The Vaccine

[tabbibus]

Honest question for my understanding.

When shit like this happens. Who decides?

*edit* Sincerely hope it's not you. I wouldn't wish that level of responsibility on anyone. There is no good answer I'm sure.

It is me. I did decide. Both unvaxxed btw.

So ?‍

 

[2kwik4u]

It is me. I did decide. Both unvaxxed btw.

So ?‍

Man, that stinks. I'm sorry you have to carry that weight, and make those decisions. I can only imagine the toll that takes mentally.

 

[Beachbummer]

If it was me, all else being equal, that would be the most important rock/paper/scissors game they will hold against each other in their lives.

 

[Ronnie]

So I’m sitting in the ER and I overhear an MD speaking with a patient in the same room I’m in, we are separated by a curtain.

MD: have you been vaccinated against Covid?

patient: no but I will, the cdc/fda haven’t approved them yet so I’m been hesitant to get vaccinated. Recently my unvaccinated coworker (borh are train conductors I think), contracted the delta strain, was hospitalized, vented and died all within a week, so I will get it soon.

md: you could have got it before you came into the ER today.

patient: excuses, excuses, more excuses.

my observation: anti vaxxers are only anti vaxxers until an anti vaxxer they know gets sick and dies.
I can only hope that this guy actually gets vaccinated not just for himself but to protect others.

here in CA hospital patients can’t have visitors/visitors are not allowed into the hospital. So if you need to be admitted its in your best interest to see your closest friends and relatives first, as you may not have another chance to do so.

FYI I brought in my vaccination card and my negative test result from late last week. No one bothered to ask or look at them. They just took my word for it.

 

[mwalker4]

I'm in Silicon Valley this week. I'm pretty sure most of these folks are vaccinated since I see people driving around in convertibles with masks on. Of course, in Palo Alto a lot of people wear masks outside but are eating inside. Never have quite understood the eating exemption. I guess you don't catch covid while eating and drinking.

 

[Bruce]

I see people driving around in convertibles with masks on

I suspect this is a contributing factor Air quality advisory enters 5th straight day in Bay Area

I have started wearing a mask while mowing the yard. It avoids the potential need for benadryl afterward.

Eating indoors around strangers certainly is a risk. Although lower risk in highly vaccinated areas.

I doubt that people who mock others for wearing masks have any concern about where they eat or how many people they eat around.

 

[mwalker4]

I suspect this is a contributing factor Air quality advisory enters 5th straight day in Bay Area

I have started wearing a mask while mowing the yard. It avoids the potential need for benadryl afterward.

Eating indoors around strangers certainly is a risk. Although lower risk in highly vaccinated areas.

I doubt that people who mock others for wearing masks have any concern about where they eat or how many people they eat around.

Air is beautiful out here. Sky is clear and blue south of San Francisco. I'm getting tired of the sun.

 

[Ronnie]

I landed in San Jose last night around 5. What I thought were clouds or fog was actually smoke. Air quality was a lot better today though.

 

[2kwik4u]

Had a long conversation about FDA approval this weekend with a friend. He didn't realize that the vaccines were NOT fully FDA approved. I asked if he thought the beer he was drinking was (fun fact, it's not unless it becomes contaminated). With that realization, we started digging into the FDA website and found this quote that really helped it sink in for him that FDA approval was still a judgement call, just by someone other than him.

FDA will allow a product to present more of a risk when its potential benefit is great — especially for products used to treat serious, life-threatening conditions.
Link to FDA Official Website

What finally solidified the premise that the FDA approval doesn't really fundamentally change the situation was the realization that the FDA doesn't do the testing, it only reviews the data that the company has gathered. Furthermore, the idea that it's a judgement call to allow the use of a treatment means that someone with the appropriate credentials has already reviewed preliminary data, and made the assessment that the benefits outweigh the risks for an emergency approval, and the likeliness of an overturn here is low (less than 32% - data below).

We also found an article from NPR in 2017 that shows more asserts 1/3 of drugs that get FDA approval have problems. However, they only quote 3 out of 222 (and don't link to their data for further probing) as being removed from market. That certainly doesn't help the case, but if you consider that statistic, you're nearly as likely to have issues from a random drug your doctor prescribes as you are the vaccination. So again, under the idea of risk mitigation due to unapproved drugs, the vaccine is a marginal difference, it has about a 32% chance of having a problem that is required to be addressed and about a 1.4% chance of being removed from market.

