And the hapless FDA (Food and Drug Administration) in the United States, has only said it has “scheduled a meeting” of its “outside advisory panel” to discuss Pfizer and BioNTech’s application for emergency use authorization for a coronavirus vaccine for December 10.
No rush here…, just go on ahead and takes your sweet time!
The FDA in the United States obviously sees no sense of urgency regarding this matter.
And what the hell is an “outside advisory panel?”
The FDA has an annual budget of $6 billion, and they don’t have the resources within their own administration to handle this?
Anyway, according to Emma Reynolds, Stephanie Halasz, Frederik Pleitgen and Lindsay Isaac for CNN, “The United Kingdom has become the first Western nation to approve a Covid-19 vaccine, a landmark moment in the coronavirus pandemic that paves the way for the first doses to be rolled out across the country next week.”
Congratulations to the United Kingdom for moving quickly on this.
Long live the Queen!
‘“Help is on the way,’ Health Secretary Matt Hancock announced Wednesday morning, after UK regulators granted emergency authorization for a vaccine made by US pharma giant Pfizer and its German partner BioNTech.”
“A final analysis of the Phase 3 trial of Pfizer’s vaccine shows it was 95% effective in preventing infections, even in older adults, and caused no serious safety concerns, the company said last month.”
“The announcement means the UK has vaulted past the United States and European Union in the race to approve a vaccine, months into a pandemic that has killed almost 1.5 million people worldwide.”
And I just have to say again, thanks China!
And thanks for nothing FDA!
The American people all realize you have other more important things to do, but…
‘“We believe it is really the start of the end of the pandemic,’ BioNTech CEO Ugur Sahin told CNN in an exclusive interview on Wednesday. Pfizer CEO Albert Bourla hailed the emergency authorization as ‘a historic moment in the fight against Covid-19.’”
“The UK has ordered 40 million doses of the vaccine — enough to vaccinate 20 million people. Hancock told the BBC (British Broadcasting Company) that an initial 800,000 doses would be delivered from Pfizer’s facilities in Belgium to the UK next week, and ‘many millions’ more before the end of the year.”
In the meantime, the FDA in the United States has “scheduled a meeting” of its “outside advisory panel” to discuss Pfizer and BioNTech’s application for emergency use authorization for a coronavirus vaccine for December 10.
“Prime Minister Boris Johnson called the news ‘fantastic’ in a tweet, adding that ‘it’s the protection of vaccines that will ultimately allow us to reclaim our lives and get the economy moving again.’”
“The UK health department said the approval ‘follows months of rigorous clinical trials and a thorough analysis of the data’ by the Medicines and Healthcare products Regulatory Agency (MHRA), which had ‘concluded that the vaccine has met its strict standards of safety, quality and effectiveness.’”
The same data that has been available to our own FDA.
MHRA 1, FDA 0.
“MHRA chief Dr. June Raine insisted that ‘no corners have been cut’ during a news conference Wednesday. Raine said the clinical trials were ‘overlapping’ to progress the process faster. ‘Separate teams have been working in parallel to deliver this review,’ she added.”
What a novel concept!
Do you see what they’re doing over there in the UK, FDA?
“The news of the UK authorization could also cause a bit of a stir in the United States. Earlier this week, President Donald Trump privately demanded to know why the Food and Drug Administration hadn’t granted emergency use for Pfizer’s vaccine yet?”
Good question, Mr. President?
A question that our fake news, liberal propaganda, mainstream media, I’m sure, has not been too eager to pick-up.
“BioNTech and Pfizer submitted their vaccine candidate to the FDA in mid-November.”
And again, in the good old USA, the FDA (Food and Drug Administration) continues to drag their feet while the China virus pandemic continues to take its toll of American lives on a daily basis.
The FDA sees the China virus as such an urgent threat that they all took four days off around the Thanksgiving holiday!
Kaitlan Collins, for CNN, reports that, “White House chief of staff Mark Meadows is scheduled to meet with Food and Drug Administration Commissioner Stephen Hahn in the West Wing Tuesday, as President Donald Trump has privately demanded to know why the agency hasn’t granted emergency use for Pfizer’s coronavirus vaccine yet, according to two sources.”
“Two sources?!” That may be a new record for CNN! Usually one anonymous source, or even one fictitious anonymous source, is plenty to run with a story!
Can I really help but be cynical of CNN’s reporting?
The correct answer to that is “no,” by the way.
“Meadows summed [I believe she means ‘summoned.’] Hahn for a progress update over the weekend. Hahn requested their meeting happen over the phone, one source said, but was told by the White House that the chief of staff preferred to meet in person. That appears to have led to concern within the FDA that the meeting could become tense, leading Hahn to issue a statement to Axios Monday night defending the FDA’s timeline.”
Oh my gosh, a tense meeting!
Whatever shall he do?
‘“Let me be clear — our career scientists have to make the decision and they will take the time that’s needed to make the right call on this important decision,’ Hahn said in the statement.”
Remember…, “it’s all about the science!”
When in doubt or in question, throw a scientist at them!
“A person familiar with the meeting tells CNN that Hahn is prepared to explain to the President’s team that the decision about granting the emergency use authorization is not up to him. The review is conducted by career scientists and not a decision he makes on his own.”
So, Mr. Hahn is letting the press (the propaganda wing for the liberals and the ‘deep state’) exactly what he plans on saying to the Chief of Staff, presumably to deflect any level of accountability away from himself.
“Pfizer applied for the emergency use authorization November 20. Emergency use authorization from the FDA is not the same as full approval but allows products to be used under particular circumstances before all the evidence is available for approval, according to previous CNN reporting. The FDA has previously said it has scheduled a meeting of its outside advisory panel to discuss Pfizer and BioNTech’s application for emergency use authorization for a coronavirus vaccine for December 10.”
“But [President] Trump has become privately frustrated over how long the process is taking, sources told CNN. He has proudly and publicly admitted to pressuring the FDA to move faster.”
The only people who shouldn’t be frustrated are the Chinese Communist Party, and their friends, the American democrat leadership.
“Amid complaints from The President that the FDA is working too slowly, White House press secretary Kayleigh McEnany said on Fox News Tuesday that, ‘We want a safe vaccine, absolutely. We also want a fast one because lives are at stake and a vaccine by the end of the year is key and paramount.’”
Well stated, Ms. McEnany.
“It’s not clear how the meeting between Meadows and Hahn will go until it takes place,” CNN reported.
You don’t say.
And this what they call “journalism” these days?
“A sense of distrust between Trump’s closest advisers and career scientists [Translation: Career ‘deep state” liberal scientists.] on the FDA already existed before the FDA issued public statements about the meeting Monday night.”
That, I believe, should go without saying.
‘“The FDA has been preparing for the review of EUAs for Covid-19 vaccines for several months and stands ready to do so as soon as an EUA request is submitted,’ Hahn said in a statement shortly after Pfizer applied for emergency use authorization for the vaccine in late November. ‘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.’”
Just shut up and approve the vaccine for the American people already, Hahn.
The time for bureaucratic paper shuffling an establishment political double-speak is over.
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