In retrospect, probably the last thing America’s bungled Covid-19 vaccine rollout needed was for the Trump administration to spend its final week in power promising the states extra vaccines that didn’t exist. Last Tuesday, departing Secretary of Health and Human Services Alex Azar announced that the federal government would release its stockpile of Covid-19 doses instead of holding the vaccines in reserve for the second round of shots. Some states, accordingly, started widening their first-tier vaccine eligibility plans to include all individuals above the age of 65, for example. Then The Washington Post reported on Friday that the U.S. had actually started shipping doses directly from the manufacturing line in late December, without holding any back. There is no vaccine stockpile.
All of this confusion took place during a time of increasing urgency, as hospitals struggle to accommodate post-holiday travel surges and more transmissible Covid-19 variants like B-117 have begun circulating in the U.S. Nearly every day, the U.S. is breaking previous records on new Covid-19 cases and deaths. “It feels like a race against time to be able to get to as many people as possible, as quickly as we can,” Dr. Grace Lee, chief medical officer for practice innovation and infectious diseases physician at Stanford Children’s Health, told me. “We’re at a critical point in the pandemic.… We just need to get doses into arms as quickly as possible, with mindfulness about making sure it is as equitable as possible.” And so far, that isn’t happening. The two biggest questions in U.S. pandemic response right now are simple: Why, exactly, are the bottlenecks happening, and what’s the best way for the Biden administration to fix them?
There are many reasons why the vaccine rollout didn’t go as smoothly as hoped, but chief among them was a lack of top-level planning. There doesn’t seem to have been any process to make sure states received a steady supply of doses, which would have made it easier to schedule appointments in clinics; or to train and deploy vaccinators to get shots into arms; or to communicate with those in the highest-priority groups about when vaccines became available; or to equip states with mass vaccination sites. The Trump administration left everything up to states, where health departments were already working around the clock to test for Covid-19 cases and trace contacts. To implement the biggest, fastest vaccination campaign in history, states initially received a total of about $200 million in funds. “The main culpability on the part of the Trump administration, as they head out the door, was a real failure to help support the development and operation of a vaccination delivery program beyond the shipping and manufacturing of vaccine doses,” Dr. Jason L. Schwartz, an assistant professor at the Yale School of Public Health, told me.
In order to correct these mistakes, Biden’s incoming administration needs to build a steady supply of doses, communicate clearly about which groups are prioritized and how, and expand the health workforce along with the number and type of sites where vaccines may be administered. And it needs to do it fast.
The first reason why it’s been hard to administer the doses is, paradoxically, because we don’t have enough, Dr. Lee said. When doses show up late, or the quantity has changed, it disrupts the whole workflow. “It’s hard to do planning. You want to schedule people into a regular clinic, but if you don’t know what your supply is going to be the day before that clinic, it makes that really difficult,” she said. “The more steady we can make it, the better it is.” Getting the timing exactly right is also important because of the finicky nature of the vaccines. They need to be thawed and swirled and examined in certain ways, and once taken out of the refrigerator, both the Moderna and the Pfizer-BioNTech vaccines expire after six hours—an unusually fast pace. After the shots are administered, each patient needs to be monitored for 15 to 30 minutes to make sure they don’t have a reaction—but all the while, patients and administrators need to maintain physical distancing.
One of the major hiccups, though, hasn’t had to do with supply at all. “The issue is not that we don’t have enough vaccines in our health care setting. It’s that we’re not able to get the vaccine that we already have distributed, into people’s arms swiftly and efficiently,” Schwartz said. Pharmacies have run into bureaucratic barriers and delays in vaccinating the staff and residents of long-term care facilities. Some hospitals with extra doses have discarded them because they were unsure whether they were permitted to vaccinate lower-priority workers.
Offering extra doses to less vulnerable people is not a bad strategy as long as the vaccines aren’t being wasted. But by explicitly including people above the age of 65 or with Covid-exacerbating health conditions among the priority groups, experts worry the floodgates have been opened, and bottlenecks will continue due to demand far outstripping supply. The Trump administration “essentially jettisoned some of the core features of the prioritization model that had been developed over many months,” Schwarz said—a plan devised to avoid many of these roadblocks and bottlenecks.
