Posted on 08/01/2020 10:27:54 AM PDT by SeekAndFind
A highly anticipated clinical trial for a potential COVID-19 vaccine managed in part by the American drug company Moderna has resulted is some adverse effects in more than half of the trial's participants, with one test group reporting "severe" symptoms.
The trial, which is also being sponsored by the National Institute of Allergy and Infectious Diseases, administered the vaccine "as a 0.5-ml injection in the deltoid muscle" in two shots spaced about one month apart. Two separate groups received 25-microgram and 100-microgram doses, respectively. A third group with a 250-microgram dose was subsequently added.
The vaccine "induced anti–SARS-CoV-2 immune responses in all participants," the research team reported Tuesday in the New England Journal of Medicine. Researchers said that "no trial-limiting safety concerns were identified." Yet a majority of participants still reported at least one side effect.
"Solicited adverse events that occurred in more than half the participants included fatigue, chills, headache, myalgia, and pain at the injection site," the report states. Fever, joint pain and nausea were also reported.
Side effects grew more common with more (and larger) injections, the scientists write: "Systemic adverse events were more common after the second vaccination, particularly with the highest dose, and three participants (21%) in the 250-μg dose group reported one or more severe adverse events."
Notably, every participant in the two larger-dose groups reported adverse reactions after their second injections. One study participant in the smallest-dose group, meanwhile, was removed due to having developed hives after the first round of injections.
(Excerpt) Read more at justthenews.com ...
“Look to Trump”, true, an amazing Christian President. Not official, but word is no federal mandatory vaccinations. Fearful Demoncrat states I understand can try to mandate them in their states, good luck with that....forced vacinations may just turn into another Cuomo mandated murder fest ( by putting Covid positive patients into nursing homes)...and of course, the vacination makers have been given immunity from lawsuits by people harmed from them, a harbinger in the making...
I don’t care if a vaccine is effective or not — as long as the easily manipulated people fall for it. If that’s what it’ll take to get rid of social distancing and masks, bring it on.
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Yup. I’m with you.
‘Just a certain level of shirked responsibility for taking reasonable precautions to preserve human life.’
utter nonsense; not taking a vaccine does not automatically endanger someone else’s health...it is not a ‘shirked responsibility’, particularly if its efficacy of said vaccine has not been established...
Just shut up and go away hack. Everyone here has extensive experience with the likes of you.
BTW your “Patriot Act” handle isn’t fooling anyone.
I am not willing to risk my health on a rushed vaccine that bypasses the usual protocols of development. Vaccines can take years not a few months to get right. We have treatments that can work. Is the trade off in potential side effects and probable deaths worth it?
I am not willing to risk my health on a rushed vaccine that bypasses the usual protocols of development. Vaccines can take years not a few months to get right. We have treatments that can work. Is the trade off in potential side effects and probable deaths worth it?
Agree and I will add the ZPak to the recipe.
Allow me to apologize in advance for this long reply, but your question is absolutely important and worth a real, honest, in-depth discussion.
First, let’s address what we actually mean when we talk about the use of fetal stem cells in vaccine development, because I think saying “uses dead baby parts” is misleading and inflammatory, but I also agree with your moral objection to using fetal stem cells; particularly those taken from an unborn child that was aborted. Although it is easier to use those cells, there are viable alternatives and we should be making more use of them. And thankfully, nearly all vaccines do have ethical alternatives developed without the use of fetal stem cells. You are absolutely right to object to the use of fetal stem cells and I am 100% with you on that.
Modern uses the HEK-293 stem cell line to grow the Spike protein needed for their vaccine. HEK-293 is a stem cell line obtained from a embryonic kidney cells from an unborn baby girl who was aborted in the Netherlands in 1973. The abortion was elective (not medically necessary) and legal under Dutch law at the time. After the abortion was completed, some of the cells from the kidney were taken and have been cultured for decades for various purposes, including growing samples of viruses or pieces of viruses. NONE of those cells are present in the actual vaccines themselves. But the ethical problem DOES remain that the end product exists in part thanks to cells obtained after an abortion was performed. And again, I do NOT think this is ethical and would much prefer alternative methods be used for these processes.
