In our wide-ranging Q&A, Dr. Makary outlines his vision, addresses low morale, asserts his independence, explains his stance on Novavax, and says "no" to an agency reorganization.
STAT news reported today that Markary very possibly doesn't intend to approve updated mRNA covid shots for the fall— with this roadblock to Novavax approval how does he ignore the science that there have been at least 13,000 covid deaths in 2025?
Additionally, he's not expressing strong support for MMR vaccine--that would tend to contradict his statements in your interview.
He's allowed political appointees to be involved with ACIP
"It’s unclear whether the FDA will hold a vaccine advisory committee meeting on Covid-19 strains, an agency official who was not authorized to speak publicly told STAT, as HHS has not given the go-ahead."
The question of annual boosters is not up to Makary or the FDA but the CDC. I believe they will recommend boosters for high risk people (possibly twice per year) and that others "may" receive it. The evidence for that approach is reasonable. The FDA can't revoke the full approval of Pfizer and Moderna without creating a total scandal, so I don't see that happening. Novavax is a different story because it remains under emergency use authorization. In tomorrow's Inside Medicine, I'll explain a bit more on why I think Marty's view on the Novavax vaccine approval is problematic.
The issue that the FDA does control is over what strains to use for annual Covid shots. I'll ask around on how this would work if they fail to make a recommendation, but it may just be that we outsource this and use the recs of other nations (which is not optimal, in my view, since we have great people here).
Voting members of ACIP so far remains unchanged, thankfully. As I wrote last week, FDA sent their representative to the meeting and it was a little...weird. But it did not have an effect on voting.
I don't trust Makary with a 10 foot pole. According to Politico, His first official act after being quietly sworn in, was to fire Peter Marks (the top vaccine official), of course with Kennedy's backing. Now he's saying that Novavax is trying to get approval for an "entirely new drug", which is patently false. He claims to not want the influence of industry, yet he is greatly under the influence of politics under Kennedy and in his admitted collaboration with DOGE. My take from your interview with him: he's a real smooth talker, and dangerous.
I asked Moderna about boosters and they replied that they need FDA approval and then hope for CDC recommendations, so FDA approval is essential
I'll put Katelyn Jetelina's post from today--if Markary insists on full clinical trials to provide FDA approval of new boosters, they will not be available: "And until we get clarity, it’s unclear whether updated Covid vaccines will be available this fall—or if they’ll be delayed by shifting expectations and new rules."
It's very simple. The anti-vax types at HHS, CDC, and FDA will continually move the goalposts with regards to vaccines and testing. It'll always be the bull(censored) of another test is needed. It's an effective ban on vaccines without calling it a ban.
They ignore the deaths because chronic diseases are all they're interested in!! RFK Jr wrote a whole book trashing Dr Fauci, took down a poster of Fauci after working over 50 YEARS at the NIH, Dr Bhatt. trashed Fauci/others while sitting in the Oval Office with his Great Barrington Declaration to just let Covid rip for the younger, healthier however that's defined. I could go on... but get the point they won't push any Covid vaxes or really any preparedness for upcoming outbreaks which will happen. It's only when not if.
What troubles me is the tone. If they don't agree with something, they should reach across the divide and discuss it. They claim they were victims of being silenced (which I really don't think is accurate). But now that they are in control, they are doing petty things like taking down paintings of Tony and putting up fan service on the white house website that makes the pandemic look like the fault of Tony and Andrew Cuomo. Transparently cynical, in my view.
Yep just wait.......you think Covid 19 vax uptake was low this past year or two just wait. And how much will the pharma comps invest in Covid 19 vaxes whether the older vaxes or any new Covid vax hum? They aren't going to have a lot just sitting getting older on shelves or in refigs. They know the messaging even now.
Haven't even touched on global health & cooperation. The US is out of WHO or however the process works to get out of WHO. Think the global south will get much help from the US not just with Covid but other outbreaks like Ebola, Mpox, AIDS with PEPFAR who knows what happens with it.
ACIP's recs for 2025-2026 may end up being similar to countries (which recommend boosters for high risk people). The question of which strain to use and who is high risk is one that we need our scientists to weigh in on. I hope they do.
Per Moderna and my health department, they need FDA approval of a 2025-2026 updated shot prior to being able to create and market it. And if Markary insists on clinical trials rather than the strain rule, the new booster will not be approved. That's my understanding of the process.
