@@@ Pfizer <5 vaccine trial results!!!

[noodleoo]

I just noticed this on CNN!!  3 dose data is in and it looked very good!

www.cnn.com/2022/05/23/health/pfizer-covid-vaccine-results-young-children/index.html

It’s not even a major headline, it was buried under a picture. Seriously, no one cares about us parents of youngest children. 

ETA. WaPo says the FDA will meet to discuss both Moderna and Pfizer on 6/15. 

www.washingtonpost.com/health/2022/05/23/children-coronavirus-vaccine-pfizer-data/

[Susie]

I saw an alert pop up on my watch about this, this morning.  I'm so relieved.  I hope this will be it for us parents of <5s.

My under-5 is on day 10 today of his covid isolation, and has been symptom free for a week now.  Even having gotten through it, and now having a 90 day reprieve from exposure quarantines, I'm so anxious to move past this phase of our lives, and into the fully vaccinated times.

[melmaria]

My little ones just recovered from Covid and I too am looking forward to a hopeful June vaccine.

[meowmaps]

This is good news but I still feel like Charlotte in SATC...set the date! I need to know the day I can bust into my pediatrician's office and get my kids jabbed.

[heat40]

This would be amazing if they get approval by summer. A huge weight off our shoulders when considering summer travel. Crossing my fingers it happens!

[madDawg228]

I feel like I can't get excited by this, since the <5's have been teased by hope too many times in the past. When there is an actual approval, then I'll get happy.

[seeyalater52]

I’m annoyed as fuck that they’re releasing this efficacy number in the media when it’s based off of a sample size of only 10 symptomatic infections. When they finalize the analysis the efficacy will drop, likely substantially.

Also beyond pissed that FDA went from strongly signaling a June 8 review meeting for Moderna to pushing it out a week to June 15th and analyzing side by side with Pfizer. All while claiming the two applications are completely separate from one another and they weren’t waiting on Pfizer to set a VRBPAC date and that they couldn’t put anything on the calendar until Moderna’s application was fully completed. Here we are mere hours after Pfizer’s press release that their submission is forthcoming and it’s all on the same date, thus delaying Moderna’s application which has been complete for 2 weeks (and top lines in since March 23rd.) Bunch of liars delaying this process for absolutely no reason.

[sillygoosegirl]

May 23, 2022 12:27:29 GMT -5 seeyalater52 said:

I’m annoyed as fuck that they’re releasing this efficacy number in the media when it’s based off of a sample size of only 10 symptomatic infections. When they finalize the analysis the efficacy will drop, likely substantially.

Also beyond pissed that FDA went from strongly signaling a June 8 review meeting for Moderna to pushing it out a week to June 15th and analyzing side by side with Pfizer. All while claiming the two applications are completely separate from one another and they weren’t waiting on Pfizer to set a VRBPAC date and that they couldn’t put anything on the calendar until Moderna’s application was fully completed. Here we are mere hours after Pfizer’s press release that their submission is forthcoming and it’s all on the same date, thus delaying Moderna’s application which has been complete for 2 weeks (and top lines in since April 23rd.) Bunch of liars delaying this process for absolutely no reason.

Yeah, seriously. Why do they like Pfizer so much better? I'm curious how many parents actually are planning to choose Pfizer over Moderna if both are approved together. I don't have a kid in this age range, but between Moderna's better effectiveness among adults, and the schedule allowing full vaccination months earlier (presumably still with the option of a booster added later if it turns out to be needed), I'm pretty sure I'd be leaning really strongly toward Moderna, assuming both are approved.

[seeyalater52]

May 23, 2022 12:38:45 GMT -5 sillygoosegirl said:

May 23, 2022 12:27:29 GMT -5 seeyalater52 said:

I’m annoyed as fuck that they’re releasing this efficacy number in the media when it’s based off of a sample size of only 10 symptomatic infections. When they finalize the analysis the efficacy will drop, likely substantially.

