What does this Emergency Use Authorization mean?
An Emergency Use Authorization is for vaccines that have been studied for at least two months, whereas typically a full approval comes only after following participants for more than six months. The research process is the same. It’s just the follow-up data submitted with the initial submission that may be shorter. The process that’s been used throughout the pandemic is really the standard process we use any time we study vaccines.
What does the COVID-19 vaccination series look like for children younger than 5?
Keep in mind that two vaccines were approved simultaneously. The Moderna product is a two-dose series separated by 28 days. The Pfizer product is a three-dose series, with the second dose administered three weeks after the first, and then a third dose administered two months later. Moderna is continuing to study whether a booster dose will be needed for young children. We’ll probably see those data later this summer.
Is the dosing the same as what older children and adults receive?
The dose per vaccine is smaller. For Moderna, children under 5 will receive a quarter of what adults have received. For Pfizer, children will receive one-tenth the dose of what adults receive. This was really done to ensure that the children had tolerable side effects—fever and injection site pain, for example—while still ensuring that they received enough medication to have an effective immune response.
Can families who want their young children vaccinated get this right away?
For some of the youngest children, potentially the only place to get vaccinated will be through their pediatrician. There may be other vaccine sites, but we do anticipate some age restrictions on those, which are state-dependent. As for all childhood vaccines, families should touch base with their pediatrician to figure out how they logistically can get it.
Why doesn’t the EUA account for children younger than 6 months old?
The children enrolled in the trials were only as young as 6 months. It’s important to remember that the initial pediatric vaccine series occurs at 2, 4, and 6 months, so we’ll really need to look at, if the COVID-19 vaccines are given earlier than 6 months, how exactly can it be administered with the other vaccines.
Do you think this will become part of routine vaccines for children?
It’s too early to tell. At this moment, we’re vaccinating children against COVID-19 at all different ages. That will actually be helpful. We’ll really understand, ‘When is the ideal time to get your COVID vaccine?’ I do anticipate this virus will be with us for a long time. This will be something that every winter, we may see spikes of disease. We’ll have to determine, long term, where this vaccine fits into routine schedules.
I will say, the vaccines administered to adults are the most studied vaccines of all time. I anticipate the epidemiology of these pediatric vaccines is going to fall in line with that. We’re going to be able to thoroughly study how children do over the course of their childhood related to whether they had infection prior, when they’ve been given their vaccines, and how old they are. We’ll continue to have a lot of data related to this pandemic. There’s an incredible push to make sure we really get through this to the other side.
Do you recommend that children younger than 5 get this vaccination?
100%. What we know about COVID-19 and kids under 5 is that most children have mild disease. However, there are a small percentage who have a more severe presentation, with hospitalization and emergency room visits. What we’re really trying to do is move this into a mild illness for children, make this, at worst, a sore throat and a cough, and keep kids out of the hospital.
What do you say to families hesitant to get this shot for their youngest members?
People have started to ask us, ‘How do we know this vaccine is safe?’ In terms of what was studied in the trials, children had the standard immune response that we expect after getting a vaccine. We saw cases of fever, of pain at the injection site, fatigue—all things we anticipated. There were no signals of the rarer side effects like myocarditis, though we’ll continue to track that. And without a doubt those mild symptoms are significantly less risky than getting a COVID infection itself.
Ultimately, we’re really trying to prevent those rare, severe events. That’s our strategy for influenza, varicella, things that most kids can tolerate, but we’re trying to prevent the complicated outcomes that we know some children have. Pediatric vaccination is different than how we think about the adult series. We’re trying to help kids continue to live their normal lives.
Do you suspect that eligibility for this group will help us, writ large, move COVID-19 from pandemic to endemic?
I do believe this is a piece of that. Parents of children under 5 have continued to be challenged by the need to quarantine their unvaccinated children after exposure. They still have kids out of school or camp for five to 10 days because a friend or a teacher or counselor showed up with COVID-19. We need to be able to help families stop living like this—it’s something that we’re all really longing for.