Emergency Use Authorization vs full approval.

We now have three vaccines the FDA has approved for Emergency Use Authorization (EUA). My question is if these vaccines have undergone a "rigorous development process" then why not give them the full approval? I did a little research and it seems the main difference between the two approvals is EUA vaccines have not been studied for their long term effects. So basically those of us who chose to get the vaccine are now part of the long term study.

Another interesting tidbit I stumbled across is the rules were changed for authorizing EUAs on February 4, 2020. The "use of EUAs is covered under section 564 of the Federal Food, Drug, and Cosmetic Act." The short version is "the EUA program was established in 2004, in the aftermath of the September 11, 2001 terror attack in the U.S., to authorize the use of an unapproved medical product or an unapproved use of an approved medical product during a declared public health emergency." Prior to February 4, 2020 "the HHS Secretary determined that there is a public health emergency (EUA) authority allowed FDA to help strengthen the nation’s public health protections against chemical, biological, radiological, and nuclear (CBRN) threats" ONLY. The original authorization did not include infectious diseases. They changed the rules, and in record time.

A public health emergency was issued on January 31, 2020. "A determination under section 319 of the Public Health Service Act that a public health emergency exists, such as the one issued on January 31, 2020, did not enable the FDA to issue EUAs." Four days later "the that has a significant potential to affect national security or the health and security of United States citizens living abroad, and that involves the virus that causes COVID-19."

One final thing I'd like to point out is the FDA approved the use chloroquiquine phosphate and hydroxychloroquine sulfate for treatment of COVID-19, March 28, 2020, under an EUA. So Trump wasn't the nutbag the media was trying to portray him as regarding the use of these drugs. I would be remiss if I didn't also point out that EUA was revoked on June 15, 2020 after "the FDA had determined that the statutory criteria for EUA as outlined in Section 564(c)(2) of the Food, Drug, and Cosmetic Act were no longer met. Specifically, FDA has determined that CQ and HCQ are unlikely to be effective in treating COVID-19 for the authorized uses in the EUA."

a reply to: ratcals

This is GREAT information- thanks so much for putting it together!

Anything and everything connected with the so-called Patriot Act of 2001 is 100% suspect. Not at ALL surprised to see these awful humans using things from the “Patriot Act” to perpetrate this farce on this country.

originally posted by: ratcals
We now have three vaccines the FDA has approved for Emergency Use Authorization (EUA). My question is if these vaccines have undergone a "rigorous development process" then why not give them the full approval? I did a little research and it seems the main difference between the two approvals is EUA vaccines have not been studied for their long term effects. So basically those of us who chose to get the vaccine are now part of the long term study.

That is correct. Normally any drug would need to go through much MORE rigorous testing over a much longer period of time before being allowed for human use. If the FDA had not allowed this emergency use, we would still be waiting for a vaccine and complaining how slowly the government works. So here you are. You want a vaccine? Go for it, but you still don't have to take it.

originally posted by: schuyler
You want a vaccine? Go for it, but you still don't have to take it.

The problem is you WILL have to take it if you want to be a participating member of society. The vaccine is going to be de facto mandatory. A school district in LA already forces students to use COVID app to enter campus

I think health passports are being discussed in another thread so I will leave it at that.

originally posted by: schuyler

originally posted by: ratcals
We now have three vaccines the FDA has approved for Emergency Use Authorization (EUA). My question is if these vaccines have undergone a "rigorous development process" then why not give them the full approval? I did a little research and it seems the main difference between the two approvals is EUA vaccines have not been studied for their long term effects. So basically those of us who chose to get the vaccine are now part of the long term study.

That is correct. Normally any drug would need to go through much MORE rigorous testing over a much longer period of time before being allowed for human use. If the FDA had not allowed this emergency use, we would still be waiting for a vaccine and complaining how slowly the government works. So here you are. You want a vaccine? Go for it, but you still don't have to take it.

So far we don't have to take it, what about those doses for every American that Biden ordered.

www.nbcnews.com...

It would be ridiculous to spend that much and then not use a vaccine with a shelf life. Among other things makes you wonder who has Pfizer and Moderna stocks? Why Hunter might be even appointed chairman of the board

WASHINGTON — The government is working to buy 200 million more doses of Covid-19 vaccines, a move that could provide enough doses to fully inoculate nearly every American by the end of the summer, President Joe Biden said Tuesday.

