccine Adverse Event Reporting System, the Centers for Medicare & Medicaid Services database, and a preliminary study of the Veterans Affairs database turned up no signal for an increased risk with either Pfizer or Moderna’s bivalent vaccines, both of which were first authorized opens in a new tab or window in late August.

Furthermore, Pfizer-BioNTech’s global safety database detected no signal for ischemic stroke with their updated vaccine, nor have surveillance systems from other nations.

“Often these safety systems detect signals that could be due to factors other than the vaccine itself,” the agencies stated. “All signals require further investigation and confirmation from formal epidemiologic studies. When one system detects a signal, the other safety monitoring systems are checked to validate whether the signal represents an actual concern with the vaccine or if it can be determined to be of no clinical relevance.”

The CDC and FDA noted that confounding factors may have contributed to the signal identified.

“Although the totality of the data currently suggests that it is very unlikely that the signal in VSD represents a true clinical risk, we believe it is important to share this information with the public, as we have in the past, when one of our safety monitoring systems detects a signal,” they noted.

These and other data from vaccine safety systems will be presented at an already-scheduled January 26 meetingopens in a new tab or window of FDA’s Vaccines and Related Biological Products Advisory Committee, according to the statement.

by Ian Ingram, source

— Also made no difference for more severe COVID outcomes

by Ingrid Hein,

Everyhting about – The COVID Vaccination read here

Story by ylee@businessinsider.com

After a string of failures over the past few decades, biotech companies seem to be returning to the difficult and elusive hunt for Alzheimer’s treatments.

Alzheimer’s disease affects roughly 6.5 million Americans, and there is no cure. For decades, drugs focused on treating the condition have languished in clinical trials, failing to show that they could treat or slow the progression of the disease.

But amid some positive news, companies focused on Alzheimer’s have said they’ve received an influx of investor interest. This month, the Food and Drug Administration granted accelerated approval for a new Alzheimer’s drug called Leqembi, developed by the Japanese pharmaceutical company Eisai and Biogen, a biotech company based in Cambridge, Massachusetts.

Feds Probe Stroke Link to New Pfizer COVID Booster 

Ahead of the Martin Luther King Jr holiday weekend, federal health officials announced that they were looking into a potential stroke risk in seniors who received the Pfizer-BioNTech bivalent (two-strain) COVID-19 booster. However, follow-up investigations in the United States and other countries and by the company have not found the same signal.

In a Jan 13 statement, the Food and Drug Administration (FDA) said it and the Centers for Disease Control and Prevention (CDC) said the CDC’s Vaccine Safety Datalink (VSD) system, which tracks vaccine safety in nearly real-time, met the statistical level to prompt an investigation into whether there is a safety concern about whether people ages 65 and older who received the new Pfizer booster were more likely to have an ischemic stroke in the 3 weeks following vaccination compared to 22 to 44 days after vaccination.

The FDA said the preliminary signal hasn’t been seen with the Moderna bivalent booster and that there may be other confounding factors in the VSD that require further investigation. It added that no signs of an increased stroke risk have been found in three other federal vaccine safety tracking databases. Also, the signal hasn’t turned up in Pfizer’s global safety database or in monitoring systems in other countries.

Considering all the data, it’s unlikely that the signal in the VSD represents a true clinical risk, the FDA said, adding that it’s important to share information about any potential safety signal with the public. The FDA’s vaccine advisory committee will discuss the issue at its Jan 26 meeting.

In light of the new development, federal officials said there are no changes in COVID-19 vaccination recommendations, which is for everyone ages 6 months and older to stay current with their COVID-19 vaccinations, including those who are eligible to receive the bivalent boosters, which target the original virus plus Omicron variants. Lisa Schnirring source

‘Kraken’ variant & vaccine stroke risk: Everything you need to know with Sandra Fryhofer, MD

AMA Update covers a range of health care topics affecting the lives of physicians, residents, medical students and patients. From private practice and health system leaders to scientists and public health officials, hear from the experts in medicine on COVID-19, monkeypox, medical education, advocacy issues, burnout, vaccines and more.

In today’s AMA Update, the latest on Pfizer’s COVID vaccine and stroke risk. Sandra Fryhofer, MD, breaks down vaccine safety statistics following new FDA and CDC announcements about possible increased risk of stroke after getting Pfizer’s bivalent booster shot. Also covering VSD, other vaccine databases and what’s expected at the Vaccines and Related Biological Products Advisory Committee (VBRPAC) meeting this January. Plus everything you need to know about the ‘Kraken’—a.k.a, the XBB.1.5 Omicron variant. AMA Chief Experience Officer Todd Unger hosts.

