President Biden beckoned leaders of two of the world’s largest pharmaceutical companies to the White House on Wednesday and credited his administration for the “nearly unprecedented collaboration” between the longtime rivals, Merck and Johnson & Johnson, now jointly producing a coronavirus vaccine.
“Biden can take credit for finishing the deal, that’s for sure,” said Paul Mango, a former Health and Human Services deputy chief of staff and one of those Trump officials. “But it wasn’t an original idea he had.”
Pharmaceutical executives credited Biden’s team for critical work to forge the alliance but acknowledged the deliberations began during the Trump administration.
“When the Biden administration came in, they took a new look at this,” Merck CEO Ken Frazier said. “It’s not a black-or-white situation. We were inclined to do something. They made it more possible for it to happen in a timely way.”
Since taking office 50 days ago, Biden has overseen significant strides in the nation’s quest to curtail the pandemic. Vaccinations have more than doubled to 2.2 million per day; coronavirus cases have plunged more than 70 percent from their mid-January peak; and the White House has repeatedly promoted new deals to secure hundreds of millions of doses in additional vaccine supply.
But after turning last year’s race for the White House into a referendum on the nation’s coronavirus response, Biden officials are building on some Trump-era ideas, while confronting challenges that also dogged Trump officials, including how to roll out a new vaccine and reopen schools. Like their predecessors, they have made abrupt changes to vaccine prioritization, recently elevating teachers in a directive that sowed confusion in some states.
These dynamics cast the early rollout in a new light. They undercut the notion that Biden started from scratch on efforts to distribute and administer vaccines, which has been central to his administration’s messaging, and show instead that he has accelerated efforts by scientists and pharmaceutical companies, as well as by career health and military officials, some of whom are still laboring inside his government.
“For me, the first big test was going to be how well they did with the J & J distribution, which was totally their thing and not left over from the prior administration,” said Walid Gellad, a pharmaceutical expert at the University of Pittsburgh, referring to the single-shot doses that were first authorized under the Biden administration last month.
Of the 3.9 million Johnson & Johnson doses that began shipping out at the beginning of last week, about 630,000 had been administered as of Thursday, according to Centers for Disease Control and Prevention data. Biden administration officials say there is a data lag, just as their predecessors insisted in December.
“So far it seems there is room for improvement,” Gellad said.
No longer ‘drop-shipping vaccines to states’
Biden addressed the nation Thursday evening, describing the toll of the pandemic, while also touting his administration’s efforts to curb it by summer, and unveiling a new goal of ensuring all adults would be eligible for shots by May 1.
Biden officials have repeatedly said the Trump administration left them “no plan” to carry out vaccinations and failed to secure sufficient supply, claims faulted by fact-checkers. The new president also had pledged to deliver 100 million doses in his first 100 days — a promise that Biden on Thursday said he’ll achieve in 60 days. He claimed that critics had panned his target as “way over the top,” although most had argued he had aimed too low given the scale of the public health crisis.
Moncef Slaoui — a registered Democrat and pharmaceutical industry veteran who helped lead Trump’s Operation Warp Speed initiative to speed vaccine development — expressed bewilderment about the blame directed by Biden and his top advisers at the early immunization effort, which equipped the United States with multiple vaccines as well as contracts allowing the government to snap up more supply than any other country.
“Honestly I find that unwarranted, unwise and un-understandable,” said Slaoui, who resigned at the Biden administration’s request. “I’m amazed that people felt the need to belittle the work that was done.”
Trump, who had little involvement in the vaccine accelerator managed by his administration, gave voice to these criticisms on Wednesday, saying in a release distributed by his office that the vaccine would not exist were it not for his efforts.
“If I wasn’t president, you wouldn’t be getting that beautiful ‘shot’ for five years, at best, and probably wouldn’t be getting it at all. I hope everyone remembers!” he said, using the sort of hyperbole that characterized his vaccine promises.
Biden officials and close advisers have scoffed at such complaints, saying execution is among the hardest steps and that they deserve credit for quickly mustering federal resources to speed production and delivery of vaccines.
