The FDA is in No Hurry to Approve Pfizers 95 percent Effective Covid-19 Vaccine.

Saturday, November 21, 2020

Pfizer has developed a Covid-19 vaccine that is 95% effective in preventing someone from contracting the virus.

Yesterday, Pfizer submitted a request to the U.S. Food and Drug Administration for distributing the vaccine for use...with the elderly being at the top of the recipient list. (5 out every 100 people over the age of 70 who contract Covid-19, perish from the disease.)

The FDA approval committee says it will meet on December 10th to begin discussing Pfizer's request..

The Food & Drug Administration announced Friday that its committee on vaccines will meet Dec. 10th to review Pfizer's request for emergency use authorization (EUA) of its Covid-19 vaccine.

This comes two days after Pfizer, with their German partner BioNTech, released promising final results that show their vaccine is 95% effective and protects elderly adults who are most at risk of dying. Pfizer had submitted the EUA request earlier in the day Friday.

An FDA spokesperson told FOX Business the three-week window is necessary because "this amount of time will allow the FDA to thoroughly evaluate the data and information submitted in the EUA request before the meeting, and to be prepared for a robust public discussion with the advisory committee members."

"While we cannot predict how long the FDA’s review will take, the FDA will review the request as expeditiously as possible, while still doing so in a thorough and science-based manner, so that we can help make available a vaccine that the American people deserve as soon as possible," FDA Commissioner Stephen M. Hahn said Friday.

More at: www.foxbusiness.com...

The average number of people dying per day with Covid-19 here in the USA has been approximately 1,300 over the past 7 days, with the number of daily deaths trending upward over that 7 day period. (Yesterday was 1,862)

Source: covidtracking.com...

Given the upward trajectory of Covid-19 deaths this Fall, it's disgraceful for the FDA to not even begin talking about approving a ready-to-go vaccine until December 10th...3 weeks from now! And who knows how long those "approval discussions" will last. Every day of delay enables more future deaths.

Pfizer submits an EMERGENCY request, and the FDA says, "OK...maybe in 3 to 4 weeks, your request will be approved." Something is wrong at the Food and Drug Administration.

-CareWeMust

a reply to: carewemust

Gotta wait for Joe ...
Can't let Donald have any credit.

originally posted by: Mike27
a reply to: carewemust

Gotta wait for Joe ...
Can't let Donald have any credit.

The Speaker of the House is withholding Stimulus checks and Unemployment Funds.
The FDA is withholding approval of an already proven Covid-19 vaccine.

Yep...there's a sick, disgusting, pattern emerging.

Gotta have their reset. They won't let people's health get into the way of that. Power and money, that's what COVIDS about.

originally posted by: carewemust

originally posted by: Mike27
a reply to: carewemust

Gotta wait for Joe ...
Can't let Donald have any credit.

The Speaker of the House is withholding Stimulus checks and Unemployment Funds.
The FDA is withholding approval of an already proven Covid-19 vaccine.

Yep...there's a sick, disgusting, pattern emerging.

We the people, the teaming millions should be quoting this for 2020 and beyond...

a reply to: carewemust

Something is wrong at the Food and Drug Administration.

Because they're following due process ? , as with any new drug due diligence needs to be followed before it is licensed for release.

originally posted by: Mike27
a reply to: carewemust

Gotta wait for Joe ...
Can't let Donald have any credit.

Imagine if the vaccine WAS approved, and it started killing people.

How do you think that would make Trump - the man who wanted it rushed through - look?

originally posted by: carewemust

originally posted by: Mike27
a reply to: carewemust

Gotta wait for Joe ...
Can't let Donald have any credit.

The Speaker of the House is withholding Stimulus checks

Don't blame the speaker, blame the person who put in a last minute amendment that falls outside of the scope of the original plan, and was added for political reasons.

Like that time a veterans bull was withheld because people added totally unrelated riders on to it. If those people hadn't tried to tack their own issues onto the bill it would have passed easily.

originally posted by: AaarghZombies

originally posted by: Mike27
a reply to: carewemust

Gotta wait for Joe ...
Can't let Donald have any credit.

Imagine if the vaccine WAS approved, and it started killing people.

How do you think that would make Trump - the man who wanted it rushed through - look?

They claim that it is 95% effective, guess that means you have a one in twenty chance of a serious injury.

a reply to: carewemust

wait what, you are now suggesting covid to be taken seriously, all year you have claimed its a nothing burger now you say this

Given the upward trajectory of Covid-19 deaths this Fall, it's disgraceful for the FDA to not even begin talking about approving a ready-to-go vaccine until December 10th...3 weeks from now! And who knows how long those "approval discussions" will last. Every day of delay enables more future deaths.

when your previous threads include posts such as

Dr. Anthony Fauci says an Explosion of Deadly Covid-19 is Imminent.

Lots of ways to correlate Covid-19 Hysteria

are you catching the hysteria bug now

As long as a majority of the population does not buy into the lies, society will be fine

are the lies of covid now truths regarding number of deaths attributed to it?

Once the Covid-19 hoax is behind us, a ton of information will be exposed as deceptive.

So its a hoax now its not a hoax, is this information in the OP deceptive?

If this Covid-19 HOAX had happened in the 1980's, we would all be screwed.

more repeating of covid is a hoax

CDC and Biden Mask Hysteria Ramps Up as Covid-19 Declines - What is Their Motive?.