Seventy-one of the 222 drugs approved in the first decade of the millennium were withdrawn, required a "black box" warning on side effects or warranted a safety announcement about new risks, Dr. Joseph Ross, an associate professor of medicine at Yale School of Medicine, and colleagues reported in JAMA on Tuesday. The study included safety actions through Feb. 28.
Link to NPR news article

Further reading into the article really underscores the lack of weight that should be given to FDA approval. The approval is nothing more than a peer review from other subject matter experts that the data agrees with the manufacturers intentions and assertions. It is not the FDA themselves designing, completing, or recording the testing, just a review of what the manufacturing company has completed.

"All too often, patients and clinicians mistakenly view FDA approval as [an] indication that a product is fully safe and effective," he says. "Nothing could be further from the truth. We learn tremendous amounts about a product only once it's on the market and only after use among a broad population."
Link to NPR news article

With this information in hand, we agreed that the FDA approval was NOT the silver bullet of safety we thought it was. Essentially putting him at greater ease with the decision he had already made to get vaccinated. Perhaps it was because I had a sympathetic audience, but laying out some of this information in front of him really helped increase both of our understandings of the system, it's benefits, and it's pitfalls. Hopefully someone else here can do the same with someone they know. No condescending tone, just some facts and counterpoints to the FDA approval process, and what it really means.

 

[Julian]

Further reading into the article really underscores the lack of weight that should be given to FDA approval. The approval is nothing more than a peer review from other subject matter experts that the data agrees with the manufacturers intentions and assertions.

I'm not sure that this characterizes the process accurately. The FDA themselves has a division called CDER (Center for Drug Evaluation and Research) who's job it is to evaluate new drugs. Below is a summary of this process:

Drug Development & Approval Process

Get to know FDA’s drug development and approval process -- ensuring that drugs work and that the benefits outweigh their known risks.

www.fda.gov

Here is the list of their top staff (All MD, PHDs) - they and their teams (5,600 fulltime people) carefully review the data, the test methods, the peer reviews of new drugs as they become available. Yes, they aren't doing their own tests - but peer review is in effect - testing the tests.

CDER Leadership Bios

CDER Leadership Bios

www.fda.gov

With regards to drugs that are pulled, keep in mind that many drugs are developed for diseases that few people contract. There are incentives to develop treatments for these diseases. A close friend, who I spent time with on the outer banks last month, is running the clinical trial for one such drug. The hard part is finding patients with the disease! Now imagine that you have quite a number of these diseases for which the trials are relatively small. Then YES - some of these drugs fail and are pulled long term because they have small trial done (simply because there aren't enough people to test it on!). Now think about the size of the trials done with the Covid Vaccines - Moderna's included 28,000 people. Then think about the number of people who've actually gotten a Moderna shot, and that we trace reactions to it, and the "trial" is now in the millions!

Here is an interesting site on vaccination worldwide rollout - also has more detailed US data further down the page:

More Than 12.7 Billion Shots Given: Covid-19 Tracker

Bloomberg counted up the shots administered in 184 countries and 59 US states and territories

www.bloomberg.com

The J&J vaccine was briefly halted - why - because the process called for that to happen because there was a side effect concern. The side effects were reviewed and subsequently approved.

Another interesting point is that none of the life saving treatments we have are FDA approved. Monoclonal anti bodies are EUA approved only. So do you take the vaccine -that millions of people have proven is safe AND effective, or wait until you are in the ICU and then take an unapproved treatment to save your life?

 

[Evil Sports]

Even though I had Covid in December I got the J&J this Sunday. My research found if you had it you should be good with 1 shot so thats why I went with J&J. Now I should have super Antibodies

 

[Jim_in_Delaware]

Since we have a good post, above, about the FDA and the approval process, I wanted to add some additional information.

I have spent my career in public service, working the past 35+ years for the FDA. My area of expertise is human/animal pharmaceutical manufacturing, drug manufacturing regulations, and FDA pharmaceutical inspections. I can share my knowledge of FDA with y’all, but I need to note that this is in a personal capacity and I’m not speaking on behalf of the Agency.

