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Virus vaccine information

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Virus vaccine information

#1

Virus vaccine information

Bill Tindall, E.Tn.

Holston Medical Group Research Division, Kingsport TN is conducting a 300 person portion of the Pfizer vaccine trial. I had a chance today to chat with the person managing this trial. The news I wish to convey is that he was interviewed by USA Today for a 6 part series on vaccines for the virus to be published some time in mid October. He seemed impressed by the interview process that lasted 2 hours. We could hope an informative series results that may be of interest to some.

Can someone tell me if this article can be viewed on line? I have no idea where to go to buy a copy.

In an unprecedented release Pfizer made public the vaccine trial plan. All you ever might want to know about it:

https://pfe-pfizercom-d8-prod.s3.amazonaws.com/2020-09/C4591001_Clinical_Protocol_0.pdf

Normally vaccine trial plans are confidential so as to not give away information to competitors.

Re: Virus vaccine information

#2

Re: Virus vaccine information

Mark Nowicki

I see it on line.

Re: Virus vaccine information

#3

Re: Virus vaccine information

Tom Dunlap

137 page report visible to me too

Re: Virus vaccine information

#4

Re: Virus vaccine information

Wiley Horne

Very good move by Pfizer to start making this all real and transparent starting now. It will create confidence.

Wiley..and yes, it’s all there! Thank you.

Re: Virus vaccine information

#5

Re: Virus vaccine information

Walt

I think there is SO much skepticism about COVID 19 vaccines that the manufacturers see a need to be be open or few people will get the vaccinations. There is some reason for caution, this has been developed much more quickly than normal so what are they skipping over or not disclosing? There is also a political aspect to this whole pandemic. Using the suffering and death of thousands of people to score political points is unforgivable to me.

Re: Virus vaccine information

#6

Rapid development information

Bill Tindall, E.Tn.

The vaccines currently, or about to be, in trial became available at what appears to be astonishing speed compared to former vaccines. Years were cut from the typical time line. The reason is not that corners were cut except Phase 2 and 3 of these trials were combined as a result of favorable results in the Phase 1 trial. So what changed?

Not making the news is a government funded program begun before this virus hit to come up with new ways to make a vaccine that didn't take years to develop. Advances in biochemistry have enabled new approaches to getting a piece of the virus into a person's body so as to develop an immune response.

For example, the vaccine being tested by Pfizer, developed by BioNTech a German company, injects some biochemicals that enter a person's cells. These biochemicals cause the cell to make the spike protein from the Corona virus. Early studies have shown that the presence of this spike protein triggers a strong immune response. In a nutshell your body is employed to make the vaccine, saving the lengthy steps to figure out how to make it outside the body and then inject the result.

With modern technology, it was a relatively easy task to figure out what the spike protein was and then make the biochemicals that would cause your cell to replicate it, saving years of conventional vaccine development. 42,000 people will be given this vaccine (more than 30,000 already) to see if there is any unforeseen adverse effect. If no adverse effects and at least 50% disease prevention it will be released. These 42,000 trial participants are closely monitored by an independent organization for adverse side effects and whether they are protected. Pfizer is betting $1.5 billion dollars of their stock holders money on the hope it works.

Other companies have taken different, and novel, approaches to getting something into a person's body that resembles a piece of the virus that triggers an immune response. In these cases too the shortening of the time to development is a result of a shorter way to get a piece of the virus into a person's body, not short cutting steps of convention vaccine development.

I suspect a person's motivation to take the vaccine when released will be strongly dependent on their aversion to getting the disease. If you are in a situation where there is a 10% chance of dying from the disease and a 0.001% chance of an adverse reaction the choice could be clear. Pfizer modeling predicts that of the people in the trial, 1.5% of them will be exposed to the virus sufficient to become infected in in the next year. There's your odds, take your chances.

Re: Virus vaccine information

#7

Re: Rapid development information

Larry Barrett

Thanks for this explanation, Bill. This is the kind of information that news organizations, or the AMA, or other respected sources of public information should be getting into the public domain.

Re: Virus vaccine information

#8

more information

Bill Tindall, E.Tn.

Since there seems to be some interest....

Phase 1 trial determines first round of safety and develops information on dosing. Several hundred people enrolled. Phase two expands population of phase 1. Since there is a rush if Phase 1 looks especially good phase 2 and 3 can be combined as is the case with Pfizer and Moderna. This combination is the only short cut being taken.

If you are in a Phase 3 trial (Pfizer trial because I know the most about this one) you get two telephone screens, an on site health screen by nurse and a final examination by a Dr. before being injected and blood sampled. Pfizer is screening for healthy participants, never infected, that represent an average sort of population but no health issues that could bring more complications if there was an adverse vaccine reaction. Nose sampling to see you don't have virus, blood to see you have not had it and other baseline stuff I don't understand.

Every 7 days a diary is filled out by cell phone checking for virus infection and adverse reactions. Participants carry a card and present it any time they interact with health care. Dr. administering health care reports what is going on to Pfizer to alert for possible adverse reaction or catching virus.

After 3 weeks another health check, virus check, and second injection. Diary continues to be updated.

After 30 days another health check, blood sampled to see if antibodies are developed and other stuff.

This all goes on for 2 years. Basically you are loaning your body to Pfizer for 2 years to do the test. If vaccine declared a success at some time those on placebo are notified and offered vaccine. So a benefit of participation is getting to the head of the line for vaccination. Merck and J&J trials signing up participants if you are interested.

All this information is described in the Trial Plan available from the company running the trial. Chemistry of how the vaccine works available from company developing vaccine.

Re: Virus vaccine information

#9

Re: Rapid development information

jergle

Larry, I just felt a need to comment on your post where you mentioned the AMA as a "respected" organization. I realize there may be a public perception that the AMA represents the medical establishment, and at one point, many years ago, that may have been true. The current AMA is purely a (mostly liberal) political organization. They unfortunately have a monopoly on publishing the coding references that physicians use, and make millions of dollars doing so, but the vast majority of physicians would agree that the AMA does NOT represent them in any way. I have been a family physician for 20+ years, and I know of NO actively practicing physicians that are members of the AMA. Now, the CDC has been the organization that we have looked to for years for guidance on medical issues, but unfortunately they have royally mishandled things during the pandemic. Their constant changing of recommendations and backpeddling has caused them to lose a lot of respect. I hope they can recover that at some point. Just my 2 cents.



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