Good news at last –And last but not least-seems to be in the offing for about 28 million of the youngest residents of the United States. After an advisory meeting called yesterday, the FDA is likely about to give the green light to a pediatric dose of Pfizer’s COVID-19 vaccines for Americans ages 5 to 11, a move months in the making.
Following the agency’s expected emergency clearance, Pfizer’s formulation will require a recommendation from CDC director Rochelle Walensky, which is expected to weigh in next week, after its own advisory committee takes a vote. But the nation is ready: already, 15 million pediatric doses of Pfizer’s vaccine, which will be administered on a third of the amount distributed to adults– have become available for states to pre-order.
Yesterday’s discussions were tense, understandably. These vaccinations protect both the children they have and the people they interact with, and they represent one of the few major levers left for the government to fight the coronavirus. But as the age of eligibility for COVID-19 vaccines continues to drop, the risk-benefit calculations become more difficult and emotional. This age group is much less likely than others to get severe cases of COVID-19. In addition to that relative resilience, there are two rare but serious side effects of vaccines: myocarditis and pericarditis, or inflammation of the heart and surrounding tissue, which are more common in boys and young men who have received mRNA-based COVID-19 vaccines. Most cases were relatively small — less severe, for example, than the heart inflammation that can follow SARS-CoV-2 infection — but the phenomenon remains poorly understood.
That of the FDA analysis of the (somewhat limited) data on this age group, presented at yesterday’s meeting, came out in the advantage from giving pediatric shots the official okay. After all, COVID is now one of the top 10 causes of death in children aged 5 to 11 years; the disease has also hit black, Latino and Indigenous children especially hard. But a side effect that is “less risky than COVID” could still be cause for concern. Perhaps the vaccine should only be given to a small group of children, some committee members argued, for example people with medical conditions that increase their chance of becoming seriously ill. Still, the panel gave an almost unanimous thumbs up for the vaccine, with one member abstaining.
Now comes the hardest part: getting inoculations in small arms, by no means a slam dunk. As injections become available, just before the holidays, parents will have to sign up their children to receive them – two more shots, on top of the recommended seasonal flu shot, which may have side effects and may provide protection for the durability discussed. Adopting a new health intervention takes a gamble, but it can be extremely fraught. There’s still a lot we don’t know about COVID-19 in the youngest among us, and the vaccines we use to protect them.
To help understand what’s next, I caught up with Sallie Permar, the chair of pediatrics at Weill Cornell Medicine and chief pediatrician at New York-Presbyterian Hospital in New York. Our interview has been lightly edited for length and clarity.
Katherine J Wu: The FDA is likely on track to approve this vaccine in a few days — ahead of the CDC’s advisory panel, ACIP, meet next week. What is the biggest impact this could have on the pandemic in general, assuming we successfully convince parents to enroll their children in injections?
Sally Permar: For me the most important thing is that this vaccine eliminates three new diseases that we are dealing with in children and that we see consistently in our health systems and ensure that they are preventable through vaccination. The first is severe COVID-19, the respiratory disease that is rarer in children but still prevalent, especially in our adolescent populations and those at high risk. The second is MIS-C, a [inflammatory] condition that happens to 1 in 3,000 or so infections in children, [and is most common] in the age group of 5 to 11 years. And the third is long-term COVID, which children suffer for months due to persistent symptoms.
The second biggest advantage would be the transmission. Children can be protected by masks and they probably broadcast less often [than adults]. But children can certainly be part of the transmission chain, especially when it comes to households, and even in environments where precautions are taken.
By vaccinating our children, we can recapture the school as we once knew it, with children choosing who to sit at their lunch table, or being able to look in any direction in the classroom, and not a certain distance from them. their neighbor—maybe even think about whether kids can safely go back to school without masks. Masks can still be a good idea if everyone is indoors and has runny noses in the winter. But we will be able to roll back many of the restrictions that were in place. We can’t even think about that until we get high [vaccine] coverage for our children.
wu: That sounds great, but an approved vaccine doesn’t guarantee a… administered vaccine. You are a practicing pediatrician – what was your idea of how parents will receive this news?
permar: I foresee that in the coming weeks I will spend a lot of my time on [navigating] Which. Parents want to make the best decision for their children. And they want to make a very careful decision, and they want to consider all the available information. It is scary to think about: If I opt for a vaccination and my child has a rare side effect, what will I think about it? That certainly goes through the minds of parents.
The chances of your child developing a serious COVID infection are rare; the chances of your child getting MIS-C are also quite rare. Not many people know someone who has had a child in the hospital with COVID. But what’s even rarer is the chance that the vaccine will have an adverse effect. We need to educate about those numbers.
Not vaccinating is still a risk, and it’s a higher risk than giving your child a vaccine. In fact, we don’t even know if myocarditis will be a concern [in 5-to-11-year-olds]. There were no cases in that age group in [Pfizer’s efficacy trial]. Myocarditis is more common in older children. So with what we know, it’s believed to be less of a concern in this younger age group. And let me just say, I’m so excited that there’s been all this work that has gone into identifying an age-specific dose for this population. We want to achieve the immune response needed for protection, with the smallest dose to reduce side effects. That’s what we should be doing for any new vaccine in the future.
A question I often get is, “I have an 11-year-old who is turning 12 in three weeks. Should I wait? The higher dose seems better, right?” First of all, don’t wait for the larger dose – you never know when COVID will enter your life or your child’s life Secondly I think I would actually rather get them the lower dose Children’s immune systems are better set up to respond to low doses. They can actually achieve a better response. We’ve been doing that for a number of years in the HIV vaccine world. A lower dose in a young age group can achieve a better immune response than even a higher dose. I wouldn’t be surprised if we look at an even lower dose with the youngest age groups.
wu: That sounds really promising. At the same time, however, we do not have security about side effects. Pfizer’s trial was small — too small to pick up a reliable signal of myocarditis, so we’ll have to wait and see what happens when the vaccine is rolled out to a much larger group. How should parents weigh the risk of a rare side effect against the risk of COVID-19, which is less common in young children? And should certain children be given priority on the vaccine and others advised to wait?
permar: If you played the numbers and read the data, you would give your child the vaccine every time. [The alternative] taking an unknown risk, and that would cause you to fail to protect your child from a known risk that you know how to protect against.
Serious infections are uncommon in children, which has been a blessing. But we have no idea what predicts who will get MIS-C. Hopefully we will move forward and identify those things. We have some idea of who may be at risk for severe respiratory COVID older adolescents, [kids with] obesity, diabetes. But there are also children that we don’t know put them at risk for infection. We also see this with the flu. Completely healthy children simply get a very serious illness. We see that perfectly healthy kids just get really sick, and you can’t put your finger on it.
wu: Will vaccinating children be less urgent if transmission rates drop?
permar: One thing we know is that there will be new variants of this virus. If the pattern is right, they are more transferable. They may even be vaccine resistant. What drove many parents of adolescents to finally get vaccines [this summer] was that case numbers soared with the more portable Delta variant. That’s nice, but it was too late. It takes five to six weeks [from the first dose] to become completely immune. So we have to anticipate that there will be other variants that we will have to deal with. I hope we get this last segment highly vaccinated, and that might slow down the variants. But we should not calculate a new variant and we should anticipate it.
wu: Getting vaccinations for young children cost a for a long time, and we still haven’t reached the under 5 group. What can we learn from this? Did it have to be this way?
permar: We have to do that differently in the future. It is a travesty that we sent children back to school without this vaccine being available to them, while adults took advantage of vaccine immunity and went to restaurants with our vaccine cards. We don’t leave children until the last. Perhaps in the future we can start testing age groups in parallel.