The Trump administration on Tuesday bypassed the traditional system of vaccine guidance and abruptly ended the government’s recommendation that two key groups of Americans receive vaccinations against Covid.Apoorva Mandavilli, a science and global health reporter at The New York Times, discusses what could be a turning point in public health.Guest: Apoorva Mandavilli, a science and global health reporter at The New York Times.Background reading: Health Secretary Robert F. Kennedy Jr. said that there was no clinical data to support additional Covid shots for healthy children.For more information on today’s episode, visit nytimes.com/thedaily. Transcripts of each episode will be made available by the next workday. Photo: Frederic J. Brown/Agence France-Presse — Getty Images Unlock full access to New York Times podcasts and explore everything from politics to pop culture. Subscribe today at nytimes.com/podcasts or on Apple Podcasts and Spotify.
Chapter 1: What announcement did Robert F. Kennedy Jr. make about COVID vaccines?
Hi, everybody. I'm Robert F. Kennedy, Jr., your HHS secretary, and I'm here today with NIH Director Dr. J.P.
So, Tuesday morning, Robert F. Kennedy, Jr., our health secretary, dropped this very big piece of news via a tweet.
I couldn't be more pleased to announce that as of today... He said that he couldn't be more pleased, those are his words, that he was announcing... The COVID vaccine for healthy children and healthy pregnant women... has been removed from the CDC recommended immunization schedule.
That the CDC's immunization schedule, which recommends who should get shots and when, would no longer include COVID shots for healthy kids and healthy pregnant women.
Last year, the Biden administration urged healthy children to get yet another COVID shot despite the lack of any clinical data. to support the repeat booster strategy in children.
And he went out of his way to say, you know, the Biden administration has been recommending this shot and there's no clinical data to support its use.
We're now one step closer to realizing President Trump's promise to make America healthy again.
Produced by the U.S. Department of Health and Human Services.
It was essentially this very short announcement of a very, very big public health policy. And I think people are extremely confused. The experts I've talked to even are very confused about what this means in terms of access, if people want to get the shot. And they're also very confused about the process because this is not how the FDA normally delivers policy announcements.
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Chapter 2: How has the CDC's recommendation for COVID vaccines changed?
And I will say it is consistent with what a lot of other countries have decided, that they don't necessarily need to recommend vaccines to healthy kids. Even the World Health Organization says kids don't need to get a shot of COVID vaccine unless they have another serious condition. So that part is not entirely unusual.
What is really unclear and surprising, if it's true, is that they don't seem to be making a distinction for kids who have never been vaccinated for COVID. Those are the kids who would be at most risk from the disease. We know that kids under two tend to be really vulnerable. And they did not seem to make an exception for kids who might need to get this for the first time.
Chapter 3: What are the implications of the CDC's updated vaccine guidelines?
Let me just make sure I understand. The new guidelines... do not distinguish between a first-time vaccine and boosters, you're saying?
It seems so. Again, I'm saying it seems so because there was not enough detail in that video announcement to be clear, and they have not responded to questions to clarify that. But at the moment, yeah, it looks like they are saying no COVID vaccine for healthy kids, regardless of whether they've had any shots previously.
And why does that first vaccine matter? Relative to a booster, which I'm guessing matters potentially a little bit less.
It matters because we know that kids under two are the most vulnerable to COVID. When you look at the hospitalization numbers for very young kids, they're on par with the hospitalizations for older adults, if you look at 65 plus. And so that... age group is at risk.
And, you know, the vaccine is not approved for kids under six months, but those kids might be protected from their mothers getting vaccinated when pregnant.
So this age group of between six months and two years, some pediatricians say it's like very important for that age group for their first exposure to COVID to be through this vaccine and not to the virus itself, because that could be really dangerous for them.
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Chapter 4: Why has the recommendation against COVID vaccines for healthy children been made?
Got it. And why would the CDC suddenly not recommend that first, I guess some people call it primary vaccination against COVID for a child? I know you're saying that they might later clarify, but if the thinking right now is that they're not recommending that, why wouldn't they recommend that?
Well, I think the people who are in charge now, and that's, you know, RFK Jr., but also Marty Makary, who heads the FDA, and Bina Prasad, who now heads the vaccine and drug approval process at the FDA, they have all been quite clear that they don't think that COVID vaccines are necessary for kids. And actually, in May 2021, when COVID was still a huge issue, RFK Jr.
filed a petition with the FDA demanding that the agency rescind its authorization for the shots. And then the next year, he also tried to stop them from proving the shots for children. So we know he's not a fan of this vaccine for kids.
And is there any risk to those very young kids from getting the vaccine that we have learned about since the vaccine was authorized that might lie behind this new recommendation?
I don't think so. You know, there are millions and millions of kids all over the world have gotten this vaccine. And I've talked to FDA officials before. I've talked to vaccine safety people at the European Medicines Agency and the CDC. And all of the studies show the vaccine to be pretty safe in kids. There is that risk of heart problems in boys above a certain age of 12.
