Amna Nawaz:
The U.S. Food and Drug Administration announced recently it will not review Moderna’s mRNA flu vaccine despite late-stage trials showing it was safe and effective.
The rejection of the experimental flu application, at least for now, has many in and outside the industry concerned about the Trump administration’s approach to vaccine development and recommendations. It’s the latest move that reflects Health Secretary Robert F. Kennedy Jr.’s criticism of mRNA technology, which was used by Moderna and Pfizer to combat the coronavirus.
Michael Osterholm is the director of the Center for Infectious Disease Research and Policy at the University of Minnesota, and he joins me now.
Dr. Osterholm, welcome back to the “News Hour.” Thanks for being with us.
Dr. Michael Osterholm, Director, University of Minnesota Center for Infectious Disease Research: Thank you very much.
Amna Nawaz:
So, let’s start with Moderna’s flu vaccine.
For those who don’t follow this very closely, why exactly is this decision causing some concern?
Dr. Michael Osterholm:
Well, first of all, let me just say that the work that was done by Moderna actually was really well done and should have been reviewed. It’s an important step forward to have an mRNA vaccine for influenza.
What happened was, despite the vast majority of the FDA staff supporting it, a single individual, Dr. Prasad, basically decided against approving it coming forward. And this sent chills up the spines of all of us in public health and the vaccine world because it’s so arbitrary.
There was absolutely no basis for which to do this. And this really leaves other manufacturers concerned about what might their future directions be in terms of confusion and recommendations.
Amna Nawaz:
So, just for context here, you mentioned there’s one FDA official who overruled career scientists recommending the review go forward. How often does something like that happen?
Dr. Michael Osterholm:
It rarely happens.
And, more importantly, when it does happen, there’s — the data are presented as to why. There this — there was no data presented, other than to say that they had not tested the vaccine against the basic best vaccine out there, which is one that’s only licensed for those 65 years of age and older.
They actually did test up against the vaccine that the vast majority of Americans in this country received every year. So that’s just an artificial reason for not going forward with this vaccine. And I think the only thing it speaks to is the ideology issue.
We’re now running the science component of public health on ideology, not on facts.
Amna Nawaz:
And so this concern that they raised, you touched on briefly there. The FDA said that it rejected the application because it considered the trials too risky for older Americans. You’re saying those risks are not real or significant.
Dr. Michael Osterholm:
Well, first of all, what could have happened is, if in fact they didn’t have the data for over 65, they could surely license it for those under 65, because that’s the standard vaccine that we are getting in this country. ‘
And so, from that standpoint, that didn’t make any sense. They also did do testing to look at how well their vaccine worked in terms of providing immune response and found that it was superior to the high-dose vaccine. So there just really was no basis for this. There was no prior warning that they were going to apply this new standard that they did to this vaccine.
And this is what’s sending chills up and down the spines of all of us in public health. We don’t know how we’re going to get new vaccines in the future, when they’re so arbitrarily decided upon by the agency.
Amna Nawaz:
You have said that twice now. It’s a powerful statement that it sent chills up and down the spines of those in public health. What are you hearing from those in the world of developing vaccines?
Dr. Michael Osterholm:
Right now, we’re seeing on a global basis a retrenchment in vaccine research and development, because the United States is in fact the 800-pound gorilla in the corner that really drives how vaccines are purchased, how they’re used.
And if in fact you have the U.S. government saying, we’re not even going to review this particular process, why does anybody else want to invest in these? These studies that Moderna did cost millions and millions of dollars to do. And so we’re going to just see, I think, the well dry up on new vaccines.
And that’s a huge challenge right now as we surely need vaccines for our old flu vaccines, for COVID, et cetera. So, again, it just makes no sense whatsoever.
Amna Nawaz:
Can I ask you about what we have already seen with childhood vaccine recommendations, which we covered recently?
Last month, the U.S. took the unprecedented step of reducing the number of vaccines recommended for every child from 17 to 11. They’re basically emphasizing individual doctor-patient decisions, rather than making universal recommendations.
We’re in new territory here, but what could be the impact of this, both short term and long term?
Dr. Michael Osterholm:
Well, the impact has already been felt.
And that is the fact that parents, often in their 20s, with their young children, wanting to do best for their child, is now hearing about this discussion or debate or recommendation that maybe we hold back on vaccines.
Well, when you’re a physician, a nurse practitioner or pharmacist trying to administer these vaccines, you have to try to explain, well, no, really, they still are just as recommended. But they’re really not because the government says they’re not. This kind of confusion just adds to the decreased uptake of these vaccines.
And, in fact, again, the FDA’s position on these vaccines and what came through the ACIP, the Advisory Committee on Immunization Practices, is not based on good science. There’s no science to support any of their recommendations. They just came out and declared that these vaccines would now no longer be standard recommended vaccines.
So, this is dangerous. And to suggest we’re getting too many vaccines, actually, they compared us to Denmark, a country where it’s the lowest level of vaccines per country around the world, including a number of low-income countries. We were right in the middle of the number of vaccine doses a child received.
And there is no scientific basis on top of that to say that these doses are a problem, so, again, smoke and mirrors, sending up a smoke signal of that we will make a decision based on ideology, not on science.
Amna Nawaz:
We now have this Moderna flu vaccine review rejected. You have got this change to the childhood vaccination recommendations. How would you say all of this fits into the broader pattern, both in rhetoric and policy, of what we have seen from the Trump administration?
Dr. Michael Osterholm:
Well, let me just put it in very simple terms for every parent, grandparent today. Children are going to die in this country needlessly, more and more are going to die because of what’s happening here.
These are not harmless policies. These are dangerous policies. And we can’t say that strongly enough. And so I hope parents hear that message, that, in fact, do listen to your physician, listen to your nurse practitioner, listen to your pharmacist. Don’t listen to the federal government, because they are not basing their recommendation on science.
Amna Nawaz:
That is Dr. Michael Osterholm, the Center for Infectious Disease Research and Policy at the University of Minnesota.
Dr. Osterholm, thank you. Good to see you.
Dr. Michael Osterholm:
Thank you. Good to see you. Thank you very much.
