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Re:Valneva and Pfizer announce Phase 2 study for Lyme diseas... by _Microft on Thursday August 26, 2021 @07:16AM (#28313324)
Prepare to read the headline "mRNA vaccine trial for <...>" a lot in the future. My guess is that they are going to produce mRNA versions of basically any vaccine (and then some) in the future. The nice thing about the technology seems to be that you only need to exchange the mRNA payload while the surrounding delivery method can be reused. That makes it not only a fast method to create a vaccine but a very convenient way as well. Nice side effect might be that for the next pandemic, we might have doses for everyone ready at the moment the trials are done. Take that with a giant grain of salt because I'm not in the industry.
Re:Valneva and Pfizer announce Phase 2 study for Lyme diseas... by amyjess on Thursday August 26, 2021 @08:05AM (#28313831)
At the beginning of the pandemic, people theorized that public health will influence future media for a generation, much like WW2 did. For decades, we got war TV shows, war movies, war comics, etc. Hogan's Heroes ran into the '70s, Sgt. Rock was published until the late '80s, and so on. And I think we're about to see the same with media based on public health efforts.

One of the things that'll come out of this is that mRNA vaccines as miracle wonder drugs that cure everything are going to get huge amounts of attention, and media will reflect that. Especially if the Lyme, Malaria, and HIV vaccines prove successful. We are going to see mRNA vaccines as plot devices and MacGuffins in media for decades to come. It's going to get the same treatment radiation got in the '60s and '70s and genetic engineering got in the '90s and '00s. For example, it wouldn't surprise me if, the next time Marvel decides to make a new adaptation of Spider-Man, the spider will have been treated with mRNA instead of radiation (the original story) or gene therapy ('90s cartoon, '00s movies, maybe others).

Re:Valneva and Pfizer announce Phase 2 study for Lyme diseas... by nyolfen on Thursday August 26, 2021 @08:29AM (#28314089)
> At the beginning of the pandemic, people theorized that public health will influence future media for a generation, much like WW2 did. For decades, we got war TV shows, war movies, war comics, etc. Hogan's Heroes ran into the '70s, Sgt. Rock was published until the late '80s, and so on. And I think we're about to see the same with media based on public health efforts.

but we actually won that war, which precipitated a rise to global hegemon status. covid has been a pathetic, fumbling showing, one that clearly reflects institutional decay and foreshadows future decline -- the reverse of the first situation

Re:Valneva and Pfizer announce Phase 2 study for Lyme diseas... by wil421 on Thursday August 26, 2021 @08:50AM (#28314264)
WW2 had the Red Scare, Japanese interment camps, and shocking amounts of human experimentation. I would like to hear about the fear mongering and downright lies that were going on during WW2 from someone who was there. I’d bet there was lots of misinformation going around, social media has made those types of things flourish.

If you look back at history through rose-tinted glasses everything will appear better than it was.

Re:Valneva and Pfizer announce Phase 2 study for Lyme diseas... by foxhop on Thursday August 26, 2021 @10:32AM (#28315445)
Especially once it stops being about race when we say we need to investigate how humans used the Scienctific process took "a solution in search of a problem" and collected samples laboratories, like searching for a needle in a haystack in Wuhan to purposefully replicate and infect chimeric rat/humans with bat viruses. Whether maliciously or not that is the likely prevailing Truth on why we now have a 5th corona virus we need to guide toward an endemic state.

I'm obviously not happy with the state of the world as a computer scientists.

Re:Valneva and Pfizer announce Phase 2 study for Lyme diseas... by acdha on Thursday August 26, 2021 @12:15PM (#28316883)
Do you have sources for those claims? As computer scientist I’m certain you should understand the importance of reproducible data and analysis.
Re:Valneva and Pfizer announce Phase 2 study for Lyme diseas... by nyolfen on Thursday August 26, 2021 @07:58PM (#28322599)
Re:Valneva and Pfizer announce Phase 2 study for Lyme diseas... by acdha on Thursday August 26, 2021 @09:03PM (#28323122)
That's an opinion piece by a journalist with a BA in Natural Sciences from 1964, not a virologist or otherwise an expert on any of the topics. His claims have not held up well and the biggest scientist he interviewed (David Baltimore) has backed away from that[1]. As they say, extraordinary claims require extraordinary proof and he had very little other than speculation.

I mention all of that because even that wobbly claim was still couched in terms like “did” or “could” while the comment I replied to described it as “likely prevailing truth”. We have no evidence and limited data supporting that hypothesis and a number of people pushing it for political reasons, which is rarely helpful to the scientific process.

1. https://nautil.us/issue/102/hidden-truths/when-a-good-scient...

Re:Valneva and Pfizer announce Phase 2 study for Lyme diseas... by nyolfen on Friday August 27, 2021 @07:42AM (#28326542)
until it stops being true that the lead scientist at the wiv pioneered work in & published papers about inserting FCSes -- which other than covid do not exist in coronaviruses -- into bat coronaviruses for gain of function research, you will be facing a very uphill battle. there are so many damning claims in that piece that would be convincing on their own that i suspect you haven't even read it.
Re:Valneva and Pfizer announce Phase 2 study for Lyme diseas... by acdha on Friday August 27, 2021 @01:47PM (#28330852)
If you read it more carefully, notice how those claims are much stronger than the supporting evidence. Note how often he says something is possible and then treats it as the most probable explanation without doing the real work of establishing it as such - this is one of the things all of the actual scientists who critiqued this op-ed focused on.
Re:Valneva and Pfizer announce Phase 2 study for Lyme diseas... by MontyCarloHall on Thursday August 26, 2021 @09:01AM (#28314370)
> covid has been a pathetic, fumbling showing, one that clearly reflects institutional decay and foreshadows future decline -- the reverse of the first situation

Against a totally novel virus, we developed and widely deployed vaccines with efficacies beyond anyone’s wildest dreams using totally novel technology in the span of a year. Not sure that quite meets my definition of “pathetic.”

