If you are like me you are probably thinking, “man how many signs can fit up there at one time??” I have often wished I had learned God’s version of the ZODIAC. He is the one who place all those lights over us… named them all, and set their paths and boundaries!!
OUR WONDERFUL LOVING FATHER NEVER CEASES TO AMAZE ME!!
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If you thought you’d seen all there is to see regarding what is being shown to us in the sky this month… Here is a new revelation.
October 2024: What’s in the sky this month?
October 2024 Night Sky Calendar
Chinese astronomy
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Euphrates Dried Up
Temple Being Rebuilt
Strange Things going on with the SUN, MOON and Stars
The Nations Coming against Israel
The Establishment of the Sanhedrin – Possibly the Coming International Court
Giants appearing
Demons Manifesting
Paganism Rising with Human Sacrifice
The Holy Roman Empire Rising
The Bible is COMING ALIVE IN OUR DAY!! For all who denied that the Bible is the TRUE and LIVING WORD OF GOD are being forced to rethink their stand.
Plagues of Moses
REVELATION IS BEING WRITTEN IN THE VERY STARS ABOVE US:
Temple of BAAL – BERN Switzerland – Part 1 – The Event and the Town
RESTORED: 5/20/22 I apologize that it took me this long to get something out about this latest TEMPLE OF BAAL event. I have been very busy and was not even aware they were taking it to Switzerland. You know I would have been on it, if I could. BUT GOD, had other things on … Click Here to Read More
Ok now, I want to get back to this last piece of the item on Smoky Quartz out of the Encyclopedia Britannica. Smoky quartz MINERAL -WRITTEN BY: The Editors of Encyclopaedia Britannica Now this article took me in a whole other direction! ST. GOTTHARD ? As in the Gotthard Tunnel?? I had to look closer … Click Here to Read More
RETURN OF HUMAN SACRIFIC – Part 1
This article was originally posted in October 2020 under the title HUMAN SACRIFICE RETURNS. As I added items to it the post became so huge as to prevent readers from staying through to the end. I hate to break topics up because people rarely read all the parts. But, this topic is so important, I … Click Here to Read More
You can watch the video about this subject in here: [The Bear – Symbology During the Middle-Ages]
When people ask you “what animal is the king of all animals?” the first creature to come to mind is the lion. But in truth, before the church imposed the lion as the king of all the animals, the bear was the real king, at least in the European continent. The bear was the symbol of power, strength and majesty.
It is possible that our ancestors during prehistoric times already worshiped bears. We can find bear skulls aligned in niches in caves, and they weren’t placed in there at random. There might have been an early bear cult, and unlike the image we grow up with, of people living in caves, our ancestors actually built houses made of huge animal bones and tusks, tree-trunks and animal skins, so those caves with beautiful paintings, were in fact out ancestors’ first temples. But let’s not go back so much in history.
Anyway, we can find traces of the utmost respect, even fear and also admiration our ancestors had for these creatures, in folktales, changed by time and the different political and social realities throughout history, and of course, changed by new faiths. We can also see it in sacred places, christianised, but were once the places of pagan deities and with the new faith became the dwelling places of saints and Christian mythological accounts. For instance, the Celts worshiped a goddess which was represented with a bear on her side or in front of her. The bear goddess called Artio, and the name has a lot of similarities with Arthur, who in turn is also a name connected with bears. This was a primitive deity, linked to the fertilizing force of the earth, in a time when gods had not yet been anthropomorphized and were still represented as animals.
There were certain early Cristian accounts that show the importance the bear had to the pagans, and as such, the devil often took the form of a bear to come and terrorized the monks. The king of animals was turned against those who admired it, by demonizing the poor animal. In the Jewish and Christian traditions, the bear often has a negative symbology, and you can see that in the Old Testament.
When the missionaries began their process of evangelization through Europe, they encountered a variety of pagan deities, many of which were either associated with bears, or were bears themselves. To the Germanic and Celtic populations of Europe, the bear was the animal associated with royalty, so it isn’t a coincidence that the most famous legendary king, Arthur, was also associated with the bear. It’s interesting to see that the bear, well, the she-bear, was connected to the warrior goddess Brigid, of whom the Celtic kings were sons of, making them little bear cubs. So there was the necessity to christianise this goddess, and so Saint Brigid was born, and later, this pagan goddess, now christianised, was associated with a real abbess of Kildare named Brigid, who died more or less in the year of 525 of our era.
