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  1. #11
    twowhat? is offline Red Diamond level (10,000+ posts)
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    Quote Originally Posted by o_mom View Post
    No, that one is a manufacturing lot trial.

    This is the one:
    https://clinicaltrials.gov/ct2/show/...&draw=2&rank=9

    If the link doesn't work, the trial number is NCT04368728.

    The primary end date will not change at this point because they have to run it through August to get 6 months of follow up. If the data looks good, they may be able to submit with just 2 months follow up. I am not sure how likely that is since there are far fewer adolescent participants, and they are more likely to have asymptomatic cases.
    Yes, this is the one. I think it's possible for the primary endpoint to to shift up, if the patients recruited on the earlier end have enough events. Or, it could shift back if not enough events are being collected. But I agree with o_mom that it's unlikely to change too much.

    Has anyone ever wondered whether vaccine trial participants are less likely to be infected, just because trial participants are more likely to believe in/want to contribute to science and therefore take a more science-based approach to risk mitigation? I've always wondered that. On the flip side, vaccine participants are taking on risk by agreeing to be a part of the study, so there's that.

    EUA (not FDA approval) requires less follow-up time, so it's possible for an EUA to be granted earlier though I cannot find any recent news sources to back that up. I'm also curious if the pediatrician posted above has some insider info. I mean, it would be GREAT if an EUA were granted in the Spring and the vaccine could be delivered to 12+ starting early summer. It would be FABULOUS. And with supply chain being better now...I mean, that would be SO GREAT to get this rolling ahead of the next school year - maybe that would help so that more resources can be diverted to elementary schools for risk mitigation. My fingers and toes are crossed.

  2. #12
    JustMe is offline Diamond level (5000+ posts)
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    Quote Originally Posted by specialp View Post
    It really surprised me that the adolescent trials are 2,000-3,000 participants when the adult trials were so large at 40,000-50,000. I've read on why that is the case (kids less likely to become ill so looking at strong immune response), but still find it so surprising.
    I think this is because they are mostly looking at safety and less at other variables, but I could be wrong.

    I also think there is possibility of moving the end date up....we will just have to keep watching. As those Nerdy Girls said (see below) the fact that they are willing to test on babies as young as 6 months is very promising.

    I wanted to recommend another resource; Dear Pandemic on facebook; also called those Nerdy Girls. This is a team of women scientists who try to stay on top of things and report it out. They are great at saying what is factual info, what is CDC or otherwise recommended, and what is their opinion. They both write on facebook and have videos where they answer questions (not live questions, you have to submit them). Their latest video included the following topics. Vaccines updates - pregnant people, kids, the AZ vaccine trial kerfuttle, vaccine efficacy effect if you have to wait longer than recommended btwn doses, risk assessment for kids socializing outdoors, what is known about transmission in pools, advice for communicating with friends and loved ones who are hesitant to get the vaccine. Many on this board know that I am extremely cautious; they are not in the same category as me and do a good job of weighing all of the info. (I have no affiliation, just think this would be valuable for some of you).
    Last edited by JustMe; 03-30-2021 at 01:34 PM.
    lucky single mom to 18 yr old dd and 15 yr old ds through 2 very different adoption routes

  3. #13
    o_mom is offline Pink Diamond level (15,000+ posts)
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    Just saw this: https://www.cnn.com/2021/03/31/healt...lts/index.html

    Sounds like they will file for EUA in the next few weeks. If it is fast-tracked like the adult indications it could be just a few weeks after that for EUA.
    Mama to three boys ('03, '05, '07)

  4. #14
    o_mom is offline Pink Diamond level (15,000+ posts)
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    Quote Originally Posted by specialp View Post
    It really surprised me that the adolescent trials are 2,000-3,000 participants when the adult trials were so large at 40,000-50,000. I've read on why that is the case (kids less likely to become ill so looking at strong immune response), but still find it so surprising.
    So it looks like from the article on the data that they are only looking at antibody response, not actual COVID cases in the secondary indication trials (adults and 16-17 yos are a primary indication). This is common when you are looking at a secondary indication, but explains the lower numbers enrolled.
    Mama to three boys ('03, '05, '07)

  5. #15
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    Quote Originally Posted by o_mom View Post
    So it looks like from the article on the data that they are only looking at antibody response, not actual COVID cases in the secondary indication trials (adults and 16-17 yos are a primary indication). This is common when you are looking at a secondary indication, but explains the lower numbers enrolled.
    Yes, what I've read is kids are more likely to be asymptomatic and not get very ill so instead of tracking covid positives which would take huge, huge numbers, they are looking at immune response which I take to mean bloodwork. I get it and it makes sense to me, but I do not love it because having such large studies in adults meant a lot of data fast which made me comfortable with the vaccine for adults in my family (even though opening up placebo group meant loss of data in long term studies.). With the kids' studies, I'm more concerned about the long term studies and how that will be handled. Maybe that part will be better with small numbers.

