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 scien.. 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.