To the Germanic and Scandinavian peoples, the bear was connected to the warrior spirit, personified by the god Thor. It appears that in certain Germanic groups, one of the imposed trials to the young warriors, was the solitary bear hunt. Although it hasn’t been proven yet if these initiation rites were real or just mythical. Anyway, what is real is that the strength and the ferocity of the bear was an inspiration to the Germanic and Scandinavian warriors.
Many ancient cities throughout Europe still have the representation of the bear in their coat-of-arms. The survival evidences of the bear being the king of animals before the church replaced the symbolic functions of the bear for the lion. The lion was an exotic animal, and by the time it replaced the bear, sometime in the year 1000, the lion didn’t belong to the European Fauna so this almost mythical creature during medieval times was easily adopted. But to this day some cities such as Bern in Switzerland and Berlin in Germany, to name a few, still have the bear in their coat-of-arms.
It’s not a coincidence that during the reign of Charlemagne a lot of bears were hunted almost till extinction, because of the cult the Germanic peoples had and the pagan gods associated with the animal, and of course taking down loads of sacred trees. We all know about the forest devastation held by Charlemagne and his nobles, but we don’t often hear about the bear-hunt.
To the church, during medieval times, the bear was the personification of evil, ferocity and chaos, because the creature lived in the dense, almost unreachable, forests. The forests were the dwelling places of the pagans (in truth the forests were the places the pagans considered to be sacred, once, but now it was their refuge from the horrible acts of forced cristianization). But the bear started to enter in the christian mythology in another way. It became the symbol of the divine dominating chaos, because the only ones who could contact with these terrible creatures and turn them into docile animals, were the hermits; those who would seek the most inhospitable places to live in solitude, for spiritual reasons. Only through their faith, and the connection with the divine and the power of god, could they do such a thing, turning a ferocious beast into a docile companion. Thus the bear became the symbol of the victory of the divine over chaos, and we can actually see this representation in the story of Saint Columbanus and his many encounters with bears, and befriending them.
The bear was also associated with the Devil, and a symbol of the many vices and sins condemned by the church. There were many accounts of bears being the evil creatures of chaos, to the point that they became the creatures that would kidnap young beautiful maidens and would rape them. And we can still see this in many folktales; the bear being the “bad guy” in the story. This actually might be the beginning of the creation of the story of “The Beauty and the Beast”, highly infantilized and softened by Disney, and thank the gods for that because no child would want to hear about the real account.
So, in conclusion, the fight of the church against the bear, was a symbolic, and in some cases a very real way to free territories from their pagan past and convert them to Christianity and order over chaos. Unfortunately, the bear had a very negative connotation during the middle-ages, but at the same time, the symbolism the bear had during pagan times, somehow prevailed till nowadays, and I’m sure all of us remember the childhood stories of the she-bear being a kind and caring mother, and it isn’t a coincidence that many children to this day still sleep with their teddy-bear.
Bear Symbolism – myths symbols sandplay
Jan 24, 2021 — Celtic – lunar symbol of power; attribute of the goddess Berne (means bear)
Christian – symbol of evil, cruelty, greed, carnal appetite; on Norman churches represents Satan; battle between David and the bear symbolizes the triumph of Christ over the forces of darkness
Heraldic – signifies ferocity and protection of kindred; German heraldic symbol of the devil’s power
Finno-Ugrics – Master-of-the-forest, holy hound of God, honey paw, wise man, fur man
Greek – sacred to Artemis, virgin goddess of the hunt and the moon; the priestesses of Artemis Brauroneia (Athens) were known as she-bears and were concerned with times of transition for women; sacred to Athena, goddess of the hunt; attribute of Atalanta and Euphemia; Atalanta was nursed by a she-bear, for Aristotle, the bear symbolizes silliness
Japan – benevolence, wisdom, strength; for the Ainu people (who live in the north of the Japanese island of Hokkaido and the Kuril Islands) the bear is a mountain deity, culture hero, and devine messenger
Norse – in myth, Odin appears as the bear Björn
Persian – symbol of the foolhardy, powerful, and rich enemy
Roman – sacred to Diana, goddess of the hunt, woods, forest, and moon
Russia – emblem of Russia, friend to man; Siberian instructor of shamans and mythological ancestor
Scandinavian – sacred to Thor; female principal as she-bear Atla; the masculine principle as the heat bear Atili
Shamanistic – messenger of the forest spirits known as Shih; Chinese yang symbol, bringer of blessings; universal preserver
Twin Ursae – nurses to the infant Zeus; associated with children and the bear-mother-cult; evolved into the two biblical she-bears called by Elisha as avengers to maul the boys who mocked him (II kings 2:24)
Zuni – beast god; supernatural patron of the medicine society
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As my computer opened this morning, I happened to see the story on the
At any given time, hundreds of people are tuned into the brown bear livefeeds streaming from Explore.org, which show the most famous residents of Alaska’s Katmai National Park and Reserve in their natural habitat. Viewers may see bears playing with each other or eating salmon at Brooks Falls, but many come to the site to check one thing in particular: How fat the bears have gotten since their last viewing session.