“We think there’s a significant role for the federal government, and that’s why … right in the beginning, we started with a comprehensive plan,” said a senior White House official involved in the coronavirus response, speaking on condition of anonymity to discuss internal planning. “We’ve gone way beyond drop-shipping vaccines to states and saying ‘good luck.’ ”
The stimulus bill signed into law by Biden on Thursday provides additional funding for vaccine distribution. Already federal deployments have enabled the openings, or planned openings, of 20 mass vaccination centers. And the new administration has quickly expanded direct vaccine shipments to retail pharmacies, under a program devised by the Trump administration and advertised by CVS as early as last November.
State health officials also praise Biden administration advances, saying they have better access to senior leaders at the CDC and a clearer understanding of the federal government’s priorities. Keith Reed, Oklahoma’s deputy health commissioner, said the inauguration brought “pretty much immediate improvements in communication and predictability.”
But state and local efforts have been most directly affected by additional vaccine supply, which owes to long-anticipated improvements by manufacturers, in addition to new pressure and steps taken by Biden’s team. The current forecast — widespread access to vaccines by the spring — was predicted last year by numerous federal officials, ranging from Alex Azar, Trump’s health and human services secretary, to Anthony S. Fauci, whom Biden has made his chief medical adviser. State and local officials, however, lost faith in the projections as the government missed one target after another, in part because manufacturers kept revising down their own production estimates.
Biden was more cautious at first, keen not to overpromise as he predicted that the United States would have enough supply to cover every eligible resident by the end of July. But the president swiftly moved up his timeline, suggesting his administration’s efforts would ensure enough vaccine by the end of May.
The May target mainly results from scaled-up manufacturing, as well as the authorization of the Johnson & Johnson vaccine, according to current and former officials. In a contract secured last year by the Trump administration, Johnson & Johnson committed to delivering 100 million doses of its one-shot vaccine by the end of June — and 87 million by the end of May. It is now expected to deliver slightly more in that time frame, after senior Biden administration officials pressured one of its subcontractors to put more resources into bottling the product.
But the bulk of the supply needed to cover the adult population by May will come from Pfizer and its German partner, BioNTech, and from Moderna. The companies had originally set targets for July and June, respectively, for doses sufficient to cover 100 million people each. But federal officials familiar with their operations say these were conservative estimates that didn’t reflect steady improvements in production.
Pfizer, for instance, had been indicating for several months it could scale to more than 13 million doses a week, according to one federal official — a rate that, if maintained, would easily allow it to supply 80 million doses in April and May, after delivering 120 million by the end of March. The company also won approval in January to count six doses in each of its vials, rather than five. Asked how its accelerated timeline was affected by the Biden administration’s move in February to give the company priority access to filling pumps and filtration devices, Pfizer spokesman Eamonn Nolan did not address the question, pointing to the six-dose labeling change and to “enhancements to our … facilities and processes.”
“What we see now in terms of vaccine manufacturing — I don’t think there’s any impact from the new administration,” said Slaoui, who had been chief scientific adviser to the federal government’s vaccine accelerator. “These are natural progressions in scaled-up manufacturing capacity, where you gain more knowledge of your process, you understand which cycles you can shorten and you become more confident in publicly expressing commitments.”
Senior Biden administration officials say they have improved the government’s relationship with Pfizer, which did not take research and development money last year and kept aspects of its operations at arm’s length from the government. That detente, these officials say, helped give the company confidence in its U.S. production targets after the Trump administration had delayed using the Defense Production Act in Pfizer’s behalf, at first reserving its powers under the Korean War-era law for companies in the government’s portfolio.
Biden administration officials also said they helped Moderna overcome a bottleneck in the fill-and-finish process by freeing up space at Catalent, the New Jersey-based contractor carrying out this critical phase of the production process.
Frazier, the Merck CEO, credited the Biden administration for building on earlier Trump-era talks that were focused on the fill-and-finish process, culminating in Merck agreeing to help produce Johnson & Johnson’s vaccine.
“They expanded the discussions,” Frazier said. “And they also brought together some of the financial support that allowed us to then think about converting our factories to making this stuff.”
Slaoui also allowed that the new administration has made improvements in federally coordinated mass vaccinations. Political appointees, he said, had cautioned against mobilizing members of the military to support vaccination sites out of fear it would turn people away. Some states had already enlisted National Guard members, and Biden quickly moved to fully reimburse states for these expenses.
“The only thing I can discern that they've added to our playbook was the FEMA-run mass vaccination centers,” Mango concurred. “Good idea, if you have enough vaccines to do it. We didn't have enough in the early days.”
