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Medicine

FDA Panel Endorses Moderna's Coronavirus Vaccine (cnn.com) 73

Posted by BeauHD from the latest-developments dept.
Vaccine advisers to the US Food and Drug Administration voted easily and quickly to recommend that the agency give emergency use authorization to Moderna's coronavirus vaccine. CNN reports: The Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 20-0 with one abstention to recommend EUA for the Moderna vaccine, which is very similar in design, composition, safety and efficacy to Pfizer/BioNTech's vaccine. That was the only question facing the committee -- whether to recommend EUA. "There's no doubt in my mind that the data -- it looks like the benefits outweigh the risks, from what I've seen," committee member Dr. Steven Pergam, of the University of Washington and Fred Hutchinson Cancer Research Center, said before the vote.

That did not, however, stop the collection of academics, physicians, public health specialists and others from getting into a lengthy discussion about whether Moderna should offer the vaccine to people who got saline shots -- something that might have the effect of reducing long-term data on how well and safely the vaccine protects people from infection. "Academics have a way of getting involved in details, and what we have done for the last eight or nine hours was to go over the details," Dr. Arnold Monto, an infectious disease specialist and professor of epidemiology at the University of Michigan, who chairs the panel, said after the vote. He noted the vote this time was more one-sided than last week's vote to recommend Pfizer/BioNTech's vaccine, which came down 17 for, 4 against, with one abstention. Similar to Pfizer/BioNTech's vaccine, the Moderna vaccine uses messenger RNA or mRNA that prompts the body to produce compounds that look like the outside of the coronavirus, causing an immune response that protects against infection. The report notes that "Each vaccine is about 95% effective in preventing symptomatic illness, with few side effects."
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FDA Panel Endorses Moderna's Coronavirus Vaccine More

FDA Panel Endorses Moderna's Coronavirus Vaccine

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  • Comment removed (Score:3)

    by account_deleted ( 4530225 ) on Thursday December 17, 2020 @08:41PM (#60843530)
    Comment removed based on user account deletion

  • Definitely willing to help contribute to herd immunity.

    Hopefully this ushers in a new era of fast and effective vaccinations.

  • I miss people (Score:4, Interesting)

    by PopeRatzo ( 965947 ) on Thursday December 17, 2020 @09:12PM (#60843578) Journal

    I have a strong suspicion that I'm one of the percentage of people who have natural T-cell immunity to COVID-19, or maybe I had it already and wasn't symptomatic, but when it comes my turn, I'll be there with my sleeve rolled up to get the vaccine. I really miss seeing faces and hugging friends and family.

    Either way, I'm not worried about the safety of a vaccine. I've eaten the polish sausage with grilled onions, sport peppers, and greasy fries out of Jimmy's Red Hots on Grand Ave in Chicago since I was like five years old. Nothing in that vaccine is gonna hurt me at this point.

    • Re: (Score:1)

      by Anonymous Coward
      I miss going out to the bars and finding a stranger to bring home for meaningless sex. Once I'm vaccinated, I'm going to doing that at least twice a week for months. 2021 is going to be the year of the one night stand!

      • Re: (Score:1)

        by Anonymous Coward

        Enjoy your child support judgements and STD's!

    • ave a strong suspicion that I'm one of the percentage of people who have natural T-cell immunity to COVID-19, or maybe I had it already and wasn't symptomatic

      Why do you suspect that?

    • I've pushed through cattle, walked up to the stock tank full of windmill water and moss, and gotten a drink.... but I suspect your Chicago pathogens have you better prepared than cow slobbers ;)

      • I've pushed through cattle, walked up to the stock tank full of windmill water and moss, and gotten a drink

        I'm currently living on a sheep farm in the Blue Ridge Mountains, so I've got livestock immunity covered, too.