What originally began in 2014 as a one-day event (Fat Bear Tuesday) has since grown into a much-anticipated international event. About 55,000 voters participated in Fat Bear Week 2018. In 2019, that number grew to 250,000, and in 2020, it ballooned to 650,000. In 2022 and 2023, more than a million voters took part in the contest. And while the dates for 2024’s event haven’t been formalized yet, the event’s expected to kick off in October and promises to be just as fun and adorable as previous years.
A Substantial Idea
For people who would rather watch wildlife webcams than sports, Fat Bear Week is basically March Madness. For one week in either late September and early October, Katmai posts brackets of the park’s biggest bears on the internet. Members of the public pick which bear they think is fattest (whether they judge that by literal size, the amount of weight gained since spring, or how well the bear flaunts its flab is up to them), and the corpulent contestants with the most votes move ahead in the competition. At the end of the week, the bear that wins the final match-up is named that year’s fattest.
“It’s celebrating something we normally don’t get to celebrate, which is fatness, and fatness as something good and positive, because the bears survive on their fat,” Katmai National Park’s media ranger Naomi Boak tells Mental Floss.
Mike Fitz found the inspiration for Fat Bear Tuesday while browsing livestream comments during his days as a ranger for Katmai National Park. “Somebody in the comments watching the webcam had a picture of a bear in July and also in September, and they were like, ‘wow, look at the difference!’”
“Otis, he’s enormous! I’m a little afraid that he might explode,” one commenter said of that year’s winner leading up to the event.
“What a difference a little (a lot) of salmon can make!” another follower wrote when the bracket went live.
Fat Bear Tuesday was a success.
“It was a great way to communicate the different ways that bears get fat and why they get fat and what that means for their survival, so we decided to expand it into a whole week to give more a people an opportunity to participate,” Fitz says. Katmai kicked off its first official Fat Bear Week the following year, and its reach has grown exponentially in the years since.
“I kind of had an idea based on my interactions with the public in the past that people would enjoy it, but I had no idea that it would grow as large as it is today,” Fitz says. “It really has exceeded expectations.”
Behind the Brackets
The event is no longer the casual social media engagement experiment it was at the outset. To get the brackets ready for late September, Boak begins planning months in advance. “I start as soon as I get [to the park] in May taking pictures of skinny bears,” she says. “Because in Fat Bear Week, we juxtapose a skinny picture with the fattest picture we can get at the end of the season, so people can see really what a great accomplishment it is for the bears to get fat to survive six months of famine.”
Though Fat Bear Week is a digital campaign, much of the work required to put it together takes place in the field. To get her pictures, Boak spends weeks skulking around areas where the bears are known to frequent, such as Brooks Falls. A good photograph can boost a contestant’s chances of winning, and snapping the perfect shot is often easier said than done. The best time to take a bear’s “after” picture is in September, when they’re close to achieving their hibernation bod, but this is also when they spend most of their time in the water gorging on salmon. This makes it hard to capture their full silhouette in all its glory on camera—though it’s not impossible.
“We essentially stalk bears for a couple of weeks,” Boak says. “With 747, our winner last year, I literally stalked him for two weeks to get good enough light that wasn’t in the fog and to see him out of the water. I had to go to the falls at different hours, I had to look around the park.” In the meantime, visitors are taking their own amateur bear photographs. To widen the pool of pictures they have to choose from, the park turns to its guests, and many are willing to share their shots for Fat Bear Week.
