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Pfizer-BioNTech files for U.S. approval of COVID-19 vaccine
Reuters ^ | May 7, 2021 9:52 AM EDT

Posted on 05/07/2021 8:15:22 AM PDT by 2aProtectsTheRest

Pfizer Inc (PFE.N) and German partner BioNTech SA have filed for a full approval for their COVID-19 vaccine, which is now authorized only for emergency use, the drugmakers said on Friday. A nod by the U.S. Food and Drug Administration will make it the first approved COVID-19 shot and likely help ease hesitancy by raising confidence in the vaccine as an approval will be backed by longer-term data. It would also allow the companies to market the vaccine directly to people above 16 years of age as well as help corporations and government agencies mandate vaccinations. The Pfizer-BioNTech vaccine was the first to be authorized in the United States for emergency use in December based on two months of safety data for a 44,000-person clinical trial. Vaccines from Moderna (MRNA.O) and Johnson & Johnson (JNJ.N) have also been authorized for emergency use since then. Moderna said on Thursday it plans to initiate submission for a U.S. approval this month.

(Excerpt) Read more at reuters.com ...


TOPICS:
KEYWORDS: approval; chinavirusvaccine; covid19; dictatorship; pfizer; profitsoverpatients; vaccine; yourpapersplease
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As predicted, Pfizer has filed for full FDA approval. As stated previously, FDA is going to provide priority review, which means a response is expected within the next 6 months rather than the usual 6-12 month window. Moderna to follow suit in the next couple weeks with their filing. Interestingly, the EUA granted to J&J could potentially be forced to expire if either of these are given full approval.
1 posted on 05/07/2021 8:15:22 AM PDT by 2aProtectsTheRest
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To: 2aProtectsTheRest

With 252 million doses administered to date the dataset is so large that approval would be expected in weeks not months. Full approval is contingent on effective rate and human tolerance rate. The data is so large and convincing at this point full.approval is a formality.


2 posted on 05/07/2021 8:25:31 AM PDT by JD_UTDallas ("Veni Vidi Vici" )
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To: 2aProtectsTheRest

The husband of a friend of mine just got his 2nd dose of one of the vaccines last week. He missed a couple days of work, saying “I didn’t think it was possible to feel this horrible and still be among the living.”

I’m a hard pass on the vaccines...all of them.


3 posted on 05/07/2021 8:34:48 AM PDT by Dana1960
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To: 2aProtectsTheRest

One (weak) argument down for not getting vaccinated.

I wonder what the new and improved reason will be........


4 posted on 05/07/2021 8:38:51 AM PDT by David Chase
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To: 2aProtectsTheRest

Good deal. Next up - Moderna. My moderna shots were non eventful and glad to get them and get that done.


5 posted on 05/07/2021 8:39:49 AM PDT by plain talk
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Comment #6 Removed by Moderator

To: 2aProtectsTheRest; Jane Long; Cathi; ransomnote; bagster; numberonepal; Steve Van Doorn

7 posted on 05/07/2021 8:59:36 AM PDT by grey_whiskers (The opinions are solely those of the author and are subject to change with out notice.)
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To: 2aProtectsTheRest

we have MDs from Baylor writing in Nature that we need this: “Efforts must expand into the realm of cyber security, law enforcement, public education and international relations. A high-level inter-agency task force reporting to the UN secretary-general could assess the full impact of anti-vaccine aggression, and propose tough, balanced measures. The task force should include experts who have tackled complex global threats such as terrorism, cyber attacks and nuclear armament”

That same article links “anti-vaxxers” to right-wing extremists questioning the results of the 2020 Presidential election.

And yes, published in Nature.

This is what he says about people opposed to the experimental mRNA shots:

One campaign implies that it could turn people into monkeys.

This builds on a longer, well-documented history of Russia-sponsored disinformation, presumably to destabilize the United States and other democratic countries. The administration of US President Joe Biden has warned Russian media groups to halt their anti-vaccine aggression

Many far-right extremist groups that spread false information about last year’s US presidential election are doing the same about vaccines.

