TOPIC: Try discussing here....

Brad Mortensen wrote: And yes, part of both computer and medical science is thorough testing - a step these vaccines skipped.

Sincere question: Brad, what aspect of thorough vaccine testing do you believed was skipped in the case of the COVID vaccines? What should have been done that was not done?

I ask because my asthma specialist (a professor at Northwestern here in Chicago) told me something I didn’t know a few months ago when discussing the COVID vaccines. (This was after he was eligible for, and had gotten the vaccine, but before I could get it.) He said that it is extremely rare for a vaccine to cause negative side effects that appear more than 6-8 weeks after administration of the vaccine. The CDC agrees :

“Serious side effects that could cause a long-term health problem are extremely unlikely following any vaccination, including COVID-19 vaccination. Vaccine monitoring has historically shown that side effects generally happen within six weeks of receiving a vaccine dose.”

That information helped put my mind at ease about the safety of the vaccines. The FDA required study participants to be followed for at least 8 weeks not to rush the vaccines, but because that period conforms to what we know about when side effects are most likely to appear.

At this point, in the US, there are study participants that have been vaccinated for more than a year. Health care professionals who received the vaccine in December 2020 are coming up on six months post-vaccination. The only major safety signals we have seen are (1) anaphylactic reactions, which happen with every vaccine, and (2) the rare clotting complication for the J&J vaccine (~3 in 1,000,000). The first reaction happens within minutes of the shot. That’s why they have people wait 15 minutes, or 30 minutes if you know you are likely to have that reaction. The second happens within 2-3 weeks, and that’s why they’ve warned doctors to be on the lookout for it up to four weeks after vaccination for people who get J&J.

Is it possible that one or more of the COVID vaccines will be the exception to the general rule, and will cause some negative side effect months or years after vaccination? I suppose, in the sense that anything is possible. However, given the real world data and how vaccines work, it seems very unlikely. In contrast, we know COVID has killed hundreds of thousands of Americans, and has left many others with severe ongoing health issues. For me, that balance weighed toward getting vaccinated.

Everyone should make the decision that is best for them. I’m not trying to talk anyone into getting a shot that they believe is dangerous. (I am NOT a doctor! People should talk to their own doctors about this.) But I did feel compelled to mention that vaccine side effects appearing after ~6 weeks are rare.

I would like every member of our TD community to make it through this terrible pandemic. I hope everyone is taking steps to keep themselves safe. If those steps do not include vaccines, please continue masking and social distancing.

@Belinda - it’s my understanding that animal trials were halted early, and the test process that normally takes a couple years was shortened. There wasn’t a lot testing around interactions with other drugs or with various pre-existing conditions. I’m not saying no testing was done, but in software terms it seems like we’re using an alpha or maybe beta tested vaccine.

But I would think that if the FDA thought it had been adequately tested it would be approved for use, not just given emergency use authorization based on lack of treatments, which we now know existed since the beginning. So technically they should be retracting their EUA.

Your question might be more appropriately asked of the FDA what more testing they require, because I’m not a doctor

Brad Mortensen wrote: @Belinda - it’s my understanding that animal trials were halted early, and the test process that normally takes a couple years was shortened. There wasn’t a lot testing around interactions with other drugs or with various pre-existing conditions. I’m not saying no testing was done, but in software terms it seems like we’re using an alpha or maybe beta tested vaccine.

But I would think that if the FDA thought it had been adequately tested it would be approved for use, not just given emergency use authorization based on lack of treatments, which we now know existed since the beginning. So technically they should be retracting their EUA.

Your question might be more appropriately asked of the FDA what more testing they require, because I’m not a doctor

The vaccines have the same testing, whether it is an EUA or normal approval. The EUA only speeds up manufacturing and administrative processes. The main difference is that it allows for production of the vaccine at the same time as testing occurs, saving a ton of time. If it isn't found to be safe, they destroy what what was produced.

vaccine.unchealthcare.org/science/vaccine-approval/whats-the-difference-between-fda-emergency-use-authorization-and-fda-approval/

Brad Mortensen wrote: @Belinda - it’s my understanding that animal trials were halted early, and the test process that normally takes a couple years was shortened. There wasn’t a lot testing around interactions with other drugs or with various pre-existing conditions. I’m not saying no testing was done, but in software terms it seems like we’re using an alpha or maybe beta tested vaccine.