Learning to recognize the bears is a skill in itself. After watching them for months—or years, in many cases—Boak and her colleagues start to recognize the physical and behavioral characteristics that make them unique. (Behavior becomes especially important as the bears begin their pre-hibernation transformations.) Katmai also has bear monitors whose job it is to watch individual specimens for hours at a time and note their identifiable traits, including energy levels, sleep habits, and relationships to other bears.
All that hard work pays off come autumn. Fat Bear Week is one of Katmai National Park’s most-anticipated annual events, and it’s one of the best examples of how national parks can use technology to raise awareness of what goes on within their borders. Katmai is one of the few places on Earth where the ecosystem is functioning at its full potential. The park saw a record-breaking salmon run last year, and the life-giving fat the brown bears gained as a result is a wonder of nature. By highlighting such a pristine environment, the people involved with Fat Bear Week hope to remind the public what’s at stake as environmental threats worsen.
“The phenomenon we enjoy at Brooks Falls of bears fishing there is completely dependent on a healthy salmon run, and with climate change and other threats to salmon, like large-scale development and mining, I think the more people that are aware of this healthy, productive ecosystem, the better,” Fitz says.
The conservation message underlies the campaign, but above all, Fat Bear Week is a chance for the people putting it together and the fans voting from home to have fun. “I think it’s a great relief, a happy time, and a happy, fun event to stop thinking about fires, hurricanes, and pandemics,” Boak says.
Stiff Competition
For the last couple of years, the contest has been held on Explore.org to open it up to participants without a Facebook account. And in recent years, voters have been able to choose their favorite chubby bear cubs in addition to the mature fat bears.
Fat Bear Jr. takes place in late September, and the winning cub of that competition will get to go head-to-head with the big guys and ladies when the official Fat Bear Week kicks off.
Katmai’s bears are still in the process of bulking up for winter, but fans who have been watching the bears all year already know which contenders to keep an eye on. “I’m looking forward to seeing whether or not 747 can defend his title,” Fitz says. “He’s a giant bear, he’s the largest bear I’ve ever seen. Last year he was about 1400 pounds, so I’d be surprised if he’s any smaller this year.”
Boak agrees that 747 is the bear to beat: “I think the current champ is highly competitive. His belly is already touching the ground.” But part of the fun of Fat Bear Week is its unpredictability. Until the final votes are cast in October, no one—not even the experts who follow the bears in the park—knows who will claim the title.
“Sometimes there are really tense moments for us, where we’re thinking this bear is going to win, then all of a sudden a dark horse—or a dark bear—appears as the fan favorite,” Boak says. “It’s going to be very competitive, so who knows—because the public decides, not us.”
Discover More Fascinating Facts about Bears:
A version of this story was originally published in 2022 and has been updated for 2024.
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As I was researching the NASA OSIRIS asteroid adventures, I came across these headlines about the Japanese precursors. TURNS OUT JAPAN GETS FIRST CREDIT FOR ROCK COLLECTING FROM AN ASTEROID. But, if we kick up a little dust of our own, we discover that there is a lot more going on here. It does appear … Click Here to Read More
TRANSITIONING to THE NEW NORMAL- Human vs AI
COVID 19 was custom made to provide the perfect roll out of every wet dream the elite/illumined/freemasons have been coddling and nurturing all these hundreds of years. Amazing. Just as I was sharing with you in my article Fire Ant Scenario; January 1, 2020 They have caught us unawares just like the attack of Fire ants. If … Click Here to Read More
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Japan
The Ainu, a distinctly different people, to the north of Japan practised an elaborate bear cult into the 1920s that immediately calls to mind the Palaeolithic bear cult. The Ainu captured a bear cub, nurtured it for months and then sacrificed it during an elaborate ritual. They are the only people to have retained a full fledged bear cult into the twentieth century and the Palaeolithic elements are unmistakable; the Ainu are truly amazing from a Western anthropologist’s viewpoint.
Summary
- Arcturus is close to launching the Kostaive COVID-19 vaccine in Japan, with ongoing work on variant protection and influenza vaccine.
- The company has been able to consistently derive research revenues, maintaining liquidity and avoiding debt, with potential for significant revenue from vaccine orders.
- Valuation suggests Arcturus may be undervalued compared to peers, with a revised model showing potential for significant revenue growth by 2026.