Katelyn Jetelina just wrote about it today: "And until we get clarity, it’s unclear whether updated Covid vaccines will be available this fall—or if they’ll be delayed by shifting expectations and new rules."
I value your reporting-was an early subscriber. I almost stopped reading this interview when he touted the accomplishment of removing food dyes, but I continued reading and became even more frightened about the future of public health -or should I say the dismal future of public heath.
Thank you for supporting all of this. These interviews are a challenge because I want to get the views out there, regardless of whether I agree with every thing said, and I push back when possible. The point of this is to document what is happening and keep leaders accountable. So, we need voices like yours speaking out when there's a disconnect, like you've pointed out.
I do support you and appreciate what you are doing—I will never forget your interview with the head (I think I’m right in that title) of USAID—a tragedy. Thank you for keeping us informed—especially on critical matters of public health.
I guess I have to admit I am skeptical of any person agreeing to work for a wholly unqualified and in my opinion dangerous Secretary. Thus my response.
Here's the summary from STAT--links can be tedious:
"Approval process for Covid boosters thrown into question
Earlier this month, the FDA delayed a decision on whether to grant full approval to Novavax’s Covid-19 vaccine, and over the weekend comments by FDA Commissioner Marty Makary and an HHS official suggested that the annual process for approving updates for Covid boosters might require manufacturers — possibly including Pfizer and Moderna as well — to undertake new effectiveness studies.
By the time such studies are completed, say infectious disease experts, it would be too late to get the vaccine out. “It makes no sense at all,” said Michael Osterholm, director of the University of Minnesota’s Center for Infectious Disease Research and Policy. “Unfortunately we’ve got a combination of government scientists and public relations people who don’t understand what they don’t understand. And this is potentially a very dangerous concern.”
Manufacturers of Covid vaccines need to regularly update the strains their vaccines target, just as they do with annual flu shots, and the FDA’s strain change rule has allowed these updates in the absence of additional effectiveness studies. Read Helen Branswell’s story to learn more."
STAT news reported today that Markary very possibly doesn't intend to approve updated mRNA covid shots for the fall— with this roadblock to Novavax approval how does he ignore the science that there have been at least 13,000 covid deaths in 2025?
Additionally, he's not expressing strong support for MMR vaccine--that would tend to contradict his statements in your interview.
He's allowed political appointees to be involved with ACIP
"It’s unclear whether the FDA will hold a vaccine advisory committee meeting on Covid-19 strains, an agency official who was not authorized to speak publicly told STAT, as HHS has not given the go-ahead."
https://www.statnews.com/2025/04/29/fda-vaccine-criticism-seeping-into-official-policy-rfk-jr-marty-makary/
https://www.nbcnews.com/health/health-news/fda-appears-slow-walking-vaccine-approvals-rcna202596
The question of annual boosters is not up to Makary or the FDA but the CDC. I believe they will recommend boosters for high risk people (possibly twice per year) and that others "may" receive it. The evidence for that approach is reasonable. The FDA can't revoke the full approval of Pfizer and Moderna without creating a total scandal, so I don't see that happening. Novavax is a different story because it remains under emergency use authorization. In tomorrow's Inside Medicine, I'll explain a bit more on why I think Marty's view on the Novavax vaccine approval is problematic.
The issue that the FDA does control is over what strains to use for annual Covid shots. I'll ask around on how this would work if they fail to make a recommendation, but it may just be that we outsource this and use the recs of other nations (which is not optimal, in my view, since we have great people here).
Voting members of ACIP so far remains unchanged, thankfully. As I wrote last week, FDA sent their representative to the meeting and it was a little...weird. But it did not have an effect on voting.
I don't trust Makary with a 10 foot pole. According to Politico, His first official act after being quietly sworn in, was to fire Peter Marks (the top vaccine official), of course with Kennedy's backing. Now he's saying that Novavax is trying to get approval for an "entirely new drug", which is patently false. He claims to not want the influence of industry, yet he is greatly under the influence of politics under Kennedy and in his admitted collaboration with DOGE. My take from your interview with him: he's a real smooth talker, and dangerous.
