The Medical Thread: Vaccine Search / Staying Healthy / Treatments Etc

aka_gerbil

Rooting for the Underdogs
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2,186
Science reporting by the general press almost always leaves something to be desired.

I think people, journalists included, just want this to go away and everything go back to normal--understandable. But, I think that makes people cling to some unrealistic hopes and expectations about how this is all going to go in terms of timeline. Molecular biology techniques have improved so much over the years that it allows candidate vaccines to be made very quickly. That was a good chunk of the battle in the past. Add in our current culture's propensity for wanting things instantly.... it's fueling fantasies at the moment. The scientists who work in this field know the risks, concerns, etc. They are being actively discussed.
 

MsZem

Well-Known Member
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14,200
Moderna starts Phase III trials today, in collaboration with the National Institute of Allergy and Infectious Diseases:
I've actually seen plenty of reporting about side effects in the various vaccine trials, but I would imagine some journalists do a better job than others on this matter.
 

NinjaTurtles

Teenage Mutant
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3,654
Honestly, it’s a little too early to paint a mature safety profile. We need real Phase II/III data to have a statistically meaningful understanding of the adverse events.

Also, interim data from an ongoing blinded trial is carefully safeguarded to protect the scientific integrity of the trial...not everything can come out lest you want to destroy the whole process in the eyes of regulatory authorities and potentially cause mass or differential dropout in the participants.

DSMBs are being set up now for some of these trials and they’re being stacked with some of the best clinicians and statisticians isn’t the field...let’s see what they think of the safety and efficacy as they monitor.
 

MsZem

Well-Known Member
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14,200
Is phase 2/3 also with randomly assigned placebo or do all get the vaccine?
I did post a link...

Anyway:
The Phase 2/3 trial is designed as a 1:1 vaccine candidate to placebo, randomized, observer-blinded study to obtain safety, immune response, and efficacy data needed for regulatory review. The trial’s primary endpoints will be prevention of *********-19 in those who have not been infected by SARS-CoV-2 prior to immunization, and prevention of *********-19 regardless of whether participants have previously been infected by SARS-CoV-2. Secondary endpoints include prevention of severe *********-19 in those groups. The study also will explore prevention of infection by SARS-CoV-2, the ***** that causes *********-19. The primary efficacy analysis will be an event-driven analysis based on the number of participants with symptomatic *********-19 disease. The trial design allows for interim analyses and unblinded reviews by an independent external Data Monitoring Committee.
Data collection at multiple sites in different countries.
 

Hedwig

WoolSilk Fanatic
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18,473
Thanks. I meant generally but that is of course part of the answer as well.
sometimes no placebo is used in such trials for ethical reasons and I wonder if that is discussed in some vaccine Trials as well. 🤔
But of course a placebo based approach gives a more complete picture about side effects.
it will be interesting to read how the rest of the trials will be.
 

Cachoo

Well-Known Member
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8,041
I found this at another site---my concern is what we don't know about this *****: Second, there are serious concerns among researchers in Europe and in the US looking at patients who have recovered that major organ damage is occurring due to the inflammatory response AND there could be significant long-term neurological consequences that are not only invisible to most patients but also appear later in life. In other words, mass scale integrated system damage in recovered patients, even those without symptoms.

I've been reading about a 27-year-old professional baseball player who was positive and now has a heart ailment. If you know the rigorous physicals these professional athletes go through before they take the field you know it is unlikely the doctors missed a heart ailment. As much as I want football season I know there is no keeping them from contact and *********. And children and schools and so on and so on.....
 

Sylvia

Wishing I could go back to the Lake Placid JGP
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62,881
From the British Heart Foundation:


ABC News - The heart: Before, during and after *********-19
*********-19 can not only exacerbate existing heart problems, but cause new ones.
From STATnews:
Taken together, the two studies, published Monday in JAMA Cardiology, suggest that in many patients, *********-19 could presage heart failure, a chronic, progressive condition in which the heart’s ability to pump blood throughout the body declines. It is too soon to say if the damage in patients recovering from *********-19 is transient or permanent, but cardiologists are worried.

“These are two studies that both suggest that being infected with *********-19 carries a high likelihood of having some involvement of the heart. If not answering questions, [they] prompt important questions about what the cardiac aftermath is,” said Matthew Tomey, a cardiologist and assistant professor of medicine at the Icahn School of Medicine at Mount Sinai Health System in New York. He was not involved in either study.
ETA:

Another summary of the 2 studies by CIDRAP at Univ. of MN:

USA Today:
 
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ballettmaus

Well-Known Member
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15,338
From STATnews:

I just heard an opinion (from a German journalist no less) that stated that not sending students back to school would be punishment for students. Sure, they only have their whole life ahead of them but wanting to protect them from things like lifelong heart damage is punishment. :wall: Whatever happened to informed opinions and informed journalists?
 

taz'smum

as @Jesche says - мама knows best
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2,425
It seems that you need to have 2 doses of the vaccine for it to be effective.

