The Coronavirus Thread - Part 3

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Post by JespSwe on Thu Nov 19, 2020 12:51 pm

^ that. i was about to say the same thing. It is a joint collaboration with Pfizer. Plus there is a clinical trial to study in which first of phases requires safety before they could even proceed further to test safety + efficacy on wider population with different age groups, amongst other things.

and i guess FDA or big countries have FDA equivalent agency to evaluate the data, peer reviews from independent bodies which helps. Also its a good thing that pfizer is also holding out trials on different countries, atleast here in JPN, Pfizer has started conducting first phase of trial since October, so i guess the result will take another 6 months to yield here before another review.

That being said i also understand about the skepticism but i rather believe more in science, data when it comes to safety.

also while pfizer and moderna are ahead, world has about over 160 + candidates, so i think in time, there will possibly a better ones who knows but hopefully over time it becomes readily available for everyone

whatever gets approved if any probably will only be for emergency cases. i dont think it is the end of it, and the study is an ongoing matter for pfizer and moderna.


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Post by Arquitecto on Thu Nov 19, 2020 1:48 pm

Then I stand corrected. Gracias my friends.
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Post by Babun on Thu Nov 19, 2020 9:38 pm

A prominent UKE doctor from Hamburg (UKE - university clinic) said there'll be a 3rd and fourth wave if the soft lockdown is gradually eased. In his opinion, the soft lockdown should be kept throughout the winter until the new infection rate naturally drops then we can talk about easing the restrictions. He sees a relief with vaccine or warmer weather only.
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Post by JespSwe on Fri Nov 20, 2020 8:39 pm

@Arquitecto wrote:Then I stand corrected. Gracias my friends.


all good mate. i think its understandable on safety of vaccine because its our body. Hopefully things go towards good step. Vaccine being 95% effective doesn't necessarily mean it will go as planned to i guess more wide spread population because of limited data and test only done towards lets say 40,000 people vs millions of people being immunized so i guess the percentage of how effective is probably going to go down.

i am no medical expert but i guess as the world we know it, over time there will be better vaccine available probably compared to one another. The more the data, tests, to constantly improve the quality of results the better so i guess these are just the first steps. Unfortunately due to pandemic scenario, we may just have to go for it to know for real to see how effective it is.

i also read some article today how that there are like - double blind placebo clinical trial, unlike a standard placebo where patient dont know which vaccine is real during testing, this one apparent is another step where even researcher and doctors dont know which vaccine is given to trial patient is real and which one is dummy one. and thats one of the ways to further qualitatively run trials
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Post by VivaStPauli on Sat Nov 21, 2020 11:48 am

The standard of testing in the trials is unquestionably high (at least in Europe and the US, I would imagine also in places like Japan, S. Korea and Taiwan, but I just don't know enough about East Asia to just say something like that out loud), the real question is probably whether it is at all possible to discover all negative side effects within less than a year. There might be long-term effects we won't know about for a while, and if they're bad, billions of people might already be vaccinated by then.
I don't think it's likely, especially not with the mRNA candidates, but that's from my basic understanding of molecular biology, I'm not a pharma researcher.
So I'll be getting vaccinated, but I also think there's a (very slim) chance this rush job might bite us all in the ass in the end. But let's be real: it would need to have VERY bad side effects to be worse than the Corona pandemic.
I'd say it's like 99% worth it to get vaccinated and roll the dice.
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Post by Babun on Sat Nov 21, 2020 12:25 pm

@VivaStPauli wrote:The standard of testing in the trials is unquestionably high (at least in Europe and the US, I would imagine also in places like Japan, S. Korea and Taiwan, but I just don't know enough about East Asia to just say something like that out loud), the real question is probably whether it is at all possible to discover all negative side effects within less than a year. There might be long-term effects we won't know about for a while, and if they're bad, billions of people might already be vaccinated by then.
I don't think it's likely, especially not with the mRNA candidates, but that's from my basic understanding of molecular biology, I'm not a pharma researcher.
So I'll be getting vaccinated, but I also think there's a (very slim) chance this rush job might bite us all in the ass in the end. But let's be real: it would need to have VERY bad side effects to be worse than the Corona pandemic.
I'd say it's like 99% worth it to get vaccinated and roll the dice.
Vista and others, I took the time to translate, spread the word to reduce the number of covidiots and antivaxxers Very Happy
Translation:

