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Medicine Government United States

FDA Panel Recommends Approval of Pfizer's Covid Vaccine For Emergency Use (cnbc.com) 152

A key Food and Drug Administration advisory panel on Thursday recommended the approval of Pfizer and BioNTech's coronavirus vaccine for emergency use in people over 16 years old, the last step before the FDA gives the final OK to broadly distribute the first doses throughout the United States. CNBC reports: If the FDA accepts the nonbinding recommendation from the Vaccines and Related Biological Products Advisory Committee -- which is expected -- it would mark a pivotal moment in the Covid-19 pandemic, which has infected more than 15.4 million people and killed roughly 290,000 in the U.S. in less than a year. The committee plays a key role in approving flu and other vaccines in the U.S., verifying the shots are safe for public use. While the FDA doesn't have to follow the advisory committee's recommendation, it often does.

The FDA could grant emergency use authorization of Pfizer's vaccine as early as Friday, James Hildreth, a member of the committee, told NBC's "Weekend Today" on Saturday. An emergency use authorization, or EUA, generally allows a drug or vaccine to be administered to a limited population or setting, such as to hospitalized patients, as the agency continues to evaluate safety data. It's unclear whether the FDA will authorize Pfizer and BioNTech's vaccine for use in certain groups. Some people, including pregnant women and young children, will likely have to wait to get the vaccine in the U.S. until Pfizer can finish trials on those specific groups. The FDA said Tuesday that there is currently insufficient data to make conclusions about the safety of the vaccine in children under age 16, pregnant women and people with compromised immune systems. Regulators in Canada, the U.K. and Bahrain have all cleared the vaccine for use by most adults.

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FDA Panel Recommends Approval of Pfizer's Covid Vaccine For Emergency Use

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  • by olsmeister ( 1488789 ) on Thursday December 10, 2020 @07:37PM (#60817556)
    There are concerns.
    • by quonset ( 4839537 ) on Thursday December 10, 2020 @07:47PM (#60817586)

      Yes, especially after the UK is seeing cases of anaphylaxis [reuters.com] after people get the first shot. This condition does happen in other vaccines, but the UK has recommended people with a history of anaphylaxis to a medicine or food should not get the Pfizer-BioNTech COVID-19 vaccine.

      Anaphylaxis is an overreaction of the body’s immune system, which the National Health Service describes as severe and sometimes life-threatening.

      • by Roger W Moore ( 538166 ) on Thursday December 10, 2020 @08:03PM (#60817638) Journal

        Yes, especially after the UK is seeing cases of anaphylaxis

        Given that these were apparently not seen in the trials which were conducted months ago when most people had not been exposed to the virus I wonder if it is a result of vaccinating those who already have immunity because they had covid but were perhaps unaware of it. Regardless, there are always risks with any medical procedure even if they are very small - the question is are the risks of the vaccine less than the risks of the disease it protects against and given the vaccine has been given to over 30k people in the trials and none of them died it already seems much, much safer than catching Covid.

        • by quonset ( 4839537 ) on Thursday December 10, 2020 @08:10PM (#60817668)

          Agree that everything has risk. No doubt about it. Only pointing out the OP's comment that the vote was not unanimous. Perhaps some were wondering about this new news.

          As a side note, it will be interesting to see how much, and how soon, an effect this and Moderna's vaccine will have once people start receiving them. As of now, 1/3 of all ICU beds in the country are at 90% capacity or more, with over 200 hospitals at max ICU capacity [cnn.com]. In Nevada, one hospital has patients stuffed away in the parking garage [cnn.com] because they are over capacity for ICU beds.

          With more than 3,100 reported deaths yesterday, and closing in on 300,000 total deaths, the race is on.

          • by shanen ( 462549 )

            You were also extending the OP in a more productive direction and possibly even suspicious (as I always am) that the OP was a troll comment. Negative evidence in the subsequent silence of the OPer?

            My new concern with the vaccine is a different flavor of concern about our lack of knowledge about what we are really doing. I've started wondering if the target proteins in the cell membranes might serve other targeting purposes than welcoming SARS-CoV-2. Maybe there are normal proteins in our bodies that sometim

        • by cygnusvis ( 6168614 ) on Thursday December 10, 2020 @08:47PM (#60817806)

          are the risks of the vaccine less than the risks of the disease

          This decision should be up to the individual.

