Paul Mango, an official with the Trump administration, was involved in virtually all aspects of Operation Warp Speed, a public-private partnership.
The federal government’s partnership with industry to develop, manufacture and distribute a coronavirus vaccine in record time could hopefully “be a model for government action going forward,” a top Trump administration official who was involved told Government Executive in an interview. However, he does think communication could have been better on the front end to convey the safety and effectiveness of the vaccines.
Paul Mango served as the deputy chief of staff for the Health and Human Services Department from 2019 to 2021, during which he was the HHS secretary’s formal liaison to Operation Warp Speed, so he was heavily involved in all aspects of the initiative that President Trump announced on May 15, 2020.
“I haven't seen something like that in my lifetime and hopefully it will be a model for government action going forward,” Mango said, of Operation Warp Speed. However, “we could have come out and talked extensively about the [Food and Drug Administration] changing its processes, but not changing its standards, in fact, enhancing its standards for evaluation. In the heat of the moment, we didn't realize this would be such an issue. If we could do it over again, we probably would have done it a little bit differently.”
The Trump administration’s COVID-19 response overall was highly scrutinized and criticized by lawmakers, public health officials, Biden administration officials and others, but even President Biden and then-senior COVID advisor for the Biden White House Andy Slavitt have recognized the work of Operation Warp Speed. Moderna and Johnson & Johnson, among other companies, accepted federal money to help develop and manufacture their vaccines; meanwhile, Pfizer/BioNTech did not, but signed contracts with the government ahead of time to supply their vaccines if proven effective. The Biden administration renamed and reworked the initiative upon coming into office.
Government Executive interviewed Mango––one of several individuals to write a book recently with a personal account of the coronavirus response during the first year of the pandemic––on May 3 about Operation Warp Speed and his take on the Trump administration’s pandemic response. The interview has been edited lightly for length and clarity.
GE: What made “Operation Warp Speed” so unique?
PM: Well, there's a couple of things. It's not any single thing, but I think it was a philosophy at the highest level, which was that the federal government's role in this real national emergency was to enable the private sector, not to substitute for what the private sector could do, so enable the success and let the private sector deliver that success. And I think it was maybe a little bit unusual that the government stayed in its lane and what I mean by its lane is it helped assess some of the financial risk for potential failure, which was very important. It established a clear and concise regulatory framework for the approval of the vaccine, so that everyone knew precisely what they had to do beforehand. It used the Defense Production Act judiciously to realign the supply chain in favor of vaccine production. And then lastly it coordinated the private sector, but again, never substituted its own activities for what the private sector could do better. So, I don't know how unique that is. I would say that I haven't seen something like that in my lifetime and hopefully it will be a model for government action going forward.
GE: In the book you wrote that Operation Warp Speed overrode “normal bureaucratic structures.” Can you talk a little bit about that and how you avoided compromising safety?
PM: Virtually everyone knows there was a thing called the White House Coronavirus Task Force led by Vice President Mike Pence, very capably. But its role was to deliberate and to formulate policy on an interagency basis. For instance, banning flights from China required the Department of Transportation, Department of State and HHS to be involved. [It was a] very important role that the vice president played, but again, it's the deliberative body, sometimes taking weeks to make decisions. We couldn't afford that pace on Operation Warp Speed.
So, what we did was set up a board, which was co-chaired by [HHS] Secretary Alex Azar and [Defense] Secretary Mark Esper because this was effectively a joint venture between the DoD and the Department of Health and Human Services. And we had a direct line of sight into the Oval Office. So, if we really needed a decision made, if we needed more resources, if we needed someone to call one of the company CEOs, we'd go right over to the Oval Office and get the president to do it. He was basically the chairman of the board. And we had two co-chairs, which were Alex Azar and Mark Esper.
You asked a question about safety and I know this was probably one of our failures, which was we didn't, I don't think, aggressively communicate what the [Food and Drug Administration] did and what the FDA didn't do. What the FDA did was reorganize its internal processes and staffing to basically go through the evaluation 24 hours a day, seven days a week. So instead of working eight hours a day, five days a week, we had Peter Marks, down at the FDA, reorganized his staff–great career officials–working around the clock. So, what used to take months took 14 days and that was the pledge.
Now they actually elevated two standards above any prior vaccine that's been evaluated by the FDA. One is, it required a minimum of 30,000 persons in each clinical trial. Johnson and Johnson and Pfizer had over 40,000. A typical vaccine clinical trial phase three would have 20,000. And so more persons going through it to test as you articulated the safety and effectiveness.
The second change that the FDA made was the normal time for an adverse reaction to a vaccine. Kind of the far end of that time would be 42 days. In this case, after someone got a second dose of either Pfizer or Moderna, the FDA extended that to 60 days, just to be sure. So, more persons in the trial, longer interval between the vaccination and looking for adverse events. So, these are some of the safest vaccines ever evaluated by the FDA and some of the most effective at 95%.
