Coronavirus COVID-19 - Global Health Pandemic #108

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cujenn81

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Their medical facilities are apparently very lacking, too.


Lacking vaccines, antiviral pills, intensive care units and other major health tools to fight the virus, North Korea’s pandemic response will be mostly about isolating people with symptoms at designated shelters, experts say.
I’ve read a lot of memoirs written by North Korean defectors and one young woman described the horrifying experience of having her appendix removed. The hospital told her family they couldn’t operate unless she provided the necessary anesthesia and antibiotics, so her mom had to buy the medication on the Chinese black market and give it to the hospital.

The hospital lacked the most basic of supplies, and the staff was inadequately educated. The author described the hospital as being filthy and rat infested.

The book I’m specifically referring to is In Order to Live by Yeonmi Park. Considering the book was published in 2016, that sanctions have only increased since then, and that North Korea cut off all trade in 2020 — even with China — I can only imagine how catastrophic this situation must be.
 

Mo Thuairim

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We need a definitive exit from our Covid-19 pandemic. Here’s the roadmap​

Eric Topol

Nasal or oral vaccines, more and better drugs, and a variant-proof coronavirus vaccine could catalyze a definitive pandemic exit

As the virus accelerates its evolution, the humans capitulate. For two and a half years, the virus has been outrunning our response, getting progressively more and more transmissible, reaching a level of infectiousness that few pathogens have ever attained. Instead of taking a stance of getting ahead of the virus, and out-smarting it, people have succumbed.

(...)

There have been thousands of variants over the course of the pandemic, but only 5 major variants, affecting large populations of people, received Greek letter designations (Alpha, Beta, Gamma, Delta, and Omicron). Each of these previous variants had numerous sub-lineages, or mutations that might be considered relatives of the main variant but had no functional consequence – they did not increase transmissibility or pathogenicity. But with Omicron, we have already seen multiple subvariants with heightened infectiousness, not just BA.2, BA.2.12.1, but also BA.4 and BA.5 which are leading to a new wave in South Africa.

As we watch the virus strikingly improve its ability to find new or repeat hosts, you would think it would be considered an urgent call for action. But instead, there has been a public perception that the pandemic is over, while, at the same time, public health agencies are adopting the policy that we must “live with Covid.”

No, we don’t have to live with Covid, because the Covid we are seeing now is deeply concerning. While there has not been a surge in hospitalizations, they are clearly on the increase, with more than a 20 per cent rise in the United States over the past 2 weeks. The proportion of people getting hospitalized and dying among the vaccinated, as compared with unvaccinated, has substantially increased. As has the deaths: during the Delta wave in the United States, vaccinated individuals accounted for 23 per cent of the deaths, whereas this nearly doubled to 42% during the Omicron wave. Much of these hospitalizations and deaths among vaccinated people can be attributed to lack of a booster shot or the substantially waned effectiveness that sets in by 4 months after a booster.

Moreover, a major misconception is that the vaccines are holding steady to protect against severe disease, hospitalizations, and deaths. They are not. When a booster was given during the Delta wave, that fully restored protection against these outcomes, to the level of 95% effectiveness. But for Omicron, with a booster (or second booster) the protection was approximately 80 per cent, while still high, it represents a major, 4-fold (lack of effectiveness of 55 vs 20%) dropdown. Accordingly, the confidence that our vaccines, directed to the original strain from 2019, are highly protective from severe illness is exaggerated. No less are the clear signs that their durability of such protection reduced. All of this is tied to the marked evolution of the virus, and we yet lack any data on vaccine effectiveness versus the BA.2.12.1 variant, soon to be dominant here.

(...)

Rather than giving up, it is time to double down on innovations that have high likelihood of anticipating the further evolution of the virus and facilitating the end of the pandemic. First on the list is the development of nasal vaccines that are variant-proof. A nasal spray that induces mucosal immunity would help to block transmission, for which we have minimal defense now from the hyper-transmissible Omicron family of variants. Three such nasal vaccines are in late-stage clinical trials, but unlike the shots, there has not been any Operation Warp Speed or governmental support to expedite their execution or success. Next, with so many candidate drugs that have promise, is to speed these clinical trials.

(...)

The concept of a pan-β-coronavirus or pan-sarbecovirus vaccine is alluring and has been pursued by academic labs throughout the world over the past two years. Tens of broad neutralizing antibodies (bnAbs) have been discovered, which have high likelihood of protecting against any future variant. But there is nearly a void of developing and testing a vaccine based on these bnAbs.

(...)

The public perception that our vaccines are “leaky” is true, but it’s off-base to assign the fault to the vaccines, which have saved millions of lives around the world. It the virus’s accelerated evolution – that it’s sneaky – and became more formidable over time that is at the root of our problem now. We can outsmart and finally get ahead of the virus if we don’t submit to fatigue instead of rugged perseverance and to foolishness rather than intelligence.

 

ilovewings

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We need a definitive exit from our Covid-19 pandemic. Here’s the roadmap​

Eric Topol

Nasal or oral vaccines, more and better drugs, and a variant-proof coronavirus vaccine could catalyze a definitive pandemic exit

As the virus accelerates its evolution, the humans capitulate. For two and a half years, the virus has been outrunning our response, getting progressively more and more transmissible, reaching a level of infectiousness that few pathogens have ever attained. Instead of taking a stance of getting ahead of the virus, and out-smarting it, people have succumbed.