The side-effects from the 2nd dose seem like it will be hard to sell it to the general public.
Especially given the people involved in the testing have been handpicked fit and healthy young people

By the time they’d had two doses, every single one was showing signs of headaches, chills, or fatigue, and for at least 80 percent, this could have been enough to interfere with their normal activities. A participant who had a severe reaction to a particularly high dose has talked in detail about how bad it was: If reactions even half as bad as this were to be common for some of these vaccines, they will be hard sells once they reach the community—and there could be a lot of people who are reluctant to get the second injection.
 

aka_gerbil

Rooting for the Underdogs
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2,186
Needing more than one dose of a vaccine is fairly typical. The immune system often needs to see the vaccine antigen more than once in order to be trained to remember it.

For at least a couple of decades now, there has been research directed towards nucleic acid based vaccines. The side effects from the second dose of the Moderna vaccine were what a lot of scientists were expecting based on past work with other nucleic acid vaccines. When they first announced the Moderna candidate, my boss made the comment to me that he was doubtful this would be the one. The side effects of nucleic acid vaccines were one of his reasons. The other is that they just haven’t worked that well in the end.

Thankfully, there are a lot of other candidates under study that use different technology. I know the public is eager for their to be a vaccine. I just wish more people would get that it’s probably not going to be the Moderna candidate and it may not be one of the other early candidates either.
 

Orm Irian

Well-Known Member
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888

Sylvia

Wishing I could go back to the Lake Placid JGP
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62,881
The Australian requires an online subscription to read - can you summarize please, @Orm Irian?

CBS Baltimore report:
A reasonable timeline for wide distribution of vaccines is likely the end of 2021, according to Dr. Bar-Zeev.

“Even after we have a vaccine that works and even after we demonstrate its safety and efficacy and even after we’ve produced enough doses to go around, at least for the first round, we still need to get it delivered and that’s going to be a big challenge,” Dr. Bar-Zeev said. “What we’re seeing is science live in real time. I think in the long run, that’s good for science and that’s good for community trust. In the short run, it leaves people feeling a little bit, say, uncomfortable.”
 
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MsZem

Well-Known Member
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14,200
This is the test in question:

And there's some dispute about intellectual property rights; if this is indeed something workable, I hope that won't delay it:
 

Hedwig

WoolSilk Fanatic
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18,473
I know but I cannot figure it out on my mobile and you get to the article anyway if you click on the link

eta thanks!
 

hoptoad

Well-Known Member
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1,610
Good layman's article on airborne transmission and possible prevention strategies:


There are two key mitigation strategies for countering poor ventilation and *****-laden aerosols indoors: We can dilute viral particles’ presence by exchanging air in the room with air from outside (and thus lowering the dose, which matters for the possibility and the severity of infection) or we can remove viral particles from the air with filters.
 

Orm Irian

Well-Known Member
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888
Ha, today I was actually able to track down a better article than the one in The Ausfailian. This is from the Royal Australian College of GPs, and goes into more detail about both the vaccine and the study.

Short version: the vaccine (COVAX-19) targets the spike protein that the lurgi uses to attach to human cells. It's based on a SARS vaccine that was effective in monkeys, and is made from a synthetic protein derived from plant sugars. It aims to produce long-lasting antibodies, and has produced both antibodies and T-cell responses in test volunteers plus no side effects. However, it was a small phase 1 trial (30 live vaccine recipients + 10 placebo) and the results are preprint (not peer reviewed yet), so scaling up is going to be very important in seeing how it does.

They think the vaccine will probably be one of the ones where you get an initial dose and then a booster every five to ten years.

Phase 2 trials will start in September, and they're offering to set up some of those in the Victorian aged care system, which is a big site of the current Vic outbreak.

Just because this was a small trial doesn't mean it's shonky, by the way. Flinders University is highly reputable and Vaxine (the company) has been around for a long time and produced one of the earliest effective swine flu vaccines.
 

Immortelle

Well-Known Member
Messages
1,021
Ha, today I was actually able to track down a better article than the one in The Ausfailian. This is from the Royal Australian College of GPs, and goes into more detail about both the vaccine and the study.

Short version: the vaccine (COVAX-19) targets the spike protein that the lurgi uses to attach to human cells. It's based on a SARS vaccine that was effective in monkeys, and is made from a synthetic protein derived from plant sugars. It aims to produce long-lasting antibodies, and has produced both antibodies and T-cell responses in test volunteers plus no side effects. However, it was a small phase 1 trial (30 live vaccine recipients + 10 placebo) and the results are preprint (not peer reviewed yet), so scaling up is going to be very important in seeing how it does.

They think the vaccine will probably be one of the ones where you get an initial dose and then a booster every five to ten years.

Phase 2 trials will start in September, and they're offering to set up some of those in the Victorian aged care system, which is a big site of the current Vic outbreak.

Just because this was a small trial doesn't mean it's shonky, by the way. Flinders University is highly reputable and Vaxine (the company) has been around for a long time and produced one of the earliest effective swine flu vaccines.
Well they’ve got a good base for trials in Victoria, maybe Queensland too now there’s a risk to aged care residents there as well.
 

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