Lee was one of the 15 doctors on the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices making the now-overruled vaccine prioritization recommendations. The entire purpose of the prioritization plan was to balance a limited vaccine supply against those who needed protection the most. “The intention was never to hold people back from vaccinations—our intention has always been to give it,” Lee said. But greatly increasing the number of Americans who qualify for the vaccine when there is such limited supply could lead not only to frustration but also to inequality, she said. “The patients who have great advocacy skills, or who are healthier and more able to call in, are the ones that are able to get vaccinated, whereas our frail, elderly people, who can’t sit out overnight in front of a stadium” are not, Lee said.
These are all tricky problems for a new administration to fix. In addition to supply and distribution issues, states have run into problems registering people for shots with often complicated online systems. And then there are the hesitations some feel over the safety and efficacy of a vaccine that was developed at a historic pace.
Until the end of last week, it wasn’t clear how the Biden administration would approach these problems: Biden had previously proposed sending nearly all of the U.S. stockpile of vaccines to states, inspiring Azar’s own misbegotten announcement. But on Friday afternoon, the president-elect released a plan to relieve bottlenecks and administer a planned 100 million shots in the first 100 days of his presidency. Biden intends to increase the number and type of places where vaccinations can be received, from sports stadiums and mall parking lots to mobile vaccination units and health centers. He wants to expand the public health workforce to administer shots, among other crucial tasks, and he also proposed a massive public information campaign on the safety and effectiveness of the Covid-19 vaccines. And he plans to use the Defense Production Act to speed up manufacturing of vaccines and other equipment, like more efficient syringes that could stretch the number of doses in each vial. In addition, incoming White House press secretary Jen Psaki said the new administration will retire the name “Operation Warp Speed,” which some people worried led to public distrust of the vaccine by making it sound rushed.
Dr. Celine Gounder, one of Biden’s Covid-19 advisers, told me the large-scale vaccinations will likely take place at enormous sites like the Javits Center in New York City and Fenway Park in Boston. Mobile vaccination units will focus on harder-to-reach populations, especially those in rural areas. “The mobile units are very much [built] with equity in mind,” she said, aiming to serve those who can’t travel to a vaccination site but are nonetheless vulnerable to Covid-19. Pharmacies will also move beyond offering shots to staff and residents of long-term care facilities. “For a lot of people, the local corner drugstore or pharmacy where they already pick up their prescriptions may be the most convenient place,” Gounder said. Community health centers and primary care doctors are also going to be very important partners, she said, because they’re trusted by their communities.
The Moderna and Pfizer-BioNtech vaccines require two shots—2,000 doses will only vaccinate 1,000 people. Some have suggested giving only the first dose in order to stretch supply and potentially give more people at least some measure of protection. But it’s not clear that’s a good idea, or if it would even work: No studies have been done to see if only one dose provides any lasting protection, and we don’t know how much delaying the second shot will reduce the efficacy of the vaccine overall. “Until we have evidence that says this is a sound public health strategy, we need to stick to the vaccines the way that we know they work and focus on all those other issues: increasing the supply, strengthening delivery systems,” Schwartz said.
There’s another reason not to risk reducing the vaccine efficacy by splitting up the doses: As new vaccines are authorized for emergency use alongside the Pfizer-BioNTech and Moderna shots, it will become easier and faster to reach more people, experts said. Johnson & Johnson recently released promising early results for its vaccine candidate, and the company expects to submit trial results by the end of January or early February. If proven effective, this vaccine could be a “game changer,” Schwartz said, because it is one dose, which makes it much easier to give out, and it doesn’t need to be stored in ultracold freezers.
One of the biggest challenges, Schwartz said, will be communicating with a public “that has been through a lot.” People who learned last week that they may be eligible for the vaccine could find it extra frustrating to wait weeks or months to receive it. The communication needs to come from the top, with clear, evidence-based plans driven by equity.
None of these plans—not even the one Biden announced Friday—should be viewed as final. The Trump administration has reportedly withheld information the Biden transition team needs to hit the ground running, which means there will doubtless be bumps in the road in the next few weeks—and that’s on top of the challenges inherent to conducting the biggest vaccination campaign in history as the virus continues to spread and mutate. One of the most important parts of responding to a crisis like this, Gounder said, is rolling with the punches and changing course quickly in light of new information. “Our knowledge is not set in stone, so to speak. We keep testing what we think we know, and we adjust based on what we learn along the way,” she said. Having a plan in the first place is perhaps the most important part of an unparalleled effort like this. But identifying what is and isn’t working, and updating and improving the plan as new information comes to light, may be just as crucial.