Why a University of Michigan professor voted 'No' on Pfizer's COVID vaccine

[LovingA2andMI]

Preword: Groupthink is a powerful method to have unification. It occurs in subtle ways. First, by having someone appear as the "Authority figure of Trust". This way a parroting effect takes place. Parroting occurs when those who are not as knowledgeable on the subject matter at hand repeat what they believe is Trusted information from an "Authority Figure". The Figure can be a Person, Place or Thing, similar to a Noun.

In the case of the Seven Step Scientific Method, Groupthink can be distributing and destructive. Questioning why is how those who need to know, know any risks associated with the action that is asked to be done. That way, Humans can make a informed decision in whatever decision they ultimately decide.

I know this article will be questioned. Some might even try and have the post deleted altogether. Nevertheless, Dr. Fuller, a University of Michigan Virologist makes an VALID point that deserves thought about the Scientific Method being rushed in the case of the COVID vaccine. Also, not everyone that questions the speed in which this vaccine is being widely distributed is "Anti-Vax". That is a label used in some cases to shut down those with valid questions deserving answers.

ANN ARBOR, Mich. – The FDA advisory committee that recommended the Pfizer vaccine largely agreed it was safe and effective. Seventeen members voted for it and four voted against it.

One of those No votes came from Dr. A Oveta Fuller, a virologist and viral pathogen researcher at the University of Michigan. Dr. Fuller said she was concerned about the vaccine’s long-term impact.

“Because we are in a COVID pandemic and because so many lives are affected and because the public needs to understand so they know what to do,” Dr. Fuller said. “I felt like this is a lot. A heavy responsibility. It is very sobering and that’s how I take it.”

It’s not a lack of confidence in the research, it’s that she believes some specific questions about the risks did not get answered. Dr. Fuller said more data would help her be certain that she has done her due diligence.

As a researcher and an expert in how viruses behave, she still had questions on the table in terms of autoimmunity and hyper immunity. She just wanted a bit more research to answer a few more questions before creating a full path to widespread vaccinations to the masses.

“I am a great advocate for vaccines. I’m a virologist by training, I think viruses are amazing. I teach them. I study them. I engage the community about them,” Dr. Fuller said. “I think vaccines are a major way that we can stop or prevent infections but ‘a stitch in time saves nine.’”

****Dr. Fuller says it would be better to release the vaccine gradually instead of going almost directly from the study to being given to millions of people.*****

https://www.clickondetroit.com/all-about-ann-arbor/2020/12/11/why-a-university-of-michigan-professor-voted-no-on-pfizers-covid-vaccine/

[cwydro]

1. The FDA Poobah was saying today that anyone allergic to any of the components of the vaccine should

not take it. But he didn't say what those components were.

[LisaL]

5. PEG.

They think the ingredient causing allergic reaction is PEG.

[cwydro]

31. I don't know what that is.

I do know I’m allergic to just about everything under the sun, so I’d like to know what’s in it.

I assume PEG stands for something?

[NurseJackie]

34. That would be... "polyethylene glycol" for those who aren't good with initials.

[roamer65]

52. PEG, Polyethylene glycol...aka Miralax.

I know I am not allergic to it since I use it on a regular basis. It’s a mainstay for anyone with IBS-C.

[AllyCat]

7. If they list all the ingredients on one vaccine, the prone-to-panic public

Will assume that is for all of the rest of the coronavirus vaccines. Or all vaccines in general. It is up to the consumer to review the information provided and work with their physicians to rule out a vaccine that they might be allergic to.

[mathematic]

2. So she doesn't think the vaccine is "safe and effective" but wants the vaccine released anyway?

I'm guessing that's a recognition that the risk of the vaccine being unsafe is less than the risk of delaying a vaccine during a global pandemic.

Which, hey, news flash, everybody already understands.

[LovingA2andMI]

6. Re-Read....

She voted no on the vaccine being widely distributed right now. Her thoughts are in the article on how she felt the scientific method (Steps 5-7) should have been handled.

[mathematic]

12. I re-read the part you bolded: Dr. Fuller says it would be better to release the vaccine gradually

You bolded it! How was I not supposed to read it?

