FDA grants Pfizer COVID-19 vaccine full approval

[txradioguy]

The Food and Drug Administration (FDA) on Monday granted full approval to Pfizer's COVID-19 vaccine for individuals 16 years and older.

"The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic," Acting FDA Commissioner Janet Woodcock said in a statement issued Monday. "While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product."

The approval on Monday also paves the way for the Pentagon to mandate the vaccine among 1.3 million active-duty service members. Full licensure has been widely anticipated to boost confidence in those otherwise hesitant to receive the shot under emergency approval. U.S. Surgeon General Vivek Murthy told Chris Wallace on "Fox News Sunday" that full approval might lead to an increase in vaccination rate.

"There are universities and businesses that have been considering putting in vaccine requirements in order to create a safer workplace or learning environment," Murthy said. "And I think this announcement from the FDA would likely encourage them and make them feel more comfortable."


https://www.foxbusiness.com/healthcare/fda-grants-pfizer-covid-19-vaccine-full-approval

[mystery-ak]

FDA Fully Approves Pfizer’s Coronavirus Vaccine

Hannah Bleau 23 Aug 2021

The Food and Drug Administration (FDA) has fully approved Pfizer’s coronavirus vaccine, marking the first coronavirus injection to receive the FDA’s full approval outside of emergency use authorization.

The FDA’s full approval of Pfizer’s shot, which applies to the vaccine given to those ages 16 and older, is based on a study involving over 44,000 people for six months, with data showing the vaccine to be 91 percent effective in preventing infections, per reports. Pfizer’s vaccine for those ages 12-15 will still operate under emergency use.

USA Today reported that the license application “included more than 340,000 pages of material, three times the earlier emergency use authorization submission, which weighed in at 110,000 pages.”

more
https://www.breitbart.com/politics/2021/08/23/fda-fully-approves-pfizers-coronavirus-vaccine/

[mystery-ak]

Charlie Kirk
@charliekirk11
·
10m
How can a vaccine, that according to Axios had a 42% efficacy rate in July, get FDA approval?

[cato potatoe]

Okay.  What steps were skipped to make this happen, and why is this not done for other life-saving vaccines?

[PeteS in CA]

Okay.  What steps were skipped to make this happen, and why is this not done for other life-saving vaccines?

None were skipped.

Pfizer Phase 1/2 start, April 29, 2020: https://www.pfizer.com/news/press-release/press-release-detail/biontech-and-pfizer-announce-completion-dosing-first-cohort

Pfizer Phase 2/3 start, July 27, 2020: https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-choose-lead-mrna-vaccine-candidate-0

Pfizer Phase 1/2 data posted July 1, 2020: https://www.medrxiv.org/content/10.1101/2020.06.30.20142570v1

Pfizer Phase 3 data published December 10, 2020 in NEJM: https://www.nejm.org/doi/full/10.1056/NEJMoa2034577

When Trump declared a Public Health Emergency (January 2020?), that made (future) Covid vaccines eligible for Emergency Use Authorization. The Trump Administration also began working with vaccine developers from January 2020 onward (months before the announcement of Operation Warp Speed).

The chosen developers/technologies have a shorter development time, because they do not need to culture the target virus and figure out how to inactivate it while keeping the inactivated viruses intact enough to be recognized as a thread by vaccine recipients' immune systems. Using Moderna as an example, Moderna was producing samples of their vaccine for lab testing a week or more before the end of January 2020. That is why Moderna was able to begin testing with humans in March 2020 (and Pfizer in April 2020). Choosing vaccine technologies that use the DNA sequence of the virus - mRNA and viral vector - was a key choice that drastically reduced development time.

The FDA handled Covid vaccines via an expedited process (the status has a name, is used for other meds, but I can't recall that official name). OWS provided funding for some vaccines' testing, making the testing less dependent on the pharma companies' ability to fund, and the contracts with the several companies signed in July and August 2020 further reduced companies' financial risk in proceeding with testing and producing millions of doses in advance of EUA.

That may be TMI, but the point is that doing this "for other life-saving vaccines" is possible, but not a trivial effort.

The FDA’s full approval of Pfizer’s shot ... is based on a study involving over 44,000 people for six months

Sloppy reporting. Since Pfizer's Phase 2/3 test began in July last year, and receiving EUA was predicated on having 2 months of data on the last person in the test to be fully vaccinated, the December 2020 EUA means that the FDA now has 10 months of data for that last person fully vaccinated, and 12 -13 months of data for the first persons fully vaccinated.

[jafo2010]

This approval has about the same level of credibility as Wrecking Ball Joe.  That is,

Z   E   R   O   !

[jmyrlefuller]

This is despite the vaccine's admitted waning efficacy (first reported, oddly, by Pfizer executives and only discovered secondhand by the CDC and FDA) and the vaccine's failure to break the chain of infection.