Re:Valneva and Pfizer announce Phase 2 study for Lyme diseas... by MagnumOpus on Thursday August 26, 2021 @09:07AM (#28314426)
Not a totally novel virus. The reason why vaccines were developed within days of isolating the virus is because SARS-COV-2 is not that different from SARS-COV-1 and all the vaccine research efforts carried over.

What was pathetic was the federal coordination - hesitation on travel restrictions, CDC response, recommendations against PPE… Lessons that could have been learned even from the 1918 pandemic were painfully ignored.

Re:Valneva and Pfizer announce Phase 2 study for Lyme diseas... by EL_Loco on Thursday August 26, 2021 @09:33AM (#28314695)
What makes you think the war wasn't won /despite/ pathetic and fumbling actions by leaders and governments? Ha, my country sent a small contingent (25k) to fight against the Axis in Italy. There were new uniforms made for this expeditionary force. Turns out they chose uniforms that closely matched that of the german uniforms (!).

From a book on this subject: "Another problem in the country's preparation was the production of uniforms similar to those of the German Army. 'They even threw rocks at us in Naples thinking we were the invaders'.”

[dead]
Re:Valneva and Pfizer announce Phase 2 study for Lyme diseas... by sk2020 on Thursday August 26, 2021 @11:38AM (#28316307)
I don’t think anyone “runs” the federal government. I think offices and processes exist, and I think there’s a semi-hereditary politburo occupying said offices, but I don’t think anyone has much authority.
Re:Valneva and Pfizer announce Phase 2 study for Lyme diseas... by quasarsunnix on Thursday August 26, 2021 @08:50AM (#28314265)
To be fair this war isn’t over yet and WW2 wasn’t exactly a walk in the park for any allied power.
Re:Valneva and Pfizer announce Phase 2 study for Lyme diseas... by EL_Loco on Thursday August 26, 2021 @09:34AM (#28314714)
What makes you think the war wasn't won despite pathetic and fumbling actions by leaders and governments? WW2 wasn't a showcase of efficiency and practicality. Ha, my country sent a small contingent (25k) to fight against the Axis in Italy. There were new uniforms made for this expeditionary force. Turns out they chose uniforms that closely matched that of the german uniforms (!). From a book on this subject: "Another problem in the country's preparation was the production of uniforms similar to those of the German Army. 'They even threw rocks at us in Naples thinking we were the invaders'.”

I thought the rollout of the vaccines in the time it took, with the effectiveness it had, just went to show how the knowledge and technology of vaccines makes it one of the greatest human achievements, ever.

Re:Valneva and Pfizer announce Phase 2 study for Lyme diseas... by pfisch on Thursday August 26, 2021 @09:11AM (#28314453)
The us actually handled the 1918 pandemic even worse than this one.

Public authorities largely claimed it wasn't happening and wasn't a big deal as hospitals overflowed and we dug mass graves.

They even cancelled public gatherings but pretended it was unrelated to a health crisis. Health responses in the us were completely scattershot, and no one trusted information coming out from the government.

Compared to that this response was actually far better and more organized.

Re:Valneva and Pfizer announce Phase 2 study for Lyme diseas... by retrac on Thursday August 26, 2021 @08:32AM (#28314118)
Oh, pandemics can certainly have long-lasting social and cultural effects. I ran into something quite interesting just the other day while playing with Google's Ngram on a whim. This is the occurrence of the word "contamination" in contemporary English texts in the last century: https://books.google.com/ngrams/graph?content=contamination&... (Care to guess what happened in the early 1980s?)

I'm actually a little worried about this. Of course, I'm happy it'll boost interest in vaccine development. But the terror and fear in reaction to AIDS led to a general biosecurity obsession that became biosecurity paranoia and then hysteria and then a renewal of persecution of homosexual men for a couple decades. Who says we'll be immune to the worse effects of fear, paranoia and panic this time around?

Re:Valneva and Pfizer announce Phase 2 study for Lyme diseas... by EdwardDiego on Thursday August 26, 2021 @08:56AM (#28314322)
Why would it though?

mRNA vaccines just get your body to produce a particular protein you want to induce an immune response to, instead of injecting the protein directly.

Is it really the slow uptake of mRNA techniques that's prevented an HIV vaccine? Or is it HIV's capacity for rapidly mutating into large numbers of disparate strains inside one person, let alone in the entire community?

I mean, look at the delta variant of Covid, the mRNA vaccines reduce the severity of infection, but do not prevent infection or spreading thereof.

mRNA vaccines will enable rapid iteration, which is good. But they're not a wonder drug at all.

Re:Valneva and Pfizer announce Phase 2 study for Lyme diseas... by GrinningFool on Thursday August 26, 2021 @09:11AM (#28314445)
> I mean, look at the delta variant of Covid, the mRNA vaccines reduce the severity of infection, but do not prevent infection or spreading thereof.

I keep seeing that surface here. It is at odds with what I'm reading that says it /is/ effective at preventing infection[1] though not perfectly so. Are we looking at different metrics, or is my own ignorance of the field preventing me from fully understanding what I"m reading?

[1] most recently - https://www.cdc.gov/mmwr/volumes/70/wr/mm7034e5.htm?s_cid=mm...

