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Medicine United States

Pfizer, BioNTech Vaccine Gets Full Approval From US Regulators (bloomberg.com) 407

The Covid-19 vaccine made by Pfizer and BioNTech was granted a full approval by U.S. regulators, a move that is expected to help bolster the immunization drive amid a surge in infections caused by the delta variant. From a report: The Food and Drug Administration said in a statement on Monday that it had cleared the vaccine for the prevention of Covid-19 in individuals 16 years of age and older. It will be marketed under the name Comirnaty. The vaccine continues to be available to people age 12 to 15 under an emergency-use authorization, the agency said. The approval is expected to boost confidence in the shot and is likely to open the door to more vaccine mandates among employers and businesses. It is also likely to solidify its future as a blockbuster for its makers.
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Pfizer, BioNTech Vaccine Gets Full Approval From US Regulators

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  • by ugen ( 93902 ) on Monday August 23, 2021 @09:12AM (#61720223)

    Finally all those who claimed they won't vaccinate until FDA gives it the full approval will be joining in to get vaccinated, right?

    • Re:Well, finally (Score:5, Insightful)

      by Scutter ( 18425 ) on Monday August 23, 2021 @09:15AM (#61720233) Journal

      Expect the goalposts to be moved shortly. There will always be some excuse.

      • Missouri or one of those other backwards states already did something similar saying the vaccine had to be approved for two years. Politicians that don't know an iPhone from a calculator are legislating medical advice now.

        • Re:Well, finally (Score:4, Insightful)

          by The Grim Reefer ( 1162755 ) on Monday August 23, 2021 @09:30AM (#61720297)

          Politicians that don't know an iPhone from a calculator are legislating medical advice now.

          The same can be said for most of what they legislate. Politicians that don't know the difference between an AR15 and a SuperSoaker are legislating for or against gun laws. There are some for and others against minimum wage laws, even though none will likely never have to worry about money for the rest of their lives. And internet and copyright laws...

      • Re:Well, finally (Score:5, Informative)

        by phalse phace ( 454635 ) on Monday August 23, 2021 @09:29AM (#61720293)

        Expect the goalposts to be moved shortly. There will always be some excuse.

        Of course.

        People saying they won't get the Covid-19 vaccine because it wasn't fully approved by the FDA was a B.S. excuse when people throughout Texas, Florida, Louisiana, etc [npr.org] had no problem getting the Regeneron monoclonal antibodies even though it only had an emergency use authorization from the FDA [fda.gov] just like the vaccine.

        • Maybe conditioned by the anti-GMO crowd to believe anything, gene, is bad.

        • there's a fair amount of people who are actually hesitant. Not anti-vax, hesitant.

          They're confused. There's too much misinformation and they're not equipped to parse it. So like a deer caught in the headlights they freeze.

          This'll be enough to get a lot of them unfrozen.
          • They're confused. There's too much misinformation and they're not equipped to parse it. So like a deer caught in the headlights they freeze.

            Agreed. There's should have been a much more cohesive response from every institution in a leadership role. Also there's another phenomenon that makes it harder. No one wants to be perceived as wrong.

            • " Also there's another phenomenon that makes it harder. No one wants to be perceived as wrong."

              This is very true. There is another word for that phenomenon -- it is called "pride". As in, too proud to admit being wrong or needing help. IMHO it is actually a mental illness -- the proud cannot learn, nor can the easily tell the truth. It is essentially ball-less. It is also addictive.

              Humility and faith are the opposite -- it takes a great deal of courage and strength to be honest with oneself and everyone el

      • by e3m4n ( 947977 )
        what it will do is pave the way for more employer mandates. Some places were hesitant to mandate on something with a potential court label of 'experimental'. Now that its approved we will see how strong someone's convictions are when employment is tied to it. However, I did read there has been a large uptick in counterfeit vaccine certificates in LA when they imposed venue restrictions on the unvaccinated. So theres that too. Did you see the FDA literally had to put out a statement about taking deworming pi
        • Ivermectin is useless for covid, but I'm not a fan of trying to scare people off of it by implying it's exclusively for animals. It's an approved anti-parasitic for humans as well. Lots of human meds are also used in animals. And thanks to our insane medical system, the meds are a fraction of the price if "for animals", and some people don't see a slight difference in purity as worth paying 10, 20 times the price. And chemo drugs? Yeah, you better believe people would be paying the $5 manufacturing cost ins
    • by dmomo ( 256005 )

      As it became a sure thing that the vaccine would be approved it magically changed from an issue of safety to an issue of freedom. There is a group that does not want to rid the US of Covid and they are spending a lot of money to spread FUD.

