COVID Vaccine (2)

[X3 Skier]

I'm not a doctor nor do I play one on TV.

But a couple of comments:

"don't know" means just that, don't know.

Did any of the vaccine trials include a test objective evaluating the ability to spread the virus?

Did any of the vaccine trials include a test objective wrt long term effects?

To the best of my knowledge, the answer to both questions is "no".

"don't know" means just that, don't know.

If two years is considered “long term”, the Moderna trial I’m enrolled in had always planned to and will be tracking me and others who remain in the study. Those who choose to be unblinded and received the Placebo can choose to be Vaccinated. If everyone who initially volunteered remain, that would be 30000 to track with likely all Vaccinated. I believe this is true for Pfizer and other trials.

So the answer to question two is Yes. The only thing that changed was the issuance of an EUA.

Cheers

 

[PlasticCigar]

I agree with you to an extent, but I also disagree.

I think EVERYTHING on the internet should be taken with a grain of salt, however, that doesn’t mean it’s all untrue.

I’m assuming you’re not working in an ER or ICU setting because most of the people I know who work in those settings do post some basic information online to try to counteract the rampant misinformation that had caused a lot of harm during this pandemic and, unfortunately, has caused us to be where we are today.

Unlike you, I AM going to post some COVID information:
1) Masks reduce your risk of getting sick from COVID and reduce your risk of transmission to others.
2) The vaccine has been shown to be safe and effective.
3) Avoiding large gatherings, social distancing and avoiding meeting indoors saves lives.

Feel free to take the above with a grain of salt regardless of my qualifications (MD, MPH, FACEP in case you are interested).

When you went to dinner parties and someone talked about the low-wing “Cessna” that “crashed because the engine stalled” did you just smile and nod, or did you feel completed to correct the obvious misinformation that was being shared about something that you’re very passionate about? Some of us feel the same way about COVID.

I feel comfortable calling myself an “expert” in the clinical syndrome associated with COVID because I’ve seen at least a couple hundred people with it all the way from the asymptomatic stage to the terminal one. That being said, I’m sticking to pretty mainstream stuff here that’s generally accepted by the majority of the medical community and trying not to disguise my personal opinions as fact. If I’ve said anything here you find factually incorrect, I would welcome you to point it out.

That being said, I do agree that it’s generally not a good practice to take medical advice from an Internet forum. Or a politician. Or a newscaster.

Regardless of stated credentials, there's no way to gauge competence on an internet discussion forum. I'm a physician, but virology, epidemiology, and vaccine science are way outside of my areas of expertise, so I likewise take an MD posting COVID information here, if there are any MDs posting COVID information here, with several grains of salt. Suffice it to say that I don't come to aviation discussion forums for reliable information of any aspect of medical practice.

 

[chemgeek]

Did any of the vaccine trials include a test objective evaluating the ability to spread the virus?

Did any of the vaccine trials include a test objective wrt long term effects?

To the best of my knowledge, the answer to both questions is "no".

"don't know" means just that, don't know.

There is some useful data however. For the Pfizer and I believe also the Moderna vaccine, preclinical challenge trials in primates suggest that it prevents both nasal and lung infection. The AstraZeneca vaccine protected against lung, but not nasal infection. These studies were available in preprint some time ago. These admittedly limited results suggest that the mRNA vaccines may prevent spread, but perhaps not for the AstaZeneca vaccine. However, primates are not humans, and the studies were small. The ethics of challenge studies in humans is questionable, so we will have to wait and see as the vaccine is deployed to know more. Even a vaccine that only protects against disease is extremely valuable.

For the second question we know only potential adverse effects incidence up to two months for 15,000 individuals or more in each study. Most, but not all adverse effects occur within 2 months, which is why that time frame was chosen for starting the EUA process. This is the big compromise being made to get vaccines into rapid distribution. Likely this is a good compromise, otherwise it would normally be years before we could deploy these vaccines at all. I think most medical experts would agree that is unacceptable given the relative risks of vaccines vs. Covid.

So, of course we don't completely know the answers to these questions, but there is some encouraging supporting evidence on these questions. In science, you can never know everything for sure.

 

[Bob Noel]

please don't misunderstand me. I'm not saying any lack of test objectives wrt long term effects or virus spread was a bad thing.