Re:Valneva and Pfizer announce Phase 2 study for Lyme diseas... by bluGill on Thursday August 26, 2021 @09:47AM (#28314872)
The anti-vaxxine crowd has never had any problem with cherry picking the statistics that they can twist to show their view. I've been watching them do it for at least 10 years (and evidence they have been doing it longer), but only now is the rest of the public seeing it. I have just enough statistics to see what they are doing, but it is complex enough that most people don't understand it.
Re:Valneva and Pfizer announce Phase 2 study for Lyme diseas... by incrudible on Thursday August 26, 2021 @09:51AM (#28314917)
It is a function of time. During the trials, it was a 95% reduction, Israel last reported a 39% reduction.
Re:Valneva and Pfizer announce Phase 2 study for Lyme diseas... by GrinningFool on Thursday August 26, 2021 @01:36PM (#28317944)
But that doesn't equate to saying that it is ineffective at preventing infection. I think we'd need follow-up studies showing a trend towards zero, but that doesn't seem to exist yet.
Re:Valneva and Pfizer announce Phase 2 study for Lyme diseas... by cbushko on Thursday August 26, 2021 @08:23AM (#28314031)
So expect the next version of Spiderman to be based on a mRNA spider.
Re:Valneva and Pfizer announce Phase 2 study for Lyme diseas... by harshreality on Thursday August 26, 2021 @08:27AM (#28314070)
> For example, it wouldn't surprise me if, the next time Marvel decides to make a new adaptation of Spider-Man, the spider will have been treated with mRNA instead of radiation (the original story) or gene therapy ('90s cartoon, '00s movies, maybe others).

mRNA vaccine tech being discussed here is not gene therapy. It cannot (appreciably) alter host DNA the way radiation or gene therapy can. It simply causes the host cells to manufacture desired proteins for a limited amount of time.

Re:Valneva and Pfizer announce Phase 2 study for Lyme diseas... by detaro on Thursday August 26, 2021 @08:30AM (#28314100)
correct, but parent didn't claim it was?
Re:Valneva and Pfizer announce Phase 2 study for Lyme diseas... by honksillet on Thursday August 26, 2021 @07:27AM (#28313431)
Does anyone know why they haven't released a Delta varient vaccine? Is seems that it would just involved we changing the mRNA sequence in a computer at the factor, but I'm really just guessing. Also maybe it is considered a whole new vaccineand needs to go through approval again.
Re:Valneva and Pfizer announce Phase 2 study for Lyme diseas... by bart_spoon on Thursday August 26, 2021 @08:33AM (#28314127)
One reason is because they've found that simply boosting with the original mRNA gives a massive spike in protection even against Delta, apparently on par with variant specific versions of the vaccine.

Another is that recent studies are showing that natural infection provides much more comprehensive, long-lasting immunity against all variants than the vaccination does, while vaccination with the current vaccines offers much more immunity than individuals who have never been vaccinated or infected. So it would seem like the best course of action moving forward may be to vaccinate everyone possible initially to prime their immune systems and reduce the severity of the disease, and then allow Covid to run its course. Eventually vaccinated individuals will have break-through infections, gain the more durable natural immunity, and Covid will become a less serious, endemic virus more like the flu or cold.

In short, we don't yet have a need for a Delta variant vaccine. That may not be true eventually, especially for future variants.

Re:Valneva and Pfizer announce Phase 2 study for Lyme diseas... by bxrxdx on Thursday August 26, 2021 @08:50AM (#28314273)
I haven't seen any research that says that infection acquired immunity is stronger or longer lasting than from vaccine. The opposite in fact.
Re:Valneva and Pfizer announce Phase 2 study for Lyme diseas... by fab1an on Thursday August 26, 2021 @09:12AM (#28314457)
Not an expert, but afaik there's been quite a few studies showing that natural immunity is superior to the vaccine-induced one - I'm also fairly sure that virologists have theorized to that end even before the data became available for the following reason: the vaccine is 100% focussed on detecting the spike protein, so changes to the spike can result in evasive variants. Natural immunity OTOH is developed against more sites of the virus and thus provide a more broad and robust response to variants, present and future.
Re:Valneva and Pfizer announce Phase 2 study for Lyme diseas... by bart_spoon on Thursday August 26, 2021 @11:17AM (#28316030)
There's been some mixed signals coming out of the research, but that's in part due to how immunity is being measured. There are definitely some studies showing that particular antibody levels for vaccines can be higher or longer lasting than natural infection, but recent research is showing that those with natural infection have had a far smaller risk of reinfection than those vaccinated, even when controlling for comorbidities. There are still confounding factors, such as behavioral differences between the groups, but its a pretty stark difference. It also makes sense from a theoretical standpoint, as acquired immunity is based on more than the just spike protein, unlike the vaccines, which is a big part of the differences between variants like Delta. The thought is that natural immunity is therefore more resilient to changes between variants.

Its all early enough that its still an open question, but there's definitely early evidence that natural immunity is more resilient than vaccination only.

Re:Valneva and Pfizer announce Phase 2 study for Lyme diseas... by exhilaration on Thursday August 26, 2021 @08:56AM (#28314319)
Re:Valneva and Pfizer announce Phase 2 study for Lyme diseas... by ChoGGi on Thursday August 26, 2021 @09:15AM (#28314489)
The first thread is commenting on the preprint status of that paper.
Re:Valneva and Pfizer announce Phase 2 study for Lyme diseas... by inglor_cz on Thursday August 26, 2021 @07:39AM (#28313546)
Because it means rerunning the trials again.