(...)

There have been thousands of variants over the course of the pandemic, but only 5 major variants, affecting large populations of people, received Greek letter designations (Alpha, Beta, Gamma, Delta, and Omicron). Each of these previous variants had numerous sub-lineages, or mutations that might be considered relatives of the main variant but had no functional consequence – they did not increase transmissibility or pathogenicity. But with Omicron, we have already seen multiple subvariants with heightened infectiousness, not just BA.2, BA.2.12.1, but also BA.4 and BA.5 which are leading to a new wave in South Africa.

As we watch the virus strikingly improve its ability to find new or repeat hosts, you would think it would be considered an urgent call for action. But instead, there has been a public perception that the pandemic is over, while, at the same time, public health agencies are adopting the policy that we must “live with Covid.”

No, we don’t have to live with Covid, because the Covid we are seeing now is deeply concerning. While there has not been a surge in hospitalizations, they are clearly on the increase, with more than a 20 per cent rise in the United States over the past 2 weeks. The proportion of people getting hospitalized and dying among the vaccinated, as compared with unvaccinated, has substantially increased. As has the deaths: during the Delta wave in the United States, vaccinated individuals accounted for 23 per cent of the deaths, whereas this nearly doubled to 42% during the Omicron wave. Much of these hospitalizations and deaths among vaccinated people can be attributed to lack of a booster shot or the substantially waned effectiveness that sets in by 4 months after a booster.

Moreover, a major misconception is that the vaccines are holding steady to protect against severe disease, hospitalizations, and deaths. They are not. When a booster was given during the Delta wave, that fully restored protection against these outcomes, to the level of 95% effectiveness. But for Omicron, with a booster (or second booster) the protection was approximately 80 per cent, while still high, it represents a major, 4-fold (lack of effectiveness of 55 vs 20%) dropdown. Accordingly, the confidence that our vaccines, directed to the original strain from 2019, are highly protective from severe illness is exaggerated. No less are the clear signs that their durability of such protection reduced. All of this is tied to the marked evolution of the virus, and we yet lack any data on vaccine effectiveness versus the BA.2.12.1 variant, soon to be dominant here.

(...)

Rather than giving up, it is time to double down on innovations that have high likelihood of anticipating the further evolution of the virus and facilitating the end of the pandemic. First on the list is the development of nasal vaccines that are variant-proof. A nasal spray that induces mucosal immunity would help to block transmission, for which we have minimal defense now from the hyper-transmissible Omicron family of variants. Three such nasal vaccines are in late-stage clinical trials, but unlike the shots, there has not been any Operation Warp Speed or governmental support to expedite their execution or success. Next, with so many candidate drugs that have promise, is to speed these clinical trials.

(...)

The concept of a pan-β-coronavirus or pan-sarbecovirus vaccine is alluring and has been pursued by academic labs throughout the world over the past two years. Tens of broad neutralizing antibodies (bnAbs) have been discovered, which have high likelihood of protecting against any future variant. But there is nearly a void of developing and testing a vaccine based on these bnAbs.

(...)

The public perception that our vaccines are “leaky” is true, but it’s off-base to assign the fault to the vaccines, which have saved millions of lives around the world. It the virus’s accelerated evolution – that it’s sneaky – and became more formidable over time that is at the root of our problem now. We can outsmart and finally get ahead of the virus if we don’t submit to fatigue instead of rugged perseverance and to foolishness rather than intelligence.


Great article and very informative- thanks for posting it. I agree that this wily virus is outsmarting all of us including the scientists. They need to get going on the nasal vaccine. I am concerned about having to get a booster every few months and I don't think that is a great idea. right now I am 6 months out from my first booster- and considering what to do: have a 2nd booster now or wait till late summer or fall-- I do think there is a certain level of false hope with the vaccine because its efficacy wanes so quickly.
 

ilovewings

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Great article and very informative- thanks for posting it. I agree that this wily virus is outsmarting all of us including the scientists. They need to get going on the nasal vaccine. I am concerned about having to get a booster every few months and I don't think that is a great idea. right now I am 6 months out from my first booster- and considering what to do: have a 2nd booster now or wait till late summer or fall-- I do think there is a certain level of false hope with the vaccine because its efficacy wanes so quickly.
I do want to add that I consider the vaccine a miracle and we are lucky we got it so quickly- but the fact that loses efficacy so quickly is clearly a problem. Even though efficacy wanes, I believe we still have some protection, which is a heck of a lot better than not being vaccinated.
 

Betty P

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Great article and very informative- thanks for posting it. I agree that this wily virus is outsmarting all of us including the scientists. They need to get going on the nasal vaccine. I am concerned about having to get a booster every few months and I don't think that is a great idea. right now I am 6 months out from my first booster- and considering what to do: have a 2nd booster now or wait till late summer or fall-- I do think there is a certain level of false hope with the vaccine because its efficacy wanes so quickly.

Thank you, Dr. Topol! As the head of a top translational research insitute, he's one of the best qualified people to address this issue. No need to "wing it" and just go back to the previous status quo. More research, better vaccines to get ahead of the virus.

From the link:
"The public perception that our vaccines are “leaky” is true, but it’s off-base to assign the fault to the vaccines, which have saved millions of lives around the world. It the virus’s accelerated evolution – that it’s sneaky – and became more formidable over time that is at the root of our problem now. We can outsmart and finally get ahead of the virus if we don’t submit to fatigue instead of rugged perseverance and to foolishness rather than intelligence."