Only 51% of Americans get a Flu vaccine. The Covid-19 vaccine will probably have even fewer customers

how many do you want to have the covid vacine now?

Exactly! I bet more people died in NYC last week from stand-alone Pneumonia than those 12 Covid-19 deaths

did more people die last week because of pneumonia but now you are concerned with covid deaths

Whenever someone starts the Covid-19 Boogey-man warnings with me, I show them the graph with Hospitalizations and Deaths declining.

the covid 19 boogey man is now to be taken seriously

and thats just 2 of your 100s of threads, I really cant be bothered to show more of your inane posts which contidict your new position of concern for covid deaths

I used to think you were just passionate about the current POTUS now it really is apparent you are a flip flopping propoganda machine

originally posted by: AaarghZombies

originally posted by: Mike27
a reply to: carewemust

Gotta wait for Joe ...
Can't let Donald have any credit.

Imagine if the vaccine WAS approved, and it started killing people.

How do you think that would make Trump - the man who wanted it rushed through - look?

Thats why it has gone through phase 3 clinical trials it was tested on 40000 volunteers in 8 countries. seems to be fairly effective for every 20 people that actually caught the virus in there control group 1 person had taken there vacine.

So the looking at it 19 people who should have gotten the virus didnt. The only severe reavtion noted was fatigue so people slept more when they took the vacine.


And im betting the fact that the Pfizer vaccine, unlike others in late-stage testing, must be kept supercooled, on dry ice around 100 degrees below zero, from the time it is produced until a few days before it is injected. Mishandling the vaccine along the way from factory to patient would render it ineffective, so people who received it could think they were protected when they were not

What is truly unique about this is it uses messenger RNA. Its not using live virus or killed virus nor a signature viral protein that can dupe cells. Up until now this was all we had to fight a virus. With this what used to take years can now be created in months. It simply programs cells to produce a protein so the immune system will attack it. Think of this as direct programming. To fight a virus your body has to first identify it then absorb it and build antibodies to fight it. With an mRNA vaccine, cells are given the virus information via a genetic code without actually having to be infected by the virus, and are instructed to create the virus protein. Once this protein is created, the body is triggered to create antibodies to fight the virus.

This is a huge leap forward because it can be used to combat any virus.

a reply to: carewemust

Didnt trump already sign right to try EO? Why not just ammend to allow voluntary covid immunization to those who wish to accept the risk?

a reply to: dragonridr

I think what they are unsure of at this point is how the vaccine affects people who already had covid.

originally posted by: Mike27
a reply to: carewemust

Gotta wait for Joe ...
Can't let Donald have any credit.

I’m just pondering how far gone someone has to be to think that people are delaying a worldwide vaccine to make Donald Trump look bad.

Narcissism must be contagious.

originally posted by: gortex
a reply to: carewemust

Something is wrong at the Food and Drug Administration.

Because they're following due process ? , as with any new drug due diligence needs to be followed before it is licensed for release.

Don't think anybody is saying skip the steps to the "process" what they are saying is can't the FDA just begin their process earlier than 3 weeks from now, you know since this might be more important than the labeling on a mayo jar.

Posters need to make up there Minds here and Trump as well .
another thread says there is NO vax at all and yes old Trump is wanting credit for a vax exactly what credit does he want ?
saying make one if you can ? well ok Trump said make a vax asp .
wow how hard was that ?

Trump spoiled brat .
Next question who will be lining up to take This amazing Trump vax YOU ?
poster's HERE ?

Most people I talk to are very very Leary OF TRUMPS vax as He tries to short cut the testing so much taht many groups LIKE pregnant women and people who had it BUT got over it have no study's .
and of course kids 15 and under we force vaxing them with trumps potions when only a hand full even got sick and one or two died ?

I won't deny I'm confused by this. This is the kind of product that the FDA should have been monitoring while being developed, and the 3-4 week review shouldn't be necessary. I'm not up to speed on what Warp Speed entailed, but I had assumed it would have included at least weekly meetings between companies and the regulators to present data for review and set up studies and protocols. The companies in question should have had FDA approval at every step to minimize waiting times, and the FDA should have been getting regular study summaries instead of data dumps at the end.

originally posted by: Mike27

originally posted by: AaarghZombies

originally posted by: Mike27
a reply to: carewemust

Gotta wait for Joe ...
Can't let Donald have any credit.

Imagine if the vaccine WAS approved, and it started killing people.

How do you think that would make Trump - the man who wanted it rushed through - look?

They claim that it is 95% effective, guess that means you have a one in twenty chance of a serious injury.

You’re guessing wrong. A 95% effectiveness rate means a 5% ineffectiveness rate. In other words, a one in 20 chance of not giving you enough antibodies to prevent you from getting a COVID infection. That’s not a “serious injury”. That’s no injury at all.

The FDA is right to put the brakes on a rushed vaccine that scientist are admitting they have little history with, because of its novel status.

Everything about the vaccine is guess work. The FDA will be destroyed as an agency for public safety, if they allow themselves to be brow beatened into labelling a product as safe, when there is not enough data to support that it is.

According to the World Economic Forum, it can take up to 10 years to fully develop a vaccine. There is nothing about COVID-19 that warrants putting lives at risk, based on guess work.