These requirements will have to be loosened for anti-Covid vaccines. They are tailored to other diseases, but SARS-CoV-2 mutates too fast. The flu vaccine has an exception, too, otherwise it wouldn't be possible to prepare the correct vaccine (against the expected dominant strain) on time.

Re:Valneva and Pfizer announce Phase 2 study for Lyme diseas... by kingkawn on Thursday August 26, 2021 @07:43AM (#28313591)
One bad autoimmune reaction from a poorly engineered vaccine and the whole society will boycott the mRNA vaccines forever after. Safety is higher priority to ongoing viability than speed.
Re:Valneva and Pfizer announce Phase 2 study for Lyme diseas... by inglor_cz on Thursday August 26, 2021 @07:52AM (#28313699)
Safety and speed must usually be balanced in a trade-off, and we are actually used to it, that is why people drive a car, even though it comes with a risk of dying or being maimed.

I have no doubt that some kind of safety-related trials must be run on boosters and that they will be run, but they will likely only take weeks in the future, not months.

Re:Valneva and Pfizer announce Phase 2 study for Lyme diseas... by kingkawn on Thursday August 26, 2021 @09:23AM (#28314566)
You presume the time required is a function of something other than observing the physiologic reaction to the inoculation over an adequate period of time.
Re:Valneva and Pfizer announce Phase 2 study for Lyme diseas... by f6v on Thursday August 26, 2021 @08:12AM (#28313910)
> but they will likely only take weeks in the future, not months.

We need just one Jesse Gelsinger to shut the whole thing down.

Re:Valneva and Pfizer announce Phase 2 study for Lyme diseas... by inglor_cz on Thursday August 26, 2021 @08:18AM (#28313981)
J.G. is a famous case and his death definitely delayed development for a decade or more, but it should be noted that when he died, the technology was extremely untested in humans.

We now have a few hundred million people who got mRNA vaccine and had no trouble. I don't think that even after a death, mRNA would be completely toast. It has already proven its merit.

Re:Valneva and Pfizer announce Phase 2 study for Lyme diseas... by bewaretheirs on Thursday August 26, 2021 @09:05AM (#28314402)
mRNA?

J.G.'s death involved an experimental modified adenovirus (the same family of viruses used as the vector for several non-mRNA COVID vaccines: Johnson & Johnson/Janssen, Astrazenica/Oxford, and Sputnik V).

Re:Valneva and Pfizer announce Phase 2 study for Lyme diseas... by inglor_cz on Thursday August 26, 2021 @09:15AM (#28314493)
The OP was mentioning J.G.'s case as an example of what could happen, too with rushed mRNA vaccines, and that the fallout would be bad.
Re:Valneva and Pfizer announce Phase 2 study for Lyme diseas... by incrudible on Thursday August 26, 2021 @09:54AM (#28314962)
The number of people dead or severely ill from TTS is already in the hundreds. Where is the boycott of viral vector vaccines?
Re:Valneva and Pfizer announce Phase 2 study for Lyme diseas... by harshreality on Thursday August 26, 2021 @08:33AM (#28314122)
But it doesn't make sense in this context. They're literally changing nothing except the mRNA sequence.

If a new vaccine is made by taking a gene sequence from a virus protein that's already in the wild, and packaging it into a delivery mechanism (LNP) that's already approved for another vaccine...

If there are any strange reactions to the new spike protein, that would also be caused by the wild virus spike protein, so it's an obvious competing harms situation where the vaccine should be approved, at least so long as the pandemic is ongoing.

Re:Valneva and Pfizer announce Phase 2 study for Lyme diseas... by bxrxdx on Thursday August 26, 2021 @08:48AM (#28314252)
Right, all you're changing is the mRNA, but that can still be really dangerous. What if you code for a protein that causes cross-reactivity with a human protein and you give millions of people an auto-immune disorder?

I'm 1000% pro mRNA vaccines and pro covid vaccines, but they still need to be tested.

Re:Valneva and Pfizer announce Phase 2 study for Lyme diseas... by harshreality on Thursday August 26, 2021 @12:04PM (#28316712)
Then the virus variant itself would cause autoimmune disease, and we'd have a much bigger problem than deciding whether to approve a new vaccine.

For fuck's sake, I'm not saying do no testing. I would assume they do basic checks, first in humanized animals, then using bioassays to try to detect all sorts of problems including antibody cross-reactivity with a wide variety of human cells. I'm also not against a preliminary limited human trial, with bloodwork checked after a few weeks to try to see if the assays missed anything obvious.

Short of that, what do you want them to do? We can't wait years to see if people develop symptomatic auto-immune problems. If we even wait 3-6 months for each new protein, the time advantage offered by mRNA or adenovirus vaccine tech is blown, or at least reduced to the point where there's no ability to react quickly to changing dominant viral strains in a pandemic, or new outbreaks of known diseases.

Re:Valneva and Pfizer announce Phase 2 study for Lyme diseas... by rddlob on Thursday August 26, 2021 @12:54PM (#28317436)
>Then the virus variant itself would cause autoimmune disease

You clearly have no idea what you are talking about or why the GP comment mentioned an autoimmune disease specifically. mRNA vaccines express specific proteins whereas the virus expresses entire viral molecules. A novel protein expression could cause an autoimmune disease because the novel proteins couls cause the immune system to attack the cells producing the isolated proteins, a problem you wouldnt have with cells producing entire viral bodies.

Re:Valneva and Pfizer announce Phase 2 study for Lyme diseas... by harshreality on Thursday August 26, 2021 @02:20PM (#28318570)
I think you misunderstood the (G)GP comment which mentioned cross-reactivity, i.e. the immune system's antibodies cross-reacted with both the spike protein and an endogenous human protein, like what can happen with Epstein–Barr virus Nuclear Antigen-1.

