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Will Omicron-specific booster shots be more effective at combating COVID-19?

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By Prakash Nagarkatti and Mitzi Nagarkatti

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However, in human clinical trials and laboratory studies, both Pfizer-BioNTech and Moderna found that their initial version of the bivalent vaccine, which was directed against the original SARS-CoV-2 virus and an earlier omicron strain, BA.1, induced a strong immune response and longer protection against both the original strain and the BA.1 variant.

This is a very important note, the main point of the trials for the new version of the vaccine is to prove they have a higher efficacy in producing immunity, else there would be no point in using them instead of the already available shots.

But safety is a much less important thing to be tested compared with the originally developed vaccines, the technology is the same so any specific problem with the mRNA vaccines would have been already found out by now. The difference in the new version of the vaccine is the sequence of the spike antigen, but this is the same protein to which literally millions of people have been exposed world wide, since there is no report the variants are causing any extra risk compared with the original SARS-CoV-2 infection this becomes very strong evidence the sequence of the spike protein brings no extra risk to the vaccine either.

5 ( +14 / -9 )

BigYen, CDC reported that 94% of those deaths were 'with' covid, as in more than one other comorbitdity. Also, the average age of a covid death is 81.5 years old. I think you're a little misinformed. I appreciate the quote though. The data used for FDA approval was from 8 mice.

-4 ( +10 / -14 )

any specific problem with the mRNA vaccines would have been already found out by now

Or maybe in 5 years? 10 years? The next generation? What was the long term data to back up this statement? The decades of testing done on animals of which the safety data was not sufficient to grant approval? I'm not sure how you can make this conclusion?

-9 ( +6 / -15 )

I very much doubt that this new booster will be any more effective or safer than previous versions.

Anyway, considering the recent infection rates, it appears that natural herd immunity is approaching, which is expected to provide much broader, more robust, and longer lasting protection than any of these "vaccines" could provide.

Having said that, the inhaled COVID-19 vaccine recently approved in China seems quite promising...

-7 ( +7 / -14 )

any specific problem with the mRNA vaccines would have been already found out by now

They have! There is lots of data confirming their serious adverse effects. Unfortunately, this information is often withheld or censored because it might lead to vaccine hesitancy.

-6 ( +9 / -15 )

BigYen, CDC reported that 94% of those deaths were 'with' covid, as in more than one other comorbitdity.

And what do you think this means? if 100% of the deaths by malnutrition were "with" malnutrition (but due to other things like infections of renal insifficiency for example) would that mean that malnutrition was not the cause?

People can have many years of productive life left with their comorbidities controlled by medical treatment, but die thanks to the acute infection, there is nothing wrong with saying the infection was the cause of the death.

The data used for FDA approval was from 8 mice.

No it is not, the data from the previous version of the bivalent vaccine is included in the information used to prove the efficacy of the boosters, as is clearly writeen in the article.

Or maybe in 5 years? 10 years? The next generation? 

Or never, if not being vaccinated is without a doubt a much more risky option there is no logic in rejecting the vaccines because it may not be so in the future, without any evidence of this being even possible, much less likely.

I very much doubt that this new booster will be any more effective or safer than previous versions

But that is because of your personal bias, the experts that evaluate vaccines professionally for a living clearly contradict you and they are a much more reliable source of information about it.

Anyway, considering the recent infection rates, it appears that natural herd immunity is approaching, which is expected to provide much broader, more robust, and longer lasting protection than any of these "vaccines" could provide.

No, not really, specially with the amount of reinfections that is being observed, and much more counting the specific extra cost from the natural infection which is exposing the people to much higher risks than any of the vaccines against covid bring.

Having said that, the inhaled COVID-19 vaccine recently approved in China seems quite promising

Having the evidence of the clear underperforming of the Chinese injectable vaccine compared with the other options available "promising" is not something that can be said about it, they were unable to achieve what was the standard of safety and efficacy with their injectable version of the vaccine, seeing how inhaled vaccines have been unable to replace injectable vaccines for respiratory infections would make it even less likely they were able to surpass the standard having this very important handicap.

They have! There is lots of data confirming their serious adverse effects.

And none of them are even comparable with the frequency and gravity of the problems caused by covid, so the vaccines keep being the much safer option compared with not vaccinating for every population for which the vaccines are recommended.

6 ( +14 / -8 )

The data used for FDA approval was from 8 mice.

No it is not, the data from the previous version of the bivalent vaccine is included in the information used to prove the efficacy of the boosters, as is clearly writeen in the article.

Yeah, they used data from a previous version. The version the FDA approved had never been tested in humans.