 

[Matthew Rogers]

I'm not a doctor, and I am certainly not an anti-vaccer, just a retired scientist, but I do read a couple of medical journals, including the British and New England journals.
The testing for the vaccines was seriously flawed, done in such a way that it's virtually impossible for the test to fail. That's the conclusion of both journal articles.
The esteemed Dr. Fauci is closely $$$$ affiliated with Modena. Check out the financial reports for yourself.
Neither vaccine will prevent someone who as been vaccinated from spreading the disease.
There has obviously been no testing for long term effects, which can be a serious issue with any vaccine. Remember the problems with the "live" polio vaccine decades after people were vaccinated?
A couple of flu vaccines in the last 15 years have killed more people than they cured.
Personally, I'm going to wait awhile.

And COVID is causing plenty of long-term side effects in a wide range of people from those with serious cases to those with asymptomatic cases. A 21 yo college basketball player recently collapsed on the court and has serious heart damage, people are getting severe mental illnesses after mild cases, long term effects are unknown, and plenty of deaths may still be ahead from COVID complications. The vaccine sure sounds like a safer bet.

 

[Bob Noel]

And COVID is causing plenty of long-term side effects in everyone from those with serious cases to those with asymptomatic cases. A 21 yo college basketball player recently collapsed on the court and has serious heart damage, people are getting severe mental illnesses after mild cases, long term effects are unknown, and plenty of deaths may still be ahead from COVID complications. The vaccine sure sounds like a safer bet.

"COVID is causing plenty of long-term side effects in everyone from those with serious cases to those with asymptomatic cases."... um, the very definition of "asymptomatic" would preclude any long term side effects, wouldn't it? oh, and "everyone" has long term side effects? everyone? based on what?

However, I don't disagree that the vaccine sounds like a safer bet.

 

[Matthew Rogers]

"COVID is causing plenty of long-term side effects in everyone from those with serious cases to those with asymptomatic cases."... um, the very definition of "asymptomatic" would preclude any long term side effects, wouldn't it? oh, and "everyone" has long term side effects? everyone? based on what?

However, I don't disagree that the vaccine sounds like a safer bet.

I meant "everyone" referring to the range of cases from those with little to no symptoms to those with severe cases and months of hospitalization developing COVID-related but newly discovered long term effects. I will change the wording.

Most people say a case is asymptomatic if you don't have acute symptoms (or very mild symptoms that people pass off as other things) in the near term. These other effects are months after contracting the virus and after recovering from any "active" infection. Otherwise you would never be able to declare any virus, bacteria, or disease to have asymptomatic cases, as you could always develop something related months, years, decades down the line that has not been discovered.

 

[MacFly]

I agree with you to an extent, but I also disagree.

I think EVERYTHING on the internet should be taken with a grain of salt, however, that doesn’t mean it’s all untrue.

I’m assuming you’re not working in an ER or ICU setting because most of the people I know who work in those settings do post some basic information online to try to counteract the rampant misinformation that had caused a lot of harm during this pandemic and, unfortunately, has caused us to be where we are today.

Unlike you, I AM going to post some COVID information:
1) Masks reduce your risk of getting sick from COVID and reduce your risk of transmission to others.
2) The vaccine has been shown to be safe and effective.
3) Avoiding large gatherings, social distancing and avoiding meeting indoors saves lives.

Feel free to take the above with a grain of salt regardless of my qualifications (MD, MPH, FACEP in case you are interested).

I'm a surgeon. If I take care of a COVID patient, it's because it's a concomitant surgical emergency, or it's by accident...operating on someone who later proves to be COVID positive. My interaction with those patients is narrowly focused and their upper respiratory problem is a side issue for me.

Condescension aside, I'm sure that you're a really smart guy. Glad there are people with your passion addressing this issue on the front lines.

 

[denverpilot]

I wasn't confused by his statement about his background, because he didn't specify which branch of science he retired from, and scientists don't always agree, in any case. Anyone can subscribe to medical journals, as far as I know. As a layman, I don't know what to make of the opinions he's relaying without reading the actual sources.

As laymen, even reading the sources we don’t know what to make of all the opinions. LOL.

Which is why sticking to the math usually works out better.

 

[denverpilot]

And COVID is causing plenty of long-term side effects in a wide range of people from those with serious cases to those with asymptomatic cases. A 21 yo college basketball player recently collapsed on the court and has serious heart damage, people are getting severe mental illnesses after mild cases, long term effects are unknown, and plenty of deaths may still be ahead from COVID complications. The vaccine sure sounds like a safer bet.

As asked and not answered before, define “plenty” in a quantifiable number and compare it to similar diseases.

Just sayin’. The word “plenty” based upon anecdotes from news media is a meaningless term in regards to proper mathematical risk analysis.

Of course we can’t actually do that analysis because we can’t get a correct count of cases, so ... make of that what you will.