The immune system doesn't generate antibodies to an entire virus. It generates antibodies to specific immunogenic proteins or parts of proteins.

If the spike protein resulting from a vaccine causes an immune response that generates antibodies to the spike protein and oops, also some endogenous human protein, that's autoimmune disease.

If you get infected by a virus with the same spike protein, your body will generate antibodies to the same spike protein and also cause autoimmune disease if the antibodies are cross-reactive.

If cells expressing exogenous immunogenic proteins triggered autoimmune disease[1], even the existing wild-type (alpha variant) vaccines would cause autoimmune disease. Presumably that's not happening. The immune system may attack those cells expressing the exogenous vaccine-coded spike proteins, but normal immune systems down-regulate it well enough that it doesn't cause major problems. It would be a sign of a broken immune system if it decided to initiate a long-term attack of human cells just because they once expressed an immunogenic protein. If it did that, any virus would cause autoimmune disease.

Please tell me you work in a field related to immunology and you have a subtler point that I'm missing, and that you didn't just create an account to criticize a point you misunderstood yourself.

[1] to an unacceptable degree. Obviously, things can go wrong with the immune system and almost anything could, if you're unlucky enough, trigger an immune reaction leading to autoimmune disease eventually.

Re:Valneva and Pfizer announce Phase 2 study for Lyme diseas... by dolni on Thursday August 26, 2021 @08:56AM (#28314329)
You're making the incorrect assumption that catching some new, dangerous strain of COVID is a guarantee. It isn't.

Pushing out a vaccine that causes harm, even if it's substantially less than the virus it protects against, is asking for a lot of trouble.

Re:Valneva and Pfizer announce Phase 2 study for Lyme diseas... by harshreality on Thursday August 26, 2021 @09:28AM (#28314634)
Consider two ratios:

Harm ratio = harm caused by vaccine / harm caused by virus

Exposure ratio = projected people who would be infected by the virus / projected people who would take the vaccine

In an airborne, high-R_0 pandemic situation, the exposure ratio is high enough that only one of two cases apply:

1) The potential health problems caused by small-scale exposure to the spike protein alone is relatively small compared to problems caused by infection, in which case vaccinate everyone. This is the current situation.

2) The potential health problems caused by small-scale exposure to the spike protein are significant (for example, hypothetical antibody cross-reactivity with a normal human protein, as mentioned in a parallel comment), in which case obviously don't vaccinate everyone, but lock down the world for a few weeks since having much of the world suffer autoimmune disease is untenable.

Re:Valneva and Pfizer announce Phase 2 study for Lyme diseas... by incrudible on Thursday August 26, 2021 @10:12AM (#28315212)
The potential health problems are unknown. For example, we are assuming that Myocarditis/Pericarditis is extremely rare, or at least more rare than in a viral infection. Do we really know that, for all age groups and all vaccines? I have doubts, we are still in the discovery phase:

https://www.reuters.com/world/us/us-probing-moderna-vaccine-...

The spike protein is not necessarily a problem, but both NLP and viral vectors have never been rolled at the current scale. TTS seems to be particular to viral vectors, Myocarditis/Pericarditis more so to NLP.

Re:Valneva and Pfizer announce Phase 2 study for Lyme diseas... by slumdev on Thursday August 26, 2021 @11:17AM (#28316038)
> They're literally changing nothing except the mRNA sequence.

This is like comparing my house to the Willis Tower and saying, "they're literally changing nothing except the blueprints."

mRNA codes for proteins. Coding for a different protein will produce different effects in the body. Most will probably be harmless. If a vaccine codes for a protein too similar to proteins that already exist, that vaccine will produce autoimmune disease.

Re:Valneva and Pfizer announce Phase 2 study for Lyme diseas... by ajmurmann on Thursday August 26, 2021 @09:05AM (#28314408)
I think the best solution here would be challenge trials. With it without them we are relying on people getting sick. With challenge trials we just reduce how many people outside the trial get sick as well because we can massively cut down on time. I'd be more than happy to take the new vaccine and get exposed to Delta. It's a easy way to make a huge contribution to society.
Re:Valneva and Pfizer announce Phase 2 study for Lyme diseas... by nradov on Thursday August 26, 2021 @09:43AM (#28314830)
Human challenge trials have started in the UK.

https://ukcovidchallenge.com/

Re:Valneva and Pfizer announce Phase 2 study for Lyme diseas... by valarauko on Thursday August 26, 2021 @03:18PM (#28319323)
Couple of months ago when Pfizer & Moderna were talking about developing variant specific boosters, wasn't the discourse about how the variant boosters wouldn't need full trials again?
Re:Valneva and Pfizer announce Phase 2 study for Lyme diseas... by graywh on Thursday August 26, 2021 @09:53AM (#28314936)
isn't the flu vaccine just a cocktail of existing vaccines tailored to the strains we predict will be active?
Re:Valneva and Pfizer announce Phase 2 study for Lyme diseas... by Spellman on Thursday August 26, 2021 @10:12AM (#28315211)
Sort of.

It's a cocktail of vaccines against the expected dominant strains based on data of strains in the opposite hemisphere because it mutates too quickly to produce a targeted vaccine against any specific strain before it arrives.

But I believe they can develop the vaccine fresh as new strains arrive, as well as reuse previous vaccine strains.

Re:Valneva and Pfizer announce Phase 2 study for Lyme diseas... by cblconfederate on Thursday August 26, 2021 @08:16AM (#28313957)
Trials of the Delta vaccine have started https://fortune.com/2021/08/09/covid-vaccines-delta-variant-...

