Thread by @greg_howard

The Advisory Committee on Immunization Practices (ACIP) is the @CDCgov group that develops vaccine recommendations for children and adults. I've already submitted a comment — see my other 🧵 below — but I wanted to examine their perspective on our push to @ImmunizeUnder5s.

1/

https://twitter.com/greg_howard/status/1515376303238631426

"What Does ACIP Consider in the Vaccine Recommendation Process" asks cdc.gov/vaccines/acip/…, and the first answer is "The safety and effectiveness of the vaccine when given at specific ages." Makes sense. Let's dig into that. Safety first!

2/

Only @pfizer and @moderna_tx have the latest data, and we're eager to see it in the EUA, but we have lots of evidence already. "We now have data related to 37 million doses of COVID-19 vaccine given to children between 5 and 17 years old."
time.com/6163099/covid-…

3/

And the data says? The risk of serious side effects, mainly myocarditis, is literally one-in-a-million for kids and is "25-times higher if you get COVID-19 compared to the vaccine." "There have been no deaths in individuals <30 years and cases generally have a full recovery."

4/

Need more? "Recovery from post-vaccination myocarditis typically happens in a matter of days, while myocarditis that occurs from MIS-C or a classic kind of myocarditis caused by other viral infections can generally last much longer."
latimes.com/california/sto…

5/

"No vaccines in current use have ever been shown to cause long-term harmful side effects that present themselves years after vaccination," says a pediatric infectious disease specialist at the UC San Diego School of Medicine and Rady Children’s Hospital San Diego. Hmm, OK.

6/

What about fever? "'The rates of significant fevers are about on par with other vaccines' we give to kids," says a pediatric infectious disease specialist running trials at Vanderbilt. (And ACIP approved those other vaccines for kids, right?)
theatlantic.com/health/archive…

7/

Not everyone is comfortable with mRNA vaccines, and if that's you, you're welcome to wait for other options ... but the safety profile is clearly there for parents like me who think kids deserve the same protections available to adults. So, ✅ safety, but what about efficacy?

8/

See my other threads — and the articles I linked earlier — for my take on efficacy. @KatherineJWu summarizes what's possible since Omicron: "Forty-ish percent efficacy against symptomatic illness may be about as good as we can get with two doses"

https://twitter.com/greg_howard/status/1509795555936931841?s=20&t=gxXKr5cq43h6dyLLOHpFuQ

9/

But the ~40% efficacy is, frankly, a distraction. The real problem here is *not* an arbitrary 50% threshold that declares it's "not good enough" to protect millions of kids from symptomatic infection. (Although, seriously, compare to the flu vaccine we push every year.)

10/

The real problem is that symptomatic illness is the wrong thing to measure. Because yes, it's a *relatively* small percentage of kids who suffer greatly during the acute phase of a Covid infection. (Their suffering should matter too, but I guess that's not enough for some?)

11/

Symptomatic illness is the *easy* thing to measure, as are hospitalizations, which "among children aged 0–4 years were approximately five times as high during the peak week of the Omicron period (14.5) than during the Delta period (2.9)." Yikes.
cdc.gov/mmwr/volumes/7…

12/

But what *isn't* easy to measure in a clinical trial are the long-term effects of Covid on children (and adults too), especially with a near-guarantee of repeated infections. There's so much we don't know about #LongCovid. Answers won't come quickly. But we know a little ...

13/

"Receiving 2 vaccine doses was associated with lower risks for most outcomes. Associations between prior vaccination and outcomes of SARS-CoV-2 infection were marked in those <60 years-old, whereas no robust associations were observed in those ≥ 60."
medrxiv.org/content/10.110…

14/

"Fully vaccinated cases were less likely to have the following symptoms in the medium or long term than unvaccinated cases: fatigue, headache, weakness in arms and legs, persistent muscle pain, hair loss, dizziness, shortness of breath" (list goes on)
ukhsa.koha-ptfs.co.uk/cgi-bin/koha/o…

15/

"We found that receiving two COVID-19 vaccinations at least two weeks before SARS-CoV-2 infection was associated with a 41% decrease in the odds of developing Long Covid symptoms 12 weeks later, relative to not being vaccinated when infected."
medrxiv.org/content/10.110…

