Vaccinations for the really little guys and girls

It’s approved now (US) for the 5-and-up set, which is great, but my little guy is 2, and I’d love to get him vaccinated, too. Googling finds a few articles like this one:

which suggests that Pfizer is doing tests now, and expecting results by end-of year. But none of them seem like reliable sites.

So what is going on with the testing for little kids? When did they start? Is there a reasonable estimate for when it might actually get approved? Is there any actually good coverage of this that I’m somehow missing?

There is this CNN article. Says similar things. Initial results by end of the year.

Thanks, @Folly. Surprised that CNN didn’t show up in my search.

I assume results by end-of-year means best case for approval is late-January/early-February. Any word on how tests are going?

There’s probably not as much push for the under-5 set, because children interact with each other much less, prior to school age.

Yeah, they are at lower risk.

I was looking at my state’s covid numbers, and kids 5-14 are currently leading the pandemic, with rates of 30-35 cases per 100k. Those 15-19 are running more like 15/100k, and the little ones, 0-4, are below 20/100k, as are most other age cohorts.

(That’s new cases per day, a two week average, so a bit lagged.)

Sure, it makes sense that there are a higher portion of the under-5 set that aren’t in any kind of school or daycare, and interact with people outside their immediate families less. And for those that are in daycare, class sizes are smaller. So that all squares up.

But I’m not sure what the point is? That there is less coverage of and less effort going into bringing the vaccine to toddlers because people care less, which is because a) it’s a smaller population size and b) they’re less impacted by the virus?

They are more protected by their parents’ being vaccinated. And at very low risk of bad consequences if they do contract the disease. Any vaccination is a cost/benefit calculation. The cost is mostly the risk of the virus causing issues. The benefit is the reduced risk of catching the disease. The benefit is lower for the really little ones, so they want to be more certain the cost is low enough.

That’s also why the vaccine for school kids was approved so much later than vaccines for older folks. They were at much less risk from the virus, so regulators wanted to be REALLY REALLY sure the vaccine was safe enough. The initial tests didn’t even include them. Studies of kids were only set up when there was a lot of evidence the vaccine was safe in adults.

(Some vaccines work well but are costly. I was vaccinated against smallpox. No one is today, because the chance of contracting it isn’t worth the risk of the side effects of the vaccine.)

While not an expert, my understanding is that the younger you go the harder and harder it is to get enough data that’s statistically meaningful. There’s some value in the idea of not doing anything if you can’t tell that it’s doing anything.

And medicines in general can be higher risk for children, because there are some things that are harmless for an already-developed body, but which can have harmful effects on development. Probably not an issue for these vaccines, but you want to be really sure.

I think a lot of people are answering questions like why haven’t we approved it for the kids yet, or why are we doing that cohort last, or what’s taking so long. But none of those are my question. My question is what’s the status, and how can I monitor it?

Pfizer says:

Studies in Additional Populations | Pfizer

If safety and immunogenicity is confirmed, and pending authorization or approval from regulators, we hope to submit the vaccine for potential Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) sometime in the September-October timeframe for children 5 to 11, and soon after for 6 months to 5.

They also say that they may study the vaccine in kids under 6 months if it looks safe in younger kids. But I’ve been reading that newborns get antibodies from their moms, so there may not be much urgency in testing infants.

One of the sites doing the studies is a little more explicit about young kids:

When can you vaccinate your kids? What we know as FDA prepares to consider data from studies | News Center | Stanford Medicine

Q. When will the vaccine become available to babies, toddlers and preschoolers?

Vaccine trials in children who are 6 months through 4 years old are ongoing. The Phase 1 trials to determine the appropriate vaccine dosage in younger children began in May and included participants at Stanford’s clinical trial site. Data from clinical trials that are needed to extend the emergency use authorization to children younger than 5 are anticipated to be shared with the FDA by late 2021 or early 2022.

I do hope it is soon. My 15month old son cannot get vaccinated yet and my husband and I are keeping him out of daycare and I am pumping/ breastfeeding still so he gets my antibodies. Its scary with the new variant cropping up too.