[LisaL]

21. Considering we don't have enough of the vaccine for everyone we are releasing it gradually.

Although we decided to vaccinate the sickest (nursing home patients) among the first group and I am not sure that is a wise idea.

[uponit7771]

32. +1, Red Don's screw up her actually helped vs hurt ... dumb luck

[zipplewrath]

20. Safe for whom

That appears to be her question. There are indications that this virus may cause immune systems in some people to become over active and attack the body. It is interesting that the first problems that arose were with people with allergies. Allergies are often caused by the bodies own immune system inappropriately reacting to something.

The decision she's being asked to make is a difficult one, especially in the absence of data. It requires her to basically extrapolate from similar studies and diseases. Remember, we don't even fully understand the disease itself. If I had been discussing this with her I would have mentioned that in fact the vaccine isn't really being released "all at once". By the fact of mere logistics, there won't be wide spread distribution for months. And since the early participants will be in the medical field, there's a good chance that any anomalies can be detected early.

[LovingA2andMI]

25. Great Point!

Thank you!

[uponit7771]

33. +1

[underpants]

3. Well they ducked losing to the Buckeyes so she still wanted a big loss for the Big Blue

Go Buckeyes!

[LovingA2andMI]

8. Huh?

Is this article about College Football?

[underpants]

16. No I'm an Ohio State fan just making a joke.

[zipplewrath]

23. Buckeyes

Ya know what a Buckeye is?

An afternoon snack for a Wolverine.

[underpants]

51. It's a nut

Coach Harbaugh finally managed to not lose THE GAME

[Corgigal]

4. I'll take hers,

because the NYT says I only have to wait behind 4 million in my state. I would like to live with a little less stress, I’m sure most of us do.

[LisaL]

9. Two more months of controlled studies?

We have this virus completely out of control. Two more months is a lot during a pandemic.

[LovingA2andMI]

14. The Initial Sample Group....

Was 30,000 People. There are 315 Million People in the United States alone. The Scientific Method would say EXPLAIN the Sample Group. 2 Million - 5 Million maybe for a couple of months and have steps 5-7 answered before wide distribution. That, I believe, is what Dr. Fuller is saying and she's right.

[LisaL]

17. I realize that. My point is, how many people will die during those two months and how many get

infected. We are starting to lose 2-3k a day. So in two months we could expect 120-180 k to die from covid and millions to get infected.

[DrToast]

28. The risks of Covid-19 are much greater than any risks in the vaccine, IMO

[Happy Hoosier]

49. With 2500 people dying a day...

It strikes me that her balance of concern might be slightly skewed. There is a reason this is an emergency authorization.

[AllyCat]

10. Great. There are plenty of other folks that look at the risk/benefit analysis and

will take the skeptics places in line.

[LovingA2andMI]

18. Those who question the Scientific Method....

And believe in Vaccines that use the Scientific Method, are skeptics. Okay.

[AllyCat]

36. These vaccines still followed the scientific method.

We decided as a society that the potential risks likely are not worth delaying getting the vaccine due to the deadly and debilitating pandemic. I am exposed every working day to this dreadful disease. I have a choice. I will get this when my number comes up. I am, in my opinion, lucky that I will get the vaccine this week or next.

I’ll be the guinea pig for those who prefer to wait.

[LovingA2andMI]

39. Actually, 14 Scientists from the FDA decided this....

And do what you feel comfortable with. For sure.

[AllyCat]

42. What about all the scientists who worked to bring this about?

Fauci? The medical advisors for all the health care organizations? And this is hardly a mass rollout.

[LovingA2andMI]

44. There are upwards of 9 companies that are working on Vaccines for COVID

Three companies vaccines are being widely distributed (with the protocol of what group has access) in 2020. The other 6 or so won't be complete with their Scientific Method protocols until 2021 and some well into 2021 prior to seeking FDA Approval.

I trust the in-depth scientific method protocol which is what Dr. Fuller is stating. Others must make their own decisions.

[Happy Hoosier]

50. I think risk management plays a strong role here.

Is the balance risk to life greater in waiting, which will DEFINITELY cause significant loss of life, or in proceeding, which may have some unidentified risk? I know where I fall on this decision.

