We canceled our pfizer 3rd visit this week - my son had an adenoidecotmy instead and I have already posted about my frustrations with the process. We were initially told a hard end in April for the third dose appt (with a follow up blood draw in May). This week they’re fine with booking his third dose in June, follow up blood draw in July.
If pfizer doesn’t seem to think they’re wrapping up their trial ASAP and the FDA plans to review moderna and pfizer simultaneously, I’m banking more on fall 2022. Hopefully our youngest kids can get all shots in their series before the winter holidays, especially if it ends up being three doses. Insane.
This would not surprise me. DD (age 3) gave me and my mom covid (delta most likely) in August. The only reason we knew she had it is we got her tested. She (and the 2 kiddos she went to daycare with) all 3 tested positive and were completely asymptomatic. If it were not for the DCP getting tested (in home daycare) and testing positive I probably would not have tested. I thought I had a sinus infection, I had none of the typical covid benchmarks. My 13 year old has not had it to my knowledge, he tested negative (twice) at that time. He got vaccinated the first week his age group was allowed, though.
Not a lot of covid going around in this area, but quite a bit of flu, particularly flu A, and also Norovirus. The only place we have had to mask is the theater when we have gone to see musicals. This past show was the first where we did not have to show or vaccine card or proof of negative testing.
That 75% number doesn't surprise me. I mean I mentioned before that we caught DS1's infection (and subsequently the rest of us) on a fluke. We were all asymptomatic.
It doesn't surprise me, either. We only realized that DD and I had covid in retrospect after DH had very mild, but more traditional symptoms.
In hindsight, neither DD or I were asymptomatic, but neither of us had symptoms that would make you think covid (I had super sore muscles (similar to a very hard workout) one day and a bit of vertigo that night).
The NYT and YLE newsletters are giving me a small ray of hope on the under 5 vaccine approval. Both say that the FDA will likely move forward on the Moderna application by June/July. Basically if Pfizer is close to being ready to apply, they would try to do both but if not, they’ll move ahead with Moderna (which is what I think I’d prefer for DD2 anyway). I’m still not holding my breath, but I’m cautiously hopeful.
The NYT and YLE newsletters are giving me a small ray of hope on the under 5 vaccine approval. Both say that the FDA will likely move forward on the Moderna application by June/July. Basically if Pfizer is close to being ready to apply, they would try to do both but if not, they’ll move ahead with Moderna (which is what I think I’d prefer for DD2 anyway). I’m still not holding my breath, but I’m cautiously hopeful.
The NYT and YLE newsletters are giving me a small ray of hope on the under 5 vaccine approval. Both say that the FDA will likely move forward on the Moderna application by June/July. Basically if Pfizer is close to being ready to apply, they would try to do both but if not, they’ll move ahead with Moderna (which is what I think I’d prefer for DD2 anyway). I’m still not holding my breath, but I’m cautiously hopeful.
I'm sorry if this was covered and I missed it - why does the FDA care if it is Pfizer or Moderna?
Because they think the general public is dumb? I am pretty sure that is the real reason. Something about how it would confuse the public to have Moderna available for 6 and under but not 7-17 and uptake isn't high in kids in general so they want to wait and blah blah blah. I don't know. That is the general gist though.
The NYT and YLE newsletters are giving me a small ray of hope on the under 5 vaccine approval. Both say that the FDA will likely move forward on the Moderna application by June/July. Basically if Pfizer is close to being ready to apply, they would try to do both but if not, they’ll move ahead with Moderna (which is what I think I’d prefer for DD2 anyway). I’m still not holding my breath, but I’m cautiously hopeful.
I'm sorry if this was covered and I missed it - why does the FDA care if it is Pfizer or Moderna?
Because regulators are massively biased toward Pfizer. In most areas that are federally regulated there is a lot of crossover between industry and appointments to regulatory bodies… health care is no exception.
This whole “head to head” evaluation thing is not only a result of that bias, it slows down the process (IDGAF if they think “weeks” isn’t a slowdown, it is absolutely a slowdown) and has the potential to result in parents having fewer options for vaccine choices based on their own needs - for example, a trade off between efficacy and full vaccination timeline could be a big deal to families. That’s especially true with school timelines. Even short delays will impact whether some kids and their older siblings start another year of school (with no other mitigation measures in areas that previously had masking) without any protection.
They scheduled a VRBPAC meeting 15 days from when they expected a Pfizer submission in February. Before Pfizer even submitted their application there was a meeting on the books. I get that we aren’t living in the height of that massive surge but pediatric cases are increasing exponentially right now (I saw 48% over the past 2 weeks nationwide the last time I looked) with ~10 deaths a month in this population so it is NOT nothing. Why NOT act with urgency? What possible reason could there be in making little kids and their families wait even longer??
