Have you tested positive for COVID?

[uncfnp]

While your response may be based on cumulative observation you may have jumped on his post a little hard. His observation of skipped steps is valid and only time will tell if those steps would have mattered.

I do agree with rushing the vaccine to some extent and I will benefit in the ongoing testing and research that will continue between these first offerings to the front line health workers before I have the opportunity to get the vaccine. Sans the normal procedures we are only able to base the decision on corporate press releases, I appreciate the review by scientists and medical professionals which I will bend toward trusting over a bloviating buffoon living in a pale residence.

I obviously don’t agree.

Firstly this is posted in the medical forum and as such I think it requires a higher level of medical oversight. I held my tongue and only posted after (s)he had made several inaccurate or unsubstantiated statements.

If anyone wants to post actual research steps that were omitted during the vaccine development process they should certainly do so. And link citations. “Fast track” is not the same as “skipped steps” for the clinical trials.

 

[Marie13]

I read recently that the usual vaccine development time is around 10 years. This one took less than a year. How do you determine long term side effects with the much shorter development time?

 

[lexvil]

I obviously don’t agree.

Firstly this is posted in the medical forum and as such I think it requires a higher level of medical oversight. I held my tongue and only posted after (s)he had made several inaccurate or unsubstantiated statements.

If anyone wants to post actual research steps that were omitted during the vaccine development process they should certainly do so. And link citations. “Fast track” is not the same as “skipped steps” for the clinical trials.

Which I assumed it was based on cumulative observation, at face value based on the one quote it appears harsh. Can you give an example of a “fast track” that doesn’t skip an established step? Not trying to argue with you as I believe you are vastly more qualified than I, just taking it face value of the two posts.

 

[uncfnp]

Which I assumed it was based on cumulative observation, at face value based on the one quote it appears harsh. Can you give an example of a “fast track” that doesn’t skip an established step? Not trying to argue with you as I believe you are vastly more qualified than I, just taking it face value of the two posts.

Much of this has already been touched on in prior posts by others. Part of the fast track is simply the amount of money and support that has been poured into the effort. Another is the fact that it’s based on prior vaccine research including prior Sars vaccine research. So in a sense the research as been going on for more then 10 years. And that multiple phases were conducted simultaneously. Yet another is that the federal bureaucracy has actually gotten their collective butts in gear and doing their job.

Here is a fairly good synopsis for anyone that wants some factual info about the vaccine and it’s development.

COVID-19 vaccines are on the fast-track to approval. How will we know they're safe? | Live Science

 

[uncfnp]

I read recently that the usual vaccine development time is around 10 years. This one took less than a year. How do you determine long term side effects with the much shorter development time?

Very good question and at the heart of many people’s concerns.

When any new medication or vaccine gets FDA approval there is always post market surveillance. Always. Here is where more long term side effects, if present, will become apparent. But this is true of any new drug.

My personal take? There is almost no way that I won’t get this, if indeed I haven’t already. Most of the legitimate long term concern, if there are any among the health professions I know, is the individual’s unique response to the protein spike itself. But this is even more so with the virus itself and to the nth degree.

 

[tridacna]

Conspiratorial rumor-mongering will make this situation even worse. People start to believe these crackpot theories and refuse medical treatment. Many people still believe that Covid-19 is a hoax.

 

[-JD-]

Can't say for sure as I wasn't there watching. But obviously long term side is being skipped. And curious why people with other allergies are having bad reactions so something was skipped there too.

Allergic reactions to vaccines are not at all unheard of. Every vaccine info/disclosure sheet that I have come across always has a warning about allergies, frequently to specific components of the manufacture such as eggs. That includes the flu vaccine which, while the specific flu strains are tweaked, has been around for years and went through the normal approvals process.

Allergies are a very tricky thing and change over time. Despite having a bunch of the common "seasonal" allergy stuff, pollens, pet-danders, molds, etc. that I developed as a very small child; I have allergies to (at least): hornet-stings, melons, peppers, carrots, and certain chlorine compounds (working around that was the reason that I came to diving so late.) All of which evolved from 10 years on.

That some folks get an allergic reaction to any particular thing is not surprising. I would tend to suspect that many folks that had known vaccine allergy reaction history would self-select out of engaging in a trial. I imagine that on average - individual, perceived, net personal risk (a function of chance of catching and chance of serious outcome) will be higher for Covid than that for say the flu and that allergy-positive people will be more-likely to get a Covid vaccine vs. the flu vaccine despite the risk. I, therefore won't be surprised to see a higher level of allergic reactions even if the Covid vaccine were to have the same allergy safety profile as the flu vaccine.

 

[kelemvor]

Let’s get into semantics. Red tape is a bureaucratic measure like filling in 4 forms to get a new device for testing. It is not part of a scientific method. It delays a process. It does not impact the method. Removing redtape makes the process more efficient. The redtape to which you refer (not sure what that is) slows things down without impacting the results. If it did, it would be part of the design.

That's a huge assumption along the lines of the current process is perfect. Whether or not you like the label he gave the current process, it is a problem. According to the NY times, the first vaccine was fully created in like April. April through December (and counting, because it's still not out) was doing all the "stuff" (instead of red tape) required to get it on the market. If the approval process takes orders of magnitude longer than creating the medicine then the process is a problem.

I'm not saying we need to eliminate the process, but it needs a massive revamp (not a small change).

 

[tarponchik]

That's a huge assumption along the lines of the current process is perfect. Whether or not you like the label he gave the current process, it is a problem. According to the NY times, the first vaccine was fully created in like April. April through December (and counting, because it's still not out) was doing all the "stuff" (instead of red tape) required to get it on the market. If the approval process takes orders of magnitude longer than creating the medicine then the process is a problem.

I'm not saying we need to eliminate the process, but it needs a massive revamp (not a small change).

I'll add to this that Pfizer and Moderna vaccines are the 1st mRNA vaccines ever, and the long term effects of such vaccines had never been studied. The AstraZeneca and the Russian Sputnik-V vaccines are adenovirus vector vaccines, a much better-studied type.

 

[Esprise Me]

I get the impression some people think that, for a vaccine that takes 10 years, the process looks something like:
Year 1: develop the winning formula that will ultimately be approved, and give it to a bunch of test subjects representing every sub-group of the population.
Years 2-9: watch those test subjects carefully for long-term side effects.
Year 10: approve, manufacture, and distribute the vaccine to the masses.