GE: So, when you said you think you could have done better to communicate what the FDA was doing, do you think that could have maybe mitigated some of the massive vaccine hesitancy we saw early on?
PM: Yeah, I certainly think it's a little bit ironic that Peter Marks, who was the head of the Center for Biologics Evaluation and Research at the FDA, which is the center that approves vaccines, [is] actually the one–as I described in the book–that came up with the term ‘Operation Warp Speed.’ So, it was to convey a sense of urgency that the federal government, along with the private sector, was working on behalf of the American people at a time when hundreds, if not thousands, of Americans were dying of this virus.
In retrospect, a lot of folks who were not as close to it said, ‘Gosh it makes it sound like the government might be cutting corners you know and going too fast and these vaccines might not be safe.’ So, we could have come out and talked extensively about the FDA changing its processes, but not changing its standards, in fact, enhancing its standards for evaluation. In the heat of the moment, we didn't realize this would be such an issue. If we could do it over again, we probably would have done it a little bit differently.
GE: In your book you describe the role of the Justice Department in the distribution of vaccines. Can you explain that?
PM: Well, the Justice Department played a very important role, which was basically to adjudicate for us the potential for what are normally competitors to collaborate. So, there was a tremendous shortage of vaccine manufacturing capacity when this virus broke out in the United States. And what we needed to make sure of was that if there was excess capacity that one manufacturer had that wasn't going to use it, we needed to make sure we could get those two manufacturers to collaborate in a way where those who did have a good vaccine, could produce more vaccines. So, the Department of Justice stepped in and issued an opinion that said you can collaborate, you can exchange technologies, you can use each other's factories, you can discuss everything except one thing, which was price. So, you couldn't talk about the price of raw materials that you were acquiring. You couldn't talk about how you were going to price the vaccine. But everything else was inbounds. And that really helped us because it liberated our partners, our private sector partners, from the fear potentially of antitrust behavior or getting sued, something like that. So, it was very, very helpful.
GE: Talking about the White House Coronavirus Task Force and all the people who were involved with Operation Warp Speed, how did everyone work together? Were there any tensions? Obviously, you were under a lot of scrutiny and media attention, so how did things work internally?
PM: Well, there were actually quite a few tensions and that's not a bad thing. We did not want to inhibit very deep and broad discussion about what was the right thing to do. And scientifically, there were disagreements over which technology platforms, meaning vaccine technology development platforms, we should invest in. There were tensions over how much we should use the public sector and the public health infrastructure versus the private sector. Pretty strong tensions there. And then quite honestly, there were tensions between the team, the Operation Warp Speed team, and some of the manufacturers–in particular Pfizer. So, I write in the book that these tensions never really went away. We just overcame them. There was a lot of resilience on the team. A lot of, I think, very strong insights into what would be better for the American people. I think given the results we made the right decisions.
GE: Now in determining which vaccines or therapies to invest in, did you have a set criteria? Was it on a case-by-case basis that you judged things?
PM: There were close to 100 vaccine candidates in the spring of 2020 that the private sector mobilized very quickly. In retrospect, there's probably a little bit of a horse race. They knew the governments around the world were going to support certain vaccines and they wanted to get in the ‘pole position’ so to speak. But we had three criteria that we thought were very important. Is this a company that has the resources to get through a phase three clinical trial and does it have experience with the FDA in a way where it knows how to submit data and those types of things? Such that it could get an emergency use authorization before the end of the year of 2020.
The second criteria was: is this a vaccine we believe can be manufactured at scale? Because you could have a great vaccine, but if you can only produce a million doses a year, it quite honestly would not have been useful to us. And then the last criterion was: based on the early trial results, did we think it was going to be effective in those over age 65? Because we knew, even in the summer of 2020, this is a virus that disproportionately affected the elderly, some with underlying health conditions, but not as much the young.
So, we used those criteria and Moncef Slaoui, the chief scientific advisor for Operation Warp Speed, proposed a slate of six vaccine candidates. Two in each of three different technology platforms. So, in August of 2020, we said, ‘That's great Moncef. We're going to trust, but verify here.’ So, what we did was use those three criteria and we talked to a bunch of experts inside and outside the Operation Warp Speed team on an anonymous basis. And we had them evaluate the probabilities of those three criteria that we talked about earlier being met by that vaccine candidate. And on a cumulative basis what it revealed to us even in August of 2020 is that we had about a 75% probability of having at least one safe and effective vaccine manufactured at scale effective in those over age 65 before the end of the year. And of course, we wound up with two and then the third one came very shortly thereafter in February 2021.
GE: You’ve been pretty critical of the Biden administration’s pandemic response, but there were many, many allegations of political interference by Trump political officials in the COVID-19 responses by lawmakers and reports in the media. Also, Dr. Deborah Birx, White House coronavirus task force coordinator under the Trump administration, wrote in her new book that while she gave credit to Operation Warp Speed, there was a disconnect between words and actions in the Trump administration and she had some concerns about how the team handled things. Can I get your response to that?
