I'm guessing Nov 8th because it's after any local elections and they won't have to answer mandate questions.
OMG, you’re totally right. That’s a shitty reason for timing as far as potentially delaying families who need this, but could also save the election since NJ’s gubernatorial election is this year and we don’t want Murphy ousted.
So if I’m reading correctly - they would file for EUA in early October, and then it’s thought that it will be anywhere from 3-6 weeks after that for FDA to finish and actually approve? That would put it somewhere between about Halloween and Thanksgiving.
The best new news out of that is the data on the daycare set (0.5-5 year olds) should be submitted a month later! That means everyone* but the youngest babies might be eligible by the beginning of 2022!
Post by boiler717 on Sept 14, 2021 18:30:55 GMT -5
The drug I work on has a PDUFA date of 10/15 so that would be fun but I don’t think it will be that early. I would be very surprised for EUA in October. The 12-18y EUA took a month from submission to authorization. I honestly think there is still a chance for a more nuanced EUA based on risk/benefit ratio and wouldn’t be surprised if it takes a little longer even with more public pressure. I think 11/10 or 11/12 could be options and still get gets vaccinated by Christmas which is what I think the goal will be. 11/9-11/24 would be my bet for range and fall into getting kids fully vaxed before school resumes in January.
Our local health department is betting on the FDA getting its approval done right before the October 20th CDC meeting. Then the CDC can make a recommendation that day, with shots rolling out locally on October 22nd.
(ETA: ‘locally’ to me. That is the first day of multiple county planned weekend vaccine clinics for kids. Other places may be on the ball for oct. 21 or it might actually take longer to get the vials distributed. But that is what they are planning towards).
I wonder if this is weight- specific. My 11 year old son is larger than many adult women and I’m worried that a lower dose wouldn’t be enough.
Vaccines have nothing to do with weight & everything to do with immune system maturity.
I think I also read at one point that, in the interest of time, they didn't test lower doses on adolescents. They tested the adult dose for safety and efficacy and went with it. It's very possible the dose for 5-11 year olds would be just as effective for 12-17 year olds.
Vaccines have nothing to do with weight & everything to do with immune system maturity.
I think I also read at one point that, in the interest of time, they didn't test lower doses on adolescents. They tested the adult dose for safety and efficacy and went with it. It's very possible the dose for 5-11 year olds would be just as effective for 12-17 year olds.
This! I have been waiting very impatiently for my 11 year old. But I want the lower dose for him because he has heart issues, and I figure there will be less of a chance of myocarditis with the lower dose.
Our local health department is betting on the FDA getting its approval done right before the October 20th CDC meeting. Then the CDC can make a recommendation that day, with shots rolling out locally on October 22nd.
(ETA: ‘locally’ to me. That is the first day of multiple county planned weekend vaccine clinics for kids. Other places may be on the ball for oct. 21 or it might actually take longer to get the vials distributed. But that is what they are planning towards).
This ACIP meeting is unfortunately after the FDA Ad Comm, which is scheduled for 10/26 for the pediatric dosing. ACIP doesn’t discuss until after FDA approval, which won’t be until after the Ad Comm. I’m surprised they are scheduling when the Ad Comm date is public info.
I wonder if this is weight- specific. My 11 year old son is larger than many adult women and I’m worried that a lower dose wouldn’t be enough.
I do not have a source to share but the lower dose for children reflects not their body size/weight but that they have a much more robust immune system. Their immune response has been documented well in clinical trials and represents the current dosing requirements.