At the same time, decisions about where to erect these sites have raised eyebrows among some at the CDC, where one senior official wondered why FEMA was opening a center in Atlanta, when Fulton County had already set up a vaccination site at the Mercedes-Benz Stadium in the city’s downtown. At the same time, the official praised new efforts to send the vaccine directly to community health centers, saying this channel could help address racial disparities that have given Black and Latino Americans less access to the vaccine than Whites. The biggest change, the official said, was more money for states and more supply.
A new rollout, with similar challenges
The Biden administration has made vaccine administration a priority, saying their predecessors did little more than ship the product to states. But in striking ways, challenges involved in rolling out Johnson & Johnson’s single-shot vaccine mirror difficulties that marred the vaccination campaign’s inception late last year.
In particular, CDC data suggests the shots have been slow to reach arms, with only about a sixth of allocated doses administered as of Thursday. The pace is all the more surprising because of the vaccine’s easier handling requirements. Unlike the Pfizer-BioNTech and Moderna products, it does not need to be kept frozen.
Still, some providers are proceeding slowly — a sign of how little control authorities in Washington have over the pace of inoculations performed throughout the country. A shipment arrived Monday at Albany Area Primary Health Care in Dougherty County, Ga., to the surprise of the medical group’s chief executive, Shelley Spires. She said her staff would be trained in handling the new vaccine and prepared to start administering it next week.
The sluggish pace in doling out the new vaccine owes to uncertainty about supply, as well as to challenges in communicating about the vaccine’s efficacy to the public, said state and local officials.
Originally, governors were told supply would dry up for several weeks after an initial burst last week. But they were informed Tuesday by members of the White House’s coronavirus task force that about 400,000 doses could be available to order starting Sunday. The supply, which includes another 200,000 doses for pharmacies and mass sites, was allocated Wednesday, according to two federal officials, after regulators certified the product from one of the company’s manufacturing sites in the Netherlands. A Johnson & Johnson spokesman declined to comment.
Different jurisdictions have diverged in how they distribute the single-shot vaccine, and in how much information they share with residents about which products they will get. After briefly weighing a more centralized distribution for the new vaccine, federal officials decided to leave the decisions largely to states and local jurisdictions, as they did with the initial vaccines.
Detroit Mayor Mike Duggan caused a minor stir last week when he turned down a Johnson & Johnson shipment, saying it was his “intention, as long as possible, to stick with the Moderna and Pfizer vaccines and get Detroiters 95 percent protected.” His comments were rebuked by health officials who noted that head-to-head comparisons of the vaccines’ efficacy rates are impossible because they were tested in different countries and at different points during the pandemic.
Duggan cleaned up his comments in an op-ed in the Detroit Free Press, in which he celebrated all three authorized vaccines and urged residents to take the first one available to them. He also spoke with Jeffrey Zients, the coordinator of the White House’s coronavirus task force, about the matter, said the mayor’s spokesman, John Roach.
Allies say Biden’s team has been forthright about these challenges.
“They’re not hiding key information. They’re not trying to obfuscate. They’re not trying to pretend things are other than they are,” said Celine Gounder, a physician who served on Biden’s covid-19 advisory board. “They’re not afraid of being held accountable for their performance.”
Gounder herself criticized the Biden administration’s announcement last week to prioritize vaccinating teachers, writing on Twitter that the plan “doesn’t make any sense” given ongoing steps to protect high-risk teachers and the administration’s own call for equity in vaccinations. “This means taking vaccine away from higher-risk persons & communities of color to [vaccinate] young healthy teachers,” she added.
Biden’s move on teachers also caught states by surprise, deepening dilemmas about eligibility while supply remains sharply limited.
Governors, including Republicans Charlie Baker in Massachusetts and Spencer Cox in Utah, expressed frustration about the lack of consultation during a call Tuesday with members of the White House’s coronavirus task force, according to people who participated in the conversation and spoke on the condition of anonymity because it was held privately. They asked whether teachers should displace those already in line for shots this month — residents who have been prioritized because they are at high risk from the coronavirus — or simply be added to the pool. The White House provided no clear answer, these people said.
Cox emphasized that Utah had been vaccinating teachers since January, said the governor’s federal liaison, Gordon Larsen, “but that governors can be most helpful when they’re at the table and not surprised by announcements from the White House.”