Lets start with some basics. First the Food & Drug Administration is an agency that is part of HHS (Health and Human Services). The head of the FDA (the FDA Commissioner) is typically a political appointee who reports to the Secretary of HHS, who in turn reports to the President. All of the Center Directors are civil servants. The FDA has an Office of the Commissioner (his/her immediate office) and several Centers, including CBER (Center for Biologics Evaluation and Research), CDER (Center for Drug Evaluation and Research, CDRH (Center for Devices and Radiologic Health), CFSAN (Center for Food Safety and Applied Nutrition), CVM (Center for Veterinary Medicine, and CTP (Center for Tobacco Product). In addition, one addition Office is ORA (Office of Regulatory Affairs). ORA is the field inspectional office for FDA and does inspectional/investigational work for all of the office described above. Vaccines are biological products, so their review falls to FDA/CBER.

Let’s talk about the post:

Had a long conversation about FDA approval this weekend with a friend. He didn't realize that the vaccines were NOT fully FDA approved.

True. As of this time, the covid-19 vaccines are approved under EAU (Emergency Use Authoriations). There is still an on-going review of data to, hopefully, support full authorization.

FDA will allow a product to present more of a risk when its potential benefit is great — especially for products used to treat serious, life-threatening conditions.

This is also true. FDA’s charge is to make sure that drug and biologics are safe and effective for their intended use. However, there is also a weighing of benefit to risk, especially when there are no other worthwhile treatments for a disease.

What finally solidified the premise that the FDA approval doesn't really fundamentally change the situation was the realization that the FDA doesn't do the testing, it only reviews the data that the company has gathered.

This is also true. However, it is not a situation where a company dumps data on the FDA and the Agency rubber stamps their interpretation of the data. There is a lot of data (raw data and not just summary data) that is reviewed by CBER and CDER for application reviews. Often during the CDER/CBER review, the corresponding Center will ask for clarification of the data and for additional data. Some products may have a Rolling Application where rather than wait until the studies are complete, the Center will review data in blocks as it is available. The Reviewers at both CBER and CDER are made up of PhD’s and MDs.

Furthermore, the idea that it's a judgement call to allow the use of a treatment means that someone with the appropriate credentials has already reviewed preliminary data, and made the assessment that the benefits outweigh the risks for an emergency approval, and the likeliness of an overturn here is low (less than 32% - data below).

While there may be unforeseen adverse events, post approval, few of them cause a drug product to be withdrawn from the marketplace. More likely, there are some adverse advents that may not have been seen during the safety and efficacy studies, or maybe at a different rate, as the study populations are much smaller than the general population. Companies (Sponsors of an application) make a commitment, in their applications, to notify FDA of any unforeseen serious adverse events they become aware of, both known and unknown.

We also found an article from NPR in 2017 that shows more asserts 1/3 of drugs that get FDA approval have problems. However, they only quote 3 out of 222 (and don't link to their data for further probing) as being removed from market. That certainly doesn't help the case, but if you consider that statistic, you're nearly as likely to have issues from a random drug your doctor prescribes as you are the vaccination. So again, under the idea of risk mitigation due to unapproved drugs, the vaccine is a marginal difference, it has about a 32% chance of having a problem that is required to be addressed and about a 1.4% chance of being removed from market.

These statements need to be parsed a bit more. Like discussed above, “problems” could be ‘minor’ adverse events not previously know, or possibly at a different rate. Occasionally, there could be ‘major’ adverse events. Major adverse events could cause a drug to be withdrawn from the marketplace or the creation of a ‘blackbox’ statement on the product labeling.

NPR News Article said:

Seventy-one of the 222 drugs approved in the first decade of the millennium were withdrawn, required a "black box" warning on side effects or warranted a safety announcement about new risks, Dr. Joseph Ross, an associate professor of medicine at Yale School of Medicine, and colleagues reported in JAMA on Tuesday. The study included safety actions through Feb. 28.

Again, there is a huge difference between a drug being withdrawn, a blackbox statement added to the product labeling, and finding known (or new) additional minor adverse events.

