FDA grants Pfizer COVID-19 vaccine full approval

[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.