Speaker

• Sandra Fryhofer, MD, chair, AMA Board of Trustees and AMA Liaison to ACIP

Unger: Hello and welcome to the AMA Update video and podcast. Today, we’re discussing new announcements from the FDA and CDC about a possible increased risk of stroke following the Pfizer bivalent COVID booster and what we know about the new XBB Omicron variant.

I’m joined today by AMA Board Chair Dr. Sandra Fryhofer who’s also the AMA’s liaison to ACIP, the CDC’s Advisory Committee on Immunization Practices and a member of ACIP’s COVID-19 vaccine workgroup. I’m Todd Unger, AMA’s chief experience officer in Chicago. Dr. Fryhofer, thanks for joining us today.

Dr. Fryhofer: Todd, thanks for having me.

Unger: Well, let’s get right into it. What do we know about this possible link between the updated Pfizer booster and increased risk of stroke?

Dr. Fryhofer: A new preliminary safety concern and increase in stroke risk has been identified for those 65 and older after receiving a dose of Pfizer’s bivalent booster. Now, I want to be clear. There is no established link. This is just an early safety signal and one of many vaccine safety monitoring platforms. And on Friday the 13th of January, CDC and FDA made this joint announcement that an increased risk of stroke had been identified for those 65 and older who had received Pfizer’s Omicron bivalent booster.

The preliminary signal found an increased risk of ischemic stroke and the 21 days following the Pfizer bivalent vaccine dose as compared with days 22 to 42 following vaccination. As I said, this is just a signal. The signal has only been seen for Pfizer’s bivalent vaccine, not for Moderna’s bivalent version. And the signal is only from one vaccine safety platform, VSD. That CDC’s vaccine safety data link. And there are multiple different platforms which look at vaccine safety in different ways.

This signal has not been seen in the other vaccine safety platforms. Again, no other safety systems have shown this signal. So this may be a false alarm, or it could turn out to be real. Only time and further study and more data will tell.

Unger: Dr. Fryhofer, this announcement demonstrates a lot of transparency on behalf of the CDC and FDA. And it’s especially important since the mRNA vaccine platform is somewhat new. And safety is being closely monitored and scrutinized. Tell us more about that.

Dr. Fryhofer: Well, I agree. Transparency is so important to encourage trust in the system and trust in vaccines. And that’s why CDC and FDA made the joint decision to alert the public so early about this preliminary safety concern. But again, it’s still unclear if this is a real signal or just an aberration.

We need more data. This preliminary signal has only been seen in just that one platform, VSD, CDC’s Vaccine Safety Datalink. And the signal only applies to Pfizer bivalent updated vaccine. This signal has not been observed for Moderna.

Unger: So you said the possible stroke concern has been identified in one safety platform. Can you just for the perspective of folks out there, how many different safety platforms look at COVID vaccines?

Dr. Fryhofer: Well, there are several of them. And there’s been no signal so far in the BA database. It has not been observed in the CMS database. It has not been observed in VAERS, which is CDC and FDA’s Vaccine Adverse Event Reporting System. In addition, Pfizer’s global safety database has not indicated the safety concern is real, which seems to be a step ahead of us.

And vaccination administration has also not reported this finding. There have been no red flags from any of the other vaccine safety platforms indicating an increased risk of ischemic stroke. This preliminary signal has only been seen in just this one platform, CDC’s Vaccine Safety Datalink.

Unger: So at this point, has the CDC made any changes to its COVID vaccine recommendations?

Dr. Fryhofer: No. There is no change in current recommendations. CDC continues to recommend everyone six months and older stay up to date on COVID vaccinations. And that includes getting a dose of the updated bivalent vaccine when eligible.

Unger: So what’s the current evidence supporting COVID vaccination with the updated bivalent booster doses?

Dr. Fryhofer: Well, here’s what we do know. Getting a dose of the updated vaccine, which is the bivalent vaccine, cuts the risk of hospitalization by nearly three-fold as compared to those previously vaccinated but not bivalently boosted. The updated COVID vaccine also reduces risk of death by COVID by nearly 19-fold as compared to those who are unvaccinated. To repeat, at least for now, there is no change in CDC recommendations for COVID vaccination. But for transparency, CDC and FDA wanted the public to be aware.

FDA described this finding to the media as listening to the radio and hearing static in the background. Now, static doesn’t mean someone is really talking. This issue will be addressed at the upcoming VRBPAC meeting on January 26. VRBPAC is FDA’s independent Vaccine and Related Biologicals Product Advisory Committee. So more to come.

Unger: So you outlined a lot of benefits, obviously, of getting the bivalent booster. In this case, there isn’t—this transparency does engender confidence in the system. But I think it probably could be a little confusing to folks out there. So could you help us put this in context for everyone?