But I would think that if the FDA thought it had been adequately tested it would be approved for use, not just given emergency use authorization based on lack of treatments, which we now know existed since the beginning. So technically they should be retracting their EUA.

Your question might be more appropriately asked of the FDA what more testing they require, because I’m not a doctor

As I understand, in software terms, we have a Java class (let’s call it mRNA.vaccine) that was well tested and used in a different product (sars). Now we are importing that class into a new product (covid-19). Given the class was already well tested, we are much less concerned about the mRNA.vaccine class giving us any troubles.

Brad Mortensen wrote: @Belinda - it’s my understanding that animal trials were halted early, and the test process that normally takes a couple years was shortened. There wasn’t a lot testing around interactions with other drugs or with various pre-existing conditions. I’m not saying no testing was done, but in software terms it seems like we’re using an alpha or maybe beta tested vaccine.

But I would think that if the FDA thought it had been adequately tested it would be approved for use, not just given emergency use authorization based on lack of treatments, which we now know existed since the beginning. So technically they should be retracting their EUA.

Your question might be more appropriately asked of the FDA what more testing they require, because I’m not a doctor

Pfizer and Moderna have both applied for full FDA approval of their vaccines.

balthasar wrote:

Brad Mortensen wrote: @Belinda - it’s my understanding that animal trials were halted early, and the test process that normally takes a couple years was shortened. There wasn’t a lot testing around interactions with other drugs or with various pre-existing conditions. I’m not saying no testing was done, but in software terms it seems like we’re using an alpha or maybe beta tested vaccine.

But I would think that if the FDA thought it had been adequately tested it would be approved for use, not just given emergency use authorization based on lack of treatments, which we now know existed since the beginning. So technically they should be retracting their EUA.

Your question might be more appropriately asked of the FDA what more testing they require, because I’m not a doctor

The vaccines have the same testing, whether it is an EUA or normal approval. The EUA only speeds up manufacturing and administrative processes. The main difference is that it allows for production of the vaccine at the same time as testing occurs, saving a ton of time. If it isn't found to be safe, they destroy what what was produced.

vaccine.unchealthcare.org/science/vaccine-approval/whats-the-difference-between-fda-emergency-use-authorization-and-fda-approval/

This is exactly how the vaccine became available so quickly. Not from cutting corners, but by running the various steps at the same time instead of sequentially. This was possible because so much money was being put into it that it was affordable to do so. Normally, budgets require waiting for one thing to be complete before working on another step, because it would be wasteful if the previous step didn't work out. But dealing with covid is so important that time was more important then money.

I'll just leave this right here. Think it explains it's self.

CDC says vaccine link to heart inflammation is stronger than previously thought

Although it has not been officially confirmed to be an associated problem, the agency is investigating 226 cases of myocarditis and pericarditis among young, vaccinated men.

By
Christian Spencer | June 14, 2021

thehill.com/changing-america/well-being/prevention-cures/558321-cdc-says-vaccine-link-to-heart-inflammation-is

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CDC calling emergency meeting over reports of heart inflammation in some adolescents after getting COVID vaccine

www.wtnh.com/news/health/coronavirus/concerns-grow-over-reports-of-heart-inflammation-in-teens-tweens-after-getting-covid-vaccine-cdc-calling-emergency-meeting/

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Women Are Reporting Worse Side Effects From the COVID-19 Vaccine—Here’s Why Experts Think That’s Happening

www.health.com/condition/infectious-diseases/coronavirus/covid-vaccine-side-effects-women

Rebeg wrote: I'll just leave this right here. Think it explains it's self.

CDC says vaccine link to heart inflammation is stronger than previously thought

Although it has not been officially confirmed to be an associated problem, the agency is investigating 226 cases of myocarditis and pericarditis among young, vaccinated men.

