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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.
Pfizer and BioNTech plan to submit the efficacy and safety data from the study for peer-review in a scientific journal once analysis of the data is completed.
www.pfizer.com...
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.
originally posted by: KansasGirl
a reply to: carewemust
5 out of every 100 people over 70 who get covid-19 die from it? Where are you getting that number?
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?
originally posted by: AaarghZombies
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: carewemust
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.
How long would it take if it were NOT an "Emergency Request"?
As complex biological products administered to millions of generally healthy people, vaccines have been among the most carefully evaluated medical products.Historically, it has taken years to move a vaccine from initial discovery to US Food and Drug Administration (FDA) approval.1 But the unprecedented impact of the coronavirus disease 2019 (COVID-19) pandemic has brought attention to the process of vaccine development and evaluation and whether it can be expedited
www.healthaffairs.org...
originally posted by: underwerks
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.
Just a couple weeks after Democrat California Gov. Gavin Newsom announced he would not automatically distribute a vaccine for the coronavirus if one is approved while President Donald Trump is in the White House, three more Democrat governors are putting politics ahead of public health in their states by also saying they don’t trust the Trump administration in the matter.
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.
originally posted by: underwerks
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: carewemust
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..
More at: www.foxbusiness.com...
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.
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