What does the US Food & Drug Administration say about the covid vaccine safety and efficacy?

The Centre of Biologics Evaluation and Research (CBER) have been monitoring the progress of the different vaccine productions in the US. This was their report dated 22/10/2020. Their next report / meeting is scheduled for 10/12/2020.


Again, no mainstream media seem to care or even know about the meeting, or perhaps they deem it unworthy of reporting? Russia is so much more entertaining. After all, you do not need pesky things like evidence when you can blame Russia and Putin for "anti-vaxx propaganda" - just "a minister told me so" will suffice. What a joke "journalism" has become. Filth.


So, it's left to us conspiracy theorists! Back to the report:


Slide 9 looked interesting:


COVID-19 Vaccine Monitoring Data Considerations:


"Large databases of tens of millions of patients for evaluating vaccine rare serious adverse events"


"High quality data to assess and confirm potential adverse events or safety concerns for COVID-19 vaccines"


Slide 16 is particularly interesting:


DRAFT Working list of possible adverse event outcomes ***Subject to change***


. Guillain-Barré syndrome

. Acute disseminated encephalomyelitis

. Transverse myelitis

.Encephalitisncephalitis/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


I thought we were told there would be nothing to worry about. They're "perfectly safe." Seems like we need some long term trials after all. Oh wait! - We are the long term trial!


These sound like awful risks to take for a virus our immune systems can handle, and for the 0.5% of the population who can't that have a plethora of antivirals to choose from.


A conspiracy theorist may suggest the tone of this meeting was also highlighting the need for a mass surveillance system, for our safety of course! Otherwise, how will they possibly keep track of all the feared adverse reactions to this "perfectly safe" vaccine?


Perhaps it is time to not place our trust in Governments, pharmaceutical corporations and bought and paid for scientists. Especially when the media are on their payroll and do not report on such trivial matters such as actual science and risks of rushed vaccines.


Governments, giant corporations and worldwide media companies....these conspiracy theorists eh? Such a dangerous breed. Ironically, it seems they are very comfortable in spreading misinformation (or suppressing may be more appropriate) and risking possible deaths. As well as causing actual deaths which we've all seemed to have stopped caring about.


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Sources


Vaccines and Related Biological Products Advisory Committee October 22, 2020 Meeting Presentation - https://www.fda.gov/media/143557/download


It's Putin again! - https://www.dailymail.co.uk/debate/article-9021779/DAN-HODGES-Vladimir-Putins-anti-vaxxers-trying-use-Covid-kill-us.html


2020 Meeting Materials, Vaccines and Related Biological Products Advisory Committee - https://www.fda.gov/advisory-committees/vaccines-and-related-biological-products-advisory-committee/2020-meeting-materials-vaccines-and-related-biological-products-advisory-committee


Care home deaths - https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31199-5/fulltext