Dr. Fryhofer: Well, Todd, you are so right. And I respect and appreciate the transparency. But the announcement comes at a time when daily COVID deaths are rising and vaccine uptake remains low. CDC says only 16% of those age five and older have received the updated bivalent booster. This signal involves those age 65 and older. And this is group is one of the most vulnerable to complications from COVID. And only 39% of them have been bivalently boosted.

So this message is very confusing and a little scary if you only read the headline and not the fine print. And that’s why we’re talking today. And it may make some people afraid to get the updated shot. FDA told media outlets that if they continue to dig deeper, they hope the signal will disappear.

And, of course, that’s my hope too. And I think everyone hopes that. But understand this preliminary safety signal is only for Pfizer, not for Moderna. Those who need a dose of updated vaccine and feel nervous about this announcement could go ahead now and get a Moderna dose of updated COVID vaccine. So there is another option.

Unger: Dr. Fryhofer, let’s turn our attention now to XBB, which is the latest Omicron variant and perhaps one of the most transmissible that we’ve seen so far. What can you tell us about this new variant?

Dr. Fryhofer: Well, since Omicron became dominant, it’s made many twists and turns. First, there was BA.1. And then we went on up to BA.5. Then the shift to BQ. But now, if you look at CDC’s COVID tracker, the new Omicron variant, as you mentioned, XBB is taking over. All these variants are subvariants and part of the Omicron family. BQ is a descendant of BA.4 and BA.5. XBB is a variation of Omicron BA.2. And the 1.5 version of XBB is the one that’s now spreading like wildfire.

CDC’s COVID tracker, survey with ending January 14 says this variant’s responsible overall for up to 43% of all U.S. COVID cases. Its proportion is even higher in the Northeast where it’s already to blame for more than 80% of COVID infections. And it’s probably also spreading faster because most people are no longer wearing masks. And this might be a good time to start wearing a mask again if you’re not already. And I will say I’ve seen a lot more people wearing masks in the airport.

Unger: Do we have any evidence on how effective vaccines work against XBB or about the severity of the infection with this subvariant?

Dr. Fryhofer: Well, since this subvariant is new, there’s not yet any real world data on vaccine effectiveness for it against severe disease or death. But published studies are showing neutralizing activity of a bivalent boost seems to be lower against XBB. WHO, the World Health Organization, says XBB.1.5 is the Omicron variant with the highest immune escape to date. But although XBB.1.5 is one of the most antibody-resistant variants, it doesn’t seem to carry any mutation known to be associated with a potential change in severity. However, studies of disease severity are now ongoing.

Unger: Now, some people are calling XBB.1.5 the “Kraken” variant. It brings “Clash of the Titans” to mind. We’ve heard lots of different names for different variants and subvariants. How did this one happen?

Dr. Fryhofer: Well, it is definitely an unusual name. “Kraken” is the name of a mythological sea monster. And XBB was given this name by a Canadian biology professor who has been trying to demystify COVID variants by giving them mythological names. Now, it is a little easier to say the XBB.1.5. But the name sounds scary. But just because it’s been given the nickname of a sea monster doesn’t necessarily mean it’s more dangerous. Of course, we need hard data to make that determination.

Unger: I hope to give Harry Hamlin a call and see what he can do about the “Kraken.” Dr. Fryhofer, before we sign off, any final thoughts?

Dr. Fryhofer: A reminder. The stroke risk signal for Pfizer’s bivalent booster for those 65 and older is just a preliminary signal at this point. This signal was not seen from Moderna’s updated vaccine. The signal has been detected in just one of many vaccine safety platforms. CDC says the totality of the data currently suggest it’s very unlikely this signal and only one vaccine safety platform represents a true clinical risk.

So at this point, there has been no change in COVID vaccination recommendations. Everyone six months and older should get a dose of updated COVID bivalent vaccine when eligible. Again, this signal is only for Pfizer and has not been seen in those who received Moderna’s bivalent version.

Unger: Well, thank you so much, Dr. Fryhofer for being here today and providing us that information. We’ll keep folks out there updated as there are developments. And that’s it for today’s episode. We’ll be back soon with another AMA Update. You can find all our videos and podcasts at ama-assn.org/podcasts. Thanks for joining us today and please take care. source

Everyhting about – The COVID Vaccination read here

New research in mice shows how doctors may be able to use an anticonvulsive drug to help the brain heal

By Robby Berman source

Anticonvulsant Drug May Boost Functional Recovery after a Stroke

Scientists at the Ohio State University report that gabapentin, currently prescribed to control seizures and reduce nerve pain, may enhance recovery of movement after a stroke by helping neurons on the undamaged side of the brain take up the signaling work of lost cells.