[LovingA2andMI]

57. There do not have to be a "Risk of Life"

There is a Treatment available for adverse reactions to COVID 19. Unfortunately, one has to be a "Friend of Trump" to receive it. That strikes an ethical balance in science that is disturbing at best.

[Happy Hoosier]

59. There is no proof of a 100% effective treatment.

And until there is, and it is universally available, the risk of death or long term injury must be considered.

[LovingA2andMI]

63. Was it said that the Cocktail was 100% Treatment?

No, or else it would not be called a Treatment. However, it is a Treatment just like the Vaccine. A Treatment which is also not 100% effective. If the vaccine was 100% effective, it would still be a treatment until the long-term effects of the Treatment was placed under the scientific method protocol. Which is the point, in part, that Dr. Fuller is making.

There was a way to provide Treatment and expanded Scientific Method Protocols with the Vaccine. In fact, the Emergency Use Authorization Trial could have been explained to allow those with adverse reactions to COVID-19 to receive the Cocktail on a wider use basis. Yet, that was not done.

Again, Dr. Fuller point as merit and she took a vote on her merit and methodology creating the decision she made. One of the nine vaccines will begin their wide distribution processes. Two or three of the nine will likely have approval by the end of this year. The other six or so will continue their clinical trails into 2021 and then seek approval. For me, I am comfortable with following the mitigation guidelines until vaccines that have followed the full scientific method process, are approved. Everyone has a right to make their own choices on their level of comfort.

[Happy Hoosier]

72. With all due respect....

The vaccine has certainly followed a scientific method process. Yo7 are just not satisfied with level of confidence in the safety data. You can decide what you like for yourself. I personally think given the current state of affairs, emergency approval is more than justified.

BTW, are you aware of any study on the effectiveness and long term safety of the treatment cocktail? I’m not.

[ProfessorGAC]

65. I'm With You

This is not a vaccine for an illness that affects a million people with a death rate of 1%. Or a flu that infects 50 million, but only kills 1 in 4,000
This thing is killing 2% and it's spreading rapidly with 15 million already infected.
The risk analysis that would typically be prudently followed is based upon a different level of risk than currently experienced.
And, I don't believe that all the researchers & developers were motivated by other than helping the public.
It wasn't rushed for any other reason than we are in a crisis of a proportion we have not experienced in over a century.

[Happy Hoosier]

74. This is a weird post.

The scientific method has NOTHING to say about making risk assessments in such a situation. We are faced with a known outcome of many tens of thousands of deaths if the vaccine is significantly delayed versus a potential unknown safety risk unless that potential risk will cause many tens of thousands of deaths, the balance of task favors approval. Individuals can choose to wait if 5hey assess matters otherwise.

[SWBTATTReg]

11. So the good doctor recommends that the vaccine should be given gradually,

so how many lives will this course of action you're advocating will cost? Has anyone done a cost analysis of all of the possible actions (there are like four (at least) different vaccines, and better therapies being derived as we speak (expensive too)), etc., so to wait until everything is perfect, could result in another 200,000 lives gone, or more? Right now, the lives gone due to the CV should be laid at djt's feet and no one else's. Murderer.

[LovingA2andMI]

24. There is a Treatment by the way....

Why is the Experimental Treatment that Trump and Friends of Trump have had only given to those individuals (i.e. - The cocktail)? Why is this treatment not being given to those who are distributing what at this point are the known severe reactions to COVID 19? This could be a fail/safe to save lives until the vaccine sample group is explained?

We will never know at this point.

[SWBTATTReg]

27. I heard estimates that this particular treatment that rudi / trump / etc. costs upwards of $100-$200

thousand dollars per patient. Rather costly, and more than likely, very very limited (why so costly, ingredients are hard to obtain/etc.).

Still, what is the value of human life and why hasn't it been more widely made available (I hadn't heard that this treatment hasn't been made more widely available)? And why did rudi deserve the treatment? Why are they 'wasting' the treatment on him when he isn't practicing safe procedures in distancing himself or wearing a mask, etc.?