      • Re: (Score:2, Interesting)

        As it became a sure thing that the vaccine would be approved it magically changed from an issue of safety to an issue of freedom. There is a group that does not want to rid the US of Covid and they are spending a lot of money to spread FUD.

        There is a group that doesn't want to rid anyplace of covid ... but it's those who "never let a crisis go to waste".

        (obDisclaimer: I"m vaccinated, I mask, blah blah)

      • The "my body my choice" argument is the most hypocritical of them all. So you're fine with a woman's right to have an abortion? Oh no we really don't mean that...

        • A woman who gets an abortion can't spread abortion to other people.

          A fucking moron who doesn't get the COVID vaccine can spread COVID to many more people.

        • Re: (Score:2, Insightful)

          by Anonymous Coward
          Uh, it's MY body, MY choice, not HER body HER choice! Those are two different things!
    • by LatencyKills ( 1213908 ) on Monday August 23, 2021 @09:31AM (#61720301)

      Sure, the vaccine is approved, but the tracking chip is still on an emergency use authorization. /s

    • Yes this was the last reason. I am sure the goalposts will not change again.
    • Re: (Score:3, Interesting)

      by quall ( 1441799 )

      Does this mean that the government has taken away their immunity from lawsuits, such as those from unknown side-affects and long-term affects? If the problem is that they aren't legally liable for long-term side-affects or health issues caused by the vaccine, then approval isn't all that meaningful here. If Pfizer is now liable, then I agree, no more excuse if they were claiming themselves as "test subjects".

      I cannot find any mention of the government removing their immunity and the article does not mention

      • Re: (Score:2, Informative)

        by bws111 ( 1216812 )

        Why would it be different than other vaccines? If you are injured by a vaccine (and can prove it) you file a claim with the government.

        • by quall ( 1441799 )

          Huh? It's different because the government has given them immunity from liability over side-affects and long-term affects. Did you not know this???

          You can file a government claim, but the vaccine companies are not liable. The government has set up limited funds, and beyond that you're screwed. Ask those who suffered a stroke how much having their droopy face and permanent brain damage is valued by the government? That is, if their claim ever gets approved. Hardly anything.

          To give a perspective on likeliness

      • Re: (Score:2, Informative)

        by jeff4747 ( 256583 )

        The government assumed liability for all vaccines in the 1980s. If you are actually injured by a vaccine, you get paid by the government. The COVID vaccines are no different.

        But lying about this sure does sound truthy!

    • by fred6666 ( 4718031 ) on Monday August 23, 2021 @09:54AM (#61720407)

      I don't want to be a guinea pig. I will only take the vaccine after hundreds of millions of people got it before me. Oh wait...

    • by leonbev ( 111395 )

      Does this mean that we'll soon be seeing drug commercials for this on TV? I can't wait to see the commercials with old people driving away into the sunset with their convertible with the voice-over:

      "Ask your doctor if Comirnaty is right for YOU!"

  • by GlennC ( 96879 ) on Monday August 23, 2021 @09:16AM (#61720237)

    They'll just find another reason to not get vaccinated.

    They know "the REAL truth" and nothing will convince them otherwise.

    • It's too late. Covid-19 in a self-defense maneuver is making the infected stupid [youtu.be] and unable to fight back.

    • by OzPeter ( 195038 )

      They'll just find another reason to not get vaccinated.

      They know "the REAL truth" and nothing will convince them otherwise.

      Hey, those goalposts ain't going to move themselves!

    • I disagree (Score:5, Insightful)

      by rsilvergun ( 571051 ) on Monday August 23, 2021 @09:43AM (#61720357)
      Why would the anti-vax care if the FDA approved it or not?

      Well, there's anti-vax and there's vaccine hesitant. The anti-vax are constantly trying to convince the hesitant to become anti-vax, and losing this talking point will hurt them.

      A lot of the vaccine hesitant are that way because of confusion. They hear things like "emergency approval" and thing "I'm healthy, I don't need emergency medicine". If you follow the news and read about sick & dying people who didn't get vaxxed that's what they site as a reason over and over again.

      Point being, the anti-vaxx don't have to convince you vaccines are *bad*, they just have to put a seed of doubt in your mind. FDA approval makes that much harder.

      Studies show the #1 thing that convinces the vaccine hesitant is talking to their doctors, but since America lacks single payer healthcare lots of people don't have doctors. It's why countries like the UK & Canada are gradually pulling ahead of us in vaccinations as supplies stop being an issue there.

