What parents need to know about a possible COVID vaccine for children under age 5

Pfizer asked the Food and Drug Administration Tuesday to authorize two low-dose shots for children between six months and 5 years old. Dr. Yvonne Maldonado, a professor of pediatric infectious disease at Stanford University who has helped conduct trials for the under-5 vaccine, joins Judy Woodruff to discuss.

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  • Judy Woodruff:

    Children younger than 5 may be able to get a COVID vaccine by the end of this month.

    Pfizer asked the Food and Drug Administration today to authorize two low-dose shots for children between 6 months and 5 years old. At the same time, Pfizer and its partner, BioNTech, are investigating whether three doses would work better.

    This has been long awaited by many.

    And, for more, we turn to Dr. Yvonne Maldonado. She's a professor of pediatric infectious disease at Stanford University. She has helped conduct trials for the under-5 vaccine.

    Dr. Maldonado, welcome back to the "NewsHour."

    So, what do you think of this move by Pfizer?

  • Dr. Yvonne Maldonado, Stanford University:

    Well, I think it's going to be a cautious move forward.

    We know that the two-dose vaccine trials didn't give the results that were expected in the 2-to-4-year-olds in particular, and the third dose will be a hopeful next step. But, in the meantime, it does appear that there may be some data to support a limited use of the two-dose vaccine, that it may actually have some effectiveness.

    It's clearly very safe, so that's not the concern.

  • Judy Woodruff:

    And it's been reported that Pfizer was encouraged by the Food and Drug Administration to go ahead and request authorization.

    And I just want to clarify something you just said. And that is the trials showing that the two-dose, much lower dose, regimen was working well, providing protection for children 6 months through up to 2 years, but, as you just said, 2 to 4, it wasn't.

    Can you explain what that's all about? Is it the amount of vaccine, or what?

  • Dr. Yvonne Maldonado:

    Well, first of all, let me just say that we haven't seen any of the data, even though we're doing the trials. We're all blinded to the data, which is important. The FDA will be posting the data, we hope, and we will be able to get a better look.

    But the bottom line is that the dose that's being given to the under-5's, by necessity, needs to be lower because the higher doses given to the 5-to-11-year-olds, which themselves were less than the adult dose — so it's 30, 10 and three micrograms, so a stepwise lowering of the dose — they just provide a better tolerance of the vaccine.

    So, the three-microgram dose, the lowest dose, provides a very acceptable safety profile, less fevers, for example. But it also didn't provide the same high degree of antibody responses that we're seeing in the older children and adults.

    But we just don't know the data. We haven't seen it yet. So it will be helpful to see to what degree there were positive antibody responses in that age group. And perhaps there may even be some data around prevention of disease and prevention of symptomatic cases.

  • Judy Woodruff:

    And what I was quoting a moment ago has been from news reports.

    But I hear what you are saying, that the official — that all the data has not been released.

    But, on balance, does it sound like a wise thing to do right now to go ahead and seek this authorization, get the authorization, even as you wait to see how effective a third dose would be?

  • Dr. Yvonne Maldonado:

    You know, that's a good question.

    I really think — first of all, I don't think that the industry sponsor or the FDA would move ahead if they didn't think they had a compelling argument. There are — they are very good. Both the company and the FDA are very good at this vaccine approval process. They have been doing it well for — even before the pandemic, and they have done an excellent job during the pandemic.

    So I think they must have data that is going to support their argument. But, not having seen the data, I can't really make a final judgment. We will just have to take a look and make sure that their messaging is not only to those of us in the fields of vaccinology, but to the general public as well.

  • Judy Woodruff:

    Well, I think, to parents listening, what you're saying, it could be reassuring.

    We know, Dr. Maldonado, that among parents of children of, what, from age 6 through 11, there's already been a degree of reluctance to have their children vaccinated. I think the uptake is something — is under a third, something like 29 percent.

    How concerned are you that there's going to be ongoing reluctance among parents of these youngest children?

  • Dr. Yvonne Maldonado:

    Well, you know, that's a great point. It is really frustrating to see people who are very anxious to get their kids vaccinated, but then this whole group of people who haven't done it.

    And I am not really sure that it's a safety issue or a fear issue. I really think that the messaging about the significance of COVID in children has been really underplayed. This is a disease that is the eighth most common cause of death in children in the U.S.

    But when you compare it to the data in adults, clearly, children are not dying, fortunately, at the same rate. That doesn't mean it's not an important disease that needs to be prevented in kids. And that's the message that I don't think is getting out to the general public.

  • Judy Woodruff:

    You're saying there's a lot at stake here, that there's a reason to get the vaccine for these youngest children?

  • Dr. Yvonne Maldonado:


    We know that tens of thousands of children have been hospitalized. More recently with Omicron, we have been overrun with hospitalizations. We know that there have been over 1,000 children who have died. And, again, not to make light of that number, we know that adults have died in many higher numbers.

    But that is not a reason to allow children to die unnecessarily. And we know that this vaccine is safe. It has been shown over and over again. So, the messaging is really about families thinking that this is a risk/benefit that is in their favor, in their children's favor.

  • Judy Woodruff:

    I think you're right that many people — that that story is not one that has been widely, widely dispersed.

    Dr. Yvonne Maldonado at Stanford University, thank you very much.

  • Dr. Yvonne Maldonado:

    Thank you.

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