Despite Slow Roll-Out, COVID Vaccinations Will Accelerate, Former FDA Chief Says

Duke-Margolis Center director Dr. Mark McClellan addresses media

Vials of the Covid-19 vaccine delivered to Duke.
Vials of the Covid-19 vaccine delivered to Duke.

Hope and frustration have collided across the nation in recent weeks with the rollout of the first wave of two COVID-19 vaccines. Shots in arms offer a welcome glimmer of optimism to a haggard nation, but the rollout hasn’t moved as quickly as federal officials had anticipated.

On Wednesday, Duke health policy expert Dr. Mark McClellan discussed myriad aspects of the rollout.

In a virtual briefing for members of the media, McClellan, a former commissioner of the U.S. Food and Drug Administration, discussed the logistics of the rollout, vaccine skepticism, and his optimism that the national vaccination effort will gain momentum soon. Watch the briefing on YouTube.

Here are excerpts:

ON A SLOW VACCINE ROLLOUT

“This is the most complex undertaking ever in the U.S. public health history in terms of the number of people who need to be reached, two vaccines, complex conditions for storing and transporting the vaccines, all in the midst of an unprecedented public health emergency.”

“This is complicated; it is going to get better.”

“The federal government has held back some of the doses because these two initial emergency vaccines are two-dose vaccines. They’ve prioritized making sure there will be doses available for people to be able to get their follow-ups shots. Those follow-ups are starting to happen now.”

“The real challenges have been getting that last mile, or the last inch, from the vaccines being distributed out to health care facilities, or are going to be used in nursing homes, getting from there into people’s arms. That’s not a matter of logistics and distribution at the national level.”

“It’s a matter of what’s the capacity for these health care organizations to set up vaccination programs? Many of these hospitals are very hard-hit right now. How much willingness is there on the part of the affected staff or residents to take the vaccine? There’s still a significant amount of skepticism among, particularly, some subgroups in the population.”

“Add in all of those local logistical details, for people and health care organizations that are very busy, and you can see why it’s been a bit of a challenge.”

“I think this is all going to get better over time. We’re going to get more experienced with how to do this work locally.”

ON ROLE OF NATIONAL GUARD IN NC, OTHER STATES

“The Guard has played an important role in many aspects of public health emergency response since the beginning of the pandemic, in help delivering supplies, in helping with testing in surge areas, and now I think it’s a very appropriate use to help with access to vaccinations.”

“One of the big restraints is just bandwidth. Hospitals just don’t have a lot of staff they can devote to expansive vaccination programs. So the more we can augment them, the better.”

“My preference would be to see the National Guard help focus on some of the highest-risk groups that are otherwise hard to reach. There are a lot of people who want to get the vaccine now, who will stand in a line or call repeatedly until they get through. I’m also worried about reaching front-line workers who may not have the time, bringing the vaccines to them.”

“A lot of governors have started calling in National Guard assistance to help with this last-mile problem.”

ON SLOW VACCINATIONS IN NURSING HOMES

“I do think again I expect the numbers to pick up there. … It is an area where there will need to be some additional attention. While the numbers are going to accelerate, it may be not getting nursing homes done by mid-January, but by late January or into February. Those are still the highest-risk settings. We need to keep our attention there.”

“Also an issue here around, in some parts of the country, many of the nursing home staff have declined to get vaccinated at this stage. We need to pay attention to not just the logistics of getting the shots available, but the communications plan, the outreach.”

ON VACCINE RELUCTANCE AMONG HEALTH CARE WORKERS

“These concerns unfortunately are not new. If you look at surveys of the American public … people in more rural areas, Republicans now, people from racial and ethnic minority backgrounds, there is more skepticism out there. Some of that is long-term skepticism.”

“These are treatments where there are a lot of evidence behind them. … What I hope people will take away … is that there is very strong information on the safety and effectiveness of the vaccines. We’ve seen leaders from throughout the public health community, in government, out of government, black, brown, lots of different background, state very clearly and put their arms out to get vaccinated.”

ON DIFFERING GUIDELINES FROM STATE TO STATE

“States are taking different approaches. Some states, for example Florida, are providing broader access to people who are over 65. I think you’re going to see more of this variation across states.”

“You’re going to see more variation emerging across states in their basic plans for how they plan to expand access. You’ll also see more pressure with the vaccine numbers not being where we’d ideally like to see, more pressure to expand out access.”

ON IMPORTANCE OF SECOND DOSE

“The federal government has very much prioritized keeping second doses available and building into their distribution plan that those doses go out to the same places. As long as health care organizations … can keep up and provide sufficient access the federal government is trying to make that as straightforward as possible.”

“There are going to be gaps, people missing the vaccine, people who don’t get their information tracked properly. Right now we don’t have a whole lot of evidence on what happens if you delay your (second dose) a bit. Based on what we know from other vaccines … if you don’t get your second dose right at that scheduled time, that’s probably OK. If it’s a week or a few weeks later, you’re probably going to get a strong and lasting immune response. Further out than that, we’re really in uncharted territory.”

ON HOW TO SPEED VACCINES

“Expand, as quickly as we can, the help we’re getting in administering vaccines. Beyond hospitals, beyond very stretched public health departments, let’s find ways to partner with pharmacies. They have significant capacity. Let’s find ways to partner with medical practices, not hospital-based but out in the community. Those are not places that are doing lots of vaccinations right now. It was envisioned that they’d become part of this process over time, but let’s accelerate that process.”

“It’s very important to not just move down the list but to pay close attention to where gaps are emerging. States are tracking the number of people who get vaccinated but also where they are. What communities they’re in. What backgrounds they have. Are they in nursing homes? Are they in high-risk settings like prisons? If we see gaps emerging, that’s where we need to put some more public health efforts.”

ON IMMEDIATE IMPACT OF BIDEN ADMINISTRATION

“The Biden administration has already identified dealing with COVID generally, and increasing vaccinations in particular, as among the highest priorities. They’ve set a goal of a million vaccinations per day for the first hundred days of the administration. We are not there yet but we are headed in that direction. We ought to be able to get there. We ought to be able to get well past 1 million doses per day.”

“We’ve got enough vaccine supply. We’ve got to match that up with the ability to go that last mile, to go that last inch, into people’s arms. I think we can get to well over 1 million a day, maybe closer to a goal of 2 million a day. It is going to take a lot of action on all these fronts.”

Meet the expert:
Dr. Mark McClellan is a physician and economist who directs the Duke-Margolis Center for Health Policy, where he works on strategies and policy reforms to improve health care. He was commissioner of the U.S. Food and Drug Administration and administrator of the Centers for Medicare & Medicaid Services. Dr. McClellan serves on the boards of Johnson & Johnson and Cigna; each company is involved in aspects of the COVID-19 response.
--
Duke experts on a variety of other topics related the coronavirus pandemic can be found here.

###