The Health 202: Operation Warp Speed chief says coronavirus vaccine distribution is ‘working perfectly’

Slaoui, who this week spoke with The Health 202, will step down next month from leading President Trump’s initiative to speed development of coronavirus vaccines and treatments as Biden’s team takes over. He’ll leave in the midst of the nation’s largest mass vaccination effort, one that has materialized far more quickly than many experts predicted one year ago.

By The Washington Post’s count, more than 30 million doses have been shipped around the country. About 11 million people have actually received the shots. That rate is better than most European countries, but it’s still prompting concerns health providers don’t have the resources and coordination they need for rapid administration.

In our conversation, Slaoui responded to some of those concerns and laid out his expectations for vaccine manufacturing over the next few months. The interview has been lightly edited for clarity and brevity.

H202: The Biden administration — and now the Trump administration — will start shipping nearly all vaccine supplies as they become available. Are you concerned this could lead to some Americans not getting their second shot if supplies run short?

Slaoui: It’s not a new policy; it frankly was part of the plan. We were expecting to reasonably quickly move from a more conservative approach where we store second doses to a more rolling basis. I think this carries slightly higher risk, but there is a way to manage it.

The time between which the [vaccine] has been produced in a big flask and then will be put into bottles is more than 21 days. Which means we have effectively three to four weeks in advance certainty the vaccine exists. So if there is a major manufacturing challenge, we’ll know it three or four weeks in advance and start to manage the vaccines that are in the pipeline … to ensure we will deliver the second dose to the subjects that got the first dose.

H202: How many doses of the Pfizer and Moderna vaccines are on the way for the rest of January and into February?

Slaoui: We now are at a cadence where we can have 30 million doses per month of each one of the vaccines produced.

H202: Do you stand by your prediction that there will be enough vaccines for every American by June?

Slaoui: Yes I do, and it’s vaccine doses available. I hope we will translate those vaccine doses into people immunized. I specify this is contingent on the fact that more vaccines will get approved. 

What we now know is we will have 400 million doses from Moderna and Pfizer vaccine by the end of June, 200 from each, maybe slightly more. The plan is to have the Johnson & Johnson vaccine (which is one dose), adding slightly more than 100 million doses, and that will achieve that objective.

H202: When do you think the country will reach “herd” immunity, where the virus can’t spread anymore?

Slaoui: We’re working very hard to be there by this summer. I think when we will have immunized 80 percent or so of the population we can be there. I think immunizing the large majority of the highest-risk population, the elderly and people with comorbidities and the highest transmitters or people highly exposed, the first-line people and health-care workers, will have a dramatic impact on the deaths.

What’s really key is to realize that until then, until the summer, we should continue to, of course, stick with our masks, keep our distance, wash our hands and be aware of the virus. 

Secondly, we are studying whether these vaccines are impacting transmission or not. I think they will impact it. Whether they will impact it very well or moderately is a question, and once we know the answer to that question, we will know how fast we will get back to normal.

H202: What do you anticipate as the biggest changes to vaccine distribution strategy under the incoming Biden administration? 

Slaoui: I don’t know, frankly. What I’ve said is I will share with them every single thing I know, every idea I have, and then it will be their call. I don’t think there is a need to change anything about distribution. Distribution is frankly functioning and working perfectly. I think there are needs to continue to continue to accelerate administration of the vaccine. I would predict by next Wednesday that number will be much higher and therefore there is a clear acceleration of uptake, as the states and [health] centers learn more.

H202: Do you regret promising to make 20 million doses available in December? You’ve been slammed for it.

Slaoui: No, I don’t regret at all. I could have regretted saying on May 15 we will be able to have vaccines by the end of the year. I believe that if one doesn’t set objectives that are very ambitious but credible, one is not trying hard enough, particularly in the context of a pandemic. 

I remind you that we have had 20 million doses of vaccine [manufactured]. I’m sure I had interviews where I said we will make 20 million doses available to the American people and maybe one or two interviews where I said we will immunize 20 million people — my mastery of the English language being what it is…it’s not my mother tongue. But I’m not trying to find excuses.

H202: Are providers adhering too strictly to the priority guidelines for who should get the shots first?

Slaoui: Not enough people have been immunized. Clarifying we need to continue to vaccinate people in 1A [priority group] and … start 1B is the right thing to do. It’s a matter of de-bottlenecking the hospitals and centers for immunization.

H202: Getting the vaccines administered has been hampered with delays. What should [Warp Speed] have done last year to pave the way for getting the vaccine into arms?

Slaoui: What we planned over months was the distribution, and as discussed it has gone exactly according to plan. What we have discussed at length with each department of health in the states was their need to tell us where to send the vaccine. 

I think now, looking backwards, we could have been more specific into the discussion around what resources they may need to actually deliver those vaccine doses into the arms from the moment they have been delivered to them. I should note that no single state has raised that question to us during the months of September, October, November, where on a weekly basis we were visiting the departments and discussing plans and how it will go. We received 70,000 addresses and area codes to be validated into the system that would be the recipient of the vaccine doses, and at each week the state department of health ordered vaccine doses on the basis of their granular knowledge of their situation. 