It seems the sole purposes of full approval are (1) to provide cover to vaccine mandates, and (2) give ammo to vaccine skeptics and anti-vaxxers who used lack of FDA approval as one of many reasons to not get the shot.

[jmyrlefuller]

Sloppy reporting. Since Pfizer's Phase 2/3 test began in July last year, and receiving EUA was predicated on having 2 months of data on the last person in the test to be fully vaccinated, the December 2020 EUA means that the FDA now has 10 months of data for that last person fully vaccinated, and 12 -13 months of data for the first persons fully vaccinated.

In which time we are already seeing diminishing efficacy after 8 months. Yet they approved it anyway.

[cato potatoe]

It seems the sole purposes of full approval are (1) to provide cover to vaccine mandates, and (2) give ammo to vaccine skeptics and anti-vaxxers who used lack of FDA approval as one of many reasons to not get the shot.

Maybe to repay Pfizer donors, before people realize the shot doesn't work nearly as well as advertised?

[Right_in_Virginia]

https://mobile.twitter.com/JackPosobiec/status/1429876525252366338

[libertybele]

In which time we are already seeing diminishing efficacy after 8 months. Yet they approved it anyway.

Gee, I wonder how Jesse Jackson feels about this vaccine?   He was vaccinated in January and now is in the hospital.

I still stand by my statement that the vaccines weaken the immune system and do more harm than good.

[libertybele]

Charlie Kirk
@charliekirk11
·
10m
How can a vaccine, that according to Axios had a 42% efficacy rate in July, get FDA approval?

They needed to speed up the process so that they can mandate that everyone must get the vaccine.

Of course that will include all those coming across the border and the refugees coming in. 

[mountaineer]

Chuck Callesto
@ChuckCallesto
BREAKING REPORT: Biden Calls on Private Sector Companies to MANDATE COVID VACCINE For Employees Following FDA’s Pfizer Approval...
4:15 PM · Aug 23, 2021


This is what it was all about.

[Smokin Joe]

Did they dismiss the liability waiver, then? Or are you still on your own if you have a bad result/reaction?

[DefiantMassRINO]

This is the vaccine Jesse Jackson got.

The virus has the advantage of being on natural selection offense.  Variants are evolving - via mutation and recombination - to outcompete other variants for dominance.  So far, it looks like the Delta variant has, and will keep, the current lead.

What differences are there between the covid-19 lambda and delta variants?

Both the Delta and Lambda variants are present in the US and are highly contagious. What are the differences between the two types of covid-19?

Greg Heilman
Update: 22 August 2021 20:24 EDT

https://en.as.com/en/2021/08/23/latest_news/1629677182_776181.html

Outbreak of SARS-CoV-2 Infections, Including COVID-19 Vaccine Breakthrough Infections, Associated with Large Public Gatherings — Barnstable County, Massachusetts, July 2021

https://www.cdc.gov/mmwr/volumes/70/wr/mm7031e2.htm?s_cid=mm7031e2_w

[libertybele]

Chuck Callesto
@ChuckCallesto
BREAKING REPORT: Biden Calls on Private Sector Companies to MANDATE COVID VACCINE For Employees Following FDA’s Pfizer Approval...
4:15 PM · Aug 23, 2021


This is what it was all about.

 Yes.  What prey tell is in the vaccines is what I'd like to know.  I have been to a couple of doctor's offices where some of the medical staff aren't getting the vaccines.

Secondly, the vaccine is still not available at doctor's offices.  They are available around here at supermarkets and drug stores. That in itself doesn't exactly compel me to get the jab.

[mountaineer]

Did they dismiss the liability waiver, then? Or are you still on your own if you have a bad result/reaction?

My understanding is that the drug companies still are protected from civil suit, unlike in the case of any other FDA-approved drug. If I'm mistaken, I'll gladly stand corrected.

So no legal recourse for people adversely affected, and still insufficient clinical trials - compared to every other FDA drug approval process. Nothing to see here.

[mountaineer]

https: //twitter.com/Rifleman4WVU/status/1429910354616803333

[Fishrrman]

mountaineer posted:
"BREAKING REPORT: Biden Calls on Private Sector Companies to MANDATE COVID VACCINE For Employees Following FDA’s Pfizer Approval..."



full disclosure:
I got the vaccine a couple of months after it was released.
Not an "anti-vaxxer" here, sorry.

[PeteS in CA]

Yes.  What prey tell is in the vaccines is what I'd like to know.  ...

Secondly, the vaccine is still not available at doctor's offices.  They are available around here at supermarkets and drug stores. That in itself doesn't exactly compel me to get the jab.