Each variant is more transmissible than the previous one

In recent months, we experienced a striking jump in transmissibility when the Omicron (BA.1) variant became dominant with at least a three-fold increase in reproductive number beyond Delta. Despite the hope that this might be reaching the upper limit of the virus’s spread ability, we quickly transitioned to a BA.2 wave with at least another jump of about 30% transmissibility, and now we are heading, in the United States, to a dominant subvariant known as BA.2.12.1, which is another 25% more transmissible than BA.2 and already accounting for close to 50% of new cases.



The most relevant quote (JMO):

Moreover, a major misconception is that the vaccines are holding steady to protect against severe disease, hospitalizations, and deaths. They are not.

 
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BetteDavisEyes

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Great article and very informative- thanks for posting it. I agree that this wily virus is outsmarting all of us including the scientists. They need to get going on the nasal vaccine. I am concerned about having to get a booster every few months and I don't think that is a great idea. right now I am 6 months out from my first booster- and considering what to do: have a 2nd booster now or wait till late summer or fall-- I do think there is a certain level of false hope with the vaccine because its efficacy wanes so quickly.
DH and I had our original boosters on November 16 - six months ago today. We are not quite ready to get the second booster for the same reasons that you've suggested. In our early 70s, we are both in good health, don't go out unless we have appointments, need groceries, go to a restaurant occasionally, and we avoid crowded places. I think we will be alright if we postpone the second booster for another month or two.
 

ilovewings

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Thank you, Dr. Topol! As the head of a top translational research insitute, he's one of the best qualified people to address this issue. No need to "wing it" and just go back to the previous status quo. More research, better vaccines to get ahead of the virus.

From the link:


Each variant is more transmissible than the previous one





The most relevant quote (JMO):

Moreover, a major misconception is that the vaccines are holding steady to protect against severe disease, hospitalizations, and deaths. They are not.


Kinda scary, but we need a dose of reality and he gave it to us!
 

Mo Thuairim

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Great article and very informative- thanks for posting it. I agree that this wily virus is outsmarting all of us including the scientists. They need to get going on the nasal vaccine. I am concerned about having to get a booster every few months and I don't think that is a great idea. right now I am 6 months out from my first booster- and considering what to do: have a 2nd booster now or wait till late summer or fall-- I do think there is a certain level of false hope with the vaccine because its efficacy wanes so quickly.
I am really interested in these nasal vaccines. I don't know too much about them yet but I hope they might be a better option for the people who had adverse reactions to the mRNA or other original vaccines, or who were concerned about getting the shots for that or other reasons. And if the nasal vaccines do end up being effective against an array of Covid variants, better again for everyone. I agree we can't keep boosting our way out of this with vaccines designed to target older versions of the virus.
 

Sundog

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I am really interested in these nasal vaccines. I don't know too much about them yet but I hope they might be a better option for the people who had adverse reactions to the mRNA or other original vaccines, or who were concerned about getting the shots for that or other reasons. And if the nasal vaccines do end up being effective against an array of Covid variants, better again for everyone. I agree we can't keep boosting our way out of this with vaccines designed to target older versions of the virus.

Do we know how the nasal vaccines work and what the ingredients are, and how they might be safer (if they are) than the vaccines that are injected into muscles?
 

Mo Thuairim

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Do we know how the nasal vaccines work and what the ingredients are, and how they might be safer (if they are) than the vaccines that are injected into muscles?
I still don't know too much about them or if they will definitely be safer but here is some info on how they would be expected to work...

Nose Spray Vaccines Could Quash COVID Virus Variants​


(...)

The relentless evolution of the COVID-causing coronavirus has taken a bit of the shine off the vaccines developed during the first year of the pandemic. Versions of the virus that now dominate circulation—Omicron and its subvariants—are more transmissible and adept at evading the body’s immune defenses than its original form. The current shots to the arm can still prevent serious illness, but their ability to ward off infection completely has been diminished. And part of the reason may be the location of the jabs, which some scientists now want to change.

To block infections entirely, scientists want to deliver inoculations to the site where the virus first makes contact: the nose. People could simply spray the vaccines up their nostrils at home, making the preparation much easier to administer. There are eight of these nasal vaccines in clinical development now and three in phase 3 clinical trials, where they are being tested in large groups of people. But making these vaccines has proven to be slow going because of the challenges of creating formulations for this unfamiliar route that are both safe and effective.

What could be most important about nasal vaccines is their ability to awaken a powerful bodily defender known as mucosal immunity, something largely untapped by the standard shots. The mucosal system relies on specialized cells and antibodies within the mucus-rich lining of the nose and other parts of our airways, as well as the gut. These elements move fast and arrive first, stopping the virus, SARS-CoV-2, before it can create a deep infection. “We are dealing with a different threat than we were in 2020,” says Akiko Iwasaki, an immunologist at Yale University. “If we want to contain the spread of the virus, the only way to do that is through mucosal immunity.”

Iwasaki is leading one of several research groups in the U.S. and elsewhere that are working on nasal vaccines. Some of the sprays encapsulate the coronavirus’ spike proteins—the prominent molecule that the virus uses to bind to human cells—into tiny droplets that can be puffed into the sinuses. Others add the gene for the spike to harmless versions of common viruses, such as adenoviruses, and use the defanged virus to deliver the gene into nasal tissue. Still others rely on synthetically bioengineered SARS-CoV-2 converted into a weakened form known as a live attenuated vaccine.