      If you can't get to a doctor to have your worries taken care of FDA approval is the next best thing.
      • Yeah everything is an excuse for socialism and more government programs.

        Does anyone stop to think that maybe we should focus on making our existing government programs more effective at their job.

        Selling the vaccine is one great example of the whole-of-government stepping on the rake at the same time. I don't know how many times I've seen Francis Collins or Anthony Fauci or Rochelle Wollensky or Vivek Murthy or Jerome Adams or any of these people go on a nominally-serious news program like NPR or PBS or any

      • Studies show the #1 thing that convinces the vaccine hesitant is talking to their doctors, but since America lacks single payer healthcare lots of people don't have doctors. It's why countries like the UK & Canada are gradually pulling ahead of us in vaccinations as supplies stop being an issue there.

        People in Canada definitely do not talk to their doctor about COVID-19 vaccine. Unless they had an appointment for something else. We just don't call our doctor to discuss stuff like that. It's hard enough to get access to our doctor when we need it. And what do you expect the doctor to say anyways? They just know the same thing as we all do: the vaccine is recommended, benefits outweighs the risks.

        Canada is ahead in vaccination because Canada doesn't have the republican party. But the part of the country m

        • Studies show the #1 thing that convinces the vaccine hesitant is talking to their doctors, but since America lacks single payer healthcare lots of people don't have doctors. It's why countries like the UK & Canada are gradually pulling ahead of us in vaccinations as supplies stop being an issue there.

          People in Canada definitely do not talk to their doctor about COVID-19 vaccine. Unless they had an appointment for something else. We just don't call our doctor to discuss stuff like that. It's hard enough to get access to our doctor when we need it. And what do you expect the doctor to say anyways? They just know the same thing as we all do: the vaccine is recommended, benefits outweighs the risks.

          Canada is ahead in vaccination because Canada doesn't have the republican party. But the part of the country most aligned with it (Alberta) also have the lowest vaccination rate.
          There is also a lot more people in the USA who think climate change is a hoax/not happening/not caused by human activity. I think it's the same anti-science rationale which is fueling vaccine hesitancy.

          I'm not going to say one party or the other is stupider. If you were to ask a room full of Democrats "How do you know the Earth is round" you'll get some dumb looks, and at least one smelly idiot that hasn't discovered deodorant might offer his horribly uninformed opinion on the matter while everyone else looks on dumbfounded. One or two people will try to give a reasonably intelligent answer, but totally inappropriate for the level of intelligence that would ask the question, like using orbital mechanics

    • by quall ( 1441799 )

      Such as still not being able to sue for long-term health side-affects or any other unknown health issue that results from the vaccine. If the government hasn't revoked their immunity then I suppose this approval doesn't really bring anything new to the table, right?

      • by sphealey ( 2855 )

        In the United States all vaccines added to an NIH recommended list are covered by a government-sponsored insurance pool. You cannot sue the maker of your latest dTAP booster directly either.

      • The government assumed liability for all vaccines in the 1980s. If you are actually injured by a vaccine, the government pays. COVID vaccines are no different.

        Does lying about this on Slashdot actually pay well?

      • by torkus ( 1133985 )

        The hypothetical "long term health side effects" is a red herring. Nothing more.

        The "but I can't sue" is equally BS. Did you know it's rather difficult to sue anyone when you're dead?

    • Believe it or not, the entire world is not "smart in-group" versus "lol, so dumb out-group." The reasons people are in the unvaccinated camp are myriad and potentially quite complex. In areas where there have been covid surges, vaccination rates have also spiked, meaning people are doing their own risk assessments. Lowering the perceived risk of vaccines approaches that from the other end. Will this convince everyone? No. But the fact 100% vaccination is unreachable doesn't mean you should forego trying

      • by sphealey ( 2855 )

        When 1,995,000 out of 2,000,000 medical professionals in the US strongly recommended getting one of the COVID19 vaccines I'm not sure what research and risk analysis an individual citizen is supposed to be able to do that outweighs that advice.

    • Lots of people have been getting vaccinated in recent weeks. Are these useless blanket statements necessary?
  • by Jedi Holocron ( 225191 ) on Monday August 23, 2021 @09:35AM (#61720319) Homepage Journal

    ...vaccine requirements for flights.