IIRC these trials should last 3 months

Re:Valneva and Pfizer announce Phase 2 study for Lyme diseas... by f6v on Thursday August 26, 2021 @08:06AM (#28313842)
I’ve read somewhere that they don’t just take a sequence. There’re some tweaks they make to produce effective immune response. CureVac failed to produce a good vaccine for this reason. My take is that mRNA technology is being overhyped, although it’s a massive step up over other approaches.
Re:Valneva and Pfizer announce Phase 2 study for Lyme diseas... by murgleburgle on Thursday August 26, 2021 @07:07PM (#28322171)
CureVac probably failed because they used unmodified RNA base pairs. Both Moderna and BioNTech/Pfizer use modified nucleosides such as N1-methyl-pseudouridine. Extracellular unmodified mRNA - which could arise from the lipid nanoparticles which contain the mRNA breaking down before transfection of cells - can trigger a deleterious innate immune reaction against said mRNA. This interferes with the desired immune recognition of the spike protein. The modified mRNA largely evades that undesired immune reaction. That's probably what sunk CureVac's vaccine.
Re:Valneva and Pfizer announce Phase 2 study for Lyme diseas... by swalsh on Thursday August 26, 2021 @07:40AM (#28313562)
I think our approval processes haven't kept up with the technology. The existing vaccine is already approved, and boosters seem to have some beneficial affects.
Re:Valneva and Pfizer announce Phase 2 study for Lyme diseas... by pfdietz on Thursday August 26, 2021 @08:40AM (#28314184)
If the GOP weren't so foolish against vaccines, they could have made hay criticizing the slowness of the FDA.
Re:Valneva and Pfizer announce Phase 2 study for Lyme diseas... by myko on Thursday August 26, 2021 @10:13AM (#28315232)
Being foolish against vaccines hasn't stopped conservative media from criticizing the speed of the FDA:

https://twitter.com/RadioFreeTom/status/1429946530782498818

Re:Valneva and Pfizer announce Phase 2 study for Lyme diseas... by phreeza on Thursday August 26, 2021 @07:29AM (#28313456)
Probably because going through another round of certification is harder than using the existing vaccine as a booster, the hope being that this will already significantly improve delta resistance.
Re:Valneva and Pfizer announce Phase 2 study for Lyme diseas... by darkerside on Thursday August 26, 2021 @08:04AM (#28313824)
Why not both?
Re:Valneva and Pfizer announce Phase 2 study for Lyme diseas... by f6v on Thursday August 26, 2021 @08:13AM (#28313916)
Because pharma companies don’t work for the public, but for the shareholders.
Re:Valneva and Pfizer announce Phase 2 study for Lyme diseas... by darkerside on Thursday August 26, 2021 @04:53PM (#28320571)
And if they are first to develop a new Delta specific vaccine, they will be making their shareholders money hand over fist
Re:Valneva and Pfizer announce Phase 2 study for Lyme diseas... by linuxftw on Thursday August 26, 2021 @08:08AM (#28313866)
There's nothing to update. The mRNA allegedly encodes for the 'spike' protein, which is the infection vector. The theory at the time was that by targeting that protein specifically, if the virus were to mutate, it would loses it's ability to infect because it could no longer successfully bind to the ACE2 receptors.

In practice, the efficacy is a fraction of what the trials stated it was. It didn't lose efficacy due to the delta variant, the manufacturers just lied about the efficacy by cherry picking the data.

The only option they have now is to blame people's immune systems for lack of response, thus the 'boosters' are needed.

Re:Valneva and Pfizer announce Phase 2 study for Lyme diseas... by f6v on Thursday August 26, 2021 @08:13AM (#28313923)
Can you back that up?
Re:Valneva and Pfizer announce Phase 2 study for Lyme diseas... by zz865 on Thursday August 26, 2021 @07:42AM (#28313581)
HIV was a few days ago. Amazing if it works. https://gizmodo.com/moderna-set-to-test-experimental-hiv-mrn...
Re:Valneva and Pfizer announce Phase 2 study for Lyme diseas... by _Microft on Thursday August 26, 2021 @07:47AM (#28313646)
BioNTech is working on a malaria vaccine as well. If this one works out well, it would be a huge win for all mankind.

https://investors.biontech.de/node/10366

Re:Valneva and Pfizer announce Phase 2 study for Lyme diseas... by ianhawes on Thursday August 26, 2021 @07:26AM (#28313420)
The biggest investment that Pfizer made was the creation of a way to reliably manufacture mRNA vaccines. Now they must recoup those investments.
Re:Valneva and Pfizer announce Phase 2 study for Lyme diseas... by bildung on Thursday August 26, 2021 @08:08AM (#28313871)
To my knowledge Pfizer didn't really invest anything, it was the German population who financed Biontech through funds paid with taxes: the lab infrastructure pre-covid (through funded cancer research), the vaccine trials, and mass production (both directly and through pre-purchases before the vaccine existed).
Re:Valneva and Pfizer announce Phase 2 study for Lyme diseas... by bluGill on Thursday August 26, 2021 @09:55AM (#28314978)
Biontech invested in the early research. Pfizer invested a lot more into manufacturing and the trials. Both are needed at different times. What Pfizer invested in was a lot lower risk (don't confuse that with low risk - it wasn't except by comparison!), but they invested far more money.

Quit trying to sell either short - without both investments we would be in lockdown yet.