1. This webpage has the ingredients for each of the Covid vaccines currently used in the US, https://portal.ct.gov/vaccine-portal/Vaccine-Knowledge-Base/Articles/Ingredients-In-Vaccine?language=en_US

2. IRL, vaccinations are being done through the pharmacies at those supermarkets and drug stores, the same pharmacies where people buy their prescription medications. The persons administering the shots are the pharmacists, the pharmacy technicians, or nurses. The vaccines are also available at events organized by health organizations. One of my immediate family was vaccinated at an event organized by Kaiser Health Foundation and held at a Kaiser hospital. Other family members were vaccinated at events organized by Sutter Medical Foundation.

[mountaineer]

Oh, well, it's FDA approved. What's to worry?

One-Third Of New Drugs Had Safety Problems After FDA Approval
May 9, 2017
12:29 PM ET
Sydney Lupkin

The Food and Drug Administration is under pressure from the Trump administration to approve drugs faster, but researchers at the Yale School of Medicine found that nearly a third of those approved from 2001 through 2010 had major safety issues years after the medications were made widely available to patients.

Seventy-one of the 222 drugs approved in the first decade of the millennium were withdrawn, required a "black box" warning on side effects or warranted a safety announcement about new risks, Dr. Joseph Ross, an associate professor of medicine at Yale School of Medicine, and colleagues reported in JAMA on Tuesday. The study included safety actions through Feb. 28.

"While the administration pushes for less regulation and faster approvals, those decisions have consequences," Ross says. The Yale researchers' previous studies concluded that the FDA approves drugs faster than its counterpart agency in Europe does and that the majority of pivotal trials in drug approvals involved fewer than 1,000 patients and lasted six months or less.

It took a median of 4.2 years after the drugs were approved for these safety concerns to come to light, the study found, and issues were more common among psychiatric drugs, biologic drugs, drugs that were granted "accelerated approval" and drugs that were approved near the regulatory deadline for approval. ...

NPR

No doubt, NPR was reporting this back in 2017 because they perceived it as a slam on Trump.

[mountaineer]

Alex Berenson
@AlexBerenson
Hey @us_fda
 - before you approve the @pfizer vaccine today, I have one simple question: How many doses is the regimen? Two, three, TBD?

How can you approve a "vaccine" - which by its very name is supposed to have a FIXED-DOSE REGIMEN - if you can't even answer that question?
9:23 AM · Aug 23, 2021·

[PeteS in CA]

https: //twitter.com/Rifleman4WVU/status/1429910354616803333

Since Pradaxa was approved for children nearly 2 months ago, and what makes it unique is that it's oral rather than injected or by IV, no, the timing is not "interesting". "Worse" still for the meme, the approval would have been based would have begun many months ago, probably well before any Covid vaccine was authorized. The principal use for Pradaxa is in preventing stroke in people who experience atrial fibrillation.

[PeteS in CA]

Alex Berenson
@AlexBerenson
Hey @us_fda
 - before you approve the @pfizer vaccine today, I have one simple question: How many doses is the regimen? Two, three, TBD?

How can you approve a "vaccine" - which by its very name is supposed to have a FIXED-DOSE REGIMEN - if you can't even answer that question?
9:23 AM · Aug 23, 2021·

From page 2 of this document, https://www.fda.gov/media/151707/download :

-----------------------DOSAGE AND ADMINISTRATION-----------------------
• For intramuscular injection only. (2.2)
• COMIRNATY is administered intramuscularly as a series of 2 doses
(0.3 mL each) 3 weeks apart. (2.3)

My emphasis. How I could find this within minutes but Alex Berenson could not, . Being somewhat familiar with the quality of the information in common circulation among anti-Covid-vaxxers, my guess is that Berenson snarked without doing even minimal research.

[mountaineer]

Two doses - but keep taking more, anyway.

[mountaineer]

Source: Jack Posobiec's twitter, citing opensecrets.org

[Polly Ticks]

https://twitter.com/AndySwan/status/1429829983711682565

[PeteS in CA]

When a med receives full FDA approval, test Phase 4 begins, years of safety and effectiveness tracking, https://www.drugwatch.com/fda/clinical-trials/ . IOW, Pfizer's vaccine will continue in the normal, post-approval, process.

[Polly Ticks]

When a med receives full FDA approval, test Phase 4 begins, years of safety and effectiveness tracking, https://www.drugwatch.com/fda/clinical-trials/ . IOW, Pfizer's vaccine will continue in the normal, post-approval, process.

Exactly.  So it is disingenuous to say everyone should take that vaccine before the safety and effectiveness has been fully confirmed via clinical studies.  Some might consider it an acceptable risk, while others might consider the risk of contracting covid the more benign option.

[PeteS in CA]

Exactly.  So it is disingenuous to say everyone should take that vaccine before the safety and effectiveness has been fully confirmed via clinical studies.  Some might consider it an acceptable risk, while others might consider the risk of contracting covid the more benign option.

