No....it’s because I never said I wouldn’t take the vaccine. I said I wanted to make an educated choice for my family. Relax man...this isn’t personal.

An interesting read without the benefit of political bias.

https://www.newswars.com/mrna-vaccines-might-prove-catastrophic-in-a-rushed-coronavirus-response/

That article is from May 2020.

Correct. And....?

And it is a dated article.

The 5 primary risks did not happen and were designed against. We do not need fear mongering articles about weaponizing mRNA to target specific ethno-types.

Sounds like a labeling change may have been made.

Many posts in this thread and throughout these Forums provide great examples of just how little many folks know about our US regulatory requirements with respect to medicine.

My first exposure was in 1978 at GE's medical equipment headquarters in MKE. I went to work as a summer student... in that role I was doing my best to help bring a new $1M vascular x-ray system through final engineering steps. The regulatory (FDA) world then is not the same as it is today.

It is hard, but not impossible for people to learn about these regulations.

It’s from 9 months ago. Sorry, RB....the last 9 months did not answer any of the proposed concerns. Your assertion that we don’t need to read everything available is asinine. Are you saying we should only read positive and hopeful articles and any questions or concerns should be blocked? This is Pelican, not Twitter!

The producers of ultra low temperature and cryogenic storage refrigeration systems and those who service them are very disappointed with this change....

I hope we didn't ramp up dry ice production! :)

...here’s the issue with “good enough”.

That’s good,for us as a country in that more people vaccinated results in a lower overall infection rate... ...but as an individual who got the “good enough” dose, your chances also go up.

It means until we have herd immunity you will still have to be just as cautious.

I think that's kinda why the FDA said Nah, we'll keep the dose the same back in January. Essentially, we're better off having a smaller percentage fully vaccinated than a larger percentage half assed vaccinated.

"Essentially, we're better off having a smaller percentage fully vaccinated than a larger percentage half assed vaccinated. "

FDA stands for Food and Drug Administration. Folks can learn about the FDA on the FDA web site.

CDC is different. Folks can learn about the CDC on the CDC web site.

The devil is in the details.



Not sure "half assed" is a term that has been or will ever be used by either.

Yep! And the FDA is the entity that said "nope" to changing the dosage. Glad I could help ya!!

And I'm sure no one at the FDA would say what I said in that only half a dose is half assed vaccinated. Those were my words... reading is FUNdamental

Indeed the devil is in the details...I'll put my own words in a sentence for you that might help. Mahler's ability to use the quote function on this website is half assed at best. Would you like more examples of me making a statement versus me quoting someone?

Little box... lower right hand of the comment you're replying to reads "quote". If you press that little box, something magical happens! You quote the person you're replying to. Try it sometime genius.

Is "half assed" someone that wasn't "well reared"?

^^^^
How did I do that!? It's a miracle!!

BTW Sooner, you said I was a twisted puppy??:D

In general, FDA does not "decide" to change the dosage of a regulated medication of vaccine. In general, the manufacturer submits a desire to change, and, as appropriate, data to back up their claims of safety and/or efficacy with their request.

Here is a link to an article from way back in January on this topic:

https://www.cnn.com/2021/01/04/health/fda-coronavirus-vaccines-doses/index.html

Likely there are others.

EUA is unusual. This global pandemic is unusual.

One might ask: "Why would a company like Pfizer submit an application for the vaccine dose labeling to change to single versus double-- wouldn't that mean they'd make half as much money?"

And a related natural question might be "If Pfizer wouldn't seek a dosing change to their labeling, and public health experts and/or officials at CDC and/or NIH or even FDA did not agree, could one or more of these government entities basically force Pfizer to change their labeling?"

And then if such were possible "would the gubmint have to then indemnify Pfizer in some way?"

All of this might by immaterial if we did not have capitalism and our current legal system.

These are complex topics. In many ways, far too complex for easily distillation for public consumption.

I have a lot of experience at the intersection of industry and FDA regulation (industry side).

I remember back months ago when folks in these Forums thought that it should be easy for essentially laypersons to pitch in and come up with ventilators. Great motivations. Ignorance of details.

I remember back in '17 when by chance I met the brother of the man that was running ODE at FDA at a business luncheon in Sarasota . That man, an engineering consultant, had been a college roommate with a gentleman that was heavily involved with IMSA on the tech side (and later was in charge of tech). In turn, that gentleman was and still is a close friend of Jerry Woods.

By the way, FDA ODE is Office of Device Evaluation. Gatekeepers.

^^^
Damn man, that's a lot of wasted typing strokes! You could have just read the article linked on the first page.

"The company is asking the FDA to update its authorization of the vaccine to allow for vials to be stored at these temperatures for a total of two weeks as an alternative or complement to colder freezers."

It is all about the math and the hospitalizations

It was noticed in the studies that people who had 1 dose and then became infected with COVID-19, had very mild cases and were not hospitalized.

The rate of infection with one dose was about 80% fewer than the Placebo group.

With two injections, this rises to 95%. And those that became infected were virtually symptom free.

One dose is effective if you want to slow down the hospitalization rate and reduce the number of deaths in the country. 2 doses definitively prevents spread.

The present CDC (yes CDC) recommendation is only 1 dose for people who have had or tested positive at some point to COVID-19.

So, you can stop the deaths and stop the hospitalizations with one dose or your can add in definitively stop the spread the with a second dose. Your choich.

My recent posts were not intended to address the storage temperature topic.

I was kind of commenting on this:

"I think that's kinda why the FDA said Nah, we'll keep the dose the same back in January. Essentially, we're better off having a smaller percentage fully vaccinated than a larger percentage half assed vaccinated."

Back to storage temp....

I am not sure who is paying for what, but in general, it is likely in the best biz interest of Pfizer to seek a change that would make legal less challenging storage requirements in the labeling.

I have had roles in exec management in companies and have led projects with such goals...

The business opportunities for Covid vaccines for companies like Pfizer, Moderna, J&J and Novavax are not likely limited to the US and present circumstances. I would hypothesize that all of them have many initiatives underway to grow their businesses.

I glanced at the Novavax ~one year stock price change ... yikes.

As I mentioned in another thread, Texas Center for Drug Development is running trials for Pfizer, Modera and Novavax. Novavax just finished the basic trials and should be submitting to FDA shortly. I do not know the results, but the nurse said they did very well.

One thing to note, the J&J vaccine, one dose is around 70-80% effective (depending on strain). I wonder how they would have done if it had been implemented as a two dose vaccine. The single dose numbers for Moderna, Pfizer and Astro-Zeneca seem similar to J&J single dose.