[Warp Speed chief operations office and Army Gen.] Gus Perna and I were always of the view that it’s very hard for anyone centrally to know there would be 2,000 people to vaccinate at this particular hospital or center. That is information that is understood by each state and each county. It’s possible there was [a financial] issue, but frankly it was never raised to us.

H202: Do you think [Warp Speed] is getting unfairly blamed for perceived delays in getting people inoculated?

Slaoui: If you spend your time thinking whether you should be rightly blamed or not, you are likely to miss your objectives. We set objectives, we set them as extremely aggressive and ambitious, and we were fortunate we met most of them, and some of them have not been met. What is very important is we have to ensure most people are immunized, because that is the final objective.

H202: There was a Politico report that some syringes distributed by [Warp Speed] aren’t efficient enough to extract a sixth dose. How did this happen, and is [Warp Speed] trying to address the problem?

Slaoui: It was impossible to predict there would be a potentially sixth dose extractible from the vials, and there are settings where indeed more appropriate syringes can be distributed. There are shortages and they are being worked on.

H202: The Trump administration has recommended the states start distributing the vaccines to a wider range of people. But could this create too much confusion and demand?

Slaoui: I have to say, it’s very interesting. Either not enough people are immunized and there is a concern, or too many people would like to be immunized and we don’t have enough vaccine and it’s a concern. 

We need to take a step back and see we are literally one year from when the virus was sequenced. Here we are, having millions and millions of doses of vaccine doses being approved and [people] immunized. Having said that, I think it is a right thing to do to accelerate vaccination by expanding the number of sites and locations in which people can be vaccinated.

The proposal comes amid a worsening pandemic and signs of a deteriorating economy, Erica Werner and Jeff Stein report. “The wide-ranging package is designed to take aim at the twin crises Biden will confront upon taking office Wednesday, with provisions delivering direct aid to American families, businesses and communities, and a major focus on coronavirus testing and vaccine production and delivery as the pandemic surges,” they write.

Biden is aiming to get GOP support for the package, titled the “American Rescue Plan,” but many Republicans are likely to balk at the $2 trillion price tag. The effort may also be complicated by Trump’s impeachment, which could leave the Senate enmeshed in an impeachment trial at the same time Biden is trying to push through his legislative agenda.

“Biden’s proposal is divided into three major areas: $400 billion for provisions to fight the coronavirus with more vaccines and testing, while reopening schools; more than $1 trillion in direct relief to families, including through stimulus payments and increased unemployment insurance benefits; and $440 billion for aid to communities and businesses, including $350 billion in emergency funding to state, local and tribal governments,” Erica and Jeff write.

The coronavirus provisions include $20 billion toward a universal vaccination program, $50 billion toward a “massive expansion” of testing and $130 billion to help schools reopen safely. Biden has said he hopes to deliver 100 million vaccine shots within 100 days and open a majority of K-12 public schools in that same time frame.

The package also includes two proposals aimed at expanding access to health coverage.

Larry Levitt, senior vice president of the Kaiser Family Foundation:

The president-elect says he intends to unveil a broader relief plan in his first appearance before a joint meeting of Congress in February. 

Christen Linke Young will join the White House as the Domestic Policy Council’s deputy director for health and veterans affairs. Young serves as a health policy adviser for Biden’s transition team. She previously worked as a deputy director in the Centers for Medicare and Medicaid Services in the Obama administration.

Meanwhile, CNN reports that Andy Slavitt, the former acting chief of CMS under Obama, is expected to join Biden’s coronavirus response team in an advisory role. Slavitt helped to fix the botched rollout of HealthCare.gov under the Obama administration, an effort that was led by Jeff Zients, who now serves as Biden’s coronavirus coordinator.

The Biden administration has not announced who it plans to lead the Food and Drug Administration, a position that has gained increased prominence during the pandemic. But Bloomberg News reports that agency veteran Janet Woodcock is thought to be a front-runner and is expected to serve as the acting head after Biden’s inauguration next week. Woodcock stepped aside from her job leading the FDA’s Center for Drug Evaluation and Research earlier this year to work with Operation Warp Speed on accelerating covid-19 therapies. Former Obama FDA official Joshua Sharfstein is also in the running for the top position at the agency.

Espaillat had recently received the second dose of the coronavirus vaccine, but experts say it can take time for the body to build up immunity after a vaccination. He is the latest House member to test positive after a pro-Trump mob stormed the Capitol last week, Felicia Sonmez reports.

Naor Bar-Zeev, an infectious-diseases physician and epidemiologist at the Johns Hopkins Bloomberg School of Public Health, said that individuals “should not really consider themselves protected until after a week or two following dose two” of the vaccine. While the vaccines have been shown to prevent symptoms and severe illness, it is unclear to what extent they prevent asymptomatic infection.

At least three other lawmakers tested positive for the virus last week, prompting the House to move forward with a rule that would fine members who don’t wear face masks.

