FDA Authorizes Covid-19 Vaccine Formula Tweaking - No Additional Testing Required.

Tuesday, February 23, 2021

When you consider that neither Pfizer or Moderna Covid-19 vaccines are fully approved by the Food and Drug Administration, it's somewhat mind-boggling that the FDA would authorize Pfizer/Moderna to "tweak" their vaccine formulas as they see fit, with no additional trials/testing required.

Monday, February 22, 2021

The U.S. Food and Drug Administration issued new guidance Monday that streamlines the vetting process for COVID-19 vaccines that are modified to target new coronavirus variants.

The recommendations, detailed in a 24-page document on the FDA’s website, are intended to speed up the review process amid worries that the new variants — some more contagious, some more able to evade current vaccines — will undermine efforts to halt the virus’ spread.

“We know the country is eager to return to a new normal and the emergence of the virus variants raises new concerns about the performance of these products,” Dr. Janet Woodcock, the FDA's acting commissioner, said in a statement.

“By issuing these guidances, we want the American public to know that we are using every tool in our toolbox to fight this pandemic, including pivoting as the virus adapts.”

The recent emergence of a spate of variants has led to rising concerns that the first generation of vaccines — which were developed based on an early version of the coronavirus — may not be well-equipped to protect people against the mix of viruses currently in circulation.

Extracted from: news.yahoo.com...

Here is the referenced FDA Guidance document: www.fda.gov...


First Concern: If a medication approved for "Emergency Use Only" by the Food and Drug Administration, the manufacturer should not be allowed to further experiment with the medication/vaccine, by tweaking the formula.

Second Concern: If 35 million people have been vaccinated against the original Covid-19, then the vaccine is "tweaked" to make it also more effective against a fast-spreading Covid-19 variant, those 35 million are suddenly not inoculated against that variant. What are they to do?

Are there additional concerns? Do the potential benefits from this flexibility outweigh the risks, in your opinion?

-CareWeMust

a reply to: carewemust

Are there additional concerns? Do the potential benefits from this flexibility outweigh the risks, in your opinion?

It's impossible for us to know all the potential risks involved. As far as the benefits, that depends on your perspective. In the eyes of some, as long as more people are helped than harmed, and it happens to harm "thee" and not "me", then the risks are worth it. For the individuals who are harmed, then no, the risks are not worth it.

The next question to ask is if these vaxxes -- experimental and tweaked -- can lawfully and morally be forced on the masses?

In the final analysis, it depends on how much we value our Republic. Are we a nation of individuals with individual rights? Or not???

a reply to: carewemust

The precedent was set but 2 months ago, and now we see what their vision of the ' New Normal™ ' entails.

Medical experimentation on the public at large.

With no liability for the consequences.
And mega billions in profit !!
What a business model !!

Our leaders are psychopaths, and we just let them push it further and further.

Most things eventually snap, when pushed too far.

Funny how only mRna are only approved

Well if your willing to line up for an untested tweaked version of a barely tested rushed vaccine for a virus with a 99.9+% survival rate. . .

I’m still not wearing a mask and still don’t give a # about the vaccine and I’m still ok. Still haven’t had a flu shot since probably 2009 when I was still serving and haven’t really gotten sick too many times over the years, maybe 2 times I can remember that where significant. People that are that concerned should consider staying in doors before making the choice to let ass holes they don’t know inject them with things they don’t understand if they are that concerned with getting the sniffles.

Mark
Of
The
Beast

Stay in denial everyone... time will reveal it. This is illegal, it's a war crime actually.

We're lab rats as far as they're concerned.

They have no idea what's going on. A healthy 25 year old dies from it, but a 90 year old recovers and they have no clue as to why.
I don't even take flu shots and I'm sure as hell not taking this.

Going to say nopesville population me for now.

Didn't like the idea of experimental vaccine to begin with.

originally posted by: Irishhaf
Didn't like the idea of experimental vaccine to begin with.

Something wrong with 'the idea' here. Am watching (older) people acting like they've been 'touched' hustling off to get this vaccine (not a vaccine). It's not loads of people, but damn, when they know they're gonna get their shots ... they start acting like zombies. Gives me the willies.

Nope. Not getting poked.

a reply to: Snarl
the excitement is palpable...just yesterday I emailed and congratulated a fellow artist who won an award...had not contacted her in months...the 2nd thing in her reply after 'thanks' was "we got our 2 vaccinations, how about you?".
Not anything more about art, life, kids, gkids...the type of people that are hinging on every word the gov't says about being safe, and totally relying on that for security. My daughter saw her on a walking trail with no one else around, fully masked up...what is up with that?
edit: I have yet to know a single person personally that has been hospitalized for the 'rona...jus sayin

originally posted by: Boadicea
The next question to ask is if these vaxxes -- experimental and tweaked -- can lawfully and morally be forced on the masses?