1. Verändern die jetzt entwickelten Impfstoffe von Biontech und Moderna die menschliche DNA?

„Hierfür gibt es bislang keinerlei Hinweise“, sagt Infektiologe Christoph Spinner. Zwar würde bei den Impfstoffkandidaten in beiden Fällen Erbinformation in Form sogenannter mRNA injiziert. „Diese Information integriert sich jedoch nicht in das menschliche Erbgut, sondern fungiert als vorübergehende Bauanleitung von Virusbestandteilen, um das Immunsystem zu trainieren.“

Und auch Virologe Friedemann Weber erklärt: „Dass ein mRNA-Impfstoff das menschliche Erbgut verändert, ist extrem unwahrscheinlich.“
1. Do the vaccines developed by Biontech and Modena change/affect the human DNA?
"There has never been a recorded case", says virolog Christoph Spinner. Although in both cases mRNA sequences are injected they serve the purpose of a guide for the human immune system to recognize and build antibodies against the real virus later on. His colleage Friedemann Weber reitirates: "Changes in human genome sequences through the injection are extremly improbable".
2. Wie funktionieren die neuen Corona-Impfstoffe?

Die Impfstoffe von Biontech und Moderna basieren beide auf der sogenannten mRNA-Methode. Wissenschaftler forschen an diesem Ansatz bereits seit zwanzig Jahren, ursprünglich stammt er aus der Krebstherapie.

Vereinfacht gesagt, wird dabei ein Bauplan für bestimmte Eiweißteile in den Körper eingespeist – im Fall von Corona ein spezifisches Molekül, das im Sars-CoV-2-Erreger vorkommt. „Dadurch wird dem Körper vorgespielt, dass das Virus im Körper ist und er bildet Antikörper“, erklärt Virologe Weber.

„Tatsächlich ist es aber nur ein ungefährliches Protein, nicht das Virus selbst, gegen das der Körper ankämpft. Gelangt der Erreger zu einem späteren Zeitpunkt dann aber wirklich in die Zellen, hat der Körper schon die nötige Immunabwehr aufgebaut und kann das Virus ohne Erkrankung direkt inaktivieren.“ Diesen Mechanismus erachten Wissenschaftler als extrem effektiv bei der Vermeidung von Infektionskrankheiten.
2. How do the new vaccine types work (mRNA based)?
The method has been in development for over 20 years and was meant to be a type of a cancer therapy.  The idea is to inject markers of Sars-Cov-2 so the body thinks it is in the system and biulds antibodies. In reality, the injection is a harmless protein. In case, the real Sars-Cov-2 enters the body it already knows how to fight beforehand. Actually, the approach is very effective.

3. Warum gibt es dann noch keinen zugelassenen mRNA-Impfstoff?

Dass bisher kein Medikament oder Impfstoff auf mRNA-Basis zugelassen ist, liegt weniger an der Wirksamkeit des Verfahrens. „Die hätte Ihnen schon vor zehn Jahren jeder Molekularbiologe bescheinigt“, sagt Weber, der das Institut für Virologie an der Universität Gießen leitet.

Aber die Herstellung von mRNA-Präparaten sei technisch extrem aufwändig, ihre Haltbarkeit gering, die Anfälligkeit für störende Umwelteinflüsse immens, der Transport etwa in Arztpraxen oder Kliniken kompliziert, erklärt der Experte weiter. Die Ressourcen dafür hätten bislang gefehlt. „Aber je größer die Not und die Hoffnung auf Linderung durch ein Präparat, desto mehr Geld fließt bekanntlich. Durch die Pandemie war der Druck offensichtlich so groß, dass so viele Mittel wie noch nie in die Entwicklung geflossen sind und jetzt vermutlich erstmals zu einer Beantragung der Zulassung führen werden.“
3. If it's that effective why a mRNA based vaccine has never been produced before?
The spread of the methology isn't a theoretical problem, any molecular biolog could attest to that. The production of the mRNA based treatment is extremly expensive due to the very short life period, susceptibility to the environment, the transportation to the docs and clinics is very complicated. The pandemic made the investment viable so out of the emergency the resources needed came fast together for a rapid development and admission.
4. Was macht die Herstellung und den Transport so kompliziert?