          • by Known Nutter ( 988758 ) on Thursday December 10, 2020 @09:32PM (#60817932)

            This decision should be up to the individual.

            Yes, it should. What seems to concern many is that the information some individuals are using to make the decision is of dubious credibility. Facebook is not research. Sadly, the source of information for many people is the 6 inch glowing rectangle echo chamber device they spend their lives staring into. Disconcerting to say the least.

          • Re: (Score:2, Insightful)

            by sjames ( 1099 )

            Of course the decision to not get the vaccine carries consequences of it's own which should be on the individual. This may include not being welcome in school or other potentially crowded situations.

          • by MachineShedFred ( 621896 ) on Friday December 11, 2020 @09:37AM (#60818980) Journal

            Sure. And if that individual chooses to not be vaccinated, then they can also choose to:
            - not travel to other countries
            - not travel by air or train
            - not go to public events
            - be refused entry / service by businesses

            I'm all for individual liberties, as long as the individual accepts the consequences of exercising those liberties. You don't get to choose to not vaccinate and then go about life like everything is normal, because there will undoubtedly be a portion of the population that cannot take the vaccine or that the vaccine is ineffective for, and they don't get the choice.

            • This would require a system of vaccination verification IDs. Best case is that these would be physical cards that you could carry around with you, worst case is that this would constitute some kind of privately-run cell phone app laden with trackers. This second case is the most likely, if it's left up to private companies to handle things. So: is that worth giving people the choice to not be vaccinated?
        • by sjames ( 1099 ) on Thursday December 10, 2020 @11:24PM (#60818204) Homepage Journal

          Digging deeper into the UK incidents, both people who had a significant reaction had a history of allergic reactions serious enough that they carried epi-pens routinely.

          Fortunately, places that will administer the vaccine routinely keep epinephrine available. SOP is to have the patient stay near for 10-15 minutes so they can get help if there is a reaction.

          Especially given the above, getting the vaccine is surely safer than risking COVID.

        • by hey! ( 33014 ) on Friday December 11, 2020 @01:24AM (#60818422) Homepage Journal

          Well, the plausibility of that depends on how quickly the reaction took place. The vaccine is unusual in that it doesn't actually contain any of the antigens it sensitizes you to. It has to make its way into your cells and start building the antigens there, a process that takes 1-2 days to reach its peak.

          So if people were having immediate allergic reactions within minutes of the inoculation I'd think it's more likely to be something that's actually in the vaccine before it was injected.

          If it takes many hours for the reaction to occur, that would be consistent with preexisting sensitivity to the S protein coded for.

        • "Given that these were apparently not seen in the trials which were conducted months ago "

          Sick people with heavy allergies tend to NOT to volunteer for studies to get random stuff injected in to them.

      • It's very surprising that it happened on the first day of vaccination, but not in the trials. It's either a statistical anomaly, or something changed with the vaccine. I wonder if there's a slight difference in the version made in Europe.
        • by dgatwood ( 11270 )

          The trials were done in the United States, Germany, Turkey, South Africa, Brazil, and Argentina. The UK isn't on that list, so there's a good chance that none of the test subjects were from the UK.

          I wouldn't discount the possibility that people in the UK have significantly different rates of allergy, whether for genetic reasons (not too likely, given that the U.S. is on that list) or because of different levels of exposure to various airborne or foodborne contaminants (way more likely because of differenc

        • by Whibla ( 210729 ) on Thursday December 10, 2020 @10:49PM (#60818126)

          It's very surprising that it happened on the first day of vaccination, but not in the trials.

          The selection process for the phase 3 trials specifically excluded those with a history of allergic reactions. I'd be more surprised if there were no 'new' side effects discovered as mass roll-out of vaccination occurred.

          It's either a statistical anomaly, or something changed with the vaccine. I wonder if there's a slight difference in the version made in Europe.

          However, one can't discount either of these as a possibility. Allergy UK [allergyuk.org] says "The UK has some of the highest prevalence rates of allergic conditions in the world, with over 20% of the population affected by one or more allergic disorder" which might go some way towards accounting for the incidents.

          I would consider the second reason to be less likely, mostly because changing the manufacturing or quality control process between the trials and roll out would risk opening the company up to huge penalties if it was found out.

          • The official report [fda.gov] (page 40) is full of technical jargon on this topic. I can't make sense of it.

            FDA independently conducted standard MedDRA queries (SMQs) using FDA-developed software (MAED) to evaluate for constellations of unsolicited adverse event preferred terms that could represent various diseases and conditions, including but not limited to allergic, neurologic, inflammatory, and autoimmune conditions. The SMQs, conducted on the phase 2/3 all-enrolled safety population, revealed a slight numerical

            • by Whibla ( 210729 )

              I read that as "The FDA looked for patterns in the reported side effects of the trial participants, which if present might indicate a risk of the listed outcomes when the vaccine is used in the wider population. There was a slight indication that the vaccine will cause allergic reactions in some recipients."

      • just to be clear, they have updated the recommendation to not effect those with only food allergies.
      • by satsuke ( 263225 )

        As I understand it (as in the link) the two people who had an allergic reaction were also known to be allergic to a lot of things .. enough where both carried and epipen with them.

        The claim by the pharma companies isn't that the vaccine is 100% safe for 100% of people.

        I'm willing to live with a few "these people should not receive the vaccine" addendums if it means ending this pandemic..

      • Yes, especially after the UK is seeing cases of anaphylaxis [reuters.com] after people get the first shot. This condition does happen in other vaccines, but the UK has recommended people with a history of anaphylaxis to a medicine or food should not get the Pfizer-BioNTech COVID-19 vaccine.

        Anaphylaxis is an overreaction of the body’s immune system, which the National Health Service describes as severe and sometimes life-threatening.

        I think it's worth mentioning this quote from your source:

        The briefing documents said 0.63% of people in the vaccine group and 0.51% in the placebo group reported possible allergic reactions in trials, which Peter Openshaw, professor of experimental medicine at Imperial College London, said was a very small number.

      • by Bengie ( 1121981 )
        Two reports of anaphylaxis and both were in people that carried epipens because they have sever allergic reactions to things.
      • and they were people who carry Epipens. e.g. they were at high risk for a reaction (and would likely have known that, choosing to get the shot anyway).

        I don't think it's too much of an issue. At least no more than the flu shot. It does mean that people who don't want to get vaccinated really need to get vaccinated so that the kind of person who has to carry an Epipen doesn't have to take that risk.
    • by Tupper ( 1211 ) on Thursday December 10, 2020 @08:03PM (#60817640) Homepage

      Yes. And concerns will not go entirely away anytime soon. That said, the benefits here are large, the known risks are reasonable, and the unknown risks are unlikely to be large.

      People in consultation with their physician should be allowed to balance their own risks.

    • by backslashdot ( 95548 ) on Thursday December 10, 2020 @08:06PM (#60817650)

      According to stat news, at least one of the people who voted no said they wanted the minimum age to be 18 instead of 16 .. so it's hardly like she thought the thing was dangerous ... just felt it was unnecessary for minors given their super low risk.

      We don't know the reasons the other 3 voted no.

      • According to stat news, at least one of the people who voted no said they wanted the minimum age to be 18 instead of 16 .. so it's hardly like she thought the thing was dangerous ... just felt it was unnecessary for minors given their super low risk.

        We don't know the reasons the other 3 voted no.

        Interesting though, as the Trump CDC Cheif ordered deletion of an email regarding the administration ordering Charlotte Kent the CDC to change a report regarding the Virus effects on children - the deleted email instructed the CDC to “water down” its reports so they would “match President Donald Trump’s efforts to downplay the virus.” https://www.rawstory.com/2020/... [rawstory.com] P So let's put Hillary in jail, amirite?

        • Does deleting that email actually violate law? Serious question, because I have no idea.

          It certainly makes the author look like a total shithead, but I think we already knew that the people running DHHS are total shitheads from them changing the reporting structure of covid case counts and hospital utilization from being reported to a largely non-partisan CDC to them, so they can bury shit before making it public.

          Unless there's specific violation of law, calling for these shitbirds to be "locked up" is jus

      • You can watch the recorded video of the meeting on YouTube. Listen to the comments from those who voted 'no.' All 8 hours is available here: https://www.youtube.com/watch?... [youtube.com]

        I didn't watch the whole thing; my impression was that those who voted 'no' would have preferred language that was not quite so broad in the panel's approval. Age (under 18, really) was an example of a group where there was not much evidence, and the same for pregnant women. The broad language of the motion did not allow for exception
    • There are concerns.