16/

"This analysis revealed that patients who received at least one dose of any of the three COVID vaccines prior to their diagnosis with COVID-19 were 7-10 times less likely to report 2 or more long-COVID symptoms compared to unvaccinated patients." [!!]
medrxiv.org/content/10.110…

17/

"We found that the odds of having symptoms for 28 days or more after post-vaccination infection were approximately halved by having two vaccine doses. [...] Almost all individual symptoms of COVID-19 were less common in vaccinated participants."
thelancet.com/journals/lanin…

18/

There's more, but you get the idea. We can't precisely quantify how much vaccination reduces the risk of cumulative organ damage from repeated infection and #LongCovid, but we know it helps, and the safety profile demonstrates it certainly doesn't hurt.

19/

So, back to cdc.gov/vaccines/acip/… and whether we've established "the safety and effectiveness of the vaccine when given at specific ages" to meet ACIP's standards for approval? I'd argue that's a clear "yes!" What's next? "The severity of the disease."

20/

"Vaccines recommended for children and adults prevent diseases that can be serious, potentially causing long-term health problems or death." The <5yo studies may not have had enough participants to "catch" a death in the control group, but this is, sadly, still an easy one.

21/

"During the recent Omicron wave [...] more than 30,000 were hospitalized. About 20% of children hospitalized during the recent Omicron wave needed care in intensive care units. The overwhelming majority of these children were not vaccinated."
time.com/6163099/covid-…

22/

We can debate how many dead 0-4yos is too many (uh, zero?) when we have a safe vaccine that can help, but we've got almost 500 deaths so far. And, as for "long-term health problems," estimates of 1 in 4 (!) don't even consider endless reinfection.
medrxiv.org/content/10.110…

23/

On to bullet #3 of cdc.gov/vaccines/acip/… ... "The number of people who get the disease if there is no vaccine." Sadly, the answer to this is "all of them." Every kid who isn't locked in a bunker is going to get this thing unless something dramatic changes in our society.

24/

I hate to be so fatalist about this — and don't even get me started on the injustice to the immunocompromised among us — but vaccines are an imperfect (but important) tool young kids cannot be denied while we struggle through the impact of #COVIDisAirborne as a society.

25/

Moving on to bullet #4 of cdc.gov/vaccines/acip/… ... "How well a vaccine works for people of different ages." We've already discussed "efficacy" in this age group. Meanwhile, ACIP will discuss access to third and fourth shots for adults while kids <5yo await their first.

26/

Would I love the perfect dosing data? Absolutely! But we all know that an initial dose of the mRNA vaccines to @ImmunizeUnder5s is just the first of the series. We have to get started if we want kids to have even imperfect protection before the fall. How long should we wait?

27/

Which brings us to the final bullet ACIP considers in their recommendation process: "How practical the recommendations are to put into practice. Factors that can impact the feasibility of implementing a vaccine recommendation can also be considered."

28/

This is the most egregious slap in the face, because @CDCDirector could wake up tomorrow and kill the off-label exclusion that's unique to @CDCgov's exclusive distribution agreement for these mRNA vaccines, unlike nearly every other treatment "not yet approved" for kids.

29/

We (or @CDCDirector, rather) could #offlabelU5 tomorrow and have diluted shots matching the clinical trial dosage in kids' arms imminently. "How practical?" All that's needed is the stroke of a pen. But we're told to "trust the process" and wait for ACIP, @US_FDA, etc.

30/

Parents and pediatricians are done waiting to @ImmunizeUnder5s. I've showed how the mRNA vaccines meet ACIP's criteria. Whether they recommend EUA or off-label usage doesn't worry me. If the latter is less objectionable to vaccine skeptics, so be it. But it's time to act.

31/

In the meantime, please #WearAMask. Not with your friends, if that's not your choice, but on transportation and in the public places we all share. It's a simple way to show you care that #CovidIsNotOver and it's #NotMildForEveryChild.

/end

Top of the 🧵:

https://twitter.com/greg_howard/status/1515855530178211840?s=20&t=Ks6RslU1lm7lA6VJkcC-Og