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The reason for expanding would be to detect more rare adverse events. We may finally be moving towards requiring more of a traditional evidence-based approach for decision making.https://t.co/TAWmTwcFjm
— Robert W Malone, MD (@RWMaloneMD) July 26, 2021
"The F.D.A. has asked the companies to include 3,000 children in the 5-to-11 year old age group ... double the original number of study participants envisioned." https://t.co/tZM3sN7NFg
— AssocAmerPhys&Surg (@AAPSonline) July 26, 2021
SCOOP: At FDA's urging, Pfizer & Moderna are expanding Covid vaccine trials for kids ages 5-11 -- a precaution to help detect rare heart problems.
— Sheryl Gay Stolberg (@SherylNYT) July 26, 2021
Unclear if this will delay authorization, which Biden said would come "soon."
w/@SharonLNYT @noahweiland https://t.co/hWNufE8D3F
Will you get your 5-11 year old vaccinated? https://t.co/6oknpqLSl6
— K Delay (@kjdelay1) July 26, 2021
„Pfizer has previously said it expects to have results for the 5-to-11-year old group in September, with results for children aged two to five shortly after.“ https://t.co/JGFnnPinF6
— teresa bücker (@teresabuecker) July 26, 2021
At the urging of federal regulators, Pfizer & Moderna expanding the size of their studies in children ages five to 11 — a precautionary measure designed to detect rare side effects including heart inflammation problems in patients under 30.
— Louisa Clary (@louisaclary) July 26, 2021
?Article: https://t.co/gAdY0qi3S2 https://t.co/OCbSSHDefi pic.twitter.com/CWkIT4qFs0
At the F.D.A.’s urging, Pfizer-BioNTech and Moderna are expanding their studies of children 5 to 11.
— NANCY (@9NANCYKUSA) July 26, 2021
? THIS - IT IS CRIMINAL TO TEST ON CHILDREN.
They skipped the animal trials and went right to kids?https://t.co/IXYwy29a9b https://t.co/eMw1ZubbJG pic.twitter.com/iNDmWy10Ud
At the F.D.A.’s urging, Pfizer-BioNTech and Moderna are expanding their studies of children 5 to 11.
— Charles Gordon (@princetongb) July 26, 2021
Strongly feel they need longer term safety data in children -- at least a year out.... $PFE $MRNA. To insure the benefit outweighs any risk. $NVAX MIA.https://t.co/mbcW5En52t
I have a 5 year old I will gladly sign up! Any one know of enrollment options in the Nashville area? https://t.co/z7d5h2U04O
— c.c.lipscomb (@TNradonc) July 26, 2021
Pfizer and Moderna Are Expanding Vaccine Studies of Kids 5 to 11 https://t.co/xOpbOVbUyH
— Matthew Herper (@matthewherper) July 26, 2021
.@AlexBerenson If the FDA thinks a group of 3,000 children (so assuming 1,500 in the vaccine group) is sufficiently large to detect any myocarditis issues, what does that say about what the FDA thinks myocarditis rates could be and/or are acceptable?https://t.co/PAA5qyVRXr pic.twitter.com/M9wJylQhaD
— Koen (@KoenSwinkels) July 26, 2021
Oh my goodness, I know a 7- and 9-year-old who would love to sign up. Anyone know any studies near Rhode Island?
— Hilary LeveyFriedman (@hleveyfriedman) July 26, 2021
Cc: @meganranney @ProfEmilyOster @ashishkjha
Pfizer and Moderna Are Expanding Vaccine Studies of Kids 5 to 11 https://t.co/r3PeZE5Hhz
Pfizer and Moderna Are Expanding Vaccine Studies of Kids 5 to 11 https://t.co/iGBuo03Pn3
— Jeffrey Levin (@jilevin) July 26, 2021
???➡️ At the request of the FDA, Pfizer-BioNTech and Moderna are expanding their trials on pediatric, gene therapy vaccines, including for children aged 5 to 11. ??????https://t.co/f9V4d0u3nq
— Nicola Bidoli ??? (@BidoliNicola) July 27, 2021
Vaccine trials for kids 5-11 expanded—possibly delayed. F.D.A. has asked the companies to include 3,000 children in the 5-to-11-year-old group, roughly double the original number of study participants. Unclear if EUA approval will be delayed or not. ?
— Eric Feigl-Ding (@DrEricDing) July 27, 2021
https://t.co/pG63RUaxa9
Ugh. FDA demanding larger vaccine trials for kids midway through the studies may delay approval
— Matt Grossmann (@MattGrossmann) July 26, 2021
https://t.co/aEMWQaim17
米国で小学生への接種の議論が進んでいますhttps://t.co/I9gw7hW4ph
— 上 昌広 (@KamiMasahiro) July 27, 2021
Deep sigh ... obviously we want sufficient study participants for good statistics to support a safe vax for kids. But MAN, this likely delay in vaccine approval for kids <12 yrs is deeply disappointing to me!https://t.co/4nAmIWvTO7 https://t.co/Fhiel8zAdN pic.twitter.com/hNACMfsl2s
— Dr. Alex Huffman (@HuffmanLabDU) July 27, 2021