[LovingA2andMI]

37. Exactly!!!

The cost of a Human Life that could be saved by a treatment if they are having to Adverse Reaction to COVID 19, is worth $100-200 Thousand Dollars. It should not be only "The Friends of Trump at Walter Reed" that are eligible to receive it.

[LizBeth]

38. I read there were 108 treatments and US govt bought all of them.

[LovingA2andMI]

41. How Many "Friends of Trump" have had COVID....

Makes one think......"The US Govt bought all of them". Umm....

[LizBeth]

45. Three we know, Trump, Christie and Guiliani. n

[LovingA2andMI]

68. And Carson....

Ben Carson got the Cocktail also.

[LizBeth]

71. Yep yep. There were some wealthy donors too, that got sick.

[LisaL]

40. The antibodies are expensive and difficult to make.

So there are very few doses available.

[Meowmee]

75. That treatment also has potential unknown side effects

And was given emergency authorization

[tblue37]

13. Because Trump's admin is so incompetent, it will be released relatively gradually in the US, rather

than all at once. They turned down 100 million doses.

[LisaL]

19. Yep. It will be pretty slow.

My concern is that they decided to jump run in and vaccinate nursing home populations. Those are people with bunches of pre-existing conditions, and I don't think they should have been made the first group to be vaccinated. Rather, start vaccinating healthier people first to figure out the issues with the vaccine before jumping right into the sickest population.

[LovingA2andMI]

30. Exactly!!!

Here is the thing about Autoimmune reactions. In some cases, humans don't know they have them until something is triggered. For instance, iodine. It is common for African-Americans to develop an autoimmune or allergy based reaction to iodine in shrimp or shellfish based foods - AFTER the age of 40. I personally know four close family members that did not find this out about their bodies until AFTER they ate shellfish -- in their 40's -- AFTER eating shellfish based products for decades prior without an issue.

This is what is not widely known about a rMRA vaccine. The first vaccine of its type that is not using a dead or diluted virus to develop antibodies. Specifically, how will people with Autoimmune reactions (adverse reactions) react to a rMRA Vaccine. Again, this is what Dr. Fuller was stating.

We will learn in the months ahead by the wide distribution but it could have been another way to learn it.

[Blue_true]

48. Should have vaccinated Nursing Home staff and left the patients alone,

keep them wearing masks. We will soon be finding out whether the current vaccine distribution procedure is correct. You can bet that if anything goes wrong, Trump will blame Biden (and take all the credit if it works).

[LovingA2andMI]

58. Of Course That POS Trump will....

Which is concerning in itself.

[TheBlackAdder]

15. The UK is also our Guinea pig.

.

.

[ucrdem]

22. I'd wondered about the four nays.

Very helpful. This is what I'd hoped the reasons were. Seems very reasonable, especially as she was surely aware that it was going to win approval with or without her yes vote, as it had already gotten the green light in several other countries.

[MichMan]

26. What is the status of the five states that said they needed to have their own independent approval ?

"At least five states – California, Nevada, New York, Oregon and Washington – and a Black medical group say they’ll conduct independent verification of any COVID-19 vaccines approved by the Food and Drug Administration."

If they won't allow their residents to receive the vaccine, the priority on distribution needs to be on those remaining states that will accept the FDA approval.


https://www.usatoday.com/story/news/health/2020/10/29/states-medical-group-add-independent-covid-19-vaccine-review-boards/3755473001/

[marlakay]

35. My governor in Oregon

Had press conference few days ago saying that the vaccine was coming and how she was going to roll it out. So she is not blocking it.

[uponit7771]

29. K&R, there is ONLY 2 MONTHS OF SAFETY STUDY for the current vaccines. I 100% agree with this

... doctor

[LovingA2andMI]

43. That is what she is stating.

And the sample group was 30K. There are 315 Million People in the United States. The Sample Group should have been explained prior to wide distribution.

[uponit7771]

46. My understanding is we're supposed to get the data for the sample group this week

[LovingA2andMI]

69. Thanks!

I will keep my eye out for the information and date from the sample group.