They approved adult Pfizer and Moderna initially in the span of just a couple of weeks and didn’t delay either or evaluate them relationally to one another. They approved J&J which had MASSIVELY less efficacy than the mRNA vaccines, also on a close but not simultaneous timeline.
Post by seeyalater52 on Apr 29, 2022 10:09:57 GMT -5
I admit I am infuriated by anything that even hints at a delay. I don’t care if it’s a day or a week or longer. It’s too long and it’s not the role of the FDA to evaluate applications head to head and it isn’t their role to pretend to be health behavior experts and make decisions based on their ideas about what motivates vaccine hesitancy or what uptake for this group will be. Full stop.
It’s disrespectful to the literal babies who were enrolled in these trials, who endured blood draws and shots and multiple follow up appointments to generate this data. It is especially disrespectful to placebo kids like my son who have to wait until EUA to cross over to get the real vaccine. I want to see the same urgency every single other group has seen in their evaluation of data and decisions on EUA submissions. I want to feel like we aren’t caught in the middle of whatever fucking dysfunction is motivating this at the FDA and the manufacturers’ shareholders and stock values. All these non-announcements and lack of transparency and misleading statements and unclear secret signals are unacceptable and I’m pissed.
Post by fluffycookie on Apr 29, 2022 11:18:36 GMT -5
COVID has finally entered the house. My 13 year old started coughing last night so I tested him since I knew numbers in his grade were up and within three minutes it was already positive. He's tired, coughing and stuffed up. He is immune compromised and on a medication that further compromises him so I am waiting for his doctor to call back to see if he should be treated. I hate this, every time he coughs I shudder because his immune compromised issue makes him more susceptible to pneumonia.
I don't remember any meaningful discussion about wanting to approve Moderna and Pfizer's adult vaccines on a similar timetable 12-18 months ago. It also wasn't a major focus when Pfizer was approved to move down in ages to teens and then age 5+ while Moderna sat on the sidelines. Why is concurrent approval now such a sticking point for under 5's?
I admit I am infuriated by anything that even hints at a delay. I don’t care if it’s a day or a week or longer. It’s too long and it’s not the role of the FDA to evaluate applications head to head and it isn’t their role to pretend to be health behavior experts and make decisions based on their ideas about what motivates vaccine hesitancy or what uptake for this group will be. Full stop.
It’s disrespectful to the literal babies who were enrolled in these trials, who endured blood draws and shots and multiple follow up appointments to generate this data. It is especially disrespectful to placebo kids like my son who have to wait until EUA to cross over to get the real vaccine. I want to see the same urgency every single other group has seen in their evaluation of data and decisions on EUA submissions. I want to feel like we aren’t caught in the middle of whatever fucking dysfunction is motivating this at the FDA and the manufacturers’ shareholders and stock values. All these non-announcements and lack of transparency and misleading statements and unclear secret signals are unacceptable and I’m pissed.
I just want to be clear - I just didn't know the answer. I too am appalled that the youngest among us are not able to be vaccinated yet.
I admit I am infuriated by anything that even hints at a delay. I don’t care if it’s a day or a week or longer. It’s too long and it’s not the role of the FDA to evaluate applications head to head and it isn’t their role to pretend to be health behavior experts and make decisions based on their ideas about what motivates vaccine hesitancy or what uptake for this group will be. Full stop.
It’s disrespectful to the literal babies who were enrolled in these trials, who endured blood draws and shots and multiple follow up appointments to generate this data. It is especially disrespectful to placebo kids like my son who have to wait until EUA to cross over to get the real vaccine. I want to see the same urgency every single other group has seen in their evaluation of data and decisions on EUA submissions. I want to feel like we aren’t caught in the middle of whatever fucking dysfunction is motivating this at the FDA and the manufacturers’ shareholders and stock values. All these non-announcements and lack of transparency and misleading statements and unclear secret signals are unacceptable and I’m pissed.
I just want to be clear - I just didn't know the answer. I too am appalled that the youngest among us are not able to be vaccinated yet.
Sorry, didn’t mean to imply that at all! I know you are. I think most of us are.
I’m so full of rage. Im being forced to travel for work in mid June and we have a family wedding on July 1 and all of this just makes these delays worse. The thought of going through yet another pandemic summer (or most of the summer) with no vaccine for my son makes me want to scream.
Post by sillygoosegirl on Apr 29, 2022 16:49:49 GMT -5
The only possible good I can see coming out of this would be if they also approved mix and match right off the bat, so the little kids could get Moderna, Moderna, and then down the road a Pfizer booster without waiting on yet another authorization to come through.
And no, I can't imagine they would actually do that.
Any idea when the Pfizer booster will be approved for ages 5-12? I want to get mine in ASAP since cases are rising again.
Not soon enough for us! After 2 years and 2 months we have Covid in the house. DD tested positive yesterday. (She is fine. Just a fever for a few hours and now a sore throat so the vaccine did it’s job for sure).