FDA grants priority review to Pfizer-BioNtech Coronavirus Vaccine.

www.pharmacytimes.com...

This article explains how the FDA has granted priority review to the Pfizer vaccine. A decision will be made by January on whether to fully approve it.

The companies completed the rolling submission of their application in May 2021, and the Prescription Drug User Fee Act goal date for a decision is in January 2022. The application is supported by clinical data from the pivotal phase 3 trial of the vaccine, which observed the efficacy and safety of the vaccine for up to 6 months after the second dose.

So I suppose the rubber will be hitting the road pretty soon on these authoritarian vaccination ideas. But I thought I would share because I didn't see this posted and it does have some information about the trials in this article and the EUA for 12-15 year olds. Simply waiting to accrue 6 months of trial data on that age group and then will apply for full approval for them too.

a reply to: Chalcedony

Well, by January close to half the world will be vaccinated.

Guess if it doesn’t get approved - they are screwed.

This is feeling like putting the cart before the horse.

Call me stupid, but shouldn’t the vaccines get approved BEFORE half the world subjects themselves to it!?!?

They need to start ‘The Twilight Zone’ episodes again. This should be the first season of the new series.

a reply to: KKLOCO

Well I think there is little doubt it will be approved for that reason. So many have taken it. I just hope it is all on the up and up and is actually safe and a good risk v. benefit situation.

Although the words "observed the efficacy and safety of the vaccine for up to 6 months after the second dose." don't exactly inspire confidence.

originally posted by: KKLOCO
a reply to: Chalcedony

Well, by January close to half the world will be vaccinated.

Guess if it doesn’t get approved - they are screwed.

This is feeling like putting the cart before the horse.

Call me stupid, but shouldn’t the vaccines get approved BEFORE half the world subjects themselves to it!?!?

They need to start ‘The Twilight Zone’ episodes again. This should be the first season of the new series.

but there are many different vaccines. Pfizer is just one of many. So if one of the trial vaccines turns out bad, there are back up plans in place.

originally posted by: Chalcedony
a reply to: KKLOCO

Well I think there is little doubt it will be approved for that reason. So many have taken it. I just hope it is all on the up and up and is actually safe and a good risk v. benefit situation.

Although the words "observed the efficacy and safety of the vaccine for up to 6 months after the second dose." don't exactly inspire confidence.

we have already been told at high volume that the vaccines are totally safe, just look at how many have not died from it. I think that's how the trials work.

a reply to: KKLOCO

They are risking all of humanity to save the most vulnerable. This is a crime against humanity and I’m one of the few speaking out against it. Twilight Zone indeed. I wish I could wake up.

a reply to: Chalcedony
This is ass backwards, it doesn’t even get out of trials till 2023.

a reply to: Chalcedony

I am not holding my breath for any approval.....nothing mRNA has ever been approved.....ever.

a reply to: KKLOCO

The vaccines are approved for "emergency use".

99% of the people being injected with these experimental vaccines are not in an "emergency" situation.

But the "experts" and media think people are stupid... So there's that.

originally posted by: BlueJacket
a reply to: Chalcedony
This is ass backwards, it doesn’t even get out of trials till 2023.

This has to be the biggest experimental vaccine trials in history.

How many guinea-pigs have participated thus far....150 million?

Wow.

a reply to: Chalcedony

By doing emergency authorization, pushing the "completely safe" narrative, and then pushing so hard for everybody to vaccinate, they've poisoned the well. There is no version of this where they don't get final approval. They painted themselves into a corner by not restricting emergency vax use to the highest risk groups. The blanket vax policy essentially stripped the final approval of any meaning.

Approving the vaccine no longer means anything, because there is no other alternative. There is no timeline where they discover a problem and deny the final approval. The vax are approved because if they aren't then the DNC has a massive problem.

Once you realize that the approval is no longer a purely objective scientific decision, you can view everything since the very early days of COVID in a new light.

a reply to: Chalcedony

Even IF it doesn't get fully approved, I assume (and that's all it is, an assumption) that they will still keep using it, it will probably still retain it's Emergency Use Authorization (EAU) status.

Drug invention to drug approval by the FDA typically take 12 years. The FDA approval process requires a period of extended study to determine the long term effects of a new drug. www.medicinenet.com...

Question - If a man and a woman are both vaccinated with the COVID-19 vaccine and then subsequently conceive will there be any abnormalities noted in the fetus? Does anyone have a link to where this has been researched?


a reply to: network dude

a reply to: Buvvy

Exctly max by 12 to 10 years its how long it takes the FDA approve a drug or vaccine but if FDA somehow approves the covid mRNA vaccine i still wouldn't trust it because it has being rushed through.

originally posted by: Chalcedony

So I suppose the rubber will be hitting the road pretty soon on these authoritarian vaccination ideas. But I thought I would share because I didn't see this posted and it does have some information about the trials in this article and the EUA for 12-15 year olds. Simply waiting to accrue 6 months of trial data on that age group and then will apply for full approval for them too.

Why do you call it "authoritarian"? Its like people make crap up to label something bad. Why isn't this a good thing? I would think 5 billion shots by then is a pretty good sample size don't you think...lol

Kind of better than the old days when they gave cowpox to children to see if it works and they said seems to work now we can give it to real people...lol

originally posted by: HawkEyi

Exctly max by 12 to 10 years its how long it takes the FDA approve a drug or vaccine but if FDA somehow approves the covid mRNA vaccine i still wouldn't trust it because it has being rushed through.

Well no it is 3 to 5 for a new drug. mRNA is decades old BTW. So what do you think they are doing during that 3 to 5 years? Typically it takes a few years to get past Phase 3, so what is the FDA doing during your so called 10 years?

originally posted by: Buvvy
Drug invention to drug approval by the FDA typically take 12 years.

So for mRNA did the 12 years start in 1992 when it was invented?

originally posted by: carewemust

This has to be the biggest experimental vaccine trials in history.

How many guinea-pigs have participated thus far....150 million?

Wow.

IDK, smallpox was like 20 children in the testing, and when they didn't die it was mass produced.

a reply to: Xtrozero

Like vaccine mandates and health pass apps and no vax no job is what I mean by authoritarian. Can't really be implemented unless they are fully approved. Can't force or mandate people to get a vaccine that is still only emergency licensed.

a reply to: Xtrozero

I think we have to consider that these vaccines are a new formulation. Yes, mRNA has been researched extensively but these vaccines themselves are brand new. Like if aspirin was reformulated we wouldn't just take it because aspirin has been around forever. We would want new data because it is a new formulation. Or at least I would. But I see where you are coming from. A lot of the previous animal trials with mRNA vaccines against RSV and similar respiratory illnesses have failed spectacularly.