Re:Valneva and Pfizer announce Phase 2 study for Lyme diseas... by bildung on Thursday August 26, 2021 @12:30PM (#28317089)
I really looked into that quite deeply. Biontech got so much money for funding the trials that they apparently had too much and put it in reserve for 2022. The public invested billions into building production capacity.

I'd be glad to see what Pfizer actually invested that wasn't backed by prepurchases.

Re:Valneva and Pfizer announce Phase 2 study for Lyme diseas... by bluGill on Thursday August 26, 2021 @03:18PM (#28319324)
I'm got surprised.
Re:Valneva and Pfizer announce Phase 2 study for Lyme diseas... by swalsh on Thursday August 26, 2021 @07:46AM (#28313627)
I think the term you're looking for is capitalize. Pfizer made some investments in a technology that had wide applications, and now they want to capitalize on it. It's good business, and a lot of people are going to be helped in the process.
Re:Valneva and Pfizer announce Phase 2 study for Lyme diseas... by lampe3 on Thursday August 26, 2021 @07:51AM (#28313690)
Can you name any big company that does not work that way? Like Apple, Facebook, Ford, Tesla, Nestle ect ect.

And what would be an alternative?

Re:Valneva and Pfizer announce Phase 2 study for Lyme diseas... by ianhawes on Thursday August 26, 2021 @08:38AM (#28314169)
My understanding is that it has been known for years that mRNA is a viable vaccine delivery vector, but the R&D hadn't been completed for the other aspect of the business - production and safety at scale.
Re:Valneva and Pfizer announce Phase 2 study for Lyme diseas... by bluGill on Thursday August 26, 2021 @09:59AM (#28315029)
No, mRNA was suspected to be viable, but it was never proven. Like most new medical developments the early tests showed it didn't work and those needed to be worked around. Some believers did the research to make it work, but they had their detractors who said they were wasting there time as the problems weren't solvable. This time the detractors were proven wrong, but there have been other cases where more effort was put into something with no result (at least so far?)
Re:Valneva and Pfizer announce Phase 2 study for Lyme diseas... by ethbr0 on Thursday August 26, 2021 @08:55AM (#28314309)
Afaik, it was backed up behind a lack of safety trials.

Given how expensive those are to run, and how mRNA's primary benefit (speed of development) wasn't a competitive advantage in "normal" times, we had something that we thought was better, but no financial case to toss the gobs of money at it to get it certified.

If SARS-CoV-2 is remembered for one thing, it should be for finally breaking the logjam and "giving" us approved mRNA platforms.

Re:Valneva and Pfizer announce Phase 2 study for Lyme diseas... by andrea81 on Thursday August 26, 2021 @08:57AM (#28314335)
Pfizer... didn't these guys tried unauthorized Trovan on children in Nigeria during a meningitis epidemic?
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Re:Valneva and Pfizer announce Phase 2 study for Lyme diseas... by _Microft on Thursday August 26, 2021 @07:41AM (#28313571)
That's incorrect. They are vaccines even while working differently.

The body develops immunity in reaction to the spike proteins that it produced itself after turning the mRNA instructions contained in the vaccine into proteins (namely the spike proteins that the SARS-Cov2 virus uses to enter cells).

Ribosomes, tiny and amazing molecular machines, read this mRNA and produce the encoded sequence of aminoacids. With every reading, a bit of the tail of the mRNA sequence gets used up and once it's too short, the whole sequence is broken down. That means the mRNA in the vaccine gets used up with time.

The mRNA never makes it into the nucleus where your DNA resides.

Ribosomes are interesting btw, you can read about them here:

https://en.wikipedia.org/wiki/Ribosome

Re:Valneva and Pfizer announce Phase 2 study for Lyme diseas... by novaRom on Thursday August 26, 2021 @08:28AM (#28314078)
Amazing technology. What I cannot understand is how can a foreign mRNA be injected so efficiently into host's cells without all the virus-like methods to be applied? Why should host cells be ready to accept any mRNA from their environment so blindly? Wouldn't it be used by natural selection to create subviral agents which will destroy such naive host cells rather quickly?
Re:Valneva and Pfizer announce Phase 2 study for Lyme diseas... by _Microft on Thursday August 26, 2021 @08:35AM (#28314149)
The mRNA is hidden inside lipid nano-droplets. These droplets merge with cells and the mRNA gets released into them. From what I understand, pure mRNA would be broken down if it ended up in the interstitium (fluid filled space between cells) without being hidden inside this lipid shell. The sequence is also slightly altered compared to original one to make it more stable and less likely to produce an immune response (one of the bases ('U') is swapped out for one that is functionally the same but does not trigger the immune system).

You can read more about the BioNTech/Pfizer vaccine and the lipid particles here:

https://berthub.eu/articles/posts/reverse-engineering-source...

https://blogs.sciencemag.org/pipeline/archives/2021/01/11/rn...

mRNA is just instructions, it does not have to "authenticate" itself with the cell. If it is in there, it will be "executed". The filtering is done before stuff should get into cells (i.e. caught be the immune system).

Re:Valneva and Pfizer announce Phase 2 study for Lyme diseas... by ethbr0 on Thursday August 26, 2021 @08:58AM (#28314345)
Lipid nanoparticles, and the research done around their ability to serve as transport and safety, are the real technological breakthrough here.

Not to say the mRNA technology isn't amazing, but if we had it but no LNPs, we'd have a whole lot of nothing.

Re:Valneva and Pfizer announce Phase 2 study for Lyme diseas... by _Microft on Thursday August 26, 2021 @04:45PM (#28320475)
You might be interested in this article. It is about a biochemist who invented the way to prepare these nanoparticles but was cheated out of his share of the fame and money.

https://www.forbes.com/sites/nathanvardi/2021/08/17/covids-f...