Peter Hansen
I have previously written about Arcturus (NASDAQ:ARCT). This is one of my preferred biotech startup plays. The company is close to the commercial launch of the Kostaive self-amplifying mRNA COVID-19 vaccine. Meiji, their partners in Japan, is responsible for the regulatory application so that the vaccine complies with the regulatory demands for the 2024-2025 flu season in Japan.
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The Japanese word Meiji means “enlightened rule”and is derived from the Chinese words ming (“enlightened”) and dji (“government”). It was first used in 1873. Meiji also refers to the reign of Emperor Mutsuhito of Japan from 1868 to 1912.This period is known as the Meiji Restoration, which marked the return of the emperor to power after the Tokugawa shōgun lost his power in 1868. During the Meiji era, Japan underwent many changes, including:
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The phase 3 data have revealed a strong immune response, validating the STARR Platform for self-amplifying mRNA vaccines. The company is also working on specific variant protection and on a quadrivalent influenza vaccine. Note that Arcturus has a separate program for mRNA therapy for cystic fibrosis and for OTC deficiency.
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The STARR® Technology platform combines self-replicating RNA with LUNAR®, a leading nanoparticle delivery system, into a single solution to produce proteins inside the human body.
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mRNA vaccines have won the race for early COVID-19 vaccine approval, yet improvements are necessary to retain this leading role in combating infectious diseases. A next generation of self-amplifying mRNAs, also known as replicons, form an ideal vaccine platform. Replicons induce potent humoral and cellular responses with few adverse effects upon a minimal, single-dose immunization. Delivery of replicons is achieved with virus-like replicon particles (VRPs), or in nonviral vehicles such as liposomes or lipid nanoparticles. Here, we discuss innovative advances, including multivalent, mucosal, and therapeutic replicon vaccines, and highlight novelties in replicon design. As soon as essential safety evaluations have been resolved, this promising vaccine concept can transform into a widely applied clinical platform technology taking center stage in pandemic preparedness.
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| Self-amplifying mRNA (SAM) vaccines can be rapidly deployed in the event of disease outbreaks. A legitimate safety concern is the potential for recombination between alphavirus-based SAM vaccines and circulating viruses. SOURCE |
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Business developments
What makes this company so compelling to me is the fact that it has been able to derive research revenues consistently, even without having any product in the commercial stage. Currently, the main driver of its revenues is the CSL agreement. In 2Q24, the company achieved more milestones in the agreement, namely due to having completed manufacturing-related activities for the Kostaive vaccine.
YCharts
As you can see, the revenue has been volatile from quarter to quarter, but it has been consistently there for the past three years. Other companies present in the sector have not been able to develop the ability to derive revenue from their research, and they have solely relied on the capital raised to develop a commercial-stage product that will finally generate cash flow. Unfortunately, the uncertainty regarding drug development makes it a shaky model, that investors should generally avoid.
Arcturus, on the other hand, has been able to extract benefits from its R&D (Research and Development) through milestone payment-based research agreements with bigger companies. This has allowed them to have a balanced cash flow while preserving liquidity and avoiding racking up on debt.
YCharts
This approach should allow it to bring the Kostaive vaccine to market, which will be its first commercial product. Obviously, the revenues will be shared with their partners, but we still do not know the details about the revenue sharing with its partners. Nevertheless, this will add a steady stream of revenues, while allowing it the time to develop it CF and OTC programs.
In the earnings call, Joe Payne, Arcturus CEO, talked about 4M doses ordered by Meiji, with a pricing guidance of JPY 10,000 per dose. At 146 USD/JPY, we are talking about $68.5 per dose, with a prospective target of $274 million for this order. Obviously, these figures are still very early, and we need to get closer to the fourth quarter to have better visibility on this issue. Nevertheless, these are exciting prospects, since the company revealed it expects to recognize revenue in the fourth quarter.
Valuation
A look at the valuation for this company provides some interesting insights. The company is trading at 3.41 times sales. That is not a shocking multiple. If we compare it against some industry peers, we actually get the idea that the company might be undervalued relative to peers on this metric.
YCharts
On the price-to-book metric, the company is more in line with its peers.
Previously, I offered a valuation model for this stock based on a bear and bull scenario. I am now revising it to offer a better reflection of the revenue estimates for this company.