-7 ( +6 / -13 )

There are as of yet no human studies on the efficacy of the new bivalent vaccine at preventing reinfections and providing long-term immune protection.

Maybe this is ok.

Most Asian medical experts advised the public to wear masks at the start of the Covid crisis even though there were no specific Covid-related studies--then again, there were no Covid-related studies that found it would be detrimental for the public to wear masks to prevent infections. Hence, everyone in Japan wore masks as far back as January 2020.

https://www.science.org/content/article/not-wearing-masks-protect-against-coronavirus-big-mistake-top-chinese-scientist-says

Despite the WHO's wrong advice against the public wearing masks, global health authorities such as the CDC came around and agreed with the other global experts, so that mask wearing became the norm. For the WHO, egg-wearing on the face became the norm.

-11 ( +3 / -14 )

Yeah, they used data from a previous version. The version the FDA approved had never been tested in humans.

Which is exactly the point, the previous version already include a bivalent vaccine that has been proved more effective and still safe so the only difference is the introduction of the mutations on the spike, which have been demonstrated as safe by the epidemiological data from infected people.

This is nothing new, influenza seasonal vaccines tests are approved without the requirement for new clinical data for every reformulation, only those that contain live viruses, which in the case of this vaccine it is obviously not the case.

6 ( +13 / -7 )

Most Asian medical experts advised the public to wear masks at the start of the Covid crisis even though there were no specific Covid-related studies

Again those experts and recommendations you can never reference? that is not an argument.

Experts and institutions recommending for masks to be prioritized for hospitals and dealing with symptomatic patients is completely congruent with what the WHO as a global scientific authority recommended, this was also the recommendation of the CDC, EMA, etc. until evidence of efficacy on asymptomatic people appeared.

As usual, pretending for scientific authorities to recommend things without any evidence is not valid, it completely defeats the point of having science based recommendations. Your link do not present any evidence for efficacy of mask use on asymptomatic patients previous to the pandemic, as usual.

Despite the WHO's wrong advice against the public wearing masks, global health authorities such as the CDC came around and agreed with the other global experts, so that mask wearing became the norm. For the WHO, egg-wearing on the face became the norm.

Making up false things that never happened is clear evidence you already understand you are wrong. The CDC explicitly recommended for masks to be used in hospitals (specially when they were very scarce) which is the same as the WHO did. Why insist on something easily disproved?

Also, what does this even have to do with the approval of the new vaccines in the US? The WHO is not even related to this in any way.

0 ( +10 / -10 )

Moreover, because it is new, it also gives some countries a chance to not lose face and finally adopt a vaccine that actually works. For example China was one of the first countries to develop and give a vaccine but its efficacy has proven to be below power, even from the early days of it being used. This is common knowledge and easily confirmed, probably because they were too hasty to get something out quick to save face

Unfortunately this is not likely to be the case, China developed a vaccine using stablished technology because they did could not produce the mRNA vaccines, this resulted in an inferior vaccine but obviously still much better than not vaccinating. Nevertheless, they made very poor efforts to vaccinate to the degree developed countries (and even some underdeveloped ones) did, and have never made any effort to procure the best available vaccines even now. It would be too optimistic to think they will change their approach now that a new version of the vaccines became available seeing how their priority until now is to use the measures that result in stronger control of their population and not those that the scientific and medical experts of the world recommend.

-1 ( +8 / -9 )

Again those experts and recommendations you can never reference? that is not an argument.

Like the source I provided in my original comment, which you failed to read in its entirety in your rush to try and make a retort in defense of the failed agency the WHO?

Making up false things that never happened is clear evidence you already understand you are wrong. 

Like the source that shows what in reality happened, despite your desperate attempt to pretend it doesn't exist? Here it is for all to see:

https://www.cnn.com/2020/03/30/world/coronavirus-who-masks-recommendation-trnd/index.html

And for a bonus, yet, another source, showing the WHO was wrong:

https://www.nationalreview.com/2020/03/coronavirus-pandemic-japan-shows-masks-help-slow-spread-covid-19/

-7 ( +5 / -12 )

Like the source I provided in my original comment, which you failed to read in its entirety in your rush to try and make a retort in defense of the failed agency the WHO?

Your source do NOT include the opinion of "most asian experts" as you said, and specifically lack any evidence that would have justified any scientific institution (much less an authority like the WHO) recommend masks for asymptomatic people on the street, obviously without this evidence prioritizing masks for symptomatic patients (which is the recommendation) is the only valid valid thing to say.