Unter anderem die chemischen Eigenschaften der mRNA-Moleküle. Weber erklärt: „RNA-Proteine sind extrem instabil und empfindlich. Schon kleinste Aerosole, die beim Sprechen entstehen, zerstören sie.“ Zudem müssen enorme Kühlketten eingehalten werden, Spezialkühlschränke die Präparate teilweise auf bis zu 70 Grad minus herunterkühlen.

Für die Herstellung der spezifischen mRNAs bedarf es darüber hinaus hochtechnisierter Gerätschaften. In Anschaffung und Unterhalt bedeuten sie für Firmen und Labore enorme Kosten.
4. What makes the production and the transport of the mRNA based products so expensive?
Weber: "RNA-proteins are extremly unstable and suspectible to the environment. Aerosols produced by speaking already destroy them rendering them useless." They have to be stored in very cold environments. During the transport, the cold chains shouldn't be disrupted to keep the temperature of the reagent stable (up to -70 degrees). For the production of specialized mRNA preparates very expensive tools are needed. Their cost and maintenance are immense for the labs.
5. Ist der Impfstoff durch die schnelle Entwicklung unsicher – und wie wirksam schützt er vor Corona?

Wenngleich die Schritte des Testverfahrens der Impfstoffe momentan so schnell ablaufen wie nie, wird keine Phase übersprungen. Vielmehr laufen sie zeitlich verschränkt und damit teilweise parallel ab. Bedenken, dass die Präparate durch die kurze Entwicklungsphase gefährlich oder nebenwirkungsreich sein könnten, halten Experten deshalb für unbegründet. „Es werden alle regulären Verfahrensschritte eingehalten“, bestätigt Virologe Weber.
Ob der Impfstoff Langzeitfolgen bewirken kann, müssten weitere Studien zeigen, betont er. Bisher aber schienen die entwickelten Impfstoffe sehr sicher. „Dass die mRNA-Impfstoffe Krebs oder Autoimmunerkrankungen auslösen könnten wie manche behaupten, dafür gibt es keine Hinweise.“

Infektiologe Christoph Spinner erklärt: „Den veröffentlichten Informationen zu den bisherigen Impfstudien nach gibt es bei den mRNA-Impfstoffen bisher keine wesentlichen Sicherheitsbedenken oder Nebenwirkungen.“ Bei den Probanden wurden in der Studienphase lediglich leichte Begleiterscheinungen wie Kopfschmerzen oder Müdigkeit registriert.

Ähnlich positiv fällt die Experten-Einschätzung zur Wirksamkeit aus: Die Hersteller geben sie aktuell mit mehr als 90 Prozent an. Dies sei beachtlich, sagt Spinner, und sehr viel höher als etwa bei anderen Impfstoffen gegen Atemwegserkrankungen wie der Influenza-Grippe. Ihre Wirksamkeit liegt bei 50 bis 80 Prozent.

5. Is the vaccine unsafe, for its developent happens too fast- and how well does it protect against corona?
Although the admission steps are taken in a rapid manner no single step is being skipped. Lots of them run parallel to each other. Fears there would be lots of side effects due the fast development are unfounded because all regular development steps are taken.
Of course, there're no studies for the long term side effects. The possibility of cancer or autoimmune sicknessescould be induced  like antivaxxers propagate are unfounded though.
Spinner: "The only side effects registered as of now have been a slight headache and tiredness in some cases." Other experts agree and attest a 90% protection for the vaccine which is extremly high for viruses. The usual influenza vaccine has a 50%-80% protection degree.
6. Wann könnte der Impfstoff verfügbar sein?

Abschließend ist das bisher nicht zu sagen. Sowohl Biontech als auch Moderna wollen jedoch noch in diesem Jahr eine Eilzulassung für die USA beantragen. Dort laufen Zulassungsprozesse teils deutlich schneller ab als in Europa. Gibt die US-Arzneimittelbehörde FDA dem Antrag statt, könnten aber auch bei uns bereits in wenigen Wochen erste Impfdosen auf den Markt kommen.