  • by rsilvergun ( 571051 ) on Monday August 23, 2021 @09:36AM (#61720327)
    and nag them into getting it. One of the things I keep hearing is "I'm not taking experimental medicine". Well it's just medicine now. So take your bloody medicine.
    • My response when someone says the vaccine is an "experiment" is to remind them, if true, that they are the control group. I actually know of someone who is now in the ICU: definitely the delta variant. Definitely not vaccinated. Unfortunately the regeneron is not available once hospitalized.
  • by backslashdot ( 95548 ) on Monday August 23, 2021 @10:01AM (#61720435)

    I refuse to use a non-FCC approved 5G device.

    • by torkus ( 1133985 )

      T-Mobile should run a promo offering improved cell service to everyone who gets their shots.

      They can make it a minor change to data caps or something so it's legal and real, but i'd love to see people lose their minds over it.

  • "Some people" will just move the goal posts.

    They wouldn't get a vaccine because "it's not an approved drug" or simply "it's experimental". Never mind the nearly 100 million people vaccinated with it. "They" know better!

    Now that it's approved they've moved on to "we don't fully know the long term effects" without any actual amount of time in mind (much less an understanding of pretty much anything related to drug testing)

    Then there's the "but it will/might make women infertile" nonsense floating around tha

  • Is it not still the case that the reason these vaccines could only receive "emergency approval" in the first place was because they weren't in use long enough to do long-term research on possible side effects?

    Regardless of your opinion on the vaccine, it seems to me that either the FDA mandates a new drug is "experimental" until the clinical trials are completed, or we just throw the whole idea out and start approving anything as soon as we see some positive benefits?

    Clinical trials typically take 6-10 year

    • by jeff4747 ( 256583 ) on Monday August 23, 2021 @01:54PM (#61721743)

      Is it not still the case that the reason these vaccines could only receive "emergency approval" in the first place was because they weren't in use long enough to do long-term research on possible side effects?

      It was never the case. Emergency approval versus normal approval is mostly about paperwork. There is more when doing a normal approval.

      There has been no vaccine in the history of vaccines where a side effect appeared long after the shot. Side effects, including long-lasting side effects, have always appeared within a month of receiving the shot. This happens because vaccines are out of your system within a week. Most are gone within 2 days.

      As a result, it's not typical to delay normal approval for vaccines until patients can be followed for years. 1 year or less is most common. The time it takes to receive full approval is about getting the paperwork in order and reviewed, not actually studying patients.

  • Once a drug is approved by the FDA, physicians may prescribe it for uses not listed by the agency (just like h*dr*x*q**n*l*ne was prescribed for COVID).
    I don't think docs are likely to use it for things other than COVID, but there could be shortages if
    a) Healthy people (non-immune-compromised) demand boosters
    b) Doctors administer it to people under age 12 (there's Emergency Use Authorization for 12-15, the new approval is only 16+)
    (I'm in favor of (b) so my grandkids can get immunized)

    And to those who say i

  • by sideslash ( 1865434 ) on Monday August 23, 2021 @12:32PM (#61721261)
    There used to be techies who distrusted the government and megacorporations. If you merely suggested a "papers please" basis for living normal life, you would have been flamed into oblivion. Now we have shameless big pharma bootlickers, cheerleaders for fascist government + Big Tech censors, and frankly blithering idiots who are dominating these threads.

    Go ahead and downvote me. I guess based on the numbers... this is your lawn, so I am the one who has to get off? lol
    • by PeeAitchPee ( 712652 ) on Monday August 23, 2021 @03:08PM (#61722193)

      Slashdot's tone has changed, but with more of a twist compared to the way you're describing it. What I see now is politics injected into pretty much EVERY topic, with a mostly left-leaning / progressive bent, and typically by the same dozen to twenty or so incredibly active users. It's driven a lot of the more old-school libertarian (small L) leaning users off the site, or at least caused them to visit and post a lot less frequently. This is tracking nicely with the rest of the Internet BTW, and even political polls. But Slashdot was never really a domain of the far right given its focus on technology and anti-religion (or at least agnostic) stance anyway.

      Having said that . . . after having watched millions get their shots before me and generally not get COVID or at least not get very sick, versus watching a whole bunch of dummies willfully not get the shot and then have to go on ventilators and / or suffer a stupid and pretty terrible death -- by all means, you can call me a "big pharma bootlicker" and "cheerleader for fascist government," but I'm confident I'm personally a lot safer with the shot than without it, and so is my family. That's all I really care about, though it is getting pretty irritating that we'll have to continue to get booster shots for the foreseeable future because a bunch of people have decided they're smarter than the actual scientists -- using junk info found on social media, no less.

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