  • They really should continue the tests by not giving the people who got placebos the actual vaccine, or tell them. It is unfortunate that there is now several tens of thousands of people who now only know there is a 50% chance they were vaccinated, but you have to have the double-blind test to get useful information, and this adds 2 months to whatever period we get information for. If any of them are worried they can always go and get another vaccine shot when available (hopefully they will report they did t

    • Gold standard, silver standard, seatbelts &par (Score:5, Interesting)

      by raymorris ( 2726007 ) on Thursday December 17, 2020 @09:36PM (#60843618) Journal

      The gold standard is of course double blind testing. It's especially important when the effect is small - a 2% increase in the rate of X.
      Yet, we know that parachutes work. Not from double-blind testing.

      Sample size is of course also important. If millions of people drive, some with seatbelts and some without, we have thousands of car wrecks to compare data about those who were wearing seatbelts vs those who weren't. We don't need double blind testing to see that seatbelts save lives.

      About 1.5 million people have died of COVID so far.
      Over the next few months, another 100,000 will die.
      Millions of people will be vaccinated.
      We can very easily look at the infection and death rates of those who were vaccinated and those who weren't.

      Suppose 10% of the population gets vaccinated by the end of the year, or whatever time - February, whatever.
      Suppose 100,000 people get diagnosed with covid. If the vaccine didn't work, you'd have about 1,000 vaccinated people with covid. If you see about zero vaccinated people with covid, the vaccine works!

      Now if the vaccine only slightly reduced your chance of getting covid, confounding variables might be a problem. But it's not a small effect we're trying to tease out. It's a very obvious drop of 95%+ in the rate of infections. You could be literally blind and see that level of effectiveness, no double-blind needed.

      It's kinda a pet peeve of mine when people say "you have to have the double-blind test to get useful information". Apparently the people who say that wouldn't bother to bring a parachute when jumping out of a plane, because parachutes haven't been proven in double-blind studies. Double-blind is the *most reliable* way to test for subtle effects. It is NOT the only way to know anything!

      • Having said what I did, I should acknowledge what larger double-blind studies WOULD give us.

        If we compare 10 million people who got the vaccine vs 10 million who didn't (not double blind), we won't know whether it's 96% effective or 98% effective. So what. Double blind would let us be more precise. And that would change our course of action how?

      • Re: (Score:2)

        by ceoyoyo ( 59147 )

        What is with this asinine parachute analogy? It's not the first time I've seen it here. Sounds like something bizzaro Jenny McCarthy would come up with.

        • To be fair, a parachute isn't subject to the placebo effect. As an example, you can't be sure that the backpack actually contains a parachute, or if it's just filled with dirty laundry just by glancing at it. Just thinking that your pack is filled with a properly packed chute isn't going to make you hit the ground any softer in the event that you get knocked unconscious on your fall down and the automatic deploy operates but there is no chute.

          • Re: (Score:2)

            by ceoyoyo ( 59147 )

            I'm not sure that's "to be fair". Sounds like one of the reasons it's an asinine analogy to me.

      • Nobody made ANY of those assertions you think they made. The reason for double blind is because of the placebo effect, and also to ensure that selection bias didn't play a role (for example, if only young people were chosen for the trial). It's well known that the placebo effect exists. It's well known that selection bias can have a major impact. When a person believes they are getting treatment, their stress levels and things like that change which in turn helps them fight off a disease. That can often pla

        • > Nobody made ANY of those assertions you think they made

          It's a direct quote, my friend. That's why it's in quotation marks, "you have to have the double-blind test to get useful information".

          > if your study only chose young college students it would be useless.

          See again you confuse "the very best possible scenario" vs "useless". There is actually a HUGE range between "best possible" and "useless". If you do a study with college-age people, you find out how the vaccine works with college-agee people!

        • By the way, I'm curious, do you like pizza?

