Vaccines for under 5
Addressing a lot of questions I've gotten
For those of you who follow me on instagram, you know in my stories I’ve been following the news closely because of my eagerness to have a vaccine option for under 5. Invariably when I share about this, I get some questions, some polite and others less so. Today I’m going to breakdown the most common ones.
Why vaccinate children under 5 if they are low risk for severe disease?
In the past week (1/20-27), 808,013 children in the US reported a positive test result. As impressive as that number is think of how many likely had COVID and tested at home or couldn’t afford or access testing and aren’t captured by this. In quieter moments of the pandemic the multiplier was 6-10x, but with increased home testing it may be more. We somehow haven’t been able to establish a national dashboard of children’s hospitalizations with and for COVID, but in 24 states and NYC where they do report this, 936 children were hospitalized in just 1 week. Nearly all of the children hospitalized for COVID (ie. sick due to the virus, not incidentally found to have COVID when hospitalized for a broken leg, assume half given high community rates, 450ish in 1 week) are unvaccinated.
That said, when we focus exclusively on what’s best for the children, even a vaccine that is low in efficacy, one that works primarily by risk reduction not eradication, has the potential for tremendous impact at this moment. We know that the vaccines are not great at preventing infection, but they are very effective at decreasing severe outcomes. Vaccines could help us take that 450 hospitalizations a week to 0.
We have no concerns about the safety of the vaccine. We have good data on the first 8 million 5-11 year olds who tolerated the vaccine extremely well. We have every reason to expect that under 5, at a dose 1/3 of the 5-11 year old vaccine and 1/10 of the adult vaccine, this vaccine will be extremely safe.
Why is it taking so long then?
When the original plans were made to study a vaccine for children, they designed the protocol to be very cautious, to wait to release a vaccine in a younger age group until we could observe millions in the older age group for adverse effects due to the vaccination. This design maximized safety, but also meant that children were some of the last to be protected.
We learned from adults that adequate immunity particularly given the potency of newer variants requires a series of 3 doses and suspect that is the case for children as well. The big debate is not if these vaccines are safe, but whether they are effective enough with two doses to justify approval before seeing the results of the third booster dose. Were we to wait another two months for these results, millions more kids would be infected and thousands more would be hospitalized. The question of what is effective enough to justify approval is a complex one. Do we need it to be 70% effective at reducing illness or is 68% OK? If we allow parents and pediatricians access, some families would elect to take a vaccine now that doesn’t meet the 70% threshold but is shown to be safe.
What would a Covid vaccine mean for parents of young kids?
While we frequently hear the refrain that children under 5 are low risk, we know that low risk isn’t no risk and nearly 1/3 children have a risk factor which puts them at increased risk. Even more children live with an elderly, newborn or immune compromised family member so vaccinating can benefit the broader family as well as the child.
A vaccine will decrease the direct risks of COVID for children, lessening their risk of severe symptoms leading to hospitalization, of MISC-C, of long-COVID, and of transmitting COVID to others. For parents whose children have risk factors for severe illness, this is an especially welcome step forward at ensuring their family's safety and ability to participate in important social and educational activities outside the home. For parents who need consistent access to stable childcare outside the home, a vaccine will hopefully lessen the number of shutdowns and interruptions and decrease the need for precautions such as masking and testing in daycare settings.
It’s important to highlight what approval of a COVID vaccine won’t mean. When the FDA voted on the 5-11 age cohort, nearly every official commented that they were against mandates for that age bracket. An EUA allowing pediatricians and parents to use COVID vaccines in younger age groups does not mean that mandates should or will follow. Please do not mistake my eagerness to offer and have a covid vaccine approved for this age group as a desire to proceed with mandates.
Are parents breathing a sigh of relief with this news?
I do think many parents have been hoping and dreaming of a time when they will have the ability to vaccinate the youngest members of their family. However, based on slow rates of vaccine uptake for school age children, it's will be important for public health messaging to make sure the message is clear. An approved vaccine will be safe and effective. Pfizer and the FDA have selected a relatively low dose for this under 5 years of age population 3mcg or 1/10th of the adult dose, intentionally to maximize safety. It's not realistic to think that the vaccine will eradicate the possibility of infection, but all that we've learned from the older groups receiving these vaccines suggests that they substantially reduce the likelihood of complications from covid and help control spread. While it's likely that a booster or variant-specific additional dose will be indicated down the line, having some protection on board now, while the omicron surge is continuing, is going to provide meaningful protection for children.
When can we take the masks off? When can we stop quarantining?
By the time the vaccine is out, the omicron surge should be subsiding. When our youngest children have the opportunity to be vaccinated and community rates dip to lower levels, I expect we'll have a great opportunity to thoughtfully reduce the need for children to mask and quarantine. I'm very excited to have my own four year old daughter vaccinated as soon as possible and then advocate for her to be in school unmasked when community spread is low to moderate (ie. not during a surge). I have to worry less about asymptomatic spread when all the people in her bubble have access to a vaccine for risk reduction.
So really when will it be in my child’s arm?
The current news cycle suggests that Pfizer will submit the data to the FDA Thursday. They have scheduled the VRBPAC/FDA meeting to review the data 2/15. If approved, then likely new vials with new mixing instructions would have to be distributed as well as additional approval from CDC and ACIP which would likely put us at the beginning of March. So I’m excited, yes, but this is far from the last hurdle in the process, and it’s possible that the committee will vote no when we see the hard numbers on how effective the vaccine is. But we’ll have the transparency that stakeholders in children’s health deserve by allowing us to understand fully the conversations that have been primarily behind closed doors.
But my kid already had COVID, should we really vaccinate?
We know from adults that natural immunity is generated by infection, we know there is an extremely broad range of duration for antibodies from 3 months to an estimated 5 years. Those with more mild infections tend to have more minimal immune response, meaning many children may have inadequate natural immunity. Looking at antibodies is not the best proxy for protection since we have memory B cells and T cells which also have roles in natural immunity. But if the vaccine is approved, it will provide reliable protection and be safe. So yes, I recommend getting the vaccine after your child is no longer isolated. If your child receive monoclonal antibodies, they should wait 3 months.
My child is near the cutoff, should I wait to get a larger dose?
If your child is 4.8 years old, you should take the dose that’s available when the vaccine is approved. It’s possible the first dose will be 3mcg and the subsequent dose will be 10mcg.
Should I wait for Moderna?
We are interested in this vaccine mostly because of how high the risk is of catching COVID now, so I do not recommend you wait. There is substantial benefit to getting it sooner in terms of risk reduction. It’s likely there will be further doses and the opportunity to mix manufacturers (ie. initial dose Pfizer, subsequent Moderna). In adults we saw the best immunity generated by this approach.
Was it rushed?
No. If anything the release of vaccines for under 5 has been exceedingly cautious from my perspective.
I just don’t feel ready, can we still be friends?
Just like with other vaccine roll-outs, I believe inherently that parents are the best decision makers and advocates for their children. If you are not as eager as I am, as convinced of the safety, you do not have to decide now. In the next few weeks we’ll have a data dump from the trial, 1-2 months after vaccine approval we’ll have data from millions of children, and you can wait and decide later.
I’ve finally hired some help with my social media, so we can look forward to improvements in my content coming soon thanks to Maxine.
And Forbes quoted me about newborn hiccups, which are cute, not scary I promise.