Like the source that shows what in reality happened, despite your desperate attempt to pretend it doesn't exist? Here it is for all to see:

How does a source from March 30 proves that any evidence was available from before the pandemic? the whole point is that the recommendation changed because of the new evidence being collected during it, this reference would prove your personal (and completely off topic) comment is still mistaken.

So here is the evidence you would need to prove your comment is correct.

a reference to "most asian experts" saying masks should be used on asymptomatic patients based on evidence available before december 2019. This is the minimum required to prove all the scientific authorities that recommended masks to be prioritized for hospitals (which also include the CDC, EMA, etc.) were mistaken in their recommendations.

Additionally it would be much better if you could justify how this has any relationship with the FDA and the CDC approving the new bivalent mRNA vaccine, which is the topic of the article.

-2 ( +7 / -9 )

Your source do NOT include the opinion of "most asian experts" as you said, 

It IS an expert from the most populous Asian country, so the expert IS included as one of the experts form the group of "most Asian experts"; and every other Asian country experts also advised the public wear masks contrary to the WHO's wrong advice.

Do you have a scientific study showing that the WHO was correct to advise the public not wear masks because masks would not reduce risk of Covid infections?

SHOW US YOUR SOURCE.

How does a source from March 30 proves that any evidence was available from before the pandemic?

Because the experts in Asia were advising to wear masks before March 30, and people in Asia were wearing masks before March 30.

Anyone in the science or medical field would know this simple fact.

Oh.

-5 ( +6 / -11 )

It IS an expert from the most populous Asian country, so the expert IS included as one of the experts form the group of "most Asian experts"; and every other Asian country experts also advised the public wear masks contrary to the WHO's wrong advice.

So you recognized you could not bring any reference for "most" of the experts and instead just bring one, which is not even based on any scientific evidence, much less anything available before the pandemic?

This is actually recognizing your comment was mistaken in the first place.

Do you have a scientific study showing that the WHO was correct to advise the public not wear masks because masks would not reduce risk of Covid infections?

SHOW US YOUR SOURCE.

Making up an imaginary argument because you can't defeat the one being used to disprove yours is called a strawman. To prove the CDC, EMA, WHO, etc were all correct in their recommendations the only thing necessary is to show there was no evidence to contradict those recommendations. Since you have indirectly accepted this evidence do not exist that means you are also accepting there is no value in expecting all those scientific and medical institutions to recommend something without scientific evidence.

> Because the experts in Asia were advising to wear masks before March 30, and people in Asia were wearing masks before March 30.

All the experts you failed to bring? using evidence that only you can see? that would still be false. People were doing all kinds of things from the beginning of the pandemic, that is not an argument for scientific institutions to baselessly recommend it.

Anyone in the science or medical field would know this simple fact.

As you have been completely unable to support this even after being asked for references for it this is still completely wrong. You have brought zero references that argue institutions should make recommendations not sustained by evidence.

And again, what is the relationship with the new Bivalent Omicron vaccines being approved for use? ignoring this question 3 times only means you clearly understand your comments have nothing to do with this article.

-4 ( +5 / -9 )

It means that they died from something else, but happened to test positive for SARSCoV2.

That would be wrong, as included in a previous comment that would be a completely invalid conclusion

"Key to understanding the issues in these posts is that, “If they had not gotten the infection,” Dr. Artandi said, “they would still be alive.”

https://www.reuters.com/article/uk-factcheck-94-percent-covid-among-caus-idUSKBN25U2IO

Actually, no. More and more studies have been showing that the serious adverse effects (and deaths) from the vaccines are higher than from the virus, especially for the younger population (below 65 or so).

That is completely false, as surely as you include none of those supposed studies.

They will be as useless as the original ones and will continue to cause SADS and myocarditis.

So the best experts of the field clearly say the original vaccines have been a wonderful medical intervention and that decrease the risks (including myocarditis) without any evidence whatsoever they increase the risk of SADS, but a nameless person on the internet says they are all wrong without any evidence.

It is not difficult to see who is correct and who is just making up things.

-3 ( +7 / -10 )

No.

-3 ( +5 / -8 )

Apparently tested on eight mouses. 8!

-3 ( +3 / -6 )

@tora

Europe is getting the human-trialed version that targets BA.1

US is getting the untrialed version that targets BA4/5.

If you want vaccine that targets the latest variants, then you don't have time for human trial other than basic minimum safety test.

Since the mRNA platform itself is already proven, it's time to skip human trial like flu vaccines.

0 ( +4 / -4 )

No

100% accuracy for the same question for previous versions so I'm going with that too.

Only if by accuracy you mean being clearly wrong according to the evidence obtained from the vaccinated people until now.

