On 3/14/2021 8:18 AM, Boron Elgar wrote:
> On Sun, 14 Mar 2021 07:59:09 -0700, Taxed and Spent
> > wrote:
>
>> On 3/14/2021 7:48 AM, Boron Elgar wrote:
>>> On Sun, 14 Mar 2021 05:33:30 -0700, Taxed and Spent
>>> > wrote:
>>>
>>>
>>>> You are missing the point - two points, actually.
>>>>
>>>> 1. These are EXPERIMENTAL vaccines, because to be fully approved they
>>>> need YEARS of study.
>>>
>>> Nope. You do realize that there are several types of Covid vaccines
>>> out there right now, yeah?
>>>
>>>> Bad things sometime happen after a lot of time has
>>>> elapsed.
>>>
>>> Yeah and every single pharmaceutical and OTC drug is required to
>>> report adverse reactions to the FDA. This isn't just for new drugs,
>>> either.
>>>
>>> The more people who are taking a med, the more likely an adverse
>>> reaction, if inherent or wildly incidental, will show up. This is just
>>> numbers, not woo-woo-new-med sort of thing.
>>>
>>> I did a study for a common brand of NSAID that had been on the market
>>> for decades, and if any of the participants said they'd had so much as
>>> an uncomfortable hiccup they felt happened while taking it, my company
>>> had to file that with the FDA.
>>>
>>> No system is foolproof, and millions of user and doses can show up
>>> anomalies that smaller, trial numbers might not reveal, but trying to
>>> scare folks off because these vaccines are "new" is pretty lame.
>>>>
>>>> 2. Being aware and cautious regarding EXPERIMENTAL vaccines does not
>>>> make one an anti-vaxxer.
>>>
>>> These are not "experimental", there should be no fear of them because
>>> of such an false implications like yours, and so, yeah, you're an
>>> anti-vaxxer for taking that stance.
>>>>
>>>> That said, I make no personal comment about anything regarding these
>>>> vaccines or whether one should or should not take them.
>>>
>>> Um...yeah, you did.
>>>
>>
>>
>> Um, no I didn't.
>
> Yup...if it quacks and walks like a duck, it's a duck, hon. You're a
> dumb duck.
>>
>> They are experimental in that they have not been licensed. They have
>> been given Emergency Use Authorization. Studies are still underway.
>
> They are not experimental. You can try to make use of that word for
> fun, but that does not make it applicable in this situation.
>
> https://www.fda.gov/vaccines-blood-b...ines-explained
>>
>> Take the shot. I am not saying not to.
>
> Sorry, you are not intelligent enough to carry this on any longer.
>


What are the plans for continued monitoring of COVID-19 vaccines
authorized by FDA for emergency use?

FDA expects vaccine manufacturers to include in their EUA requests a
plan for active follow-up for safety, including deaths,
hospitalizations, and other serious or clinically significant adverse
events, among individuals who receive the vaccine under an EUA, to
inform ongoing benefit-risk determinations to support continuation of
the EUA.

FDA also expects manufacturers who receive an EUA to continue their
clinical trials to obtain additional safety and effectiveness
information and pursue licensure (approval).

Post-authorization vaccine safety monitoring is a federal government
responsibility shared primarily by FDA and the U.S. Centers for Disease
Control and Prevention (CDC), along with other agencies involved in
healthcare delivery. Post-authorization safety monitoring during the
COVID-19 pandemic vaccination program will aim to continuously monitor
the safety of COVID-19 vaccines to rapidly detect safety problems if
they exist. There will be multiple, complementary systems in place with
validated analytic methods that can rapidly detect signals for possible
vaccine safety problems. The U.S. government has a well-established
post-authorization/post-approval vaccine safety monitoring
infrastructure that will be scaled up to meet the needs of a large-scale
COVID-19 vaccination program. The U.S. government €“ in partnership with
health systems, academic centers, and private sector partners €“ will use
multiple existing vaccine safety monitoring systems to monitor COVID-19
vaccines in the post-authorization/approval period. Some of these
systems are the Vaccine Adverse Event Reporting System (VAERS), the
Vaccine Safety Datalink (VSD), the Biologics Effectiveness and Safety
(BEST) Initiative, and Medicare claims data.