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Monday, April 5, 2021

FDA Approval and COVID Vaccine: Emergency Use Authorization Without End

Cart before the horse is the best one can reasonably argue about a COVID vaccine passport. While government always finds a way, in this case through marketing and nonspecific language about the scientific and legal status of COVID vaccines, MANDATING anything to do with vaccines NOT APPROVED by the Federal government is problem #1 with the rush to vaccinate.

If you are informed and you choose to be an early adopter, that's your choice and if you're not an early adopter of non-approved vaccines, that too, is a choice.

What is the purpose of the distinction between an EUA and an FDA approval? You can read about this on the FDA website. Here, note, that the EUA explained on the FDA website states:

"How will vaccine recipients be informed about the benefits and risks of any vaccine that receives an EUA?

FDA must ensure that recipients of the vaccine under an EUA are informed, to the extent practicable given the applicable circumstances, that FDA has authorized the emergency use of the vaccine, of the known and potential benefits and risks, the extent to which such benefits and risks are unknown, THAT THEY HAVE THE OPTION TO ACCEPT OR REFUSE THE VACCINE, and of any available alternatives to the product."

And now we understand the motivation for the Vaccine Passport, an incentive program of perks you get if you CHOOSE to be vaccinated, like the free gym bag that workout gyms used to offer with membership. However, the passport for COVID is negating CHOICE to have an EUA vaccine put into your arm because it's being used to DENY certain rights, such as travel, opportunities such as attending sports events or working at certain jobs if individuals CHOOSE not to take the EUA vaccine.

Imprecise language and marketing: What we haven't seen covered is the obvious question that should be posed to consumers, "Do you believe the FDA has approved COVID vaccines?" In my own small world, the majority of individuals I've spoken to believe the vaccines have received FDA approvals.

In this day and age when people lose jobs over the misuse of pronouns or the parsing of words out of context for any reason whatsoever, why is it that there's no backlash over the deliberate MISUSE of the word "approval" regarding vaccines rather than "authorization"? EUA is EMERGENCY USE AUTHORIZATION, not FDA APPROVAL.

Shaming as a marketing tool: Shaming those who are HESITANT to have a non-approved drug injected into their bodies is NOT the same as the more extreme versions of hesitancy attributed to people who others seek to marginalize by calling them anti-vaxxers. Shame on you if you're engaging in this conduct, period. It's the same bullying, illogical hate that motivated some to claim all Republicans are Nazis or all white people (only) are racists. Your opinion is AGGRESSION, not supported by the current SCIENCE.

When does EUA end? Here again we've got some government slipperiness going on. The government is motivated to keep us in "pandemic" mode in order to continue to push vaccinations based on EUA. The creation of "passports" showing that you've bought in also involves business time and money that motivates the stretching out of "pandemic" into endless time periods. It also buys time for government to push the use of such passports for other vaccinations and other intrusions into our private health information and status.

As "The Atlantic" noted, there is no standard for when the COVID pandemic ends. https://www.theatlantic.com/health/archive/2021/02/how-know-when-pandemic-over/618122/. The CDC also has an equally unclear means of determining deaths attributed to COVID, as you can read on https://www.cdc.gov/nchs/nvss/covid-19.htm#understanding-death-data-quality. In addition to widespread testing, the loosey-goosey guesswork of cause of death can also maintain "pandemic" status. Further, with the "variants," there's no distinction, it's still COVID, keeping numbers up and maintaining "forever pandemic" status which will conceivably keep EUAs in business for current COVID vaccines that might not be effective on these variants.

Vaccine Exemption Passports: If for WHATEVER reason, you don't CHOOSE to take an unapproved drug into your body, there should also be a provision for VACCINE exemption. Not even the most dogged bullies about COVID vaccines would argue that EVERYONE should have the vaccine, I would hope. Whether it's comorbidities or other drugs being taken by individuals, age, risk based on lifestyle or age or morality or religion, EXEMPTION cards must be issued. Remember that EUAs mean people can CHOOSE to accept or reject a vaccine.

Fraudulent Passports: The issuance of "passports" will no doubt lead to a subculture of phony passports which undoubtedly will lead to government participation in the issuance of passports, rendering these current vaccine cards void.

Duration: Right now, all we know is that some vaccines seem to be effective for at least six months. Now we have a rinse and repeat cycle regarding the non-approved drugs. Every year, every two years? Is once enough? We don't know. We don't know about the new strains. The false security of a "temporary passport" is outweighed against the threat to the deprivation of constitutional rights to privacy or travel.

People should be laughing about articles talking about "laminating" your COVID passport because it's premature, NOT justified based on the risk-benefit analysis of what you're giving up in terms of choice, privacy and rights relative to the benefits to public health based on all of the above reasons. This is not cool, hip or woke, it's deliberate misinformation being used to bully individuals and segregate individuals based on science that is not yet sufficient for even government approval of the vaccines.