The more familiar shots in the arm create a type of immune response known as systemic immunity, which produces what are called immunoglobulin G (IgG) antibodies. They circulate throughout the bloodstream and patrol for the virus. Nasal sprays assemble a separate set of antibodies known as immunoglobulin A (IgA). These populate the spongy mucosal tissues of the nose, mouth and throat, where the COVID-causing coronavirus first lands. Iwasaki likens mucosal vaccines to putting a guard at the front door, as opposed to waiting until the invader is already inside to attack.

While conventional injectable vaccines are generally poor at inducing protective mucosal immunity, nasal vaccines have been shown to do a good job of triggering both mucosal and systemic responses. Last year researchers at the National Institutes of Health conducted a side-by-side comparison of intranasal and intramuscular delivery of the Oxford-AstraZeneca vaccine. They found that hamsters that had received the vaccine through the nose had higher levels of antibodies against SARS-CoV-2 in their blood than those who received it through the muscle. The University of Oxford is now testing intranasal vaccination in a phase 1 trial, which will assess the safety of the vaccine in a small number of people.

Developing a nasal vaccine is tricky, however, because scientists know relatively little about the machinations of mucosal immunity. “While the human immune system is a black box, the mucosal immune system is probably the blackest of the black boxes,” says epidemiologist Wayne Koff, CEO and founder of the Human Vaccines Project, a public-private partnership aimed at accelerating vaccine development. What scientists do know is making them tread cautiously. Because of the nose’s proximity to the brain, substances squirted up the nasal passages could raise the risk of neurological complications. In the early 2000s, a nasal flu vaccine licensed and used in Switzerland was linked to Bell’s palsy, a temporary facial paralysis. “Since then, people have become a little bit nervous about a nasal vaccine,” Iwasaki says.

And although a spray seems like an easier delivery method than a shot, in practice, that is not the case. With intramuscular injections, a needle delivers the vaccine ingredients directly into the muscle, where they quickly encounter resident immune cells. Sprays, in contrast, must make their way into the nasal cavity without being sneezed out. Then those ingredients have to breach a thick barrier gel of mucus and activate the immune cells locked within. Not all do. One company, Altimmune, stopped development of its COVID nasal vaccine AdCOVID after disappointing early trial results.

Weakened or attenuated viruses can get through the barrier to infect cells, so some vaccine developers are turning to them. Two companies, Meissa Vaccines and Codagenix, have used synthetic biology to build an attenuated version of the novel coronavirus containing hundreds of genetic changes that drastically reduce its ability to replicate. In a recent news release, the Codagenix team reported promising results of their vaccine, CoviLiv, in a phase 1 trial. The spray induced a strong immune response against proteins shared by different variants of SARS-CoV-2, including the recent Omicron subvariant BA.2. That is because the vaccine trains the immune system to recognize all the viral proteins, not just the spike. Presenting all components of the virus makes the vaccine less vulnerable to the whims of evolution that might alter a few proteins beyond recognition. “The beauty of live attenuated vaccines is that they can provide broad long-term immunity in a very resistant context,” says J. Robert Coleman, a virologist and the company’s co-founder. CoviLiv is moving on to advanced testing in people as part of the World Health Organization–sponsored Solidarity Trial Vaccines, a giant randomized controlled trial of several new COVID vaccines.

(...)

When the researchers added spike proteins from the coronavirus that created a global outbreak in 2003—SARS-CoV-1—to their spray, they found that it induced a broad spectrum of antibodies. The combination has the potential to defend against new coronavirus strains or variants “There is a big push for a universal coronavirus vaccine,“ Iwasaki says. “We can get there, and as a bonus we can provide mucosal immunity.” She has licensed the technology to Xanadu Bio, a company she co-founded, and is currently seeking funding to launch human trials.

With no needles or syringes, nasal inoculations could reach a lot more people, and that could prove to be a big advantage. Koff, however, thinks the real deciding factor will be whether tests prove these vaccines stop infections and illness, and those results will be more important than ease of use. “At the end of the day, efficacy is going to trump everything,” he says.

(More info at link)

 

ilovewings

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Do we know how the nasal vaccines work and what the ingredients are, and how they might be safer (if they are) than the vaccines that are injected into muscles?
At this point I dont believe we have much information about the nasal vaccines that apparently
are in the trial phase--- dont have a clue about ingredients or the safety profile--:: in theory
the nasal vaccine sounds more efficacious than the mRna vaccine because the virus enters
through the nose--and the nasal vaccine attacks the virus at the point of origin.


us
 

Sundog

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I still don't know too much about them or if they will definitely be safer but here is some info on how they would be expected to work...

Nose Spray Vaccines Could Quash COVID Virus Variants​


(...)

The relentless evolution of the COVID-causing coronavirus has taken a bit of the shine off the vaccines developed during the first year of the pandemic. Versions of the virus that now dominate circulation—Omicron and its subvariants—are more transmissible and adept at evading the body’s immune defenses than its original form. The current shots to the arm can still prevent serious illness, but their ability to ward off infection completely has been diminished. And part of the reason may be the location of the jabs, which some scientists now want to change.

