(This previously began with a post about Novavax, but I’ll make that a separate post).
After months of waiting, parents of small children can finally breathe a little. It has been a long wait, made even longer as parents braved home schooling, then the return to in-person schooling without vaccine mandates, and then the dropping of mask mandates everywhere. Pediatricians and other healthcare professionals have long awaited the FDA's authorization for vaccines <5 as well.
This week, the FDA's Vaccine and Related Biological Products Advisory Committee (VRBPAC) met to review the data from Moderna and Pfizer regarding vaccines for our youngest loved ones (age 6 months to 5 years). They waited until both companies had submitted their data, which was somewhat agonizing to those of us hoping they would review on a rolling basis (the faster we could get either vaccine for protection, the better). They reviewed and voted unanimously to authorize both vaccines! They forwarded that recommendation to the full FDA, who voted to authorize and sent it on to the CDC, who, as of 6/18/22, have voted for Emergency Use Authorization! This is excellent news.
Remember: Emergency Use Authorization does not mean any skipped steps in research. As we already know, the vaccines went through Phase I, II, and III trials. EUA requires 2 months of post-trial monitoring (enough to catch any major side effects) instead of 6 months (for full FDA approval). If you recall, the child vaccination data submissions by Pfizer were delayed because they tried a much smaller dose for this age group and did not see enough of an antibody response after two doses. The FDA also demanded increased recruitment for these trials, meaning they monitored for even longer than the required time - proof that no one was rushing things here.
I'll link below to the data presented at the meeting, showing how COVID has risen to a top-5 cause of death for all kids under age 19 - emergency department visits, hospitalizations (50% of whom had no preexisting conditions and 85-90% in which COVID was the chief concern), school disruptions, and deaths. Multi-system inflammatory syndrome (MIS-C) and Post-Acute Sequelae of COVID-19 (PAS-C, or Long COVID) also occur, which leave kids laid up, sometimes for weeks or months at a time. They can sometimes cause symptoms as simple as lack of smell/taste, or the torture of smelling garbage all the time, but sometimes worsening dizziness or brain fog (a different kind of school disruption) - literal brain damage! And don't forget the lung damage and breathing difficulties. Now, with mask and vaccine mandates down and people returning to pre-pandemic behavior, our youngest loved ones deserve protection.
So what did the data show?
The Moderna vaccine is a two-dose vaccine, 25mcg each, given four weeks apart.
The Pfizer vaccine is now a three-dose vaccine, 3mcg each (a much smaller dose, hence the setback with insufficient response after two doses), with 3 weeks between doses 1 and 2 followed by 8 weeks between doses 2 and 3. The Moderna vaccine achieves its full protection in 6 weeks, while Pfizer takes 13 weeks (of note, because Pfizer needed longer to try out its third dose, they were able to get Omicron-era data and saw good results).
The study looked at immunogenicity bridging (immunobridging for short), which is measuring the quality of immune response (specific types of antibodies in the blood) and comparing that to the effectiveness of the vaccine in the older age groups (see a thread below by one of my favorite scientists, Edward Nirenberg). There was a comparable result in terms of immunogenicity. Both also showed effective protection against severe COVID, and even significant protection against any symptomatic disease (Moderna 50.6% in kids 2-5, 36.8% in kids 6mo-2, Pfizer 75-80% after 3 doses, though that was with a smaller sample size).
Side effects were comparable as well, with arm soreness, irritability/crying (these are babies, after all), mild redness, and fevers. Fevers in small children can be more dangerous than those in adults, so we must be watchful (your pediatrician can help counsel you on this).
There was no myocarditis or pericarditis seen, thankfully, but that does not mean we may not see cases down the road (remember, adult cases were literally 12 per million; we don’t have to worry about lingering effects, but some folks may respond differently).
So when can your children get vaccinated? Now that the vaccine has been authorized, doses should be available this week itself in every state except Florida. 49 out of 50 states placed pre-orders for vaccines. Which to get?
Moderna does seem like it will provide immunity faster (and a booster, possibly variant-specific, will be available sooner; it's already been authorized for immunocompromised children), but because of its higher dose, the side effects may be more intense (though temporary). Pfizer may take longer, but it may be easier on the child. Depending on exposure risk and timing, you can make the decision. If only one is available? Consider going with that one - the sooner your kid is vaccinated against this potentially life-threatening and life-altering disease, the better, especially with summer camps and, before long, school resuming. Don't mix Pfizer and Moderna vaccines just yet - just like with adults, that information will come with time, but is likely more useful for boosters than the primary series.
And yes, this can be given with other childhood vaccines! There does not need to be any disruption in schedule. Just as with other vaccinations - even if your child is otherwise healthy, if they are old enough to catch the disease, they are old enough to get vaccinated for it.
What if my child already had COVID-19? Just like with adults, they should still get vaccinated. There is data to suggest that many kids in this age group do not make effective antibodies after a COVID infection, especially against Omicron, AND we know that reinfections happen in the Omicron era more than ever before. So the protection needs to be there.
What if I live in Florida?
The Florida Department of Health did not preorder vaccines for kids under 5. They instead recommend treatment, rather than prevention (which has never been medically sound principle in communicable disease), with medications…that are not authorized or generally available to kids in this age group. Okay.
Individual providers in Florida may still order vaccines. If you live in Florida, I would still check with your primary care provider, and others have suggested finding the nearest Federally Qualified Health Center. Your pharmacy may also have kid doses in stock soon.
This vaccine for children under 5 is long-awaited, and I’m glad it’s finally here. I highly encourage you to get your children vaccinated as soon as it becomes available, to protect them and others (remember, not everyone develops the same immunity or has the same level to start with) not only from disease but from further disruptions of their lives and lasting effects of COVID-19.
As always, I welcome your questions.
The severity of COVID-19 in the youngest age group: https://www.fda.gov/media/159222/download
Ed Nirenberg's Thread on Immunobriding: https://twitter.com/ENirenberg/status/1536918989141598208?s=20&t=ehzy2ZdFPrkAX6fQSbNnhw
Moderna Data: https://www.fda.gov/media/159254/download
Pfizer Data: https://www.fda.gov/media/159195/download
Full VRBPAC Documents: https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-june-14-15-2022-meeting-announcement
VRBPAC meeting timeline: https://www.statnews.com/2022/06/15/tracking-an-fda-advisory-panel-meeting-on-covid-vaccines-in-young-children/
Poor antibody vs. Omicron in kids post-COVID: