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J&J vaccine on hold

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  • TheLurch
    replied
    Originally posted by rogue06 View Post
    Weren't Johnson & Johnson recent given control of one of the other vaccine operation's facilities or something like that because of screw ups?
    Tiny bit more complicated. A single facility was making vaccines for two different companies under contract. The screwup was that someone took ingredients for one and accidentally contaminated the vaccines made for the other. The "other" in this case, happened to be AstraZenica, and the US won't end up using their vaccine. So the company agreed to switch all production over to J&J, which eliminates the risk of that happening again.

    Leave a comment:


  • rogue06
    replied
    Originally posted by TheLurch View Post
    Today, the CDC and FDA announced that they're recommending we pause administration of the Johnson & Johnson COVID vaccine due to reports of a rare side effect involving blood clotting. Most states seem to be following this advice.

    In the US, this is literally a one-in-a-million side effect, with 6.8M doses dispensed, and 6 cases that have been tied to the vaccine. The fact that we can detect something this minor should give people confidence that the people monitoring vaccine safety are really on the ball.

    Under normal circumstances, a side effect this rare wouldn't be a reason to pause the use of anything. But in this case, the standard treatments for clotting disorders would actually make matters worse. So the FDA wants to take the time to make sure all doctors are aware of the symptoms of the problem, as well as the appropriate way to treat it.

    Since all 6 cases are women under the age of 40, there's a lot of debate about whether it wouldn't have been simpler to just steer that population away from the J&J vaccine instead of pausing it. This debate has, in part, focused on the message this sends to the people hesitant about the vaccine. Will they be reassured we're being so cautious, or scared into thinking that all vaccines are dangerous? (My personal bet is... both! Different people will respond different ways).

    In the grand scheme, this is not a big deal at the moment, as the US vaccination efforts have been mostly focused on the RNA-based vaccines from Pfizer/BioNTech and Moderna — we've got tens of millions of people vaccinated, and under 7M have received J&J, so it's a relatively small component of the overall effort. The CDC is estimating that it can maintain a pace of 4M doses a day using the RNA vaccines alone.

    That said, the timing is somewhat awkward, in that a lot of states are opening vaccinations to the general population this week, and a bunch of said people are seeing their appointments cancelled. Longer term, it'll be an issue for outside the US, as the J&J vaccine is cheap and easy to transport/store. These are the same side effects seen in the AstraZenica vaccine that was also paused in much of Europe, and would be expected to occur in other vaccines using the same technology (ie, Russia's Sputnik and China's Sinovac). On the plus side, the widespread use means that we should have a good handle on how to limit and treat the clotting issue before very long.
    Weren't Johnson & Johnson recently given control of one of the other vaccine operation's facilities or something like that because of screw ups?


    ETA: Reuters 8 days ago,

    Source: U.S. puts J&J in charge of plant that botched COVID vaccine, removes AstraZeneca


    The United States has put Johnson and Johnson in charge of a plant that ruined 15 million doses of its COVID-19 vaccine and has stopped British drugmaker AstraZeneca Plc from using the facility, a senior health official said on Saturday.

    J&J said it was "assuming full responsibility" of the Emergent BioSolutions facility in Baltimore, reiterating that it will deliver 100 million doses to the government by the end of May.

    In a separate statement late Sunday, Emergent said it expects to align with the U.S. government and AstraZeneca to ramp down manufacturing for AstraZeneca’s COVID-19 vaccine at its Baltimore plant.

    The Department of Health and Human Services has also increased Emergent’s order by $23 million for expansion of production specific to J&J's vaccine doses, Emergent added.

    "The $23 million will be used for the purchase of biologics manufacturing equipment specific to Johnson & Johnson’s COVID-19 vaccine for the potential expansion of manufacturing of that bulk drug substance into a third suite of Emergent’s Baltimore Bayview facility," the company said.

    The Department of Health and Human Services facilitated the move, the health official said in an email, asking not to be named due to the sensitivity of the matter.

    AstraZeneca, whose vaccine has not been approved in the United States, said it will work with President Joe Biden’s administration to find an alternative site to produce its vaccine.

    White House officials did not immediately respond to a request for comment.

    The development, first reported by the New York Times, further hampers AstraZeneca’s efforts in the United States. The government has criticized the drugmaker for using outdated data in the results of its vaccine trial. It later revised its study.

    Workers at the Emergent BioSolutions plant several weeks ago conflated ingredients for the J&J and AstraZeneca vaccines, the Times said earlier in the week. J&J said at the time the ruined batch had not advanced to the fill-and-finish stage.

    The government’s move to have the facility make only the J&J single-dose vaccine is meant to avoid future mix-ups, the Times said, citing two senior federal health officials.

    The top U.S. infectious disease doctor told Reuters on Thursday the country may not need AstraZeneca’s vaccine even if it wins approval.

    The United States has loan deals to send Mexico and Canada roughly 4 million doses of the AstraZeneca vaccine, made at its U.S. facility.



    Source

    © Copyright Original Source




    Last edited by rogue06; 04-13-2021, 05:11 PM.