I asked Moderna about boosters and they replied that they need FDA approval and then hope for CDC recommendations, so FDA approval is essential
I'll put Katelyn Jetelina's post from today--if Markary insists on full clinical trials to provide FDA approval of new boosters, they will not be available: "And until we get clarity, it’s unclear whether updated Covid vaccines will be available this fall—or if they’ll be delayed by shifting expectations and new rules."
https://www.statnews.com/2025/04/27/fda-covid-vaccine-approval-process-novavax-pfizer-moderna/
It's very simple. The anti-vax types at HHS, CDC, and FDA will continually move the goalposts with regards to vaccines and testing. It'll always be the bull(censored) of another test is needed. It's an effective ban on vaccines without calling it a ban.
They ignore the deaths because chronic diseases are all they're interested in!! RFK Jr wrote a whole book trashing Dr Fauci, took down a poster of Fauci after working over 50 YEARS at the NIH, Dr Bhatt. trashed Fauci/others while sitting in the Oval Office with his Great Barrington Declaration to just let Covid rip for the younger, healthier however that's defined. I could go on... but get the point they won't push any Covid vaxes or really any preparedness for upcoming outbreaks which will happen. It's only when not if.
What troubles me is the tone. If they don't agree with something, they should reach across the divide and discuss it. They claim they were victims of being silenced (which I really don't think is accurate). But now that they are in control, they are doing petty things like taking down paintings of Tony and putting up fan service on the white house website that makes the pandemic look like the fault of Tony and Andrew Cuomo. Transparently cynical, in my view.
Yep just wait.......you think Covid 19 vax uptake was low this past year or two just wait. And how much will the pharma comps invest in Covid 19 vaxes whether the older vaxes or any new Covid vax hum? They aren't going to have a lot just sitting getting older on shelves or in refigs. They know the messaging even now.
Other countries will still want the updated shots as the US will be an outlier--and Moderna is based in the US.
Way to kill public health by "following the science". Oh, and kill people too.
Haven't even touched on global health & cooperation. The US is out of WHO or however the process works to get out of WHO. Think the global south will get much help from the US not just with Covid but other outbreaks like Ebola, Mpox, AIDS with PEPFAR who knows what happens with it.
ACIP's recs for 2025-2026 may end up being similar to countries (which recommend boosters for high risk people). The question of which strain to use and who is high risk is one that we need our scientists to weigh in on. I hope they do.
Per Moderna and my health department, they need FDA approval of a 2025-2026 updated shot prior to being able to create and market it. And if Markary insists on clinical trials rather than the strain rule, the new booster will not be approved. That's my understanding of the process.
Katelyn Jetelina just wrote about it today: "And until we get clarity, it’s unclear whether updated Covid vaccines will be available this fall—or if they’ll be delayed by shifting expectations and new rules."
https://www.statnews.com/2025/04/27/fda-covid-vaccine-approval-process-novavax-pfizer-moderna/
I value your reporting-was an early subscriber. I almost stopped reading this interview when he touted the accomplishment of removing food dyes, but I continued reading and became even more frightened about the future of public health -or should I say the dismal future of public heath.
Thank you for supporting all of this. These interviews are a challenge because I want to get the views out there, regardless of whether I agree with every thing said, and I push back when possible. The point of this is to document what is happening and keep leaders accountable. So, we need voices like yours speaking out when there's a disconnect, like you've pointed out.
I do support you and appreciate what you are doing—I will never forget your interview with the head (I think I’m right in that title) of USAID—a tragedy. Thank you for keeping us informed—especially on critical matters of public health.
I guess I have to admit I am skeptical of any person agreeing to work for a wholly unqualified and in my opinion dangerous Secretary. Thus my response.
Here's the summary from STAT--links can be tedious:
"Approval process for Covid boosters thrown into question
Earlier this month, the FDA delayed a decision on whether to grant full approval to Novavax’s Covid-19 vaccine, and over the weekend comments by FDA Commissioner Marty Makary and an HHS official suggested that the annual process for approving updates for Covid boosters might require manufacturers — possibly including Pfizer and Moderna as well — to undertake new effectiveness studies.
By the time such studies are completed, say infectious disease experts, it would be too late to get the vaccine out. “It makes no sense at all,” said Michael Osterholm, director of the University of Minnesota’s Center for Infectious Disease Research and Policy. “Unfortunately we’ve got a combination of government scientists and public relations people who don’t understand what they don’t understand. And this is potentially a very dangerous concern.”
Manufacturers of Covid vaccines need to regularly update the strains their vaccines target, just as they do with annual flu shots, and the FDA’s strain change rule has allowed these updates in the absence of additional effectiveness studies. Read Helen Branswell’s story to learn more."