This is the call for a totalitarian purge, using the full force of the US government, based on baldface lies. And look, it’s all those pesky Trump voters.

“RUSSIA, RUSSIA, RUSSIA.” “FAR RIGHT EXTREMIST GROUPS THAT SPREAD FALSE INFORMATION.”

They ALWAYS go back to the same playbook.

= = = = = =

1.”Nearly one billion COVID-19 vaccine doses have been delivered in less than six months, but anti-vaccine disinformation and targeted attacks on scientists are undermining progress. These threats must be confronted directly, and the authority and expertise of the health community alone aren’t enough to do this.”

2.”Even before the pandemic, I had a front-row seat to all of this. I have co-led efforts to develop vaccines in programmes, including a COVID-19 vaccine currently being tested in India.”

3.”Teams of experts, including me, began meeting regularly online to discuss how best to amplify evidence-based messages, deliver public-service announcements and address concerns around COVID-19 immunization.”

4.”...when I ask for a more direct way to counter anti-vaccine aggression, I’m told, “that’s not our approach; confrontation gives them a platform and oxygen.” In my opinion, this attitude reflects a time when we had dial-up modems. Today, the anti-vaccine empire has hundreds of websites and perhaps 58 million followers on social media. The bad guys are winning, in part because health agencies either underestimate or deny the reach of anti-science forces, and are ill-equipped to counter it.”

5. the US State Department and the UK Foreign Office have described how Russian intelligence organizations seek to discredit Western COVID-19 vaccines. One campaign implies that it could turn people into monkeys. This builds on a longer, well-documented history of Russia-sponsored disinformation, presumably to destabilize the United States and other democratic countries. The administration of US President Joe Biden has warned Russian media groups to halt their anti-vaccine aggression, and announced sanctions tied to disinformation and other behaviour, but we need much more.”

6.”According to the London-based Center for Countering Digital Hate, these are influential groups, not a spontaneous grass-roots movement. Many far-right extremist groups that spread false information about last year’s US presidential election are doing the same about vaccines.”


8 posted on 05/07/2021 9:01:08 AM PDT by grey_whiskers (The opinions are solely those of the author and are subject to change with out notice.)
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To: 2aProtectsTheRest

I have filled out numerous reports on adverse effects. A friend of mine who works in emergency has too. We send them in, but there is never any response and I suspect that they are trashed because they have NOT had enough time to go through all the ASE reports at the CDC by a long shot!


9 posted on 05/07/2021 9:01:20 AM PDT by doc maverick
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To: 2aProtectsTheRest

Approval would negate and cancel their current fast track protection from lawsuits for damages, right?


10 posted on 05/07/2021 9:03:39 AM PDT by redcatcherb412
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To: redcatcherb412

Fast track has nothing to do with liability protection. That came 35 years ago with the National Childhood Vaccine Injury Act of 1986. Congress removed vaccines from the jurisdiction of the courts and created the National Vaccine Injury Compensation Program (”vaccine court”) to handle injuries from vaccines. This was all done because in the 1970s and 1980s, anti-vaccine activists launched so many nuisance lawsuits that vaccine makers were in danger of being run out of business. Congress didn’t want to see children getting paralyzed by polio again, so they stepped in between the two parties.

That court requires no medical proof that a vaccine caused your injury. It simply requires a reasonable explanation for how it could have done so. Its awards average in the 6-figures. And with that low bar of proof and high payout, they pay an average of 1 claim per 1 million vaccinations.

The people claiming liability protection is new are either ignorant of reality or intentionally misleading you in order to push an agenda.


11 posted on 05/07/2021 9:07:51 AM PDT by 2aProtectsTheRest (The media is banging the fear drum enough. Don't help them do it.)
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To: 2aProtectsTheRest; redcatcherb412; doc maverick
The people claiming

liability protection is new that the experimental mRNA injections are safe

are either ignorant of reality or

AND intentionally misleading you in order to push an agenda,

mainly about lining their own pockets, but also for totalitarian control

(see the post upthread about the article in Nature from the Baylor MD who links opposition to these jabs to right-wing extremists who spread myths about the 2020 election).