To block infections entirely, scientists want to deliver inoculations to the site where the virus first makes contact: the nose. People could simply spray the vaccines up their nostrils at home, making the preparation much easier to administer. There are eight of these nasal vaccines in clinical development now and three in phase 3 clinical trials, where they are being tested in large groups of people. But making these vaccines has proven to be slow going because of the challenges of creating formulations for this unfamiliar route that are both safe and effective.

What could be most important about nasal vaccines is their ability to awaken a powerful bodily defender known as mucosal immunity, something largely untapped by the standard shots. The mucosal system relies on specialized cells and antibodies within the mucus-rich lining of the nose and other parts of our airways, as well as the gut. These elements move fast and arrive first, stopping the virus, SARS-CoV-2, before it can create a deep infection. “We are dealing with a different threat than we were in 2020,” says Akiko Iwasaki, an immunologist at Yale University. “If we want to contain the spread of the virus, the only way to do that is through mucosal immunity.”

Iwasaki is leading one of several research groups in the U.S. and elsewhere that are working on nasal vaccines. Some of the sprays encapsulate the coronavirus’ spike proteins—the prominent molecule that the virus uses to bind to human cells—into tiny droplets that can be puffed into the sinuses. Others add the gene for the spike to harmless versions of common viruses, such as adenoviruses, and use the defanged virus to deliver the gene into nasal tissue. Still others rely on synthetically bioengineered SARS-CoV-2 converted into a weakened form known as a live attenuated vaccine.

The more familiar shots in the arm create a type of immune response known as systemic immunity, which produces what are called immunoglobulin G (IgG) antibodies. They circulate throughout the bloodstream and patrol for the virus. Nasal sprays assemble a separate set of antibodies known as immunoglobulin A (IgA). These populate the spongy mucosal tissues of the nose, mouth and throat, where the COVID-causing coronavirus first lands. Iwasaki likens mucosal vaccines to putting a guard at the front door, as opposed to waiting until the invader is already inside to attack.

While conventional injectable vaccines are generally poor at inducing protective mucosal immunity, nasal vaccines have been shown to do a good job of triggering both mucosal and systemic responses. Last year researchers at the National Institutes of Health conducted a side-by-side comparison of intranasal and intramuscular delivery of the Oxford-AstraZeneca vaccine. They found that hamsters that had received the vaccine through the nose had higher levels of antibodies against SARS-CoV-2 in their blood than those who received it through the muscle. The University of Oxford is now testing intranasal vaccination in a phase 1 trial, which will assess the safety of the vaccine in a small number of people.

Developing a nasal vaccine is tricky, however, because scientists know relatively little about the machinations of mucosal immunity. “While the human immune system is a black box, the mucosal immune system is probably the blackest of the black boxes,” says epidemiologist Wayne Koff, CEO and founder of the Human Vaccines Project, a public-private partnership aimed at accelerating vaccine development. What scientists do know is making them tread cautiously. Because of the nose’s proximity to the brain, substances squirted up the nasal passages could raise the risk of neurological complications. In the early 2000s, a nasal flu vaccine licensed and used in Switzerland was linked to Bell’s palsy, a temporary facial paralysis. “Since then, people have become a little bit nervous about a nasal vaccine,” Iwasaki says.

And although a spray seems like an easier delivery method than a shot, in practice, that is not the case. With intramuscular injections, a needle delivers the vaccine ingredients directly into the muscle, where they quickly encounter resident immune cells. Sprays, in contrast, must make their way into the nasal cavity without being sneezed out. Then those ingredients have to breach a thick barrier gel of mucus and activate the immune cells locked within. Not all do. One company, Altimmune, stopped development of its COVID nasal vaccine AdCOVID after disappointing early trial results.

Weakened or attenuated viruses can get through the barrier to infect cells, so some vaccine developers are turning to them. Two companies, Meissa Vaccines and Codagenix, have used synthetic biology to build an attenuated version of the novel coronavirus containing hundreds of genetic changes that drastically reduce its ability to replicate. In a recent news release, the Codagenix team reported promising results of their vaccine, CoviLiv, in a phase 1 trial. The spray induced a strong immune response against proteins shared by different variants of SARS-CoV-2, including the recent Omicron subvariant BA.2. That is because the vaccine trains the immune system to recognize all the viral proteins, not just the spike. Presenting all components of the virus makes the vaccine less vulnerable to the whims of evolution that might alter a few proteins beyond recognition. “The beauty of live attenuated vaccines is that they can provide broad long-term immunity in a very resistant context,” says J. Robert Coleman, a virologist and the company’s co-founder. CoviLiv is moving on to advanced testing in people as part of the World Health Organization–sponsored Solidarity Trial Vaccines, a giant randomized controlled trial of several new COVID vaccines.

(...)

When the researchers added spike proteins from the coronavirus that created a global outbreak in 2003—SARS-CoV-1—to their spray, they found that it induced a broad spectrum of antibodies. The combination has the potential to defend against new coronavirus strains or variants “There is a big push for a universal coronavirus vaccine,“ Iwasaki says. “We can get there, and as a bonus we can provide mucosal immunity.” She has licensed the technology to Xanadu Bio, a company she co-founded, and is currently seeking funding to launch human trials.

With no needles or syringes, nasal inoculations could reach a lot more people, and that could prove to be a big advantage. Koff, however, thinks the real deciding factor will be whether tests prove these vaccines stop infections and illness, and those results will be more important than ease of use. “At the end of the day, efficacy is going to trump everything,” he says.