Re:Valneva and Pfizer announce Phase 2 study for Lyme diseas... by manwe150 on Thursday August 26, 2021 @08:59AM (#28314353)
The short answer is that it is virus-like initially, in that it bypasses the cells passive defenses to enter the cell intact, but the payload can’t reproduce itself, so it dies out almost immediately afterwards, unlike a virus.
Re:Valneva and Pfizer announce Phase 2 study for Lyme diseas... by inglor_cz on Thursday August 26, 2021 @07:42AM (#28313584)
Technically, anything but doctor Jenner's original vaccine against smallpox, which was derived from cowpox, isn't a vaccine. Vacca is literally cow in Latin and vaccine means from cows, which the other vaccines aren't.

But that would be silly, right?

Re:Valneva and Pfizer announce Phase 2 study for Lyme diseas... by shawnz on Thursday August 26, 2021 @08:43AM (#28314208)
I am curious about this line of thinking. If you believe that mRNA vaccines should be considered "gene treatments" then why don't you also believe that traditional vaccines are "gene treatments"? What exactly makes one fall under that description but not the other?
Re:Valneva and Pfizer announce Phase 2 study for Lyme diseas... by munchbunny on Thursday August 26, 2021 @07:39AM (#28313553)
What makes them not vaccines?
Re:Valneva and Pfizer announce Phase 2 study for Lyme diseas... by kadoban on Thursday August 26, 2021 @07:46AM (#28313634)
A desire to avoid being called anti-vax.
Re:Valneva and Pfizer announce Phase 2 study for Lyme diseas... by desine on Thursday August 26, 2021 @08:15AM (#28313946)
Out of curiosity, if you're onboard with previous typical vaccination, but hesitant to jump on board with mRNA treatments, what are you? Does that now fall under "anti-vax" in internet lingo? Is wise to group everyone under one umbrella term?
Re:Valneva and Pfizer announce Phase 2 study for Lyme diseas... by munchbunny on Thursday August 26, 2021 @10:16AM (#28315263)
That depends on why they're hesitant about mRNA vaccines. The "anti-vax" label isn't just about not taking some subset of the standard vaccinations. There's a tribal element and a conspiracy/disinformation element.
Re:Valneva and Pfizer announce Phase 2 study for Lyme diseas... by kadoban on Thursday August 26, 2021 @09:40AM (#28314798)
What's the point in differentiating? They at best deluded themselves with a slightly different brand of anti-vax propaganda. Do we need a separate term?
Re:Valneva and Pfizer announce Phase 2 study for Lyme diseas... by desine on Thursday August 26, 2021 @10:54AM (#28315732)
So there's no possible valid logic for not wanting an mRNA vaccine. It's all completely "delusion" stemming from propaganda? Anyone who does not have complete faith at this point is in the wrong?

Am I understanding you correctly?

Re:Valneva and Pfizer announce Phase 2 study for Lyme diseas... by kadoban on Thursday August 26, 2021 @11:34AM (#28316239)
There are no general reasons to avoid well tested mRNA vaccines, no.

Specific medical conditions (eg allergies to components of the shot), being under the recommeded/tested ages, etc., sure.

I unfortunately know several anti-vaxxers, I've seen what they pass around as "reasons". It's nonsense. And it just so happens that they all get their news from similar places. It's a total coincidence I'm sure.

Re:Valneva and Pfizer announce Phase 2 study for Lyme diseas... by desine on Thursday August 26, 2021 @01:57PM (#28318244)
And I assume that you consider all the available variations as "well tested". Nice to hear that any personal concerns I have are not valid, and that you don't even need to read them to know that. Sad to see so many websites where discussions were once welcomed turned into echo chambers. Or perhaps I'm just one of those uneducated people who shouldn't even be on HN
Re:Valneva and Pfizer announce Phase 2 study for Lyme diseas... by kadoban on Thursday August 26, 2021 @02:54PM (#28318982)
They went through the full multi-round set of testing that all vaccines go through in the US (even ignoring the overlap elsewhere), and have since been administered to hundreds of millions of people. I'd call that well tested, yes.

What would be the point of me pretending it's up for debate? I'm not stopping you from sharing whatever concerns you have, not sure how you think I even would. I'm not likely to be interested in them if I'm being honest, I've seen far too many sites and stories already. But you do you.

Re:Valneva and Pfizer announce Phase 2 study for Lyme diseas... by jhrmnn on Thursday August 26, 2021 @07:46AM (#28313635)
Absolutely not correct. They do work exactly like conventional vector vaccines, the only difference is how the genetic material of the foreign virus is delivered to the cells of the patient. The genetic material of the patient (the genes) is not modified.
Re:Valneva and Pfizer announce Phase 2 study for Lyme diseas... by Ovah on Thursday August 26, 2021 @07:55AM (#28313739)
Technically speaking ... the genetic code of the B cell receptor gene of B cells is altered by vaccines. The same goes for pretty much all antigens the body comes across. But that's the point of the adaptive immune system and is obviously not what OP meant. https://en.wikipedia.org/wiki/V(D)J_recombination
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Re:Valneva and Pfizer announce Phase 2 study for Lyme diseas... by shawnz on Thursday August 26, 2021 @08:44AM (#28314218)
What does that mean exactly? Is that the standard by which you hold other medical treatments to as well?
Re:Valneva and Pfizer announce Phase 2 study for Lyme diseas... by raaaaraaaa12 on Thursday August 26, 2021 @08:21AM (#28314008)
that sounds great but its scary technology in wrong hands