Link to NPR news article

Further reading into the article really underscores the lack of weight that should be given to FDA approval. The approval is nothing more than a peer review from other subject matter experts that the data agrees with the manufacturers intentions and assertions. It is not the FDA themselves designing, completing, or recording the testing, just a review of what the manufacturing company has completed.

FDA gives guidance on how drug studies should be conducted and the types of data they expect to be submitted. Aside, from the application review of the data, FDA conducts inspection of the manufacturing plants, and also conducts bioresearch monitoring audits of some drugs studies.

Bottom line is I trust the reviews that are done on biological and drug products and those that lead to the emergency use authorization of these vaccines. There have been almost 200 million Americans vaccinated so far, thus, there is a lot of data available. I encouraged my mother and my wife’s parents (all in the 80’s and 90’s) to get the covid vaccine as soon as it was available. Same holds true for my adult daughter. In addition, my wife and I were both vaccinated as soon as the vaccines were made available to us.

Jim

 

[2kwik4u]

@Jim_in_Delaware thanks for sharing your insights!

 

[Bluewater272]

I was going to add quite a bit of information about the FDA review process, but Jim nailed it. We interact with FDA all the time (pharma clinical development), and the reviews are far more extensive than a 'peer review' process. FDA is also intimately involved in the entire clinical development plan from the first dose in humans (and often before) through approval and into post marketing surveillance. We don't get to run our own development program all willy nilly and then just submit for a peer review, to do so would almost be a guarantee of failure.

FDA approval is considered the gold standard for a reason, there are some countries who will 'auto approve' once FDA does.

 

[mrcleanr6]

I just got my 3rd shot 2 days ago. Zero side effects from all 3. Phizer

 

[Julian]

I just got my 3rd shot 2 days ago. Zero side effects from all 3. Phizer

I didn't think the FDA had recommended booster shots yet (the news was saying perhaps will be approved today (8/18) - for 8 months from your last shot)

 

[mrcleanr6]

I have been on an immunosuppressant for 20 years so 3rd shot has been approved in my case.

 

[2kwik4u]

I was going to add quite a bit of information about the FDA review process, but Jim nailed it. We interact with FDA all the time (pharma clinical development), and the reviews are far more extensive than a 'peer review' process. FDA is also intimately involved in the entire clinical development plan from the first dose in humans (and often before) through approval and into post marketing surveillance. We don't get to run our own development program all willy nilly and then just submit for a peer review, to do so would almost be a guarantee of failure.

FDA approval is considered the gold standard for a reason, there are some countries who will 'auto approve' once FDA does.

With this info, and @Jim_in_Delaware info....I have some non-combative, genuine curiosity questions.

Do you think it's a fair assessment to be concerned about emergency approval and NOT having full use FDA approval?
Are the people that are NOT getting the vaccine, that cite lack of full FDA approval justified in their concern?
Can you shed any light into the difference between an emergency approval and a "full" approval?
What, if anything, will change between an emergency approval and a "full" approval (or is an approval an approval regardless of naming convention?)?

Thanks for sharing. This level of "from the horses mouth" type information is more valuable (IMO) than any amount of reading I can do online.

 

[mrcleanr6]

Imo at this point there is nothing an fda approval can provide. How much more testing do you need than hundreds of millions of people all already getting them with good results.

 

[Julian]

With this info, and @Jim_in_Delaware info....I have some non-combative, genuine curiosity questions.

Do you think it's a fair assessment to be concerned about emergency approval and NOT having full use FDA approval?
Are the people that are NOT getting the vaccine, that cite lack of full FDA approval justified in their concern?
Can you shed any light into the difference between an emergency approval and a "full" approval?
What, if anything, will change between an emergency approval and a "full" approval (or is an approval an approval regardless of naming convention?)?

Thanks for sharing. This level of "from the horses mouth" type information is more valuable (IMO) than any amount of reading I can do online.

Things I've read, I'd love to hear the experts opinion too, say that full FDA approval focuses much more on marketing and sales material approval than it does on clinical issues. YES-if there were clinical issues that would be a problem, but as @mrcleanr6 says....with millions of doses being given, there is TONS of positive clinical data available. @Jim_in_Delaware - thoughts?