Lawfully?? Nope. Morally?? Definite nope. Unfortunately, they've found a means to do it, though.

hrexecutive.com...

When I dropped my dog off at my aunts yesterday I also heard them say on the news that employers can require vaccines for employment, no different than how many businesses require drug testing. That's how they're going to do it. No claims of unconstitutionality, with the cake baker fiasco used as justification. This way it's the businesses that get sued, not the government.

From there, then other businesses may require proof of vaccination in order to even let you shop there, and if you get upset, they'll tell you they have other means for you to get your supplies, such as online ordering. Each of our grocery stores here have that as an option now, you order online, park outside and someone brings you your groceries.

As time goes on I'm sure there'll be more businesses following suit regarding proof of vaccination; no more haircuts, bars, bowling, chiropractics, massages, accupuncture, dentistry, and in the end, possible straight up doctor visits. I'm already told that the type of mask I wear at work I can't bring into a hospital all because it has vents on the side.

a reply to: Necrobile

I agree... not just in this situation either... that this government/corporate collusion (pretty damn close to the actual definition of fascism) is used in many ways to "legally" effect what government itself is prohibited from doing.

In a true free market, free of government coercion in its various forms, I don't think we'd have to worry about retail businesses demanding vaccinations (or even masks), because they would lose too much business. But I wouldn't have a problem with those businesses which chose to require vaxxes or masks. I'm sure they'd have customers happy to shop there rather than maskless/vaxless places, so they would be filling a public need, and they have the right to decide the terms and circumstances under which they operate their business. As long as the business has the choice, I'm good with that.

Sadly, I think employers (particularly corporations which depend on government favors and employ the greatest numbers of people) would be more likely to do so, and especially if incentivized to do so by government freebies. One of many reasons we desperately need incorporation reform.

And another good reason to reform the many ways small businesses are regulated and taxed out of existence, while their incorporated competitors thrive.

a reply to: Necrobile

I hope this turns into an opportunity for new business models too--for examples concerts and sports for the vax free crowds (of course the vaxxers will continue to disparage those who don't march in step in line as granny killers and selfish disease vectors).

originally posted by: Zrtst
a reply to: Snarl
the excitement is palpable...

Thanks for confirming "I'm not the only one."

I know no one who has been hospitalized either. Pretty sure me and the wife came down with the Rona January of last year. Lots of folks I know say they've had it (confirmed) and even more recall (like myself) having the major symptoms ... and self-recovering. That's the normal thing for people -vs- corona viruses ... your immune system simply whoops it into submission.

I believe it's real. I believe it's highly contagious. I don't believe much of the rest of the hype.

a reply to: carewemust

Can I have my experimental DNA altering shot? Please pretty please, I'm so scared. I want it now, I'll wait in line for days to get it, just so I can still wear my mask for another year. PLEASE!!!!!

a reply to: carewemust
Is it even possible to 'return' to a new normal?

originally posted by: Boadicea
a reply to: carewemust

Are there additional concerns? Do the potential benefits from this flexibility outweigh the risks, in your opinion?

It's impossible for us to know all the potential risks involved. As far as the benefits, that depends on your perspective. In the eyes of some, as long as more people are helped than harmed, and it happens to harm "thee" and not "me", then the risks are worth it. For the individuals who are harmed, then no, the risks are not worth it.

The next question to ask is if these vaxxes -- experimental and tweaked -- can lawfully and morally be forced on the masses?

In the final analysis, it depends on how much we value our Republic. Are we a nation of individuals with individual rights? Or not???

Everyone says the Covid-19 vaccine is totally different than any vaccine ever created. I suppose many of the negative effects won't be known for years.

originally posted by: Nothin
a reply to: carewemust

The precedent was set but 2 months ago, and now we see what their vision of the ' New Normal™ ' entails.

Medical experimentation on the public at large.

With no liability for the consequences.
And mega billions in profit !!
What a business model !!

Our leaders are psychopaths, and we just let them push it further and further.

Most things eventually snap, when pushed too far.

Joe Biden says he's forcing Pfizer and Moderna to churn out 600 million doses before July 1st.

What happens if come July 1st, a Covid-19 variant is most dangerous...a variant that the 600 million doses wasn't designed to treat?

originally posted by: Quantumgamer1776
Well if your willing to line up for an untested tweaked version of a barely tested rushed vaccine for a virus with a 99.9+% survival rate. . .

Good point. Taking "Self Responsibility" is critical. Unfortunately, 80% of Americans only dine on news fed to them by the Mainstream Media. They don't come to ATS and other important sources, to learn what's really going on.