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  1. #281
    wendibird22's Avatar
    wendibird22 is offline Red Diamond level (10,000+ posts)
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    Called our local clinical research facility that is running several COVID vaccine studies (both adult and children). She said their Pfizer student for 5-11 is full and they are not enrolling anyone who will turn 12 within 6 months of the study. DD2 turns 12 in December and so wouldn't be considered for their Pfizer study even if they had space.

    They are enrolling ages 5-11 in their Novavax study, which they think will start in June. She said the adult study just completed and will be requesting EUA very soon. They are just starting the 12-16 (or 18?) study now and they will get the same dosage as the adult dose. She said it is a double blind study, 2 doses given 21 days apart and then 6 months later you get another 2 doses, 21 days apart, but of the opposite injection (so placebo or vaccine). So by December all study participants will have been vaccinated either in the June dosing or the December dosing. She isn't sure if the Novavax study will also eliminate 11yr olds turning 12 during the study or if they will still do the full double blind as I described...she said if the adult and teen populations get EUA, they might be able to fast track the study on children.

    So, I found that all interesting and thought you might too. I put DD2's name on the list for more info once they are greenlighted to start the Novavax trial.
    Mom to two amazing DDs ('07 & '09) and a fur baby.

    Gluten free since Nov '11 after non-celiac gluten sensitive diagnosis. Have had great improvement or total elimination of: migraines, bloating/distention, heartburn, cystic acne, canker sores, bleeding gums, eczema on elbows, dry skin and scalp, muscle cramps, PMS, hair loss, heart palpitations, fatigue. I'm amazed.

  2. #282
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    wendibird22 is offline Red Diamond level (10,000+ posts)
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    Darn duplicate post!!
    Last edited by wendibird22; 05-18-2021 at 10:52 AM.
    Mom to two amazing DDs ('07 & '09) and a fur baby.

    Gluten free since Nov '11 after non-celiac gluten sensitive diagnosis. Have had great improvement or total elimination of: migraines, bloating/distention, heartburn, cystic acne, canker sores, bleeding gums, eczema on elbows, dry skin and scalp, muscle cramps, PMS, hair loss, heart palpitations, fatigue. I'm amazed.

  3. #283
    MSWR0319 is online now Diamond level (5000+ posts)
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    Quote Originally Posted by wendibird22 View Post
    Called our local clinical research facility that is running several COVID vaccine studies (both adult and children). She said their Pfizer student for 5-11 is full and they are not enrolling anyone who will turn 12 within 6 months of the study. DD2 turns 12 in December and so wouldn't be considered for their Pfizer study even if they had space.

    They are enrolling ages 5-11 in their Novavax study, which they think will start in June. She said the adult study just completed and will be requesting EUA very soon. They are just starting the 12-16 (or 18?) study now and they will get the same dosage as the adult dose. She said it is a double blind study, 2 doses given 21 days apart and then 6 months later you get another 2 doses, 21 days apart, but of the opposite injection (so placebo or vaccine). So by December all study participants will have been vaccinated either in the June dosing or the December dosing. She isn't sure if the Novavax study will also eliminate 11yr olds turning 12 during the study or if they will still do the full double blind as I described...she said if the adult and teen populations get EUA, they might be able to fast track the study on children.

    So, I found that all interesting and thought you might too. I put DD2's name on the list for more info once they are greenlighted to start the Novavax trial.
    Did they say when the Pfizer study would start? I'm assuming they're waiting on the results from Phase 1. We're on the list at a research facility for DS2 and have been pre-approved but heard nothing yet. She said they'd call for more screening when they get the green light, but I know everyone probably wants in so I'll believe it if I get a call back.

  4. #284
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    wendibird22 is offline Red Diamond level (10,000+ posts)
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    Quote Originally Posted by MSWR0319 View Post
    Did they say when the Pfizer study would start? I'm assuming they're waiting on the results from Phase 1. We're on the list at a research facility for DS2 and have been pre-approved but heard nothing yet. She said they'd call for more screening when they get the green light, but I know everyone probably wants in so I'll believe it if I get a call back.
    No, no start date indicated.
    Mom to two amazing DDs ('07 & '09) and a fur baby.

    Gluten free since Nov '11 after non-celiac gluten sensitive diagnosis. Have had great improvement or total elimination of: migraines, bloating/distention, heartburn, cystic acne, canker sores, bleeding gums, eczema on elbows, dry skin and scalp, muscle cramps, PMS, hair loss, heart palpitations, fatigue. I'm amazed.

  5. #285
    MSWR0319 is online now Diamond level (5000+ posts)
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    Quote Originally Posted by wendibird22 View Post
    No, no start date indicated.
    I just got an email that said they have reached their limit as well. We were probably at the end of the list. Dang. Good news is they must be getting ready to roll!

  6. #286
    SnuggleBuggles is offline Black Diamond level (25,000+ posts)
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    Quote Originally Posted by MSWR0319 View Post
    I just got an email that said they have reached their limit as well. We were probably at the end of the list. Dang. Good news is they must be getting ready to roll!
    I would be ok missing the trial since there's a chance the kiddo would have gotten a placebo anyway. Back to square one then! That's my "glass half full" POV on this.

  7. #287
    MSWR0319 is online now Diamond level (5000+ posts)
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    Quote Originally Posted by SnuggleBuggles View Post
    I would be ok missing the trial since there's a chance the kiddo would have gotten a placebo anyway. Back to square one then! That's my "glass half full" POV on this.
    You're right. I told DH that it was probably for the best anyway because DS probably would have gotten the placebo even though it's a 2 to 1 trial. We wouldn't have changed behavior even if we suspected he got the real thing until we knew he had immunity and was unblinded, which I assume will be around the time shots get turned over to the FDA for approval, so no loss.

  8. #288
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    Quote Originally Posted by SnuggleBuggles View Post
    I would be ok missing the trial since there's a chance the kiddo would have gotten a placebo anyway. Back to square one then! That's my "glass half full" POV on this.
    Yes, the woman that I spoke to about the double blind Novavax child trial said that the placebo rate is 30%.
    Mom to two amazing DDs ('07 & '09) and a fur baby.

    Gluten free since Nov '11 after non-celiac gluten sensitive diagnosis. Have had great improvement or total elimination of: migraines, bloating/distention, heartburn, cystic acne, canker sores, bleeding gums, eczema on elbows, dry skin and scalp, muscle cramps, PMS, hair loss, heart palpitations, fatigue. I'm amazed.

  9. #289
    MSWR0319 is online now Diamond level (5000+ posts)
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    Quote Originally Posted by SnuggleBuggles View Post
    I would be ok missing the trial since there's a chance the kiddo would have gotten a placebo anyway. Back to square one then! That's my "glass half full" POV on this.
    You're right. I told DH that it was probably for the best anyway because DS probably would have gotten the placebo even though it's a 2 to 1 trial. We wouldn't have changed behavior even if we suspected he got the real thing until we knew he had immunity and was unblinded, which I assume will be around the time shots get turned over to the FDA for approval, so no loss.

  10. #290
    ang79 is offline Diamond level (5000+ posts)
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    Both my girls (12.5 and 14.5) got their first Pfizer yesterday afternoon. Both have sore arms today. DD1 has a headache but that could be related to sinuses/allergies as she has been stuffed up since cutting the grass a few days ago. DD2 had a 101 fever and chills a little bit ago. I gave her Tylenol since she had a super high fever after a flu shot a few years ago (don’t want to repeat that ER trip again!).


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