      Then take your chances.

  • PREP Act Immunity (Score:3, Insightful)

    by ebonum ( 830686 ) on Thursday December 10, 2020 @08:07PM (#60817658)

    PREP Act, 42 U.S.C. 247d-6d et. seq.

    "authorizes the Secretary of Health and Human Services (the Secretary) to issue a declaration to provide liability protections to certain individuals and entities (Covered Persons) against any claim of loss caused by, arising out of, relating to, or resulting from, the manufacture, distribution, administration, or use of certain medical countermeasures (Covered Countermeasures)"

    Pfizer has no downside. If there are severe adverse effects, they can't be sued. If there is no risk, why have all the makers of Covid vaccines demanded and received immunity?

    Keep in mind, the first group to get the vaccine will be the elderly. A group massively underrepresented in the trails.

    • Some of the vaccine side effects are reported to be "non-trivial", so some of the older folks may be damned if they take it and damned if they don't. Personally I think I'd take it no matter what.

      • Some of the vaccine side effects are reported to be "non-trivial", so some of the older folks may be damned if they take it and damned if they don't. Personally I think I'd take it no matter what.

        Taking the vaccine is a pretty safe bet. Anaphylaxis can kill a person, but it is trivially treatable. We can have a anaphylaxis reaction for just about any injection, even tetanus. The deniers might find that a better risk though, as only 50 percent of those who contract tetanus die.

        The deniers are already claiming that the vaccine will destroy your immune system. Oh hell - some claim it has an implant chip in it too.

        I don't want anyone to die or become permanently disabled, but there's a real strand

    • they can't keep selling it. And there's a ton of competitors to the vaccine. Also Pfizer just bought the thing, they didn't make it.

      But yeah, Prep act sucks. It's yet another in a long line of nasty giveaways passed during the Bush Jr years that we all ignored because OMG! 9/11! Terrorists!
    • by thegarbz ( 1787294 ) on Friday December 11, 2020 @07:43AM (#60818852)

      If there is no risk, why have all the makers of Covid vaccines demanded and received immunity?

      Show me a single drug that has ever been manufactured in the history of our human race that carries no risk. FFS comically enough even a placebo puts you at an elevated risk of developing diabetes.

      Drug companies don't carry risk because that risk is put on regulatory agencies on purpose. There's are major societal reasons for that:
      a) having an independent body carrying risk reduces the pressure to take risk.
      b) preventing the companies who invest in the R&D from being exposed to the risk makes it more likely they invest in problems that may not generate high returns, which is why society enjoys treatments and cures for edge cases that aren't experienced by the wide population.

    • Maybe because they're receiving pressure from the government to get it done fast, and fast means not doing all the testing and data analysis they otherwise would?

      Increased risk means increased liability, so they're trying to mitigate that. Besides, there are other "market-based solutions" to widespread problems with a vaccine, such as the company having to write down tens of billions of dollars worth of research and manufacturing when nobody wants their vaccine because it causes problems that others do not

  • Seems very optimistic view there.

    With anti-vaxxers running rampant in the US, how many people will get the vaccine? And how many doses will be available in the entire year of 2021?

    General estimates requires above 60% immunity to reduce R0 enough to kill it off while allow lives going back to normal. Would anything change if only 10-20% (or even 30%) of the people got vaccinated, and most of them concentrated on the rich enough to pay for the shot?

    Probably a "first step", but I think hardly "pivotal".

    • I think the vaccine is going to be free for all who want it. And in this case, if the anti-vaxxers don't want to take it then so be it - darwin might win a few more rolls of the dice.

      • most unvaxxed are just lazy people. antivaxxers are an extreme minority. Also, waiting for a product to have the kinks worked out makes sense, and the vaccine is a product.
        • Agree. Actual anti-vaccination people are fairly rare. People that are dubious of vaccination are a little more common, but a recent survey in the US put the number of people that are pro-vaccination at around 90%.

          Getting 90% of people to agree on literally anything is very hard to do. Getting them to believe on something as complex and technical as vaccination is very good.

          Would I like that to be closer to 100%? Sure. But you can't fix stupid. However, preventable disease can.

  • I need to ask, is there any other kind of use? It sure doesn't seem like it would be of a recreational use. It's been an emergency from the start as far as I'm concerned.

Crazee Edeee, his prices are INSANE!!!

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