“During the riot, House members and some staff sheltered in a cramped, windowless room with no more than an arm’s length of distance between them. But several Republican members hunkered down maskless, refusing to use the face coverings that their Democratic colleagues and staffers were begging them to wear as protection from the coronavirus, which thrives in such low-ventilation indoor environments,” Felicia writes.

“[A]ny assessment of U.S. performance has to take into account how other countries are doing. It turns out the U.S. is faring pretty well, relatively speaking. In fact, shots are getting into arms faster than in most of Western Europe, at least according to the available data,” HuffPost’s Jonathan Cohn reports.

The United States looks better or worse depending on which countries you compare it to. In Israel, the seven-day average for daily doses was 0.75 per 100 people, compared to 0.19 in the United States. But America is getting vaccines into arms faster than anywhere in Western Europe except the United Kingdom.

“The international comparisons come with two very important asterisks. One is that not every country is tracking vaccine administration the same way or with the same accuracy. In many nations, including the U.S., data may be lagging behind actual shots. The other asterisk is that different countries started vaccinating on different days because government approvals of vaccines didn’t happen simultaneously,” Jonathan writes.

Once you account for the date countries first started vaccinating, some European countries, such as Denmark, Ireland and Italy, come closer to performing like the United States. But the United States also comes closer to matching Britain’s performance.

There are also considerable differences in how the states are doing:

Pfizer-BioNTech and Moderna both increased their production forecasts in recent weeks. The new estimates suggest that the United States should have 200 million doses each from the companies by the end of July, enough to vaccinate 70 percent of adults, Carolyn Y. Johnson reports. 

“But doses on paper are different from vials in the freezer — or vaccinations in people’s arms, as the past months have demonstrated. Distribution challenges have received most of the attention, as unused doses stack up. But the risk of raw ingredient shortages, manufacturing delays and other unforeseen production issues loom as the next potential bottleneck as companies work to reach a massive scale of manufacturing,” Carolyn writes.

Pfizer-BioNTech cited growing manufacturing efficiencies and increased raw supplies behind its projection that it could produce 2 billion doses globally this year. But other experimental vaccines are struggling to ramp up supply. Johnson & Johnson, which is expected to submit its vaccine trial data for approval in the coming weeks, is unlikely to meet its contract with the U.S. government of 12 million doses by the end of February.

Still, some health-care experts are already anticipating that the United States could end up with surplus supplies. 

“We’re living in this sort of belief that the demand here is endless, and it’s not,” Scott Gottlieb, a former FDA commissioner in the Trump administration, told CNBC. “I think by the end of February, we’re going to find that we have to open up eligibility pretty wide to get people to come in to get inoculated. We’re not going to be in this rationing situation.”

“[I]t was not until this week that Biden officials were allowed to attend meetings of Operation Warp Speed, the administration’s initiative to accelerate vaccine development and distribution. They were also not invited to the two Warp Speed sessions this weekend when Trump officials decided on sweeping changes to try to speed up the sluggish vaccine rollout. Nor were they briefed on those changes in advance,” Laurie McGinley, Amy Goldstein, Lena H. Sun and Isaac Stanley-Becker report.

Some advisers close to Biden have criticized recent decisions made by the Trump administration in those meetings, including a decision to expand vaccine eligibility to everyone 65 and older and to penalize states that lag behind in administering vaccines. Some state lawmakers have said they are uncertain whether to take the latter plan seriously, because it could shift in a week once Biden takes office.

“Tensions between incoming and outgoing administrations aren’t unusual — the post-election period between Democrat Harry S. Truman and Republican Dwight D. Eisenhower in the early 1950s was especially acrimonious, for example. But it’s hard to imagine a transition more fraught than this one, with a president raging against the election results as a deadly pandemic spreads out of control,” Laurie, Amy, Lena and Isaac write.

Trump officials say that they are briefing the Biden team on relevant meetings, even if the incoming officials are not invited to participate. One administration official told The Post that it was not appropriate for the Biden team to be in decision-making meetings because the country only has “one government at a time.”

Meanwhile, the Biden team has managed to get information from long-standing contacts in health agencies and pharmaceutical companies.

“The regulation, which the Department of Health and Human Services could issue as a direct final rule within days, would mandate job reviews every five years for career federal scientists who serve as center directors at the Food and Drug Administration, Centers for Disease Control and Prevention and other health agencies. The reviews could lead to renewal — or reassignment,” Politico’s David Lim and Sarah Owermohle report.

Some career officials have questioned the move, saying that it could subject scientists to increased political pressure from the White House. The rule would have implications for center directors at NIH, including Anthony Fauci, who serves as the chief of the National Institute of Allergy and Infectious Diseases.

A senior administration official told Politico that the rule was a good-governance measure and was not targeted at particular individuals or agencies.

“One former HHS official said the Trump administration knows the midnight regulation, like many of its other last-minute regulations, will likely be tossed out in court. But the official speculated the action is intended as a roadmap for future administrations looking to more easily reassign career staffers,” David and Sarah write.