„In den nächsten vier Wochen“ sei aber nicht mit einem Impfstoff zu rechnen, wie Gesundheitsminister Spahn erklärte. Bis dahin müssten wichtige organisatorische Fragen geklärt werden, betont Infektiologe Spinner – etwa: Wie kann die Impfung im großen Stil logistisch funktionieren? Wer wird zuerst geimpft, wie die Verteilung danach geregelt?
6. When could the vaccine become available?
Biontech and Moderna will try to pass the admission of their vaccines as an urgent procedure by the FDA in the US. The admission processes happen there much faster than in Europe. If they succeed the first deliveries are due in early 2021 in Europe as well.
The rest is about German politics I think most of you don't care so I won't translate.

Source:
https://www.focus.de/gesundheit/news/die-corona-erklaerer-corona-impfstoffe-veraendern-die-dna-das-sagen-die-experten-zur-aufreger-theorie_id_12677234.html


Last edited by Babun on Sat Nov 21, 2020 12:57 pm; edited 3 times in total
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Post by JespSwe on Sat Nov 21, 2020 12:33 pm

@VivaStPauli wrote:The standard of testing in the trials is unquestionably high (at least in Europe and the US, I would imagine also in places like Japan, S. Korea and Taiwan, but I just don't know enough about East Asia to just say something like that out loud), the real question is probably whether it is at all possible to discover all negative side effects within less than a year. There might be long-term effects we won't know about for a while, and if they're bad, billions of people might already be vaccinated by then.
I don't think it's likely, especially not with the mRNA candidates, but that's from my basic understanding of molecular biology, I'm not a pharma researcher.
So I'll be getting vaccinated, but I also think there's a (very slim) chance this rush job might bite us all in the ass in the end. But let's be real: it would need to have VERY bad side effects to be worse than the Corona pandemic.
I'd say it's like 99% worth it to get vaccinated and roll the dice.


no i agree with this, so far European Medicines Agency (EMA)  i read said something like they are not going to compromise anything, safety is their number one priority over anything, Japan also said the same thing about it, hence the trial from square one is ongoing here.
i dont know about other Asian countries but i think tey have their own FDA, EMA equivalent agency to study data, and importantly it feels good to know that there will be not just them but an independent bodies doing peer review which would be important and flag them beforehand.

i dont think it would be all possible to discover negative side effects in less than a year but pfizer when submitting their data for review and approval said that they will monitor all the volunteers to good 2 years atleast for any side effects.

the first phase I and II are for safety, and since they are holding out test on various countries as well, hopefully that is a good start. I will get vaccined as well once available here publicly. Here atleast it is not made mandatory or atleast i havent heard anything like that, but we know that for 2021 even vaccines are limited. Also current vaccine that pfizer applied for approval is only for emergency use.
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Post by Robespierre on Sat Nov 21, 2020 10:43 pm

I was wondering ... which are the countries to not have obligation of masks in the world ?
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Post by Blue on Mon Nov 23, 2020 5:53 am

Btw guys I tested positive for COVID on the 13th of November. My symptoms was basically the common cold, except one I can’t get rid of it for more than a week. I am good, honestly I am in the belief you will get it eventually, unless you stay home and go nowhere. Then again I am personal trainer, who basically live in a gym. Pretty sure the people I regularly come in contact were not really concerned about getting the virus.
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Post by Babun on Mon Nov 23, 2020 9:28 am

https://www.dailymail.co.uk/news/article-8975853/Shanghai-airport-plunged-chaos-worker-tests-positive-Covid.html
Quite funny Very Happy
The visuals:

@Blue wrote:Btw guys I tested positive for COVID on the 13th of November. My symptoms was basically the common cold, except one I can’t get rid of it for more than a week. I am good, honestly I am in the belief you will get it eventually, unless you stay home and go nowhere. Then again I am personal trainer, who basically live in a gym. Pretty sure the people I regularly come in contact were not really concerned about getting the virus.

Most of people in any country, even the US, haven't gotten it yet so it's very well possible to avoid the Wuhan virus. On mondays and tuesdays, I'm in a rather close contact with over 15 people in enclosed rooms (offices). We have open windows and FPP2 masks (I've got my own FPP3), it works. Zero infections as of now. We'd like to wait for the vaccines to be sure not to get some nasty complications.
Get well soon Very Happy
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