Seeking Alpha
Arcturus is now supposed to earn $347 million in revenues by 2026, with the lowest estimate at $139 million. We will consider these values for our model while keeping the same share count as in our previous model. We will also change the sales multiple, on the bull scenario we will use a multiple close to Moderna (MRNA) and BioNTech (BNTX), while in the bear we will use a multiple of 3, close to what it is right now. We believe these figures better reflect the current expectations regarding this company.
Author’s computations
The results are in line with our past model, although our bull scenario has been revised lower due to a lower multiple. We had previously used a 10x sales multiple. However, we think this is more conservative and provides a narrower set of scenario results. Looking at the results, we can see that the risk/return asymmetry favoring the bull scenario remains.
Risks
As I have mentioned in past paragraphs, this is one of my favorite high-risk plays for the biotech sector. I believe this stock fits in a diversified portfolio because it has the potential to outperform massively, but it has characteristics that also make it significantly likely to fail. The fact that it is highly dependent on the success of its mRNA technological platform, and it is yet to launch its first commercially approved product based on that platform, makes it a high-risk investment.
Additionally, any event that slows its path to market will likely make it burn through more cash than anticipated, and in a startup at this stage that might be the beginning of the end in terms of liquidity. Although the current liquidity seems good, in a company like Arcturus, a cash-burn can spread like a wildfire.
Finally, the other therapies in the pipeline might not work as intended and the company might not be able to build on the prospects it currently has, and the ability to keep deriving revenues from partnerships might fade.
Conclusion
The 2Q24 brought encouraging signs. The ability to derive R&D revenues has been confirmed again, and it has helped conserve cash in the balance sheet. Additionally, the management revealed that the first revenue recognition from its Kostaive vaccine might be in 4Q24, which would be a fantastic milestone for the company.
Our revised model suggests there is tremendous potential in this company as a long-term investment. If the company starts deriving a consistent stream from its first commercially approved product, the rest of the pipeline gets a huge boost from both the technological validation and cash-flow infusion.
My opinion is that, although the company has a riskier profile than a more consolidated biotech company, the truth is its technology is close to being validated. For all that, I am rating it a buy.
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4611 Views – 1 year ago
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Etymology of costive by etymonline Etymonline
https://www.etymonline.com › word › costive
Apr 12, 2018 — costive (adj.) “constipated, suffering from retention of hard fecal matter in the bowels,” c. 1400, from Old French costivé, from Latin …
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Yes, the ram is a symbol associated with the devil, particularly in the form of the satanic “horned god” known as Baphomet:
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Baphomet of Mendes The satanic “horned god” symbol known as the baphomet is based on an Egyptian ram deity that was worshipped in Mendes, called Banebdjed (literally Ba of the lord of djed, and titled “the Lord of Mendes”), who was the soul of Osiris. From whence we get the name BA’AL or Ba El… Ba + EL for Lord.
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TAIVE
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TAIVE – Translation in English Taive means flexure, incurvation, crook |
Noun – taive |
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So, Taive means a hook, a curve, a bend… as in the horns of the RAM! Or the staff of the DEVIL!!
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AI Overview / Learn more…Opens in new tab
The word crook has multiple meanings and origins:
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also from c. 1200
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“Crook” comes from an old Norse word krokr meaning a hook. one thing about hooks is that they are bent, not straight. It is not a huge leap from the shape of a hook to a link with criminality. Something that is not straight is crooked. A person who does not behave in a straightforward, honest fashion is crooked. Nov 19, 2020
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Baphomet is believed to be an Old French corruption of the name “Mahomet”, or Muhammad, the founder of Islam. first appeared in trial transcripts during the Inquisition of the Knights Templar 1300s. drawn by French occultist Eliphas Lévi. Depicted Baphomet as a goat-like figure, further emphasizing its identification with the “Goat of Mendes” or the “sabbatical goat”. Baphomet is generally viewed as a symbol of the Devil.
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A shepherd’s crook is a long and sturdy stick with a hook at one end, often with the point flared outwards, used by a shepherd to manage and sometimes catch sheep. In addition, the crook may aid in defending against attack by predators. When traversing rough terrain, a crook is an aid to balance. | The Thief who comes to steal, kill and destroy. The scythe is an apt image taken from agricultural practices of the time: harvesters used scythes to reap or harvest crops that were ready to be plucked from the earth…and, well, that’s what the Reaper/Devil does, he harvests souls from the Earth. |
Meiji Seika Pharma to supply Japan with self-amplifying mRNA Covid-19 vaccine in fall/winter of 2024
March 22, 2024 08:28 AM EDTUpdated 10:27 AM Nikkei Biotechnology
Meiji Seika Pharma announced Tuesday that it plans to apply in Japan to sell its self-amplifying mRNA vaccine for Covid-19 and supply it for the fall/winter season.