In 2005, the Vatican sought to answer the questions around the moral and ethical issues of vaccines (and other medicines) that use fetal stem cell lines as part of their development in their “Moral reflections on vaccines prepared from cells derived from aborted human fetuses”. (If you’re interested in reading it, it’s here: https://www.immunize.org/talking-about-vaccines/vaticandocument.htm). In that document, they laid out the issue and created a framework for navigating it wherein you first must ask “is there any alternative that was NOT developed using fetal cells?” If the answer is yes, you have a moral obligation (per the document) to seek that out and use it instead of the one developed using the morally tainted cell lines.
For every vaccine except Hepatitis A and rubella, there are FDA approved vaccines that do NOT use ethically tainted processes to create them. They do NOT use fetal stem cells from any source to develop or produce the vaccine. If you want Hep A or rubella vaccines produced ethically, you need to go to Japan where they have versions approved for use there. If that is not an option, the Vatican’s document states one must weight the risk of harm from not taking the vaccine against the moral issues associated with it. If the risk of harm is great enough, it is permissible to accept the vaccine, but the Vatican urges everyone to take action to get ethical alternatives produced as quickly as possible (lobbying, protesting, etc.)
As it relates to COVID-19 vaccines, there are alternatives to both the Oxford and Moderna vaccine candidates (which both use fetal stem cells as part of their development). The COVID-19 vaccine candidates being developed by Novavax, Sanofi Pasteur, GlaxoSmithKline (GSK), and Sinovac, are using ethically-derived cell lines. President Trump just reached a deal with GSK to purchase 100 million doses of their vaccine. You wanted an answer about how to address moral, ethical, and religious objections to the use of fetal stem cells in vaccine development? That’s the answer, from the President.
As for the vaccines being “haphazardly throw together”, that is not the case at all. All the vaccine candidates are going through the exact same phase 1, phase 2, and phase 3 clinical trials that any other vaccine has gone through. They’re being tested on over 100,000 volunteers in the US, along with similar trials taking place in other countries around the world. What President Trump has done - and why the process is moving so quickly - is to get the Federal bureaucracy out of the way so the paperwork doesn’t take years to make its way through all the red tape. The President is streamlining the approval process, but has absolutely no control or authority to short-change the clinical testing protocols. He’s just making sure no do-nothing bureaucrats at the FDA sit on the approval applications for months or years on end.
The result will be one or more safe and effective vaccines that have gone through all the same testing as anything else, but get approved faster than any other in history. I trust that President Trump is doing the right thing here.
I would agree with you that nobody should risk their health on a rushed vaccine that bypasses the usual protocols for development and testing.
But that isn’t happening here. All the vaccine candidates have to go through the exact same phase 1, phase 2, and phase 3 clinical trials that every other vaccine has to go through. That’s where Moderna’s vaccine candidate and Oxford’s (along with a few others) stand right now. They’ve made it through phase 1 and phase 2 clinical trials without serious side effects and with evidence for efficacy.
Phase 1 trials give the vaccine candidate to up to about 100 volunteers who are then monitored just to make sure there are no serious side effects. Efficacy isn’t really a priority here; you’re just making sure you aren’t going to kill anyone with this. Once it’s confirmed nothing serious goes wrong in humans, phase 2 moves on to around 500-1,000 volunteers who are monitored to check for both side effects and efficacy, but still primarily for safety concerns. Once that’s complete, phase 3 gives the vaccine candidate to a much larger audience (thousands to tens of thousands of people). In this phase, both safety and efficacy are heavily scrutinized.
How are these vaccine candidates moving so quickly? President Trump. He’s fast-tracked the top candidates and forced the FDA’s do-nothing bureaucrats to get out of the way and not sit on approval applications for months on end. He’s streamlined the process so the manufacturers can keep moving forward. And he’s made major financial commitments (billions of taxpayer dollars) so they’ll manufacture their vaccines in parallel with phase 3 clinical trials so that if they pass all the safety and efficacy tests, they’ll be immediately available to the public. Nobody has EVER done that before. That’s why this is so fast.
We should all be THANKING President Trump rather than dumping on his work.
Sorry I really have no faith in this at all. Also given that there has never been a successful vaccine for a cornavirus is also a factor. People are looking for the Illusion of safety, and the vaccine and masks do that.