    • I signed for the COVID vaccine when it was still in the trial phase, I did a video call but they canceled my appointment to get the vaccine or placebo (saying they had an overwhelming number of volunteers). Anyway, they told me if the vaccine was released to the public those that received the placebo would be informed. Probably start running into ethical issues if you donâ(TM)t inform people. They probably also donâ(TM)t want to keep paying people $100.00 each per follow up visit. Probably no rea

  • Vax afraiders (Score:4, Insightful)

    by backslashdot ( 95548 ) on Thursday December 17, 2020 @10:06PM (#60843706)

    Vax-afraiders won't take a vaccine, which is well characterized but instead take "natural/organic" pills from shady companies. God knows what's in those pills, they have zero regulation. Also, just because something is natural doesn't mean it won't harm you. I mean, hemlock is natural. So is poison ivy. And the plague, flu, and tuberculosis, and syphilis. Plenty of plants and things in nature are deadly in the short and long term. Shit, animals had to evolve a huge organ called the liver .. just to detox from all the things plants have to try to stop you from eating their best parts. I used to spend summers in rainforests growing up .. many times I would sleep in a tree. Now I love animals, I love nature .. but one thing I learned basically .. 99% of nature would kill and eat you if it could -- they do it to each other! Another .9% of nature is actively trying to kill and eat you. Only .1% of nature gives a shit about you .. and that's basically your mom, your dog (not your cat), and maybe like 10% of humans. That's why synthetic is always superior to natural.

  • Allergies (Score:3)

    by hcs_$reboot ( 1536101 ) on Thursday December 17, 2020 @11:21PM (#60843862)
    Which of the 2 is the less allergenic? That's what matters
    • reports of the pfizer and rejections came out during testing and there have been some people affected in the UK and USA after public shoots started. Not heard of any for this one.
      • Oh wow I always thought they were pretty liberal with their gun laws in the USA but public covid shoots now that sounds like some sort of video game that I could probably get into...

  • Meanwhile, Pfizer vaccines go unused (Score:4, Insightful)

    by quonset ( 4839537 ) on Friday December 18, 2020 @07:18AM (#60844488)

    After comments from Health and Human Services Secretary Alex Azar indicating there are manufacturing problems and hiccups with Pfizer's vaccines, Pfizer came out and stated they have millions of doses of vaccines sitting in warehouses [forbes.com] because the federal government hasn't told them where to ship the doses.

    “We have continuously shared with Operation Warp Speed (OWS) and the U.S. Department of Health and Human Services through weekly meetings every aspect of our production and distribution capabilities,” the Pfizer press release said. “They have visited our facilities, walked the production lines and been updated on our production planning as information has become available.”

    Which raises a question. Why would the con artist purchase 100 million more doses of Moderna's vaccine [cbsnews.com] at a time when millions of doses of Pfizer's vaccine goes unused? It couldn't be because Pfizer corrected the con artist when he said Pfizer's vaccine was developed under Warp Speed when in fact it was not, but was instead developed in coordination with a German company.

    You don't think the con artist is deliberately not using Pfizer's vaccine while tens of thousands of more people die because he wants to spite Pfizer, do you?

    • Why would the con artist purchase 100 million more doses of Moderna's vaccine [cbsnews.com] at a time when millions of doses of Pfizer's vaccine goes unused?

      From your source:

      "The purchase increases the U.S. government's commitment to 200 million vaccine doses. Of those, 20 million doses are set to be delivered to states by the end of December, with the remainder expected to go out in the second quarter of 2021"

      So, the new order won't be delivered for another 3.5 - 6.5 months. Does that answer your question?

      It couldn't be because Pfizer corrected the con artist when he said Pfizer's vaccine was developed under Warp Speed when in fact it was not, but was instead developed in coordination with a German company.

      You don't think the con artist is deliberately not using Pfizer's vaccine while tens of thousands of more people die because he wants to spite Pfizer, do you?

      +1 Funny

    • Re: (Score:2)

      by cusco ( 717999 )

      Spite Pfizer? Probably not. More likely to spite voters for not making him king for life.

  • Comment removed based on user account deletion

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