At least one front liner here said they saw “more” with Covid but we still don’t have proper numbers on it and likely never will have truly accurate numbers until it’s long over with.

 

[David Megginson]

I'm a surgeon. If I take care of a COVID patient, it's because it's an emergency, or it's by accident, but my interaction with them is narrowly focused and their upper respiratory problem is a side issue for me.

Not a direct response to @MacFly, but I think it's entirely legitimate (and valuable) for people to post about their own experiences with C19, whether as health workers, caregivers, people infected, or their friends and family members.

As long as people stick to what they've actually experienced, there's a lot of value in qualitative info, personal stories to supplement (not replace) the impersonal quantitative data that describes the big picture.

 

[weilke]

"COVID is causing plenty of long-term side effects in everyone from those with serious cases to those with asymptomatic cases."... um, the very definition of "asymptomatic" would preclude any long term side effects, wouldn't it? oh, and "everyone" has long term side effects? everyone? based on what?

You can be asymptomatic when it comes to the the typical manifestations of acute covid-19 yet a few weeks later show up with lab and imaging evidence of myocarditis.

 

[Jim K]

I haven't been following this thread for the last couple weeks, but this morning I got an email that all the firefighters & ems in the county were eligible to get the Moderna vaccine if they wanted it. I was still undecided, but finally made an appointment and went and got stuck this afternoon. If I turn into a zombie I'll let you know. So far so good, although the injection site is sore. Second dose is in one month.

I did go fly before my appointment since I'm now grounded for 48 hours.

 

[MacFly]

Put the vaccination off for awhile, skipped the first round, but ultimately decided to go ahead. I got the first vaccination this morning (Pfizer) about 18 hours ago, feel fine. No big deal, no side effects (so far). Second dose in a couple of weeks. I'm now grounded for 48 hours, I guess, but I'm down for awhile right now anyway, so....works for me...

 

[Bob Noel]

You can be asymptomatic when it comes to the the typical manifestations of acute covid-19 yet a few weeks later show up with lab and imaging evidence of myocarditis.

Then you weren't asymptomatic.

 

[Matthew Rogers]

Then you weren't asymptomatic.

Fine, let’s change the way that all the doctors, health organizations (CDC, WHO) and news organizations have been reporting statistics just for you. We will now call it “short term acutely asymptomatic” as in you didn’t have symptoms in the period of X weeks after you were exposed to the virus.

Are you happy now?

 

[GeorgeC]

wrt vaccination, is there any guidance for folks who already have antibodies?

 

[Bob Noel]

Fine, let’s change the way that all the doctors, health organizations (CDC, WHO) and news organizations have been reporting statistics just for you. We will now call it “short term acutely asymptomatic” as in you didn’t have symptoms in the period of X weeks after you were exposed to the virus.

Are you happy now?

Let's change the definition of words on the fly.... so that words used don't have any actual meaning.

are YOU happy now?

what's the opposite of "pollyanna"?

 

[X3 Skier]

wrt vaccination, is there any guidance for folks who already have antibodies?

I have no clue. If no one else does, I’ll ask the Trial Staff during my next contact.

Cheers

 

[X3 Skier]

I received this a couple of weeks ago. Waiting for the bureaucracy to grind away.



“A Personal Message from the Principal Investigators

Thank you again for your participation in the Moderna trial. You made history! You are helping us out of the pandemic. We have one more personal favor to ask. Please consider waiting to receive your vaccine from us when we unblind everyone after the FDA approval and protocol update. Every Moderna participant will get the vaccine. If you already got the real vaccine, you will continue on the study as before. If you received placebo, you will get the vaccine. By waiting just a couple of weeks (for some of you), you will continue to allow us to study and understand how long this vaccine will be helpful to people, any longer term side effects and you will allow others the opportunity to receive vaccine faster in our community. This is very important for stopping the spread of Covid disease, to get as many people vaccinated as soon as we can. We understand human nature and the urge to get vaccine now if you can, what we are asking is for you to wait a few weeks till we have approval to give every study participant who got placebo their vaccine. Thanks for considering this and thank you for your participation in the trial. You are making this a better world!”


Cheers

 

[TCABM]

wrt vaccination, is there any guidance for folks who already have antibodies?

CDC position is that it can’t hurt, but there’s a cooling off period before getting the shots.

“Due to the severe health risks associated with COVID-19 and the fact that re-infection with COVID-19 is possible, people may be advised to get a COVID-19 vaccine even if they have been sick with COVID-19 before.”

https://www.cdc.gov/coronavirus/2019-ncov/vaccines/vaccine-benefits/facts.html

The kicker is that duration of immunity for either having it or the vaccine is unknown. Could become like the flu shot for all we know right now...suggested on an annual basis.