(More info at link)


Very interesting, thanks for posting. My guess is that if a nasal vaccine eventually becomes available, we will still need both the nasal vaccine and the intramuscular vaccine.

Also, I wonder if one spray of the intranasal vaccine would do the job, or if you would have to repeat it every so often, i.e. how long before the intranasal shot and mucosal immunity lasts.
 

Mo Thuairim

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Very interesting, thanks for posting. My guess is that if a nasal vaccine eventually becomes available, we will still need both the nasal vaccine and the intramuscular vaccine.

Also, I wonder if one spray of the intranasal vaccine would do the job, or if you would have to repeat it every so often, i.e. how long before the intranasal shot and mucosal immunity lasts.
I also think we would need both types for maximum immunity, particularly once we have improved intramuscular vaccines targeted towards newer variants, and I am guessing the nasal versions would need to be used more than once as Covid continues to evolve and immunity presumably wanes. A one-and-done seems too good to be true. But if they were proven safe and effective, it would be great to have the nasal sprays for people who don't want an injection for whatever reason.
 

ilovewings

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I still don't know too much about them or if they will definitely be safer but here is some info on how they would be expected to work...

Nose Spray Vaccines Could Quash COVID Virus Variants​


(...)

The relentless evolution of the COVID-causing coronavirus has taken a bit of the shine off the vaccines developed during the first year of the pandemic. Versions of the virus that now dominate circulation—Omicron and its subvariants—are more transmissible and adept at evading the body’s immune defenses than its original form. The current shots to the arm can still prevent serious illness, but their ability to ward off infection completely has been diminished. And part of the reason may be the location of the jabs, which some scientists now want to change.

To block infections entirely, scientists want to deliver inoculations to the site where the virus first makes contact: the nose. People could simply spray the vaccines up their nostrils at home, making the preparation much easier to administer. There are eight of these nasal vaccines in clinical development now and three in phase 3 clinical trials, where they are being tested in large groups of people. But making these vaccines has proven to be slow going because of the challenges of creating formulations for this unfamiliar route that are both safe and effective.

What could be most important about nasal vaccines is their ability to awaken a powerful bodily defender known as mucosal immunity, something largely untapped by the standard shots. The mucosal system relies on specialized cells and antibodies within the mucus-rich lining of the nose and other parts of our airways, as well as the gut. These elements move fast and arrive first, stopping the virus, SARS-CoV-2, before it can create a deep infection. “We are dealing with a different threat than we were in 2020,” says Akiko Iwasaki, an immunologist at Yale University. “If we want to contain the spread of the virus, the only way to do that is through mucosal immunity.”

Iwasaki is leading one of several research groups in the U.S. and elsewhere that are working on nasal vaccines. Some of the sprays encapsulate the coronavirus’ spike proteins—the prominent molecule that the virus uses to bind to human cells—into tiny droplets that can be puffed into the sinuses. Others add the gene for the spike to harmless versions of common viruses, such as adenoviruses, and use the defanged virus to deliver the gene into nasal tissue. Still others rely on synthetically bioengineered SARS-CoV-2 converted into a weakened form known as a live attenuated vaccine.

The more familiar shots in the arm create a type of immune response known as systemic immunity, which produces what are called immunoglobulin G (IgG) antibodies. They circulate throughout the bloodstream and patrol for the virus. Nasal sprays assemble a separate set of antibodies known as immunoglobulin A (IgA). These populate the spongy mucosal tissues of the nose, mouth and throat, where the COVID-causing coronavirus first lands. Iwasaki likens mucosal vaccines to putting a guard at the front door, as opposed to waiting until the invader is already inside to attack.

While conventional injectable vaccines are generally poor at inducing protective mucosal immunity, nasal vaccines have been shown to do a good job of triggering both mucosal and systemic responses. Last year researchers at the National Institutes of Health conducted a side-by-side comparison of intranasal and intramuscular delivery of the Oxford-AstraZeneca vaccine. They found that hamsters that had received the vaccine through the nose had higher levels of antibodies against SARS-CoV-2 in their blood than those who received it through the muscle. The University of Oxford is now testing intranasal vaccination in a phase 1 trial, which will assess the safety of the vaccine in a small number of people.

Developing a nasal vaccine is tricky, however, because scientists know relatively little about the machinations of mucosal immunity. “While the human immune system is a black box, the mucosal immune system is probably the blackest of the black boxes,” says epidemiologist Wayne Koff, CEO and founder of the Human Vaccines Project, a public-private partnership aimed at accelerating vaccine development. What scientists do know is making them tread cautiously. Because of the nose’s proximity to the brain, substances squirted up the nasal passages could raise the risk of neurological complications. In the early 2000s, a nasal flu vaccine licensed and used in Switzerland was linked to Bell’s palsy, a temporary facial paralysis. “Since then, people have become a little bit nervous about a nasal vaccine,” Iwasaki says.

And although a spray seems like an easier delivery method than a shot, in practice, that is not the case. With intramuscular injections, a needle delivers the vaccine ingredients directly into the muscle, where they quickly encounter resident immune cells. Sprays, in contrast, must make their way into the nasal cavity without being sneezed out. Then those ingredients have to breach a thick barrier gel of mucus and activate the immune cells locked within. Not all do. One company, Altimmune, stopped development of its COVID nasal vaccine AdCOVID after disappointing early trial results.

