What Can You Expect When The FDA Gives Full Approval Of Vaccines?

It’s getting closer, so, what happens?

How the FDA’s full approval could affect COVID-19 vaccinations

The rise of the highly transmissible Delta variant has put mounting pressure on the Food and Drug Administration to fully approve the COVID-19 vaccines under emergency use authorization.

Pfizer’s vaccine is expected to be the first to be granted such approval, possibly within weeks. Although it is unclear what impact this decision will have on the course of the pandemic, many public health experts believe it could make a difference in several ways.

One is that the full approval could persuade some unvaccinated Americans to get the shot.

Me, I recommend getting it, but, I’m not going to sit there and attempt to convince you. Not that I’m calling them pigs, but, remember the old saying “never teach a pig to dance. It wastes your time and annoys the pig”? Yeah, most, it’s a waste of time and you annoy your friends, coworkers, and family. Though, with family, they’re your family, you are Constitutionally allowed to annoy them, and should. Even if Delta (and soon Lamda) breaks through at a high rate, it usually means symptoms like a mild cold at worst.

Even though the COVID-19 vaccines have undergone rigorous safety protocols in order to be granted emergency use authorization by the FDA, and billions of people worldwide have now been vaccinated without any complications, many Americans continue to see the shots as “experimental.”

According to a Kaiser Family Foundation poll, 3 in 10 unvaccinated adults — 31 percent — said they would be more likely to get the shots if a vaccine received full approval. The organization notes, however, that two-thirds of the adults polled were confused about the type of FDA approval category that these vaccines currently have. Some thought they were already fully approved, and others were unsure about whether they were fully approved or authorized for emergency use. The organization says these findings likely suggest that FDA approval is “a proxy for general safety concerns.”

Sure, a lot run with conspiracy theories, but most of the “anti-vaxxers” are really just concerned with them not being fully approved. Of course, remember than many drugs are ones you see on TV, with people smiling and dancing and stuff and disclaimers like “could cause diarrhea and death.”

Other experts, however, believe people who are still hesitant about the vaccines are probably not going to be swayed by FDA approval. Dorit Reiss, a professor of law at the University of California, San Francisco, Hastings College of Law, told Yahoo News that “it will make a larger difference to the legal situation.”

Reiss, whose current research focuses on legal and policy issues related to vaccines, said the approval could give businesses and government agencies more confidence to mandate COVID-19 vaccines. Across the nation these mandates have become more common, but they continue to be surrounded by controversy, in part because the COVID-19 vaccines have yet to be fully approved by the FDA.

“It will remove the argument that the vaccines cannot be mandated because they are under emergency use authorization,” Reiss said.

Most private workplaces already have the legal authority to mandate vaccines for workers. Same with most governments for government employees (strange that Biden hasn’t mandated it for the Executive Branch). But, most hedge a bit by requiring vaccines or weekly/biweekly testing. With full FDA approval you can expect quite a bit more mandates without the option of testing.

But, if government keeps attempting to implement masking and other measures …. for the life of me I can’t understand why they don’t push for social distancing again. Wash hands. Don’t touch. Oh, right, authoritarianism lite from elected officials….it will not help, and people will simply leave their jobs. Many in the medical field, who will go elsewhere.

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18 Responses to “What Can You Expect When The FDA Gives Full Approval Of Vaccines?”

  1. Dana says:

    From Wikipedia:

    Thalidomide was first marketed in 1957 in West Germany, where it was available over the counter.[5][6] When first released, thalidomide was promoted for anxiety, trouble sleeping, “tension”, and morning sickness.[6][7] While it was initially thought to be safe in pregnancy, concerns regarding birth defects arose in 1961, and the medication was removed from the market in Europe that year.[6][5] The total number of embryos affected by use during pregnancy is estimated at 10,000, of which about 40% died around the time of birth.[6][3] Those who survived had limb, eye, urinary tract, and heart problems.[5] Its initial entry into the US market was prevented by Frances Kelsey at the FDA.[7] The birth defects caused by thalidomide led to the development of greater drug regulation and monitoring in many countries.

    Thalidomide was never approved for use by pregnant women in the United States, even though it took almost 4 years before the birth defects caused by the drug were actually associated with it. Yet the Biden Administration wants to rush through ‘full approval’ of the COVID vaccines when they have been available for less than a year.

