In FDA Hearing, Pingree Presses Commissioner on COVID Vaccine Access for Children Under 5

Statement

In a House Appropriations Subcommittee on Agriculture, Rural Development, U.S. Food and Drug Administration (FDA), and Related Agencies hearing on Thursday, Congresswoman Chellie Pingree (D-Maine) pressed FDA Commissioner Robert Califf for answers on the FDA's timeline for making the COVID vaccine available to children age 5 and younger.

"I totally understand and appreciate how important it is to evaluate safety and efficacy. That's of huge concern in America. But I'm hearing all the time from parents and caregivers in Maine, and also around the country, who are just really frustrated and feeling left behind," Pingree said during the hearing. "Any further delays that continue, these children will endure yet another school year unvaccinated. Can you commit to us that reviewing any potential authorization for a vaccine covering children under five will happen as quickly as possible? And what timeline can we reasonably expect and tell people you will follow once an application is received?"

"We now have the Moderna application in hand as you know, as soon as we're ready, which is imminent, we have a number of dates reserved for the advisory committee meetings," Califf said. "[…] The Pfizer application should be coming in sometime soon also. So, I'm definitely committed as quickly as possible. I have two grandchildren under age five, so I'm very much in the same boat that's being described."

Pingree also echoed other Members' concerns over the infant formula shortage impacting parents nationwide, saying the shortage is indicative of broader food safety leadership failures at the FDA, which has a long, troubling pattern of structural and leadership issues at the FDA.

"I think we have to dig deeper into this troubling pattern of leadership challenges and structural issues, on food safety at the FDA," Pingree said to Califf. "This isn't new, and we have to work on this. And this is a huge crisis for America, and I'm very, very concerned about where we are."

The full Subcommittee hearing can be watched here, and a complete transcript of Pingree's questioning is available below.

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Congresswoman Pingree

Thank you so much for having this critical hearing at this moment in time. And thank you, Mr. Commissioner, for being with us today and answering our questions. I just want to associate myself with the questions that have already been asked by Chair Bishop, Chair DeLauro, Mr. Valadao, really on both sides of the aisle. Obviously, this is a very troubling, troubling situation.

And I'm not going to repeat all the same questions. I just want to say that I am concerned, Mr. Commissioner, that you aren't providing us with more detailed information. I think we have to dig deeper into this troubling pattern of leadership challenges and structural issues, on food safety at the FDA. This isn't new, and we have to work on this.

And this is a huge crisis for America. And I'm very, very concerned about where we are. I'm just going to pivot because like I said, I feel really grateful that my colleagues have been answered, asking good questions. And I know others will be asking more as well. I just want to talk a little bit about vaccine access for children.

You know, I really appreciate that the FDA has done some challenging essential work over the last two years on COVID, particularly in the vaccine space. One key group was not authorized COVID vaccines are [for] children five and under. I totally understand and appreciate how important it is to evaluate safety and efficacy. That's of huge concern in America. But I'm hearing all the time from parents and caregivers in Maine and also around the country who are just really frustrated and feeling left behind.

Any further delays that continue, these children will enter yet another school year unvaccinated. Can you commit to us that reviewing any potential authorization for a vaccine covering children under five will happen as quickly as possible? And what timeline can we reasonably expect and tell people you will follow once an application is received?

Commissioner Califf

I'll answer quickly, you know, I've been involved in children's therapeutics my whole career, and one of the major lessons is that children are not just small adults.

And so you have to do specific studies for the biology and the size and mechanics of how children dispose of ... therapeutic interventions. Having said that, we now have the Moderna application in hand as you know, as soon as we're ready, which is imminent, we have a number of dates reserved for the advisory committee meetings. So as soon as we're ready, we'll have that meeting and have the advisory committee weigh in on whether the safety and efficacy are adequate. And there are others. The Pfizer application should be coming in sometime soon also. So I'm definitely committed as quickly as possible. I have two grandchildren under age five, so I'm very much in the same boat that's being described.

CP

So there were some talk for a while that the FDA would wait until the Pfizer application was in, which seems really unthinkable not to move forward as quickly as possible.

But just for some level of efficiency or I don't know what the rationale was. Can you commit that that is not going to happen?

CC

There is no delay in the Moderna application because of another application. Each one will be considered on its own. And I don't need to tell you that sometimes discussions that are held as you're developing a strategy get touted as if that's a decision that's actually been made.

That was never the case. And I want to refute that from the beginning.

CP

Well, thank you for, for setting that straight and and for moving with all appropriate speed. Obviously, that's a critical age group. And those are you know, they have different, you know, bodies and, you know, needs. So I do want to be as safe as possible.

But, you know, congratulations to you on having two grandchildren under five. I have four grandchildren under five. And, you know, again, we hear this from mothers and caregivers all the time. So thank you for the work that you've been doing. And really, please continue this conversation about food safety and the huge difficulties that people are having today.

That's really very important to the oversight of this committee. Mr. Chair, I yield back.

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