But really, in the age group of kids that we're talking about here who are at high risk from COVID, there have not been any safety concerns that I'm aware of.
So the argument would simply seem to be that it's not helping enough people to be worth children getting this vaccine, and the risk isn't high enough. So why do it? Correct. So what's going to happen to a parent who wants to give their kid a vaccine for all the reasons you just suggested?
They're going to go to their pediatrician, presumably, and say, I know that recommendation has changed, but I would still like my kid to get this vaccine. What is going to be the likely response?
Well, it's very important to remember that they did leave the door open for kids with other health conditions. So a lot depends on that kid's health status. If the pediatrician feels the kid is healthy and agrees with the FDA, it's a good chance the parent is not going to be able to get the shot.
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Chapter 5: What is the rationale for not recommending COVID vaccines for pregnant women?
The other possibility is that he kind of just hijacked the process and took it upon himself to issue recommendations that would normally go through a careful, considered process filled with medical expertise.
I mean, it would seem he did hijack the process in a way because... There was really no reason to do it in quite this way that I can see or that any of the experts I've talked to can see. Because really, we have been headed in this direction anyway. Advisors to the CDC have been talking about not having healthy kids get the COVID shot.
So in June, they were going to meet and vote on this exact issue. If at that point they didn't do the thing he wanted, he could still have overruled them. But to not even allow that discussion to happen, to not even allow those data to be public and discussed, that seems really strange to me.
Well, let me challenge you on that. I mean, so far in this administration, is that so strange? It is a presidency where decision-making is extremely centralized in a small group of people who make decisions sometimes not based entirely on a formal process, sometimes on instinct, but with a fair amount of confidence in the rightness of what they're doing.
That's a fair point. You could say this is standard for parts of the Trump administration, at least. And that's certainly how RFK Jr. has acted, even with things like cuts to federal agencies and getting rid of entire departments within those agencies. But the problem here is that the stakes are just very high.
You know, when you look at an agency like the FDA or like the CDC, its credibility, its integrity is really, really heavily dependent on this kind of process. It's very important for people to be able to see what led to the decisions. It's very important for companies to know that, because if you do this kind of decision making that seems arbitrary and, you Don't show your work.
The companies may just take their products elsewhere. We don't know what will happen with other drugs and vaccines. It just opens the door to a lot of uncertainty about health, which is a very, very important part of our lives. And so the stakes, I think, being so high makes it very important that this not be treated like any other part of what the Trump administration does.
I'm curious if you think there's going to be meaningful opposition to these new recommendations, especially given the process that you just outlined and the process that was bypassed. Could this produce lawsuits? Could this produce medical establishments issuing contrary recommendations to the federal government, which in theory could create a whole lot of confusion?
There's an absolute possibility of lawsuits and I've already heard rumblings about it. I mean, there's a process that legally they're required to do. And when they skip those steps, it does open it up to the companies, for example, could sue saying that their products are now unfairly being limited to only some populations, even though there's no safety data indicating that to be a problem.
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Chapter 6: How will this change affect newborns in terms of COVID protection?
You know, there are individuals and organizations that could sue because they now can't access the vaccine when they want to. And they could similarly argue that there are no safety reasons for them not to have the vaccine. And so there are lots of different ways this could go.
And there are already efforts to have, you know, statements that clarify where the majority of the medical or public health establishment falls. So, for example, there's now a vaccine integrity project, which is a bunch of experts who have banded together to offer what they think of as the more sane science-based stance on vaccines.
And you're right that when you have all those kinds of dissenting voices, it does create confusion. But what's really clear is when the government puts its weight behind one decision or another, it creates a lot of mistrust for the average person.
Mm-hmm. Well, let's talk about that. Vaccine use in this country is way, way down. You've talked about that on the show before. I'm curious what you suspect is going to happen as a result of these recommendations with COVID vaccine uptake and, more broadly, vaccine uptake.
Well, we've seen with other vaccines, for example, with measles, that when there is sort of public discussion about their concerns about safety that are unfounded or questions raised about how long they're effective, it does have an impact on people's willingness to go get the vaccine. And we're in the midst of multiple measles outbreaks in this country right now.
So when you damage public trust in vaccines, it's very easy to create those doubts and it takes forever to regain the trust.
Right.
But now with COVID, we could be facing a more immediate problem because... Last week, I mean, forget about this recommendation about what's included in the immunization schedule. Last week, the FDA said that they may not even approve COVID vaccines at all for anybody who is not 65 plus or doesn't have some kind of underlying health condition.
And so what that means is, it's not just a question of whether it'll be covered by insurance and whether it'll be easily available. If we had a new COVID variant come through that was... and we are actually hearing some rumblings from Asia that there's a worrisome new variant around, we would have entire populations of people who are not eligible for the vaccine at all.
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