    • Elwood P. Dowd says:

      Like so many FDA-approved drugs, doctors and patients are warned about using thalidomide while pregnant. Thalidomide IS approved for use in multiple myeloma but has a “Black Box Warning” and its use is restricted:

      See full prescribing information for complete boxed warning.
      ï‚· If thalidomide is taken during pregnancy, it can cause
      severe birth defects or embryo-fetal death. Thalidomide
      should never be used by females who are pregnant or who
      could be pregnant while taking the drug. Even a single
      dose [1 capsule (regardless of strength)] taken by a
      pregnant woman during her pregnancy can cause severe
      birth defects.
      ï‚· Pregnancy must be excluded before start of treatment.
      Prevent pregnancy thereafter by the use of two reliable
      methods of contraception. (5.1)
      THALOMID® (thalidomide) is only available through a
      restricted distribution program, the THALOMID REMSTM
      program (formerly known as the System for Thalomid
      Education and Prescribing Safety (S.T.E.P.S.®) program) (5.2).

      In the 50s and 60s regulatory agencies were more lax than now. The US FDA (and international ICH) require early and rigorous non-clinical studies in pregnant animals as well as a battery of mutagenesis tests to determine if a new drug is likely to affect male and female fertility or embryo-fetal development, even in succeeding generations of animals.

      An objective examination of published papers and contemporary accounts confirms that the preclinical tests on thalidomide were superficial, and there is no doubt that it was never administered to pregnant animals prior to its use in patients. Within a short time after its withdrawal from the market due to its suspected association with fetal abnormalities, the drug was shown to produce fetal toxicity in laboratory animals. Had there been more extensive testing on laboratory animals before the drug was launched, the disaster could have been avoided.

      Drugs that fail the non-clinical tests are either not approved OR approved with specific guidelines for use. Many cancer treatments are known to be teratogenic and harmful to the fetus, so the patient and doctor have to make the decision whether to use a particular cancer treatment in a pregnant patient.

      The current vaccines passed a battery of mutagenesis and nonclinical reproduction tests. At least two clinical trials show the Covid vaccines were effective and safe in pregnant women. In addition, pregnant women infected with Covid fare less well than non-pregnant women.

  2. Kye says:

    It is interesting that Elwood is in full support of Trump’s vaccine. Even without any clinical evidence there will be no side effects in the future. Or is he banking on there being side effects so he can blame Trump? I, OTOH, whish I hadn’t taken the damn shit.

    I can’t help but marvel at the fear and panic the radical left has managed to instill in the sheeple of America over a flu virus marginally worse than the seasonal flu with a 99% survival rate for people under 60. The ability of the commies to control the weak minded is really impressive.

    Why do they fear Freedom so much?

    • Elwood P. Dowd says:

      Over 600,000 Americans have died from Covid since the start of the pandemic. That’s much worse than most influenza seasons. The current variants are much more infectious than influenza.

      We’re surprised that Kye DOESN’t support the “trump” vaccine.

      NO evidence of no side-effects in the future, he cries. One side-effect already known is that the vaccinated are less likely to die from Covid.

      Hospitals are once again being overwhelmed with Covid patients. Fortunately, our medical communities’ experience has cut the mortality rate.

      It’s easy for Kye to now say he “whish I hadn’t taken the damn shit”, and to hypocritically urge others to risk their lives for his political cause. He’s protected from Covid. He should be grateful that with his co-morbitities he has not had a severe Covid infection.

      He’s right about one thing – the weak minded like him have fukked this up. Everybody should get vaccinated, mask up and let’s put this thing behind us and return to normal. The longer we wait, the greater the consequences. The new variants incubating in all those Americans who Kye urges to forego vaccination may end up killing him. Cruel irony, indeed.

      The Gateway Pundit and Teach claim that the vaccine is killing more Americans than Covid, yet are vaccinated and on paper “recommend” (nudge, nudge, wink, wink) vaccination.

      • Kye says:

        “It’s easy for Kye to now say he “whish I hadn’t taken the damn shit”, and to hypocritically urge others to risk their lives for his political cause. He’s protected from Covid.”

        As usual you spread lies. I do not “urge” anyone to take the Democrat Plague vaccine. I urge people to do as their heart and mind directs and NO TO BE FORCED INTO either taking or not taking the vax. Why is that so hard for you to comprehend….Freedom of Choice having to do with one’s own body not related to murdering a baby within?

        If a person choses to take the vax I’m all in for them. The same goes for those who opt out. That’s the American way which as an anti American you find incomprehensible. It must be tough trapped in that closed mind of yours.

        BTW, hospitals are not “once again overwhelmed by patients”. That’s propaganda. Which of course you must spread around.

        How many people did Hussein infect with his super-spreader birthday party?

        You lie, you misquote, you attribute false statements and beliefs and most of all you spread propaganda about those with whom you disagree.

