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From the New York Times, I'm Michael Bobaro.
This is The Daily. On Tuesday, the Trump administration bypassed the traditional system of vaccine guidance and abruptly ended the government's recommendation that two key groups of Americans get vaccinated against COVID.
Today, my colleague Apurva Mandavili, on what could be a turning point moment in public health.
It's Wednesday, May 28.
Poor Vuk, we just got some very big public health news here in the United States in the form of this video that came out on Tuesday.
Hi, everybody. I'm Robert F.
Kennedy, Jr., your HHS secretary, and I'm here today with— 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, and that We're now one step closer to realizing President Trump's promise to make America healthy again.
Produced by the US 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.
They don't just post it on Twitter.
There's a whole protocol with many, many, many, many steps before they arrive at something like this.
Some of those quite important.
And none of that happened here.
All right, well, we're going to get to all the ways in which this process was singular, exceptional, unusual.
I think to put it all into context as a public health guideline, we should begin by understanding what has been the government's recommendation for COVID vaccines up until now, when obviously it just changed.
So up until now the CDC has recommended Covid shots for everybody six months and older.
So any child regardless of health status, any adult, pregnant women, older adults, everybody.
And the idea was that the benefit from the vaccines even if it has been dwindling still outweighs any risk from the vaccine and certainly is very important given the risk of COVID.
And so that's where the CDC has been pretty much since these shots were available to those groups of people.
Got it. So this is the biggest by far change in the government's guidelines, pretty much since the vaccine became widely available.
Correct. And what does it mean for the U .S. government to stop recommending a vaccine for a particular group?
Practically speaking, like what actually changes?
Generally speaking, what it means is when the CDC's advisors recommend a vaccine, that's when insurance companies are required to cover it.
So if a vaccine falls off the CDC's recommended immunization schedule, insurance companies are highly unlikely to cover it unless they make the decision that somebody getting sick from COVID will cost them more money.
So there's a possibility they could still cover it.
But, practically speaking, what it does mean is that low income families may not be able to get the shot.
There are a lot of practical hurdles that not having the CDC's stamp of approval on something like this means in the real world, especially in our healthcare system.
Got it. Well, let's talk about these two categories of people who are now being told that they do not need this vaccine.
And from everything you've just said we'll now probably have a harder time getting it if they wanted it.
And let's begin with healthy children and why the government is saying healthy children should not necessarily be getting the COVID vaccine any longer.
What's the thinking there?
The thinking there is that we have seen decreasing numbers of severely ill children, hospitalizations, deaths from COVID.
It's not zero. I will say that the number of kids who have died from COVID is on par with what happens in an average flu season.
So there are still some children dying from COVID.
But what the government is saying is that we don't think that those numbers are high enough and we don't think this is risk enough that we should be getting healthy children to get the shot.
Now their thinking is that only children who have another medical condition that puts them at severe risk are going to end up in the hospital.
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.
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.
Got it. And why would the CDC suddenly not recommend that first, I guess some people call it primary vaccination against COVID, for a trial?
And I know you're saying that they might later clarify, but if they're 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 Makari, who heads the FDA and Binat 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 approving 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, 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, above 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 their risk isn't high enough.
So why do it? So what's gonna happen to a parent who wants to give their kid a vaccine, for all the reasons you just suggested?
They're gonna 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 gonna be able to get the shot.
But if the kid does have asthma or is obese or has juvenile diabetes, then they might still be able to get the shot from their pediatrician and not have to travel too far to get it from some place that offers it.
The problem is when you start putting in these kinds of limitations on the eligibility, the availability of the vaccine just naturally goes down.
The number of pediatricians who carry it, the number of pharmacies who carry it all starts to go down, so it just becomes harder for people to get it.
Mm -hmm. Hard, not impossible, but hard. Let's turn to pregnant women.
What do we understand motivated this change in recommendations?
This one was a lot more unexpected and really quite confusing.
There's a lot of data saying that pregnant women are at a much higher risk of COVID than non -pregnant women of the same age.
So it's not clear why they suddenly have taken off their recommendation.
Can you remind us why that is?
There are a lot of studies showing that pregnant women when they get COVID, they have a higher risk of miscarriage and stillbirth.
They can develop preeclampsia, they have a higher risk of hospitalization, they're at higher risk of dying, and we've seen that from the very beginning, from the early days of COVID.
And so there was actually a real sort of urgency to get the vaccines approved for pregnant women.
You had suggested earlier that children under the age of six months who have never been eligible for a COVID vaccine have acquired immunity from their moms getting the vaccine, I suppose in utero, essentially right.
So what now do we think happens if that recommendation is gone to babies between the ages of birth and six months old?
Yeah, it's a very scary proposition in some ways because those babies are actually at the highest risk from COVID.
And one of the reasons for vaccinating pregnant women is to protect those babies passively.
You vaccinate the mother and the antibodies go through to the fetus and then the baby's protected for maybe the first few months of life until six months when the baby can get its own vaccine.
And so to not have that protection really puts those newborns at risk of COVID and their airways are not well -developed, so a respiratory infection in a newborn is a pretty big deal.
And so this policy is going to leave newborns open to COVID.
What has been the reaction from the doctors who treat pregnant women?
They are so worried and the, you know, the experts have talked to have said they're very disappointed.
The American College of Obstetricians and Gynecologists said it's really unhappy about this decision.
You know, I also spoke to somebody who regulates vaccines for the European Union, and he said, you know, he could sort of get behind the kids' decision.