  6. #16
    twowhat? is offline Red Diamond level (10,000+ posts)
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    I've been following Dear Pandemic for a while and they are fabulous. A couple of other evidence-driven folks to follow (both on FB as well as online blog):

    Friendly Neighbor Epidemiologist: https://emily-smith.net/ (approaches data from a faith-based perspective, and is fabulous!)
    Your Local Epidemiologist: https://yourlocalepidemiologist.substack.com/ (she initially started posting in our town FB group and I think a bunch of people told her she needed a wider reach. Her posts are easy to read, concise, focused, and really great.

    It's really cool that all these ladies (and moms!) work together to help fight misinformation and provide up-to-date data. They were even all featured in a recent TIME magazine article! https://time.com/5947557/covid-19-va...ormation-moms/

    Anyway, I just read through the Pfizer/BioNTech official press release carefully and it certainly sounds very promising and I don't see any red flags. It's preliminary and topline data only, so we still need to wait for details. I'm still hoping for an EUA BEFORE fall, selfishly, because our schools start so early here... They also state the vaccine's brand name in the press release and gotta say...it's awful. LOLOL. Probably can't be helped...drug names follow pretty stringent nomenclature "rules".

    eta: Also, I think I figured out the answer to my question about whether trial participants are likely to be more careful/not really a "real-world" population. For the kids 12-15 study it seems that part of the screening process included determining exposure risk. So a participant would have to have enough exposure risk (e.g. attending school, athletics, etc) in order to be enrolled in the study.
    Last edited by twowhat?; 03-31-2021 at 09:26 AM.

  7. #17
    Philly Mom is offline Diamond level (5000+ posts)
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    The podcast In The Bubble is about to interview Paul Offit in the next couple of days. He is great and will be talking about the vaccines and kids. He also is not afraid to admit mistakes if a prior assumption of his turns out to be wrong.


    Sent from my iPhone using Baby Bargains

  8. #18
    MSWR0319 is offline Diamond level (5000+ posts)
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    This is awesome! I do have a question though. If they truly do submit their data in the next few weeks for EUA approval, why do they keep saying fall for shots in arms? Do they think it will take longer for the approval because the study didn't include as many kids as the adult trials? We also start school in early Aug and I'm fearful they'll say "masks not required" so I want a shot in DS's arm!

  9. #19
    JustMe is offline Diamond level (5000+ posts)
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    Quote Originally Posted by MSWR0319 View Post
    This is awesome! I do have a question though. If they truly do submit their data in the next few weeks for EUA approval, why do they keep saying fall for shots in arms? Do they think it will take longer for the approval because the study didn't include as many kids as the adult trials? We also start school in early Aug and I'm fearful they'll say "masks not required" so I want a shot in DS's arm!
    I don't know the answer, and I would love to hear other thoughts. I have 2 guesses one is that before trying to move teens up they want to make sure everyone over 16 has had their chance. We are still having issues with people who want the vaccine and are eligible getting it here. It has gotten better, but still an issue..so they may not want to rush out a new eligibility group, especially one they think is less "high risk". Other guess is maybe they still will, but know better than to speculate about that possibility.

    I cannot wait until ds (15) can get vaccinated; it will make such a huge difference for our family and I am not even talking about doing anything crazy. Just the usual. OTOH, one thing I do kind of look towards with some dread is what it will be like when the first vaccines for teens come out and so many parents are wanting to get it for their kids ASAP. Unless there are some really good systems for that process it is going to be insane.
    lucky single mom to 18 yr old dd and 15 yr old ds through 2 very different adoption routes

  10. #20
    bisous is offline Red Diamond level (10,000+ posts)
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    Quote Originally Posted by JustMe View Post
    I don't know the answer, and I would love to hear other thoughts. I have 2 guesses one is that before trying to move teens up they want to make sure everyone over 16 has had their chance. We are still having issues with people who want the vaccine and are eligible getting it here. It has gotten better, but still an issue..so they may not want to rush out a new eligibility group, especially one they think is less "high risk". Other guess is maybe they still will, but know better than to speculate about that possibility.

    I cannot wait until ds (15) can get vaccinated; it will make such a huge difference for our family and I am not even talking about doing anything crazy. Just the usual. OTOH, one thing I do kind of look towards with some dread is what it will be like when the first vaccines for teens come out and so many parents are wanting to get it for their kids ASAP. Unless there are some really good systems for that process it is going to be insane.
    I'm a little worried about the process too! Only Pfizer is this close to getting EUA so we'll REALLY need to lean on that vaccine in order to cover everyone from age 12 to 17 who cannot get any other vaccine at this point.

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