32 Comments
Feb 2, 2022Liked by Katelyn Jetelina

Looks like VRBAP has already been scheduled for 2/15. Does this change your thinking about the likely timeline and/or likelihood of approval?

Expand full comment
Feb 2, 2022Liked by Katelyn Jetelina

I just want to say thank you. As a mom of an under 2 and as an elementary school educator, I am so grateful for your ability to break down the process and explain the variables. As soon as I heard this news today I was anxiously awaiting your post to walk through the details. Thank you.

Expand full comment

Thanks for the comprehensive "cliff notes"...

I understand your perspective and from a best case scenario it all makes sense. But the world is not best case scenario. Its filled with pitfalls.

There are no finish lines, and whatever was a finish line has been moved repeatedly. Success has never been defined, as we remember that we were Stay at Home to flatten the curve not become prisoners with a life sentence.

My kids 10 and 12 were at a swim meet. It was abundantly clear that the age group swimmers under 10 was the lowest census there. Clearly, the past 2 years stunted the younger kids from partaking in the sport. Pools have been closed and lock downs have suspended group activities. I get the feel the 6-7-8-9 year olds lost out of social and physical and mental development. Under 5, i fear the same thing. Just the circumstantial evidence was overwhelming.

Under 5 year olds are not party to the pandemic, except for wearing masks, cloth masks, that were deemed ineffective and probably stunted emotional development.

We are supposed to protect kids!!!!

Every year in the United States there are an estimated:

3,960 fatal unintentional drownings, including boating-related drowning—that is an average of 11 drowning deaths per day.

8,080 nonfatal drownings—that is an average of 22 nonfatal drownings per day.

https://www.cdc.gov/drowning/facts/index.html

COVID is not even close to that in fatalities. We would save more lives by hiring more life guards and that would not require shooting drugs into our system hoping for no side effect.

So what is the goal? To protect the elderly? Well, that can be done through all types of mitigation that does not require more and more medication. For goodness sake we just learned that the vaccine was not effective against Omicron.

What is the end game? Its lost on most of the USA except that one political party wants to continue treating COVID with a one size fits all while another wants to target those at risk.

It seems like vaccinating a demographic that has more drownings than COVID deaths is misguided.

Expand full comment

I would love to hear your take on the Moderna trials for these young ages, as I thought they were potentially seeking approval in March and it's fascinating that FDA is eager to get Pfizer to apply and at the same time might step in front of Moderna's approval timeline and end up with children needing to go more months before the 3rd dose of Pfizer provides protection, wheras the Moderna shot would be quicker with just two shots if it is effective and safe. Is there not a realistic way forward for Moderna because of the path they took or is it potentially also a safe possiblity for our little ones?

Expand full comment
founding

What does the second graph mean- What level titre is effective? I don't quite get why as a parent I should try to get my 2-4 year old vaccinated if data indicates it is "ineffective" with 2 doses? I want to be excited but don't understand what there is to be excited about a vaccine that "doesn't work". What DOES it do? Why should I sign up for Pfizer right away vs wait for Moderna who seems to be buzzing with more positive results?

Expand full comment

Thank you for such a clear explanation of the approval process. I don't mean to complicate things, but do you have any thoughts about a child who will turn 5 between getting the second dose of the under 5 vaccine and the third dose expected two months later? I have read that a child should get their first, lower dosage for their current age, and the higher dosage for their new age group, but there seems to be no precedent for crossing the age boundary between a two dose protocol and a three dose protocol. Would the third dose be of the 10mcg vaccine or a third shot of the 3mcg? Or would it be better to allow kids close to 5 to get the 10mcg vaccine early? I hope this will also be considered by the advisory groups.

Expand full comment

This is a bit off-topic, but...

>And, what are the implications for long COVID and MIS-C

...what is the difference between long COVID and MIS-C? I thought they meant the same thing, and one was a layman's way of referring to the other. Now I'm not so sure based on your post.

Expand full comment

I have really enjoyed your extremely informative and dense, yet understandable newsletters. When my daughter turned 4.5 and speaking to our pediatrician if it was a matter of parental consent to get her vaccinated as she was still attending daycare, I was told it was guideline to not give her although our pediatrician has seen some parents lie the age of their kid to get vaccinated. I waited patiently only to have our daughter tested COVID positive from her teacher (very like Omicron) a week before Christmas which was a bit gut-wrenching as I thought about if I made the right decision to forego getting her vaccinated as a "5 yr old". Hoping some of your outstanding concerns get clarified in the next few weeks since the expected roll-out seems to be starting first week of March for under 5. Thank you as always for keeping us safe with shared knowledge.

Expand full comment
Feb 2, 2022·edited Feb 2, 2022

I am desperate for a vaccine for my 4.5 year old. Have fantasized about just passing him off as 5 before this news came out. Is antigenic imprinting as big of an issue with too high of a dose as with too low of a dose?

Expand full comment

How many kids were in the trial? Your newsletter says a couple of thousand —are we looking at 2,000? 8,000? Is that something Pfizer can share with the public?

Expand full comment