He could see that maybe not all healthy kids need the vaccine, but that it was still really important to vaccinate pregnant women.
So that part of this announcement, saying healthy pregnant women shouldn't get the vaccine anymore.
That's really thrown a lot of experts for a loop and they're quite angry about it because the data that they're familiar with says that there is a benefit and that kids should continue to get the vaccine and pregnant women especially should continue to get the vaccine.
And so they're left wondering if this is not based on science at all and if it's politically motivated.
And that makes them very nervous about what else is going to get caught up in this kind of decision -making.
We'll be right back.
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Opover, you started to hint at this at the beginning of our conversation, but I think we really need to understand how Robert F.
Kennedy Jr. and the Trump administration went around the normal procedures for announcing a change like this of this scale.
OK, so just let me geek out a little bit on how the process normally works.
Usually when you have a vaccine, the FDA will look at all of the data on its safety and effectiveness that the companies present, and its advisors talk about the vaccine.
And then the FDA makes a decision.
It says, OK, the vaccine is safe and effective and it approves it or not.
Let's say it approves the vaccine, then there are scientific advisors to the CDC who are more clinical or more sort of on the medical side where doctors, they will look at all of the data and they talk about it all and then they make a recommendation on who should get the vaccine that the FDA has said is safe and effective.
So they make the clinical decisions of who should get the vaccine, when they should get it, should they get it with other shots, or should they get it by itself, et cetera.
So that's a series of steps and eventually ends with the CDC director accepting or modifying what the CDC advisor said and then it becomes sort of official recommendation.
CDC does not make rules or laws, it just makes recommendations and then the states can decide what they do with those recommendations and it's the states that decide, okay, if a kid wants to enter kindergarten, these are all the vaccines that the kid who lives in the state must have had.
and right now for COVID, there are no states that mandate the vaccine.
Let's just get that out there.
So we're just talking about recommendations right now.
And in this case, what has happened is that the HHS secretary, RFK Jr., has just made an announcement about what's going to happen without having gone through any of those previous formal steps where there's lots of discussion, lots of review.
It's all public. It's all documented, and anybody can listen in and watch and look at the presentations and see the data.
Right, a kind of a case is made, data is assembled, votes are taken kind of thing.
Exactly, exactly. The fact that RFK Jr. did this would seem to raise two possibilities.
The first is that he and those around him decided that all of this was inevitable, that government recommendations for COVID vaccines, were going to get less and less strict over time and that he just wants to circumvent the process to get it there.
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 Junior 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, it's credibility, it's 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 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, but does not be treated like any other part of what the Trump administration does.
But Porf, 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, Kudsu 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.
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.
So there are lots of different ways this could go.
And there are already efforts to have 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.
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, you know, when there is sort of public discussion about their concerns about safety that are unfounded or questions raised about you know 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 will be easily available if we had a new COVID variant come through that was dangerous, 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.
So in a world where COVID returns with a vengeance, which could happen, it might not happen, under this administration, the lack of government recommendations for vaccines especially for healthy children, pregnant women means more people are going to be vulnerable.
And potentially the lack of approval for the vaccines means fewer doses of vaccine at the ready.
That's the situation.
Yeah, that's the situation and, you know, it's not as if people are clamoring to get the shots.
I mean, the COVID shot that was offered last fall, only about 13 % of kids got it and about 14 % of pregnant women.
But the difference is that the choice was there if somebody felt like they needed the vaccine for whatever reason, they could go get it.
Again, other countries have stopped recommending kids get the COVID vaccine.
But in those countries, the vaccine is still approved for kids.
So if the situation were to change dramatically, they could still get it.
What we're saying in this country is that kids shouldn't get it at all.
Well, of course, time will tell whether COVID ever returns with real ferocity.
And if it doesn't, this new recommendation might seem to many quite reasonable.
But at the end of the day, it feels like the meaning of what happened on Tuesday is that the Trump administration's overall approach to vaccines, putting less emphasis on them, questioning whether they have been too widely recommended.
That is now official government policy.
And I was struck, and I wonder if you were, Apoorva, by the very last line of the video that was put out on Tuesday.
And the quote was that ending the existing recommendations for children, for pregnant women, brings the United States, quote, one step closer to realizing President Trump's promise to make America healthy again.
And it felt notable that the government's health agencies were articulating this idea that not getting a vaccine was part of making America healthy again.
I think it's going to be very hard for them to argue that pregnant women who are at high risk of COVID are somehow better off or healthier for not getting a vaccine.
I think there are more solid ground when it comes to kids, but still the implication does seem to be that the vaccine is somehow harming the health of these kids.
And that's very much in keeping with what RFK jr has been saying for a lot of different vaccines, he's falsely accused many vaccines of being unsafe and dangerous.
And it does seem to portend more decisions along these lines that say it's healthier to not get vaccines than it is to get them.
Well, Poorva, thank you very much. Thank you, Michael.
We'll be right back.
We are living in interesting times.
A turning point in history.
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On Tuesday, a federal judge struck down President Trump's executive order seeking to punish the law firm WilmerHale by restricting its access to the federal government.
It was the This is the third time that a judge has ruled that Trump's actions against law firms, including Perkins Coie and Jenner and Block, were unconstitutional.
Those rulings have validated the strategy embraced by some law firms to fight Trump rather than strike deals with him, as many big law firms have done, including Paul Weiss and Skadden Arps.
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Today's episode was produced by Eric Krupke and Asta Chaturvedi.
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