I had full on covid in August 4 months after my 3rd booster. I think I will build my immunity au natural from now on.

"Full on covid" as in hospitalized, complicated, a stay in the ICU and died? because that is what is the worst case scenario on covid and what is clearly reduced by vaccination. You are free to choose the less rational option and that comes with much higher risks, what you can't do is to misrepresent it as if it was not irrational.

It might provide limited protection for a few weeks for the highly vulnerable.

But for everyone else, there's no point, and the risks of nasty side effects are likely higher than serious illness from the virus.

The experts and the data collected from vaccinated people clearly say your comment is completely false, do you even have evidence that can contradict this? or are we just supposed to believe you know more than the people that deal with human health and clearly say the decrease of risk from vaccines applies to everybody for whom they are recommended?

And of course, it won't stop transmission, as the authorities have been forced to admit after more than a year of lies and cover-ups.

Imaginary conspiracies that have never happened also make it clear you don't really have an argument.

Apparently tested on eight mouses. 8!

The data supporting the safety and efficacy includes the clinical trials for the previous bivalent vaccine, that still applies for this version, and the epidemiological data from millions of people infected with the BA variants that prove the only difference (the sequence of the spike protein) do not cause any specific problems.

that is many orders of magnitude above 8 mice and obviously includes humans.

0 ( +5 / -5 )

The efficacy of the previous bivalent treatment is shown to have decreased compared to antibody levels from previous infection. The efficacy of the "BA.5" updated (new) treatment was based on the data from 8 mice. Or as I like to call it the "Lab Rat Theory".

-2 ( +4 / -6 )

The efficacy of the previous bivalent treatment is shown to have decreased compared to antibody levels from previous infection.

Again, the data included for the approval application includes the clinical trial that proves increased efficacy by the bivalent booster compared with the original vaccine, pretending this is not the case only makes it more apparent the desire to mislead people.

Antibody levels of the bivalent booster still means significative protection, and comparing those levels to those from people that have been symptomatic enough to require treatment or even hospitalization obviously still puts the booster ahead, precisely because the protection it confers do not come with these risks.

0 ( +5 / -5 )

They can include any data they want. It was already destined to be approved either way. The increased efficacy of the new treatment was concluded based on increased antibody levels in 8 mice. To try and scew the narrative using old data which is now useless given the decreased efficacy would be the most misleading use of that data. It's hard to be objective about these sorts of things when you feel the need to pick a side and fight for it. Data is only a small part of what goes into a risk benefit analysis and unfortunately the data from 8 mice just doesn't do much to further the mRNA treatment offensive.

-2 ( +4 / -6 )

They can include any data they want. It was already destined to be approved either way

And you of course have proof of this conspiracy, right?

The increased efficacy of the new treatment was concluded based on increased antibody levels in 8 mice

Again, false, it is based on the results of the previous bivalent booster and the congruent results from the preclinical trials, and also again, this is not anything new nor that happens only for covid vaccines. Influenza seasonal vaccines are also approved without requiring clinical data for the new formulation every year, scientifically it is possible to characterize surrogates of protection based on antigenicity.

To try and scew the narrative using old data which is now useless given the decreased efficacy would be the most misleading use of that data

Can you prove the data from the tested bivalent vaccine is useless? what is your evidence, obviously you are not just making up stuff and pretending you proved it just because you said it, right?

What is the difference between both bivalent boosters results that let you conclude the data can't be shared?

It's hard to be objective about these sorts of things when you feel the need to pick a side and fight for it.

It is hard for you because you are doing it to the extreme to making up things you can't prove just to keep your prefixed conclusions afloat. For the experts is not hard, the same scientific parameters used for other vaccines or boosters are just used again in this case and it gives a conclusion that can be defended scientifically without problems.

unfortunately the data from 8 mice just doesn't do much to further the mRNA treatment offensive

But since this is not the data used to approve the boosters it has no importance, making up a false argument just so you can discuss against it has no merit.

0 ( +4 / -4 )

It might provide limited protection for a few weeks for the highly vulnerable.

But for everyone else, there's no point, and the risks of nasty side effects are likely higher than serious illness from the virus.

Exactly! That sums up very well what the data is increasingly confirming. Some studies have actually shown that for younger people, the serious adverse effects from vaccines are greater than from the infection.

-2 ( +3 / -5 )

Exactly! That sums up very well what the data is increasingly confirming. Some studies have actually shown that for younger people, the serious adverse effects from vaccines are greater than from the infection.