PM: So, I think on several occasions, I've actually said, I've thought the Biden administration did a fantastic job of taking the ball from us and getting those vaccines out to the American people in record time. So, I do want to give them credit for that. I think where the friction was is that the day they took office, they basically said they had to start from scratch, we had no plan, we left them a mess. And that was a little bit disappointing. Not for me as a political appointee because I know how politics work, but there were hundreds of career officials still working on behalf of the American people in the Biden administration on Operation Warp Speed. And I spoke to several of them afterwards and their morale just plummeted, right? Because their new leaders basically said that they hadn't done anything for the prior 10 months, which couldn't have been farther from the truth. And they were coming in seven days a week, quite honestly. So, they really put out for the American people.
On the political interference, I was in every Oval Office meeting with the president as it related to Operation Warp Speed and never once did he say anything about ‘I need this before the election’ or anything like that. Now, did he want a vaccine as soon as possible? Of course, he did. He knew Americans were dying every day and he always volunteered, ‘Do you need more resources? Do you need my help? Whatever you need from me, I'll do it.’ Interestingly, he was actually... more interested in therapeutics than the vaccines. Every meeting we had with him, he'd ask about therapeutics and say, ‘Listen, vaccines are never perfect, there's going to be some people who get vaccinated who aren't going to be immune. So, I think what American people want to know is if they get into the hospital, is there a cure for this?’ And you fast forward a year and that, that was the biggest issue. And fortunately, we have Pfizer with Paxlovid and we have molnupiravir. So, we have some really good therapeutics out there that are helping.
But I think probably in both administrations, the political interference accusations are a little bit overblown. Certainly, I didn't see it. You know, I know that some people are claiming the Biden administration is now interfering with the career officials. I believe the career officials in the United States government are upstanding, ethical persons who do the right thing. Some of them have resigned if they think they're getting manipulated in any way. So anyway, that would be my perspective. I haven't read Dr. Birx’s book, so I’ll have to. I heard it’s 529 pages, so it sounds like it’s a Homer Odyssey of some sort.
GE: I do want to ask one quick follow-up on the therapeutics note, which is that President Trump did push for hydroxychloroquine, which turned out to be unproven. Do you think it was a problem that he was such a big advocate for it before there were studies saying whether or not it would be effective?
PM: Um, no and here's why: hydroxychloroquine had been around for 50 years. People take it all over the world. It's a prophylactic against malaria and so it had been proven to be safe. Now, was it effective? I think it was proven that it wasn't effective against coronavirus, but remember the FDA originally granted it emergency use authorization and the standard for emergency use authorization is very simple. Given the full weight of the scientific evidence that's available, do the potential benefits of this therapeutic in this case outweigh the potential risks? And the risks of taking hydroxychloroquine are very minor. So, you really didn't in an emergency situation, need to prove too much on the benefits side and the FDA wound up after it had more scientific data, wound up reversing that.
But I mean, when hundreds of persons are dying every day and you find something that is safe, but maybe unproven to be effective, we didn't see the risk as a team, as an Operation Warp Speed team. And you're talking about folks who were sick to start. It isn’t like a vaccine, where are you going to be injecting it into hundreds of millions of healthy persons, where you have to be even more careful. It was really something you'd administer to folks who are sick. So anyway, I mean, we can debate this forever. I'm sure people will, but the FDA adhered to the standards of granting an emergency use authorization. And then when they got more scientific data, they reversed it.
GE: Is there anything else I didn't ask about that you'd want to add?
PM: Well, I think one of the things I bring out in the book, Courtney, is kind of the cast of characters that were in this. And I think for the listeners what they should realize is this was a very unusual group of individuals–by the way, Democrats and Republicans–who came together at a time with a set of complementary skills. That was really just unprecedented. We had Moncef Slaoui, the most successful vaccine developer of our generation, [who] put 14 successful vaccines in the market. We had Carlo De Notaristefani, who is one of the world's leading experts in vaccine manufacturing.
We had the Army Materiel Command, under Gus Perna, who had been supporting combat operations in the Middle East for 20 continuous years. There were no better logisticians on the planet than them. And they all came together and they, as I said, worked to enable the great, great private sector. I mean, these companies, FedEx and UPS and CVS and Walgreens and McKesson and Palentier, they’re just iconic American companies that have been developing capabilities for decades and we took advantage of that. So, when the listeners get a chance to take a look at the book, I think the most important thing is to understand just the great variety of characters that came together, fortunately at the right place at the right time, to make this happen.
This piece was published first on GovExec, a FederalSoup partner site ("Former Trump Official: The Program to Develop COVID-19 Vaccines Was a Success, But Communication Could've Been Better.")