Thread by @sophiacbess

Today, on #KidsVaccinesDay, I want to talk about an off-label *option* to vaccinate children < 5. Is that getting ahead of the science, you ask? No! The science and the ethics align in support of #offlabelU5. Read on… 🧵1/n

First, let’s talk about how we got here. What happened with Pfizer’s pediatric trial? @dr_kkjetelina did an excellent explainer on this topic. Bottom line: 3 mcg worked in kids 6m – 2 years, but the dose was too low for 2-5s. yourlocalepidemiologist.substack.com/p/why-did-the-…

Very important note: No safety signals were observed in either age group.

So what is the barrier to EUA for children 6m-2 years, the pediatric age group with the fastest increase in hospitalizations? It’s not the science! We have a safe and effective vaccine for babies that is blocked by the regulatory process of age de-escalation.

Now, what about 2-5s, for whom the trial actually failed? Is Pfizer testing the 10 mcg dose used for 5-12s? No. They’re betting a 3rd dose at 3 mcg can achieve the same benefits observed after 2 doses in older age groups. This is likely to work, BUT... theatlantic.com/health/archive…

There’s a huge, massively overlooked problem: TIME. Here, I am referring both to the months until EUA and the months between first dose and protection. Many, perhaps most, kids will be infected during those months. Some for a second or third time. More on that in a minute.

First, what about Moderna? Could Moderna swoop in and win the race to EUA? There was a time when I thought yes. Then, at the start of the Omicron wave, the FDA asked Moderna to expand their pediatric trial by several hundred participants. tmj4.com/news/local-new…

The reporting on this move is sparse and confusing. Regulators’ decision to expand trials that were nearing completion at the start of an unprecedented wave disproportionately affecting young children deserves close scrutiny.🧐

Statistical note🤓: Small expansions do not meaningfully improve our ability to detect rare side effects like myocarditis.

But the result of the expansion is not in question: *Any* EUA for kids under 5 is 3-6 months away. Perhaps longer for infants. Leading experts expect ~40% of the US population, including babies and toddlers, to be infected in the current wave.

https://twitter.com/trvrb/status/1483996723458445319

The choice is NOT between vaccination now and vaccination later (usual framing). It’s between vaccination now and infection now. Under current conditions, off-label access to the Pfizer vaccine is the *only* path to protection before infection for most US kids born since 2017.

Fortunately, there is strong precedent for off-label prescribing in pediatrics. Pediatricians do this all the time!

@AmerAcadPeds authors concluded in a recent commentary that “legal barriers intended to universally exclude younger children from off-label COVID-19 vaccination should be quickly removed.” publications.aap.org/pediatrics/art…

It’s worth noting that the authors reached these conclusions during Delta. Omicron-level infection ⬆️ urgency. But there's more! Medical ethicists @EthicsElizabeth @sefyfe have also written in support of an off-label option: onlinelibrary.wiley.com/doi/10.1002/ha… via @hastingscenter

Just as vaccine access is not a replacement for policy, policy is not a replacement for vaccine access. All of us, including children under 5, deserve both. If you agree, please consider reading and signing this petition: change.org/p/janet-woodco…

Physicians, there’s a separate one for you! protecttheirfuture.org/physician-lett…

Remember, vaccine access for <5 is not the finish line. We must continue to demand policies that slow transmission and protect workers, immunocompromised people, and all of us. Address terrible disparities in US vaccination rates. Vaccinate the world. We're in this together./end

Sorry @ImmunizeUnder5s, meant to tag you above!

Important clarification (thank you @EthicsElizabeth!): The authors do not reflect the official position of @AmerAcadPeds. Their commentary is in Pediatrics, a publication of the AAP. An important platform for this idea, not an endorsement.

🚨Important clarification (thank you
@EthicsElizabeth!): The Pediatrics commentary linked above reflects the authors' own position, NOT the official stance of @AmerAcadPeds. Pediatrics is a publication of the AAP. An important platform for this idea, but not an endorsement.

Evergreen advice in the pandemic: always look to data & experiences from other countries! Thank you @MamaWeasleyy for highlighting that some off-label vax of <5s is happening now in Germany. Source: zeit.de/gesundheit/202…

My German is rusty, but with a little help from google translate, it looks like this is occurring purely at the discretion of individual doctors. It is NOT blocked, however. Would love to see US media cover this!

Science folk: there is a letter for you, too! Please consider reading/signing. protecttheirfuture.org/for-scientists