An interim analysis of a Phase 3 clinical trial of the vaccine ARCT-2301, or Kostaive, showed non-inferiority in immunogenicity compared to Pfizer and BioNTech’s previously approved bivalent mRNA vaccine Comirnaty. Kostaive is a self-amplifying mRNA vaccine created based on the technology of Arcturus Therapeutics. ARCT-2301 is a bivalent vaccine based on the original strain and Omicron BA.4-5.
The subjects were healthy adults aged 18 and older who had received 3-5 doses of the approved mRNA vaccine, with at least three months having passed since the last dose. In the trial, 927 subjects were randomized to the ARCT-2301 group (463 subjects) or the Comirnaty group (464 subjects), and received an additional 0.5 mL (5 μg) dose of ARCT-2301 or 0.3 mL (30 μg) dose of Comirnaty.
The primary immunogenicity endpoints were the non-inferiority verification of the geometric mean titer (GMT) and seroresponse rate (SRR) of neutralizing antibodies against Comirnaty at day 29. The observation period was approximately 180 days. Side effects, as well as the efficacy based on the incidence of Covid-19, were also evaluated.
In this interim analysis, ARCT-2301 demonstrated significantly higher immunogenicity, including GMT and SRR of neutralizing antibodies against the Omicron BA.4-5 and original strains, compared to Comirnaty. The incidence of specific adverse events with ARCT-2301 was comparable to Comirnaty, and all events were mild or moderate in severity. The incidence rates of all adverse events were also similar between the groups.
“It has been confirmed that high immunogenicity and safety can be reproduced even if the manufacturing strain serving as the basis for the vaccine is changed due to the emergence of a new SARS-CoV-2 variant. We believe this establishes the Kostaive platform,” said Daikichiro Kobayashi, the CEO Meiji Seika’s pharmaceutical division. “We expect this platform to be applicable even in cases where the prevalent strain undergoes a major mutation or its pathogenicity changes significantly.”
Based on the trial results, the company plans to determine the manufacturing strain in line with the vaccine strain (prevalent strain) selection by the World Health Organization, Ministry of Health, Labor and Welfare, and National Institute of Infectious Diseases, and apply for partial change approval for Kostaive in preparation for the 2024 fall/winter season.
“From fall 2024 onward, we will supply a vaccine based on the new prevalent strain. Approximately 28 million people in Japan received vaccinations that started in fall 2023, so we expect around 30 million people to receive vaccinations annually going forward,” said Kobayashi.
The company plans to manufacture and supply 4 million doses of Kostaive for the 2024 fall/winter season. It is anticipated that the vaccine will be kept under frozen conditions until it reaches vaccination sites or hospitals, where it will be switched to refrigerated storage.
The company is considering a price that falls within the range envisioned by the Ministry of Health, Labor and Welfare.
The company has already begun manufacturing preparations after selecting multiple prevalent strains. It appears that, at this time, it is undecided whether the Kostaive vaccine will be monovalent or bivalent for the partial change application, but according to the company spokesperson, “The possibility of it being a bivalent vaccine containing the original strain is considered quite low.”
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(1852-1912), Reigned 1867-1912 Emperor Mutsuhito was the 122nd Emperor of Japan. He reigned at a time when Japan was rapidly evolving from a feudal state to a capitalist and imperial world power defined by the Japanese industrial revolution. The son of Emperor Komei and his concubine Nakayama Yoshiko, the young prince was given the name Schinomiya or Prince Sachi. On August 16, 1860, he was proclaimed heir to the throne, and was formally adopted by his father’s consort. Later that year on November 11, he was proclaimed as the crown prince and given an adult name, Mutsuhito, he ascended to the throne in February 1867. In September 1868, the Emperor announced that the name of the city of Edo was being changed to Tokyo, or “eastern capital” and shortly before being formally crowned in Kyoto he announced that the new era would be called “Meiji” or ‘enlightened rule’. According to Japanese custom, he is referred to as Emperor Meiji posthumously after the period that he presided over. |
Mutsuhito The Great
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| SEIKA 精華 |
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