        That’s why nobody here believes you and nobody believes that lying shit-brained party the demofascists have become.

        Why do you hate America?

    • Dana says:

      Kye wrote:

      Why do they fear Freedom so much?

      Because the left depend on fascist control, and freedom is its antithesis.

      Socialism, communism, whatever leftwing ism you want to name, depends upon total acceptance, and brutal suppression of dissent, because allowing individual rights and individual action allows better people to have better results, and socialism cannot stand that.

      In a way, the socialists/communists are like Harry Callahan: “Well, I’m all broken up about that man’s rights.”

      Dissent, we were told by our good friends on the left, was very patriotic, or at least it was from January 20, 2017 through January 20, 2021. Now? If you dissent, we have the Department of Fatherland Security to designate you as a ‘potential domestic terrorist.’


  3. Elwood P. Dowd says:

    Should pregnant women get tattoos? Tattoo ink, injected under the skin, is not FDA approved, yet millions of Americans of all ages are subjecting themselves to this experimental procedure!

    • drowningpuppies says:

      Red herring, dipshit.

      Bwaha! Lolgf https://www.thepiratescove.us/wp-content/plugins/wp-monalisa/icons/wpml_cool.gif

      • Elwood P. Dowd says:

        Really, shit-for-brains?

        Do only stupid people get tattoos or do tattoos make you stupid? It’s hard to deny the correlation.

        • drowningpuppies says:

          Poh now another non sequitur, dipshit.

          You’re pretty good with the logical fallacies.

          Bwaha! Lolgf https://www.thepiratescove.us/wp-content/plugins/wp-monalisa/icons/wpml_cool.gif

          • Elwood P. Dowd says:

            At least I’m good at something, shit-for-brains.

          • drowningpuppies says:

            Nah, Rimjob you’re good at a lot of things:

            Bringing the stupid, always being wrong, misquoting others, lying, trying to be cute, … etc.

            You should be proud of yourself, dipshit.

            #KeepItUp https://www.thepiratescove.us/wp-content/plugins/wp-monalisa/icons/wpml_yahoo.gif
            Bwaha! Lolgf https://www.thepiratescove.us/wp-content/plugins/wp-monalisa/icons/wpml_cool.gif

      • Elwood P. Dowd says:

        Sturgis, SD, pop 7,000, has more tattoo parlors than schools.

        We rest our case, shit-for-brains.

        • Kye says:

          And every black neighborhood in every democrat controlled city has more liquor stores and schools COMBINED than schools. I guess businessmen go where the customers are. Did you know there are more amusement rides in Atlantic City than in Detroit? Wonder why? Did you know the demofascists put more abortion clinics in black neighborhoods than white?

          We could do this all day you ignorant monkey.

          Why do you hate White peole?

          • Kye says:

            And every black neighborhood in every democrat controlled city has more liquor stores and schools COMBINED than schools.

            That was supposed to read: “more liquor stores than schools and churches COMBINED” than schools.

        • gitarcarver says:

          Sturgis, SD, pop 7,000, has more tattoo parlors than schools.

          Sturgis, SD, pop 7000 has more restaurants than tattoo parlors and more than schools.

          Obviously people should stop eating.

          The fact that you would even try to equate a small business that services a few people at a time to schools with hundreds of kids demonstrates a logical failure of a false equivalency.

          We get it. The left hates logic and critical thinking.

          Then again, all the left has is hate.

    • Dana says:

      Nobody should get tattoos! But the left seem to want us to get some sort of vaccine identifications!

    • gitarcarver says:

      Tattoo ink, injected under the skin, is not FDA approved, ……

      The FDA has regulatory authority to approve the ink, but they choose not to, leaving the approval of the inks to the states.

      FDA considers the inks used in intradermal tattoos, including permanent makeup, to be cosmetics. When we identify a safety problem associated with a cosmetic, including a tattoo ink, we investigate and take action, as appropriate, to prevent consumer illness or injury. The pigments used in the inks are color additives, which are subject to premarket approval under the Federal Food, Drug, and Cosmetic Act. However, because of other competing public health priorities and a previous lack of evidence of safety problems specifically associated with these pigments, FDA traditionally has not exercised regulatory authority for color additives on the pigments used in tattoo inks. The actual practice of tattooing is regulated by local jurisdictions.


      It almost seems as if you are saying that the FDA doesn’t do what they are allowed to do in one area means they should be granted unlimited trust in all areas.

      So apparently you hate the idea that the FDA should be doing its job in all cases, rather than in some.

      Then again, all the left has is hate.

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