Fixed it for you. Troll.

12 posted on 05/07/2021 9:12:55 AM PDT by grey_whiskers (The opinions are solely those of the author and are subject to change with out notice.)
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To: grey_whiskers

Adding a bunch of nonsense isn’t fixing anything. But I’m sure China appreciates your efforts:

https://www.pbs.org/wgbh/frontline/article/chinese-spam-network-aims-to-discredit-u-s-covid-vaccine-and-response-report-finds/


13 posted on 05/07/2021 9:16:49 AM PDT by 2aProtectsTheRest (The media is banging the fear drum enough. Don't help them do it.)
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To: 2aProtectsTheRest

New study from the UK government predicts 60-70% of future Covid deaths will be of those who had the 2nd shot of vaccines....

https://www.gov.uk/government/publications/spi-m-o-summary-of-further-modelling-of-easing-restrictions-roadmap-step-2-31-march-2021


14 posted on 05/07/2021 9:17:05 AM PDT by Golden Eagle (I refuse to submit to their psychological warfare, much less their injections.)
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To: 2aProtectsTheRest
The people claiming liability protection is new are either ignorant of reality or intentionally misleading you in order to push an agenda.

[excerpts] The federal government has granted companies like Pfizer and Moderna immunity from liability if something unintentionally goes wrong with their vaccines. “It is very rare for a blanket immunity law to be passed,” said Rogge Dunn, a Dallas labor and employment attorney. “Pharmaceutical companies typically aren’t offered much liability protection under the law.“

It seems possibly The people and/or Govt. then are ignorant pushing their agenda

DEC. 2020 Vaccine liability

15 posted on 05/07/2021 9:17:38 AM PDT by redcatcherb412
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To: Golden Eagle

If 95-97% of the population are vaccinated, they’re about the only ones who CAN die.

The elderly and the immunocompromised (e.g. cancer patients) can still die after they’ve been vaccinated if their immune system is still too weak to fight off the infection. A common cold can kill them.


16 posted on 05/07/2021 9:19:46 AM PDT by 2aProtectsTheRest (The media is banging the fear drum enough. Don't help them do it.)
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To: redcatcherb412

It’s not December 2020 vaccine liability protection. They’re referring to the 2005 PREP law, signed by President George W. Bush. That law created the Countermeasures Injury Compensation Program, which supplements the VICP by covering treatments beyond the scope of the 1986 National Childhood Vaccine Injury Act.

None of this is new. It’s all decades old. None of it was invented for the COVID-19 vaccines. Neither was Fast Track designation, which is used for dozens of medicines each year. Neither was Priority Review. None of it is new.


17 posted on 05/07/2021 9:22:53 AM PDT by 2aProtectsTheRest (The media is banging the fear drum enough. Don't help them do it.)
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To: Dana1960
He missed a couple days of work, saying “I didn’t think it was possible to feel this horrible and still be among the living.”

I've heard the same types of things are said about having COVID...

18 posted on 05/07/2021 9:23:06 AM PDT by GOPJ (January 6th - Patriot March Against Systemic Voter Fraud.)
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To: Golden Eagle; grey_whiskers; ransomnote

New study from the UK government predicts 60-70% of future Covid deaths will be of those who had the 2nd shot of vaccines...


I posted about this, yesterday. Unreal, isn’t it?

But, but get your fake vaccine, they said!! It will protect you and make everyone safe, they said!

🙄🙃


19 posted on 05/07/2021 9:28:57 AM PDT by Jane Long (America, Bless God....blessed be the Nation 🙏🏻🇺🇸)
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To: 2aProtectsTheRest

BZZZZT wrong answer. UK isn’t even approaching 50% injections yet, however their own government study predicts 70% of future covid deaths will be of those who were vaccinated. Therefore unvaccinated = much greater chance of survival.

It’s one of the reasons why they can’t give these shots away even for free anymore. People are even skipping the second shot now, which this study outright ID’s as the deadly one.


20 posted on 05/07/2021 9:29:52 AM PDT by Golden Eagle (I refuse to submit to their psychological warfare, much less their injections.)
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