Weakened or attenuated viruses can get through the barrier to infect cells, so some vaccine developers are turning to them. Two companies, Meissa Vaccines and Codagenix, have used synthetic biology to build an attenuated version of the novel coronavirus containing hundreds of genetic changes that drastically reduce its ability to replicate. In a recent news release, the Codagenix team reported promising results of their vaccine, CoviLiv, in a phase 1 trial. The spray induced a strong immune response against proteins shared by different variants of SARS-CoV-2, including the recent Omicron subvariant BA.2. That is because the vaccine trains the immune system to recognize all the viral proteins, not just the spike. Presenting all components of the virus makes the vaccine less vulnerable to the whims of evolution that might alter a few proteins beyond recognition. “The beauty of live attenuated vaccines is that they can provide broad long-term immunity in a very resistant context,” says J. Robert Coleman, a virologist and the company’s co-founder. CoviLiv is moving on to advanced testing in people as part of the World Health Organization–sponsored Solidarity Trial Vaccines, a giant randomized controlled trial of several new COVID vaccines.

(...)

When the researchers added spike proteins from the coronavirus that created a global outbreak in 2003—SARS-CoV-1—to their spray, they found that it induced a broad spectrum of antibodies. The combination has the potential to defend against new coronavirus strains or variants “There is a big push for a universal coronavirus vaccine,“ Iwasaki says. “We can get there, and as a bonus we can provide mucosal immunity.” She has licensed the technology to Xanadu Bio, a company she co-founded, and is currently seeking funding to launch human trials.

With no needles or syringes, nasal inoculations could reach a lot more people, and that could prove to be a big advantage. Koff, however, thinks the real deciding factor will be whether tests prove these vaccines stop infections and illness, and those results will be more important than ease of use. “At the end of the day, efficacy is going to trump everything,” he says.

(More info at link)

The naal vaccine sounds pretty comp!icated----especially ensuring its safety!!
 

Sundog

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I still don't know too much about them or if they will definitely be safer but here is some info on how they would be expected to work...

Nose Spray Vaccines Could Quash COVID Virus Variants​


(...)

The relentless evolution of the COVID-causing coronavirus has taken a bit of the shine off the vaccines developed during the first year of the pandemic. Versions of the virus that now dominate circulation—Omicron and its subvariants—are more transmissible and adept at evading the body’s immune defenses than its original form. The current shots to the arm can still prevent serious illness, but their ability to ward off infection completely has been diminished. And part of the reason may be the location of the jabs, which some scientists now want to change.

To block infections entirely, scientists want to deliver inoculations to the site where the virus first makes contact: the nose. People could simply spray the vaccines up their nostrils at home, making the preparation much easier to administer. There are eight of these nasal vaccines in clinical development now and three in phase 3 clinical trials, where they are being tested in large groups of people. But making these vaccines has proven to be slow going because of the challenges of creating formulations for this unfamiliar route that are both safe and effective.

What could be most important about nasal vaccines is their ability to awaken a powerful bodily defender known as mucosal immunity, something largely untapped by the standard shots. The mucosal system relies on specialized cells and antibodies within the mucus-rich lining of the nose and other parts of our airways, as well as the gut. These elements move fast and arrive first, stopping the virus, SARS-CoV-2, before it can create a deep infection. “We are dealing with a different threat than we were in 2020,” says Akiko Iwasaki, an immunologist at Yale University. “If we want to contain the spread of the virus, the only way to do that is through mucosal immunity.”

Iwasaki is leading one of several research groups in the U.S. and elsewhere that are working on nasal vaccines. Some of the sprays encapsulate the coronavirus’ spike proteins—the prominent molecule that the virus uses to bind to human cells—into tiny droplets that can be puffed into the sinuses. Others add the gene for the spike to harmless versions of common viruses, such as adenoviruses, and use the defanged virus to deliver the gene into nasal tissue. Still others rely on synthetically bioengineered SARS-CoV-2 converted into a weakened form known as a live attenuated vaccine.

The more familiar shots in the arm create a type of immune response known as systemic immunity, which produces what are called immunoglobulin G (IgG) antibodies. They circulate throughout the bloodstream and patrol for the virus. Nasal sprays assemble a separate set of antibodies known as immunoglobulin A (IgA). These populate the spongy mucosal tissues of the nose, mouth and throat, where the COVID-causing coronavirus first lands. Iwasaki likens mucosal vaccines to putting a guard at the front door, as opposed to waiting until the invader is already inside to attack.

While conventional injectable vaccines are generally poor at inducing protective mucosal immunity, nasal vaccines have been shown to do a good job of triggering both mucosal and systemic responses. Last year researchers at the National Institutes of Health conducted a side-by-side comparison of intranasal and intramuscular delivery of the Oxford-AstraZeneca vaccine. They found that hamsters that had received the vaccine through the nose had higher levels of antibodies against SARS-CoV-2 in their blood than those who received it through the muscle. The University of Oxford is now testing intranasal vaccination in a phase 1 trial, which will assess the safety of the vaccine in a small number of people.

Developing a nasal vaccine is tricky, however, because scientists know relatively little about the machinations of mucosal immunity. “While the human immune system is a black box, the mucosal immune system is probably the blackest of the black boxes,” says epidemiologist Wayne Koff, CEO and founder of the Human Vaccines Project, a public-private partnership aimed at accelerating vaccine development. What scientists do know is making them tread cautiously. Because of the nose’s proximity to the brain, substances squirted up the nasal passages could raise the risk of neurological complications. In the early 2000s, a nasal flu vaccine licensed and used in Switzerland was linked to Bell’s palsy, a temporary facial paralysis. “Since then, people have become a little bit nervous about a nasal vaccine,” Iwasaki says.