That is completely false, there is no study that demonstrate that, there have been instead studies that have been misrepresented or plainily contradicted to appear to reach that conclusion, but none has actually presented evidence that proves vaccines are more risky than the natural infection.

-1 ( +3 / -4 )

When they announced the expectation of approval before data is submitted then lo and behold it's approved based on whatever data is supplied, that's somehow a conspiracy theory. Right...

0 ( +4 / -4 )

Again, the data included for the approval application includes the clinical trial that proves increased efficacy by the bivalent booster compared with the original vaccine, pretending this is not the case only makes it more apparent the desire to mislead people.

They only looked at the production of serum antibodies (in humans for BA.1, and in mice for BA.4/BA.5). As far as I know, they never looked at protection against infection or against severe symptoms. So they do not have any data that "proves increased efficacy".

-1 ( +3 / -4 )

This is a very important note, the main point of the trials for the new version of the vaccine is to prove they have a higher efficacy in producing immunity, else there would be no point in using them instead of the already available shots.

Not true, because fewer side effects would also be desirable.

-1 ( +3 / -4 )

When they announced the expectation of approval before data is submitted then lo and behold it's approved based on whatever data is supplied, that's somehow a conspiracy theory. Right...

Since they had already the data from previous booster candidates and there was no reason to think something widely unexpected to happen (most of the antigen is the same, as well as the technology) there is definetely need for an irrational conspiracy theory to think the reason to expect an approval is anything other than the terribly obvious one.

They only looked at the production of serum antibodies (in humans for BA.1, and in mice for BA.4/BA.5). As far as I know, they never looked at protection against infection or against severe symptoms.

At this point it is terribly clear that neutralizing antibody titers have been already characterized as a valid surrogate of protection, so there is no need to look directly to reduction of infection or severe symptoms to compare between vaccines. The whole point of characterizing a surrogate is to use it instead of the more complicated, slow or expensive measurements, it is also unethical to do it once the surrogate has been validated.

Not true, because fewer side effects would also be desirable.

That does absolutely nothing to disprove that the main point is to examine efficacy, what are you imagining was done to reduce side effects that you think this would be the main thing that they were interested in demonstrate?

-2 ( +2 / -4 )

That does absolutely nothing to disprove that the main point is to examine efficacy, what are you imagining was done to reduce side effects that you think this would be the main thing that they were interested in demonstrate?

This "claim" does nothing to disprove my point, is not based in fact, and is unsubstantiated by science.

-1 ( +3 / -4 )

This "claim" does nothing to disprove my point, is not based in fact, and is unsubstantiated by science.

Yes it does, the vaccine has been actualized for efficacy, so that is what is being tested for principally, there has been no extra effort to reduce side effects, so you have no argument to say efficacy should not be the main thing to be examined.

What "science" is that you imagine is making the testing of side effects the main purpose? that sounds simply like an excuse you are using to baselessly criticize a comment you did not understand and are unable to discuss with arguments.

-1 ( +2 / -3 )

The new booster shots – one by Moderna and another from Pfizer-BioNTech – come as more than 450 people are still dying of COVID-19 every day in the U.S.

Dying of Covid or with Covid?

The system of data collection has been found to be skewed in the US.

And my previous comment on the role of large profits in the pharma business is a definite continuing impetus for drug rollouts ad naseum!

Not my opinion!

Proof below…

https://www.newsweek.com/big-pharma-companies-profits-industries-study-1490407

0 ( +2 / -2 )

Dying of Covid or with Covid?

False dichotomy, what If I told you nobody dies of malnutrition but with malnutrition. The principal cause of death for malnourished people are infections or other things. Would that make the problem disappear in your eyes?

The system of data collection has been found to be skewed in the US.

And the people that trained years to do epidemiological analysis of cases and deaths say covid is an important cause for those deaths, what evidence do you have that they are doing their work wrong?

And my previous comment on the role of large profits in the pharma business is a definite continuing impetus for drug rollouts ad naseum!

Then why no roll out of dozens and dozens of drugs for covid? why dirt cheap generic drugs like dexamethasone are still being used? Your argument do not prove there is a global conspiracy including every recognized institution of the world to push for things that have no use. It just proves you are willing to believe irrational conspiracy theories instead of accepting what the doctors have proved with evidence.

What if companies profit from insulin or antibiotics? would that make diabetes and infections also some fake diagnosis to profit? are people dying so much that life expectancy in general drops just because?

1 ( +2 / -1 )

Also, why aren’t I dead from the virus? I had Corona in April this year.

I feel a bit sorry for @virusrex. For 2+ years he's been trying to educate idiots.

0 ( +1 / -1 )

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