We will just have to wait and see and hope disaster doesn’t take place.
I understand your skepticism and I hope that my and President Trump’s optimism about the vaccine candidates doesn’t turn out to be wishful thinking. In the end, my goal (and I would guess yours as well) is the preservation of human life, particularly for Americans.
But I do think that if anyone can create an environment where we can get such a quick, safe, and effective vaccine, it’s President Trump. He’s shown time and time again that he can accomplish really great things, and I hope this is one of them.
I think a disaster has already taken place from an economic and social point of view. It’s key one or more of these vaccines make it out of the trials successfully, the vaccines are properly approved, the vaccines are already manufactured and distributed and the vaccines are given to those who want the protection as soon as possible. That’s Trump’s game plan, he is actually implementing it and I definitely support Trump in this.
Wow. Quite a response. Someone might believe that with all that wordage you spewed you actually said something or answered points raised. You did not.
You are blowing smoke in aid of an unprecedented and destructive response to a bug that isn’t even very much of a threat to the people in general. You are making believe that these idiotic masks and fake distancing are actually effective. Why? You CAN’T believe that they would be effective AT ALL if C19 killed half of the people it infected because the distancing is FAKE and the masks are a funny joke. Teleport these ludicrous Americans back to the middle of the pneumonic plague of London and they’d be doomed in the tens of millions. That is NOT hyperbole of a joke or snark: IT IS THE LITERAL TRUTH!
As for the immune system there are elements to it that learn over time and develop responses to invasion. Over time. Via challenges. The specific immune system. You forgot to mention that in your zeal to shoe-horn “microphages” and such into the conversation.
You might want to explain microphagesthingies to the MDs who were and are saying that keeping children out of proximity to one another will be harmful. Maybe the innate immune system is an on/off thing but there’s a lot more to it than just that and you know it.
Now, what about NEXT year? What is your threshold, going forward, for shutting down the country? Since, I’d guess, you were talking your hysterical response when, say, 75000 were dead. is 75,000 the threshold? More? Less? What?
You are putting your own narrow interests ahead of the good of the nation. I can only surmise that you’re afraid for someone or yourself because weakening or taking down a whole nation for 150000 dead or 300000 or even a million isn’t rational. It’s never been done or even contemplated...until now.
Since I doubt you’re an idiot I’m going with Fear.
"Now, what about NEXT year? What is your threshold, going forward, for shutting down the country? Since, I’d guess, you were talking your hysterical response when, say, 75000 were dead. is 75,000 the threshold? More? Less? What?"
My threshold would be when the harm done by the pandemic is clearly and greatly more damaging to the country than a shutdown or lockdown would be. COVID-19 has NEVER reached that, which is why I have NEVER been in favor of a shutdown or lockdown for it. I have always favored Sweden's approach where everything stays open, but with changes that help slow the spread and protect vulnerable people. If this were weaponized smallpox and half the country were at risk of death, I would feel very differently. But SARS-CoV-2 is no smallpox. A shutdown throws people into poverty and that poverty will inevitably lead to many, many unnecessary deaths. It's a panic response to something that warrants no panic; just thoughtful, rational responses to limit the damage it can do.
We should NOT be afraid of COVID-19 or responding to it with panic or fear. We should be taking reasonable, rational steps to preserve human life.
That sounds just fine to me-I trust my own immune system with good reason-not going to f*** with it...
Someone else, can have my CV19 vaccine.
There is NO NEED for a VACCINE. The Front Line Doctors have demonstrated this very well. You are a shill for globalism. One of many to come to this forum.
Funny, it’s the front line doctors posting here who have been looking forward to a vaccine becoming available. Your post seems to be at odds with them.
Your post is also suggesting you think President Trump (whose Operation Warp Speed has committed billions of Federal taxpayer dollars to rapid vaccine development and deployment) is a “shill for globalism”.
Is that what you believe? That President Donald J. Trump is a shill for globalism pushing an unnecessary vaccine on the American people? I’m genuinely curious if you hate President Trump as much as you seem to hate me over this issue.
Yadda Yadda Bladda Bladda. You are a globalist shill.
Same here, and they are welcome to it...
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