And although a spray seems like an easier delivery method than a shot, in practice, that is not the case. With intramuscular injections, a needle delivers the vaccine ingredients directly into the muscle, where they quickly encounter resident immune cells. Sprays, in contrast, must make their way into the nasal cavity without being sneezed out. Then those ingredients have to breach a thick barrier gel of mucus and activate the immune cells locked within. Not all do. One company, Altimmune, stopped development of its COVID nasal vaccine AdCOVID after disappointing early trial results.

Weakened or attenuated viruses can get through the barrier to infect cells, so some vaccine developers are turning to them. Two companies, Meissa Vaccines and Codagenix, have used synthetic biology to build an attenuated version of the novel coronavirus containing hundreds of genetic changes that drastically reduce its ability to replicate. In a recent news release, the Codagenix team reported promising results of their vaccine, CoviLiv, in a phase 1 trial. The spray induced a strong immune response against proteins shared by different variants of SARS-CoV-2, including the recent Omicron subvariant BA.2. That is because the vaccine trains the immune system to recognize all the viral proteins, not just the spike. Presenting all components of the virus makes the vaccine less vulnerable to the whims of evolution that might alter a few proteins beyond recognition. “The beauty of live attenuated vaccines is that they can provide broad long-term immunity in a very resistant context,” says J. Robert Coleman, a virologist and the company’s co-founder. CoviLiv is moving on to advanced testing in people as part of the World Health Organization–sponsored Solidarity Trial Vaccines, a giant randomized controlled trial of several new COVID vaccines.

(...)

When the researchers added spike proteins from the coronavirus that created a global outbreak in 2003—SARS-CoV-1—to their spray, they found that it induced a broad spectrum of antibodies. The combination has the potential to defend against new coronavirus strains or variants “There is a big push for a universal coronavirus vaccine,“ Iwasaki says. “We can get there, and as a bonus we can provide mucosal immunity.” She has licensed the technology to Xanadu Bio, a company she co-founded, and is currently seeking funding to launch human trials.

With no needles or syringes, nasal inoculations could reach a lot more people, and that could prove to be a big advantage. Koff, however, thinks the real deciding factor will be whether tests prove these vaccines stop infections and illness, and those results will be more important than ease of use. “At the end of the day, efficacy is going to trump everything,” he says.

(More info at link)

So would this particular intranasal vaccine ( the one described in this section of the article above and quoted below) be similar to how the Johnson & Johnson covid-19 intramuscular vaccine works?

From the article -

Weakened or attenuated viruses can get through the barrier to infect cells, so some vaccine developers are turning to them. Two companies, Meissa Vaccines and Codagenix, have used synthetic biology to build an attenuated version of the novel coronavirus containing hundreds of genetic changes that drastically reduce its ability to replicate. In a recent news release, the Codagenix team reported promising results of their vaccine, CoviLiv, in a phase 1 trial. The spray induced a strong immune response against proteins shared by different variants of SARS-CoV-2, including the recent Omicron subvariant BA.2. That is because the vaccine trains the immune system to recognize all the viral proteins, not just the spike. Presenting all components of the virus makes the vaccine less vulnerable to the whims of evolution that might alter a few proteins beyond recognition. “The beauty of live attenuated vaccines is that they can provide broad long-term immunity in a very resistant context,”
 

Mo Thuairim

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So would this particular intranasal vaccine ( the one described in this section of the article above and quoted below) be similar to how the Johnson & Johnson covid-19 intramuscular vaccine works?

From the article -

Weakened or attenuated viruses can get through the barrier to infect cells, so some vaccine developers are turning to them. Two companies, Meissa Vaccines and Codagenix, have used synthetic biology to build an attenuated version of the novel coronavirus containing hundreds of genetic changes that drastically reduce its ability to replicate. In a recent news release, the Codagenix team reported promising results of their vaccine, CoviLiv, in a phase 1 trial. The spray induced a strong immune response against proteins shared by different variants of SARS-CoV-2, including the recent Omicron subvariant BA.2. That is because the vaccine trains the immune system to recognize all the viral proteins, not just the spike. Presenting all components of the virus makes the vaccine less vulnerable to the whims of evolution that might alter a few proteins beyond recognition. “The beauty of live attenuated vaccines is that they can provide broad long-term immunity in a very resistant context,”
I think both J&J and AZ are adenovirus (viral vector) vaccines that use a different (carrier) virus rather than using attenuated (weakened) versions of the actual Covid virus. But I'm open to correction on this from someone who knows more!


COVID-19 viral vector vaccines use a modified version of a different virus (a vector virus) to deliver important instructions to our cells.
 

ilovepierre

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I think both J&J and AZ are adenovirus (viral vector) vaccines that use a different (carrier) virus rather than using attenuated (weakened) versions of the actual Covid virus. But I'm open to correction on this from someone who knows more!


COVID-19 viral vector vaccines use a modified version of a different virus (a vector virus) to deliver important instructions to our cells.

The J&J and AZ vaccines don’t have the COVID virus in them, you are correct. Neither do the Pfizer or Moderna ones.
 
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