 

[David Megginson]

I did go fly before my appointment since I'm now grounded for 48 hours.

I think the 48 hour grounding is a good idea. Transport Canada doesn't require it--up here, you can hop straight in the plane right after your jab. I always voluntarily ground myself 48 hours after a vaccine anyway (I've had lots for work travel to the tropics), because I'm often not at my best for a day or so.

 

[weilke]

Then you weren't asymptomatic.

Covid presents 2-14 days after exposure with one or more of the following symptoms:

• Fever or chills
• Cough
• Shortness of breath or difficulty breathing
• Fatigue
• Muscle or body aches
• Headache
• New loss of taste or smell
• Sore throat
• Congestion or runny nose
• Nausea or vomiting
• Diarrhea

If someone doesn't develop any of those symptoms yet tests positive on either RT-PCR or viral culture, they are considered 'asymptomatic cases'.

If someone presents later with lab or imaging evidence of damage typical for past covid infection, it does not retroactively change their symptom status during the acute infection.

 

[weilke]

I received this a couple of weeks ago. Waiting for the bureaucracy to grind away.
....

Unless you are part of one of the groups 1 or 2 and eligibile for fairly early vaccination, odds are you are going to get it through the study faster than through the community route.

 

[Matthew Rogers]

Let's change the definition of words on the fly.... so that words used don't have any actual meaning.

are YOU happy now?

what's the opposite of "pollyanna"?

Your semantical badgering doesn’t bring anything to the forum. Thanks for nothing.

 

[David Megginson]

Unless you are part of one of the groups 1 or 2 and eligibile for fairly early vaccination, odds are you are going to get it through the study faster than through the community route.

Yes, but the good news is that the UK just approved the Oxford vaccine today. I'm sure that Health Canada and the U.S. FDA won't be far behind. That will add a third vaccine to the rotation, and hopefully speed things up.

The Oxford vaccine was less effective than Pfizer or Moderna in the main trial, but a subgroup that received only a half dose for the first jab suggests it can get up to 90% by tweaking the doses (more research needed, of course). And the good news is that the Oxford vaccine costs only 10% as much as the others per dose, and needs only normal refrigeration, so it's suitable for use in poorer countries and remote areas of richer ones.

 

[David Megginson]

Your semantical badgering doesn’t bring anything to the forum. Thanks for nothing.

I wish it were possible to block individual users, like on Twitter (from your post, I can see you'd probably feel the same).

I love intelligent disagreement -- I'd never want to block someone for having a different opinion than mine on LOP, high wing vs low wing, stabilised approaches, preventative maintenance, preheating, etc etc. -- but a certain type of post just doesn't add value to threads.

 

[nauga]

I wish it were possible to block individual users, like on Twitter (from your post, I can see you'd probably feel the same).

Click on a username, in the small popup that appears, to the far right of the row about 1/3 of the way down select 'ignore.' You can also add or remove users to/from your ignore list in your user profile.

Nauga,
doing his part

 

[X3 Skier]

Unless you are part of one of the groups 1 or 2 and eligibile for fairly early vaccination, odds are you are going to get it through the study faster than through the community route.

I’m 99% certain I had already been Vaccinated back in Sept and just waiting for verification

Cheers

 

[weilke]

Yes, but the good news is that the UK just approved the Oxford vaccine today. I'm sure that Health Canada and the U.S. FDA won't be far behind. That will add a third vaccine to the rotation, and hopefully speed things up.

The Oxford vaccine was less effective than Pfizer or Moderna in the main trial, but a subgroup that received only a half dose for the first jab suggests it can get up to 90% by tweaking the doses (more research needed, of course). And the good news is that the Oxford vaccine costs only 10% as much as the others per dose, and needs only normal refrigeration, so it's suitable for use in poorer countries and remote areas of richer ones.

I am not even sure it is 'less effective'. The Oxford trial actually did surveillance testing on their participants. I would have to dig through their approval data to see how their 'effectiveness' measure compares to that used by Moderna and Pfizer.

A 'less effective' vaccine that has fewer distribution constraints may actually be the faster way to get mass vaccinations done.

 

[David Megginson]

A 'less effective' vaccine that has fewer distribution constraints may actually be the faster way to get mass vaccinations done.

Agreed. 150 million people in the U.S. inoculated with even just a "65% effective" vaccine would do a lot more to slow down the disease than 15 million people inoculated with a "95% effective" vaccine.