By
Christian Spencer | June 14, 2021

thehill.com/changing-america/well-being/prevention-cures/558321-cdc-says-vaccine-link-to-heart-inflammation-is

---

CDC calling emergency meeting over reports of heart inflammation in some adolescents after getting COVID vaccine

www.wtnh.com/news/health/coronavirus/concerns-grow-over-reports-of-heart-inflammation-in-teens-tweens-after-getting-covid-vaccine-cdc-calling-emergency-meeting/

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Women Are Reporting Worse Side Effects From the COVID-19 Vaccine—Here’s Why Experts Think That’s Happening

www.health.com/condition/infectious-diseases/coronavirus/covid-vaccine-side-effects-women

Both of those conditions can be treated with over the counter medication. Also, this is based on VAERS reports, so it needs to be researched. About a decade ago the database had an entry in which a doctor, James Laidler, claimed a flu vaccine turned him into an Incredible Hulk. There were also people claiming infants died from the vaccine before it was even being given to children, so I would wait until their meeting this week and any announcement they make afterwards.

balthasar wrote: The vaccines have the same testing, whether it is an EUA or normal approval. The EUA only speeds up manufacturing and administrative processes. The main difference is that it allows for production of the vaccine at the same time as testing occurs, saving a ton of time. If it isn't found to be safe, they destroy what what was produced.

vaccine.unchealthcare.org/science/vaccine-approval/whats-the-difference-between-fda-emergency-use-authorization-and-fda-approval/

This is an excellent link, thanks for sharing!

Rebeg wrote: I'll just leave this right here. Think it explains it's self.

Links to some news stories saying that some younger men are experiencing heart inflammation and they are investigating it. 80 out of the 226 people that developed it improved on their own. The others are taking ibuprofen.

A quote from the articles linked:
“This is not something like a heart attack or anything like that. This is very different; it’s mild inflammation of the heart muscle, called ‘myocarditis’ which we have been able to treat and discharge the patient without any problem.”

-Dr. Juan Salazar of Connecticut Children’s

A link to another news story that says women in general have more reactive autoimmune systems than men and that their increased risk of side effects from vaccines is nothing new.

Seems very run of the mill and ordinary. What I find more fascinating is the tidbit posted in the third story that says that out of the 13.6 million people given doses when the study was published, there were only 6994 reported (self-reported I might add) cases of side-effects. That's SO incredibly few.

Brad Mortensen wrote:
But I would think that if the FDA thought it had been adequately tested it would be approved for use, not just given emergency use authorization based on lack of treatments, which we now know existed since the beginning. So technically they should be retracting their EUA.

I'm thrown off by this. What treatments do we have? Not much according to the CDC:

www.covid19treatmentguidelines.nih.gov/management/therapeutic-management/

There are apparently EUA treatments, and only a single drug that has full approval (and it's not the one you talked about in the other thread, so please don't bring that up again).

You say we had these from the beginning. We did? Why do you think we weren't using them?

Brad Mortensen wrote:

bpsymington wrote:
I think the vaccines are well past "experimental." Yes, in the US they are still under an EUA, but they are not new - they are based on research that has been conducted for years.

I've heard that argument before, so I assume it isn't original with you, but it strikes me as specious. Just because a certain class of vaccines has been studied for years doesn't mean that any particular vaccine in that class is safe. It would be like me telling my boss, "Computer science and the C# language have been thoroughly studied for decades. This software was written in C# so why test it? Let's just go straight to production." The difference is, none of our software will kill anyone if we get it wrong. And yes, part of both computer and medical science is thorough testing - a step these vaccines skipped. If you feel the testing was adequate for you and your family to take it, that's up to you.

@Mike Steele- thank you. Almost everyone I know has gotten one of these vaccines or another, so I sincerely hope I'm wrong to be concerned. It wouldn't be the first time. If I was convinced I was right I would have been begging everyone I know not to get it.

It is absolutely false to say these vaccines skipped thorough testing. They have been throughly tested. They are still being thoroughly tested.

If you can't or choose not to get tested, fine, but don't spread falsehoods.