Also beyond pissed that FDA went from strongly signaling a June 8 review meeting for Moderna to pushing it out a week to June 15th and analyzing side by side with Pfizer. All while claiming the two applications are completely separate from one another and they weren’t waiting on Pfizer to set a VRBPAC date and that they couldn’t put anything on the calendar until Moderna’s application was fully completed. Here we are mere hours after Pfizer’s press release that their submission is forthcoming and it’s all on the same date, thus delaying Moderna’s application which has been complete for 2 weeks (and top lines in since April 23rd.) Bunch of liars delaying this process for absolutely no reason.

Yeah, seriously. Why do they like Pfizer so much better? I'm curious how many parents actually are planning to choose Pfizer over Moderna if both are approved together. I don't have a kid in this age range, but between Moderna's better effectiveness among adults, and the schedule allowing full vaccination months earlier (presumably still with the option of a booster added later if it turns out to be needed), I'm pretty sure I'd be leaning really strongly toward Moderna, assuming both are approved.

All my epi and statistician peeps are like WTF to this press release. No info on the primary endpoint of immunobridging (assume they met it but nothing said explicitly) and they’re running with 80% in the media like that isn’t a preliminary analysis they’re not even allowed to formally do since the N is too small. Staggering, honestly. I’m still not surely sure what is driving this Pfizer favoritism thing but it is becoming really problematic. They lied to a congressional oversight committee! Just… why!?

Technically I guess I don’t have a dog in this because my kid will cross over in the study and get the real Moderna vax as soon as either is approved but I’d probably go with Moderna at this point too if that is an option for non-trial families (I wouldn't be shocked if FDA doesn’t authorize Moderna pending the booster trial results.) The Pfizer 3 dose series will have efficacy somewhere north of 50% (and likely well below the 80 they’re reporting today) but with 13 weeks to complete the series for full vaccine action that is a tough sell for families looking for protection before school starts again. The whole thing is so disappointing.

[krystee]

If Moderna can come even remotely close to the realistic efficacy rate and not the 10-case 80%, who would suffer through dragging their under 5 kids to THREE shots instead of two?! I can’t figure out why Moderna isn’t being prioritized when parents are much more likely to start and finish a two-shot series, IMO.

[cherryvalance]

I'm at the point where I see the government as actively harming this population (really caretakers of this group) with the nonstop gaslighting and back and forth.

[seeyalater52]

May 23, 2022 14:45:33 GMT -5 krystee said:

If Moderna can come even remotely close to the realistic efficacy rate and not the 10-case 80%, who would suffer through dragging their under 5 kids to THREE shots instead of two?! I can’t figure out why Moderna isn’t being prioritized when parents are much more likely to start and finish a two-shot series, IMO.

Moderna efficacy for prevention of symptomatic infection was 37% for 2-6 and 51% for under 2 if I’m remembering correctly but they met immunobridging and *then some* for both groups why v may be a more realistic benchmark. Pfizer’s 2-dose efficacy was never reported so it can’t be compared head to head (perhaps it will be released as part of this days review in mid June) and they’re not reporting immunobridging results with this release even though that was the primary endpoint of the study which raises my suspicions. Moderna will eventually be 3 shots but the 3rd dose will be 6 months after the initial series which to your point seems more reasonable to keep up with than 8 weeks. Plus the primary series confers some actual protection whereas Pfizer initial 2 doses don’t so it’s a better one to have “incomplete.” There’s every reason to believe Moderna’s efficacy with the 3 doses would be comparable to Pfizer’s with 3 if not better, although in reality neither of them are going to be 80% with omicron, and will probably continue to fare poorly against new variants as per their adult counterparts.

No doubt about it though, the 80% number is meaningless nonsense. I’m guessing they just got lucky with good results in a tiny sample.

[seeyalater52]

May 23, 2022 15:21:13 GMT -5 cherryvalance said:

I'm at the point where I see the government as actively harming this population (really caretakers of this group) with the nonstop gaslighting and back and forth.

Gaslighting is a great word for it. 2 weeks ago they dismissed concerns that they’d sit on Moderna waiting for Pfizer (reported by sources within the FDA!) as rumors and gossip. Today they are blatantly doing just that. It’s offensive honestly.