[DeminPennswoods]

56. Sanjay Gupta was explaining this on CNN

yesterday with Blitzer. He said that if there are serious side effects they show up on average 42 days after the vaccine. That's why there is the 2 month (60-62 days) safety window.

The real ethical question that was kind of pushed off was whether or not to give the 15,000 clinical trial volunteers who got the placebo the vaccine or continue them as a control group.

[LovingA2andMI]

67. Great Point!!!!

The real ethical question that was kind of pushed off was whether or not to give the 15,000 clinical trial volunteers who got the placebo the vaccine or continue them as a control group.

That definitely should have been done as it would have backed up the approval by like one or two months, however, the outstanding questions on the scientific methodology would have been far less.

[DeminPennswoods]

79. Now that the clinical trial is over, the question

was if to tell the placebo group now and give them the vaccine. Sorry I wasn't clearer.

[kcr]

47. A much better example of groupthink

are the morons who think Covid is a hoax. Not anyone who wisely gets the approved vaccine for Covid.

[roamer65]

53. I think Moderna's vaccine will get a stronger vote of approval.

I think it will be more widely available and probably a bit safer.

[LisaL]

62. What is the reason to believe it's a bit safer?

Both vaccines appear to be very similar. They are both based on RNA. Moderna's will be somewhat easier to distribute. But I haven't seen anything to suggest Moderna's is safer.

[roamer65]

78. A report I heard on the news that it had less side effects during the clinical trial.

[LovingA2andMI]

66. It is a possibly.....

Especially, if Moderna's is not released until the first quarter of 2021 for wide distribution.

[msfiddlestix]

54. Frankly, I cannot find fault with her reasoning and logic.

a stitch in time saves nine. let's at least have those questions on the table answered before moving this process on mass escalation at this juncture, seems reasonable to me.

[uponit7771]

77. +1, honestly I don't trust Trump. I can imagine him doing something stupid to make people

... trust the virus less than what America already does

[JonLP24]

55. I have been dealing with a lot when it comes to the virus

Year was pretty much ruined and top of that there was a lot of misinformation while experts & hospital workers were sounding the alarm.

Whatever the risks I will take the vaccine if I can and I'm sure those that voted in favor are also qualified have good reasons for supporting it. It is better than being stuck inside.

[LovingA2andMI]

60. Agree....

It is hard being stuck inside however, in reality, we will be dealing with COVID for at least three years after wide distribution of the vaccine. Those with underlying conditions will need to continue to be careful after taking the doses as 0.5% is a small chance but it is not 100%. Also we do not know how long the antibodies created from the rMRA vaccine last. Is it forever, for a set number of years, is this an annual booster vaccine event?

There are many unknowns and I worry that many have been led down a pathway that the vaccine is the cure. It is a Treatment similar to the Cocktail Treatment it appears those with adverse reactions to COVID 19 cannot obtain outside of a Emergency Use Authorization that has not been widely shared and if they are a "Friend of Trump".

We have a long road to go here and expectations need to be set to coordinate with the reality of what will be faced.

[JustABozoOnThisBus]

61. Her reason may be reasonable, but her math sucks.

Releasing it now might cause a number of allergic reactions.

Releasing it later will cause thousands of deaths per day.

Do the math.

[LovingA2andMI]

64. Scroll up...

Her math does not "suck". It's called following the scientific method and this has been discussed in the threads above.

[Happy Hoosier]

73. Have you ever performed a safety risk analysis?

I have. I respectfully disagree with you and her.

[Blasphemer]

70. Totally fair point. If the pandemic was handled properly in the first place, we'd have the luxury...

of time. Trump's failure of leadership shifted the cost-benefit analysis. So, here we are.

[moondust]

76. My question about it.

Maybe already answered?

What if the temperature of the vaccine is not consistently maintained along the full path of distribution? What if it heats up for a while somewhere along the way due to freezer malfunction or some other problem? And is there any way to tell if that has happened before injecting it?

[LanternWaste]

80. Wow. An editorial. By one author.

Maybe strategic information overlooked by thousands.

Or maybe chum for the victims of groupthink implied but never specified..

Or maybe both.

I guess.