Their study (“Harnessing cortical plasticity via gabapentinoid administration promotes recovery after stroke”), carried out in mice and published in Brain, mimicked ischemic stroke in humans, which occurs when a clot blocks blood flow and neurons die in the affected brain region. Results showed that daily gabapentin treatment for six weeks after a stroke restored fine motor functions in the animals’ upper extremities. Functional recovery also continued after treatment was stopped, the researchers found.

“Stroke causes devastating sensory-motor deficits and long-term disability due to disruption of descending motor pathways. Restoration of these functions enables independent living and therefore represents a high priority for those afflicted by stroke. Here, we report that daily administration of gabapentin, a clinically approved drug already used to treat various neurological disorders, promotes structural and functional plasticity of the corticospinal pathway after photothrombotic cortical stroke in adult mice,” the investigators wrote.

“We found that gabapentin administration had no effects on vascular occlusion, hemodynamic changes, nor survival of corticospinal neurons within the ipsilateral sensory-motor cortex in the acute stages of stroke. Instead, using a combination of tract tracing, electrical stimulation, and functional connectivity mapping, we demonstrated that corticospinal axons originating from the contralateral side of the brain in mice administered gabapentin extend numerous collaterals, form new synaptic contacts and better integrate within spinal circuits that control forelimb muscles.

“Not only does gabapentin daily administration promote neuroplasticity, but it also dampens maladaptive plasticity by reducing the excitability of spinal motor circuitry. “In turn, mice administered gabapentin starting one hour or one day after stroke recovered skilled upper extremity function. Functional recovery persists even after stopping the treatment at six weeks following a stroke.

“Finally, chemogenetic silencing of cortical projections originating from the contralateral side of the brain transiently abrogated recovery in mice administered gabapentin, further supporting the conclusion that gabapentin-dependent reorganization of spared cortical pathways drives functional recovery after stroke. These observations highlight the strong potential for repurposing gabapentinoids as a promising treatment strategy for stroke repair.”

Gabapentin found to block protein activity

The Ohio State University team previously found that gabapentin blocks the activity of a protein that, when expressed at elevated levels after an injury to the brain or spinal cord, hinders re-growth of axons, the long, slender extensions of nerve cell bodies that transmit messages.

“When this protein is high, it interferes with neurological recovery,” said lead author Andrea Tedeschi, PhD, assistant professor of neuroscience, in the Ohio State’s College of Medicine.

“Imagine this protein is the brake pedal, and recovery is the gas pedal. You can push on the gas pedal but can’t accelerate as long as you’re also pushing on the brake pedal,” Tedeschi said. “If you start lifting the brake pedal and continuously press on the gas, you can really speed up recovery. We think that is gabapentin’s effect on neurons, and there is a contribution of non-neuronal cells that tap into this process and make it even more effective.”

This work builds upon a 2019 study in which Tedeschi’s lab found in mice that gabapentin helped restore upper limb function after a spinal cord injury.

The primary treatment focus after an ischemic stroke is re-establishing blood flow in the brain as quickly as possible, but this research suggests that gabapentin has no role at that acute stage: The recovery results were similar whether the treatment started one hour or one day after the stroke.

Instead, the drug’s effects are evident in specific motor neurons whose axons carry signals from the central nervous system to the body that tell muscles to move.

After the stroke in study mice, the researchers observed, that neurons on the undamaged, or contralateral, side of the brain began sprouting axons that restored signals for upper extremity voluntary movement that had been silenced by neuron death after the stroke. This is an example of plasticity, the central nervous system’s ability to fix damaged structures, connections, and signals.

“The mammalian nervous system has some intrinsic ability to self-repair,” said Tedeschi, also a member of the Ohio State’s Chronic Brain Injury Program. “But we found this increase in spontaneous plasticity was not sufficient to drive recovery. The functional deficits are not so severe in this experimental model of ischemic stroke, but they are persistent.”

Because a technique that temporarily silenced the new circuitry reversed behavioral signs of recovery, Tedeschi said the findings suggested the drug normalizes conditions in the damaged nervous system to promote cortical reorganization in a functionally meaningful way.

Compared to control mice that did not receive the drug, mice that received six weeks of daily gabapentin treatment regained fine motor function in their forelimbs. Two weeks after treatment was stopped, researchers observed, functional improvements persisted.

“This confirmed that functional changes are solidified in the nervous system,” Tedeschi said.

Gabapentin also appeared to have an effect in the stroke-affected brain on non-neuron cells that influence the timing of message transmission. An examination of their activity after the drug treatment suggested these cells can dynamically change their behavior in response to variations in synaptic communication, further enabling smooth sprouting of axons that were compensating for the lost neurons.

The team is continuing to study the mechanisms behind stroke recovery, but Tedeschi said the findings suggest gabapentin holds promise as a treatment strategy for stroke repair. source

This already-approved drug could help repair the brain after stroke