 

[David Megginson]

Click on a username, in the small popup that appears, to the far right of the row about 1/3 of the way down select 'ignore.' You can also add or remove users to/from your ignore list in your user profile.

Nauga,
doing his part

Thanks! I wasn't aware of that option in this forum software.

 

[weilke]

I’m 99% certain I had already been Vaccinated back in Sept and just waiting for verification

Cheers

Well, 0.5% of the recipients of the Pfizer placebo (saline) had a reaction severe enough to discontinue the study ;-)

 

[weilke]

Agreed. 150 million people in the U.S. inoculated with even just a "65% effective" vaccine would do a lot more to slow down the disease than 15 million people inoculated with a "95% effective" vaccine.

It's going to be challenging to get the mRNA vaccines into every vaccine fridge in every doctors office and, pharmacy, Krogers, Safeway and Walmart. We have the infrastructure to administer 170mil flu doses in a 3 month season every year, we should be able to leverage that infrastructure to get the covid thing done.

 

[David Megginson]

Well, 0.5% of the recipients of the Pfizer placebo (saline) had a reaction severe enough to discontinue the study ;-)

This placebo thing is a highly-dangerous drug, given all the serious reactions reported in thousands of trials over the past century or so. We should ban it.

 

[X3 Skier]

Well, 0.5% of the recipients of the Pfizer placebo (saline) had a reaction severe enough to discontinue the study ;-)

Based on my reaction from the shots and positive antibodies verified from another experiment to develop a rapid COVID Test using saliva I was in, I’ll take a bet. Still mask wearing, etc though.

Cheers

 

[Lindberg]

From many news reports and Facebook posts by the people who got the vaccines bragging about them.

“ParCare, a well-known network of six clinics that serves Orthodox Jewish neighborhoods in Brooklyn and upstate Orange County, openly bragged that it had 3,500 doses of the Moderna vaccine.”
https://www.nydailynews.com/coronavirus/ny-covid-20201226-eg3fuoc5mzex5ofqvnalslvape-story.html

“But it’s clear that those vaccinated by ParCare include prominent Orthodox leaders. Rabbi Hershel Schachter and Rabbi Mordechai Willig, both head teachers at Yeshiva University, were vaccinated at ParCare last week, and the network tweeted a video of their vaccinations. Neither Schachter, 79, nor Willig, 73, is a frontline health care worker or nursing home resident or worker, the two categories currently eligible for vaccines.”
https://www.timesofisrael.com/half-...clinic-under-investigation-unsure-whats-next/

You mean the Joos? They control everything, so of course they'll get the vaccine first. I didn't know we allowed this sort of garbage here.

But since we're on the subject, my friend who's an orthopedic surgeon, doesn't treat COVID patients, and doesn't see anyone who hasn't been screened for COVID got the shot already because she's a medical professional. Can you explain, without resorting to religious stereotypes, why she should be in line ahead of an elderly community leader who interacts with hundreds of unscreened community members on a weekly or daily basis?

 

[chemgeek]

wrt vaccination, is there any guidance for folks who already have antibodies?

The general advice is that unless you received recombinant antibody treatments (e.g. Regeneron) for COVID (which would interfere with the immune response to the vaccine for up to 3 months) it is not only safe, but beneficial to receive a COVID vaccine. There are a couple of reasons: (1) the immunity developed via natural infection is highly variable, and (2) the vaccines generate an immune response that is for almost all individuals many times greater than that for convalescent patients as measured by antibody and T-cell response, and is likely to be more reliably consistent among individuals. For most, the vaccines are likely to produce a longer-lasting immune response based on the typical antibody and T-cell titers. (We will know more when the Phase 3 trial participant data starts getting extended in time. At this point we have good data for a 3 month timeline.)

 

[SoonerAviator]

You can be asymptomatic when it comes to the the typical manifestations of acute covid-19 yet a few weeks later show up with lab and imaging evidence of myocarditis.

Wouldn't it be a bit presumptuous to attribute myocarditis to COVID-19 unless the symptoms were concurrent with the infection? Kind of like seeing a bruise/cut and not knowing how it got there.

 

[kyleb]

Can you explain, without resorting to religious stereotypes, why she should be in line ahead of an elderly community leader who interacts with hundreds of unscreened community members on a weekly or daily basis?

Because we're gonna have enough problems distributing the vaccine to a half dozen tiers of people. Creating enough carve-outs to prioritize on "one-off" needs would take longer than developing the vaccine, and then implementing the vaccination priorities would turn into a nightmare. You'd need a flowchart-ologist to figure out who's next in line.