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  • Juvenal
    replied
    Originally posted by Cow Poke View Post

    You're doing that thing again where you're weaponizing math --- facts and math and truth over superstition and rumor or something --- aren't you?
    It's much worse than that. I'm acting responsible, like I was surrounded by young, impressionable kids and I was the only adult in the room. Please forgive me. I promise to go and sin some more.

    Leave a comment:


  • Cow Poke
    replied
    Originally posted by Juvenal View Post

    Thanks, that was useful. It's kinda academic for me because I got my second Pfizer dose a week ago. But I've go students, and the more I know, the better I can answer questions.
    You're doing that thing again where you're weaponizing math --- facts and math and truth over superstition and rumor or something --- aren't you?

    Leave a comment:


  • Juvenal
    replied
    Originally posted by TheLurch View Post
    2 reasons:
    It roughly 100% effective at keeping people out of the hospital.
    Its effectiveness was measured at 2 weeks, but follow ups shows that it continues to rise considerably after that period.

    This has more details if you want them:
    https://news.ncsu.edu/2021/04/which-...-should-i-get/
    Thanks, that was useful. It's kinda academic for me because I got my second Pfizer dose a week ago. But I've go students, and the more I know, the better I can answer questions.

    Leave a comment:


  • TheLurch
    replied
    Originally posted by Juvenal View Post

    Since you're stopping by, I'd like to grab the chance to ask a related question that's been weighing on me. I understand the guidelines are for recommendation of any vaccine which is at least 50 percent effective, but the clinical trials showed the Janssen vaccine to be insufficiently effective to create herd immunity for anything but the most optimistic values of R0. With widely available vaccines that are more than 90 percent effective, and an infrastructure sufficient to maintain the necessary temperature regime, why are we using the Janssen vaccine at all?
    2 reasons:
    It roughly 100% effective at keeping people out of the hospital.
    Its effectiveness was measured at 2 weeks, but follow ups shows that it continues to rise considerably after that period.

    This has more details if you want them:
    https://news.ncsu.edu/2021/04/which-...-should-i-get/

    Leave a comment:


  • Juvenal
    replied
    Originally posted by TheLurch View Post
    Since all 6 cases are women under the age of 40, there's a lot of debate about whether it wouldn't have been simpler to just steer that population away from the J&J vaccine instead of pausing it. This debate has, in part, focused on the message this sends to the people hesitant about the vaccine. Will they be reassured we're being so cautious, or scared into thinking that all vaccines are dangerous? (My personal bet is... both! Different people will respond different ways).
    Since you're stopping by, I'd like to grab the chance to ask a related question that's been weighing on me. I understand the guidelines are for recommendation of any vaccine which is at least 50 percent effective, but the clinical trials showed the Janssen vaccine to be insufficiently effective to create herd immunity for anything but the most optimistic values of R0. With widely available vaccines that are more than 90 percent effective, and an infrastructure sufficient to maintain the necessary temperature regime, why are we using the Janssen vaccine at all?

    Leave a comment:


  • TheLurch
    started a topic J&J vaccine on hold

    J&J vaccine on hold

    Today, the CDC and FDA announced that they're recommending we pause administration of the Johnson & Johnson COVID vaccine due to reports of a rare side effect involving blood clotting. Most states seem to be following this advice.

    In the US, this is literally a one-in-a-million side effect, with 6.8M doses dispensed, and 6 cases that have been tied to the vaccine. The fact that we can detect something this minor should give people confidence that the people monitoring vaccine safety are really on the ball.

    Under normal circumstances, a side effect this rare wouldn't be a reason to pause the use of anything. But in this case, the standard treatments for clotting disorders would actually make matters worse. So the FDA wants to take the time to make sure all doctors are aware of the symptoms of the problem, as well as the appropriate way to treat it.

    Since all 6 cases are women under the age of 40, there's a lot of debate about whether it wouldn't have been simpler to just steer that population away from the J&J vaccine instead of pausing it. This debate has, in part, focused on the message this sends to the people hesitant about the vaccine. Will they be reassured we're being so cautious, or scared into thinking that all vaccines are dangerous? (My personal bet is... both! Different people will respond different ways).

    In the grand scheme, this is not a big deal at the moment, as the US vaccination efforts have been mostly focused on the RNA-based vaccines from Pfizer/BioNTech and Moderna — we've got tens of millions of people vaccinated, and under 7M have received J&J, so it's a relatively small component of the overall effort. The CDC is estimating that it can maintain a pace of 4M doses a day using the RNA vaccines alone.

    That said, the timing is somewhat awkward, in that a lot of states are opening vaccinations to the general population this week, and a bunch of said people are seeing their appointments cancelled. Longer term, it'll be an issue for outside the US, as the J&J vaccine is cheap and easy to transport/store. These are the same side effects seen in the AstraZenica vaccine that was also paused in much of Europe, and would be expected to occur in other vaccines using the same technology (ie, Russia's Sputnik and China's Sinovac). On the plus side, the widespread use means that we should have a good handle on how to limit and treat the clotting issue before very long.

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