Every newly approved med has this ongoing process. "Fully confirmed" is a word game, because in the real world it can take decades for a side effect to be detected, e.g. the DES fiasco, in which the side effect was detected 2 decades later in the children of the women who took DES.

I have no problem at all with people making their own risk-benefit decision. Both risks and benefits should be assessed using, as best as possible, accurate information. Anti-Covid-vaxxer claims are pig manure quality, to be blunt, so obviously bad that even though I'm in no medical/pharmaceutical career field even I can recognize the falsehoods. After the many months' barrage of that pig manure, I have grown to be rather irascible. The wildly self-contradictory messages and messaging from the Biden gooberment aren't really much better, though possibly less odoriferous.

I've both contracted Covid and been vaccinated. Only the former put me in the hospital for nearly 2 weeks. Two of my immediate family have also had Covid and been vaccinated. Neither were hospitalized, but even the member with the milder Covid case had a vaccine reaction much less unpleasant than their relatively mild case of Covid. Of course, vaccine reactions and Covid case severity vary, but the data I've seen indicate that severe Covid cases are on the order of 100 times more common than severe vaccine reactions.

As for the prediction of mass deaths from Covid vaccines, see my signature, which I'll be updating as my walking endeavors progress. I have two more timed 5K events planned, and then in October I'll be doing at least one timed 10K. The planning is based on practical considerations mostly unrelated to my current, improving, capabilities. If the relevant county PTBs allow it to be run, I'm hoping to do a 5K in December that is 668' climb up, and then 668' back down. I would have done all this anyway, but being able to mock the stupid prediction makes the work all the sweeter.

[mountaineer]

FDA Safety Surveillance of COVID-19 Vaccines :
DRAFT Working list of possible  adverse event outcomes
***Subject to change***
 Guillain-Barré syndrome
 Acute disseminated encephalomyelitis
Transverse myelitis
 Encephalitis/myelitis/encephalomyelitis/meningoencephalitis/meningitis/encepholapathy
 Convulsions/seizures
 Stroke
 Narcolepsy and cataplexy
 Anaphylaxis
 Acute myocardial infarction
 Myocarditis/pericarditis
 Autoimmune disease
 Deaths
 Pregnancy and birth outcomes
 Other acute demyelinating diseases
 Non-anaphylactic allergic reactions
 Thrombocytopenia
 Disseminated intravascular coagulation
 Venous thromboembolism
 Arthritis and arthralgia/joint pain
 Kawasaki disease
 Multisystem Inflammatory Syndrome in Children
 Vaccine enhanced disease

https://www.fda.gov/media/143557/download - page 17

[mountaineer]

Is there any research on the long-term effects of the Pfizer-BioNTech COVID-19 vaccine?

Because COVID-19 vaccine clinical trials only started in the summer of 2020, it's not yet clear if the vaccines will have long-term effects. However, vaccines rarely cause long-term effects.

A portion of the children ages 12 through 15 enrolled in the ongoing Pfizer-BioNTech COVID-19 vaccine study were monitored for safety for at least two months after being given the second dose of the COVID-19 vaccine.

As part of its first request for emergency use authorization of its COVID-19 vaccine in 2020, Pfizer Inc. created a safety monitoring plan. The plan now includes the monitoring of adolescents given the COVID-19 vaccine.

In addition, in the U.S. all vaccination providers are required to report serious adverse events, such as allergic reactions, to a national program called the Vaccine Adverse Event Reporting System.

Mayo Clinic: COVID-19 vaccines for kids: What you need to know

So, that would be a "no"?

[PeteS in CA]

Actually, the first clinical (i.e. with human participants) trials of the BioNTech vaccine began in April 2020, and of the Moderna vaccine began in March 2020, not summer 2020. Then again, the existence of the SARS-CoV-2 virus was not known outside of China until December 31, 2019, so saying that the Covid vaccines' long-term effects are not known is not really saying much.

[LegalAmerican]

This approval has about the same level of credibility as Wrecking Ball Joe.  That is,

Z   E   R   O   !

 

[Smokin Joe]

Actually, the first clinical (i.e. with human participants) trials of the BioNTech vaccine began in April 2020, and of the Moderna vaccine began in March 2020, not summer 2020. Then again, the existence of the SARS-CoV-2 virus was not known outside of China until December 31, 2019, so saying that the Covid vaccines' long-term effects are not known is not really saying much.

I'm not so sure the chimera was unknown. The 2014 research documented in the journal Nature in 2015 pretty much described the pathogen, created by grafting together a bat coronavirus and SARS, from it attacking lung cells, to antiviral resistance, to using the ACE 2 receptor site to attack the cells. There were two researchers from Wuhan Institute of Virology on that team.

That isn't conspiracy theory, it was published in the journal shortly after the research was moved to Wuhan from North Carolina. Interestingly enough, the abstract to that article has been altered since this started.