The government is seeking 100 million doses from Pfizer/BioNTech and 100 million from Moderna, an order that would be made available over the summer. They would be in addition to the 400 million combined doses the companies had already committed to provide the U.S., Biden said. He said he expects to be able to confirm the purchase soon.
"It will be enough to fully vaccinate 300 million Americans to beat the pandemic," Biden said.

originally posted by: ratcals
We now have three vaccines the FDA has approved for Emergency Use Authorization (EUA). My question is if these vaccines have undergone a "rigorous development process" then why not give them the full approval? I did a little research and it seems the main difference between the two approvals is EUA vaccines have not been studied for their long term effects. So basically those of us who chose to get the vaccine are now part of the long term study.

Indeed, the entire world is now an active guinea-pig for Phase IV of the vaccine trials, due to a panicky ambience and a perceived need to save time and money - hence why a safe version of a Covid-19 antigen is not being used, instead opting for 'groundbreaking' albeit cheaper messenger RNAs (for the first time in mass use) and assorted Monkey Cold antigens cutely dressed as Covid, etc.

Meanwhile, medical experts will be monitoring any 'problems' during the next two years...

Short-term, they will be safe, and probably highly effective (according to current analyses). But long-term...?

NOBODY KNOWS...

NOBODY... Not even Phage!


And I'm a hypocrite, because two weeks ago I was unconcerned... but, upon closer analysis as my own turn nears, I'm getting cold feet as I ponder going anywhere near these jabs until a standard Phase IV period of time has elapsed among those willing to be guinea-pigs (of course without them necessarily realising they are under the 'Emergency Use' headlines).

This is no standard Conspiracy Theory drivel and hyberbole - it's simply a genuine medical concern amongst all the noise, for which nobody has an answer. Because there is no way they CAN answer.

If we're really unlucky, the Persuaders in authority might try and use a modified version of a 26-year-old song to make us feel guilty for being so sceptical...

Double Post.



EDIT: I hate to waste space with a DP, so, to avoid thread drift, here's the UK's own AstraZeneca 'chimp' antigen disguised as Covid-19...

originally posted by: ratcals

originally posted by: schuyler
You want a vaccine? Go for it, but you still don't have to take it.

The problem is you WILL have to take it if you want to be a participating member of society. The vaccine is going to be de facto mandatory. A school district in LA already forces students to use COVID app to enter campus

I think health passports are being discussed in another thread so I will leave it at that.

You are ALREADY required to have vaccines before entering school. And perhaps most of you don't remember it, but it used to be that along with your passport you were issued a yellow "vaccination record" the same size as a passport, done in three languages, to record all your vaccinations that were REQUIRED before you could visit foreign countries (or come back from visiting foreign countries). More vaccines were required to visit Africa than Europe. As more and more countries came up to "standard" that requirement seems to have faded out. IOW this is NOT SOMETHING NEW.

Vaccinations eliminated polio, scarlet fever, TB, small pox, DPT, and a host of other diseases that once ravaged the population. Some of you people apparently would be cool with going back to that.

originally posted by: ratcals those of us who chose to get the vaccine are now part of the long term study.

indeed so. i don't think all the recipients have grasped this aspect.

originally posted by: schuyler

And perhaps most of you don't remember it, but it used to be that along with your passport you were issued a yellow "vaccination record" the same size as a passport, done in three languages, to record all your vaccinations that were REQUIRED before you could visit foreign countries (or come back from visiting foreign countries).

You must be talking pre 1986. Because I have lived outside of the US for a total of 25 years and visited countless countries, to include Africa, and NEVER ONCE was I REQUIRED to show a vaccine record.

Furthermore I don't have a problem with having to be vaccinated to travel abroad. That is the ONLY reason I have chosen to be vaccinated. However, having to prove I'm vaccinated just to participate in life is wrong.

a reply to: schuyler

Some vaccines "real vaccines" are needed, but no all of them, soo you have a choice of vaccine to get, the china virus injection is not a "vaccine" soo that is why is no "mandatory", anybody that try to do that right now, can be sue for violation of rights. Mandatory and required do not mean the same thing and can be argued about depending the state your reside.

Vaccine passes is a scaremongering tactic to make people think that is going to be mandatory to have it, no so, because it will create segregation and prejudice within the population, and a third class citizens, taking into consideration that liberals are all about equality, I do not see it happening, too many legal reasons for law sues.

The china virus injection has been approved under emergency authorization, but been trial injections is not approved like regular vaccines are, once the emergency is gone I wonder what will happen.

The immunity for the makers of this injections will be over in 2024