On the morning of March 31, roughly 25 Biden administration officials gathered at the White House, double-masked, for a meeting called on short notice by a member of the National Security Council. They were there, they believed, to debate how best to broaden the federal government’s COVID-19 response beyond U.S. borders, and reclaim America’s traditional role as the world’s public health leader.
The challenges they planned to address were daunting. The Trump administration had poisoned relations with the rest of the world, first severing ties with the World Health Organization and then politicizing the pandemic, referring to COVID-19 as the Wuhan virus and even “kung flu.” Into the vacuum rushed Russia and China, who began currying favor around the world by distributing their own vaccines—of possibly dubious quality.
Inside the U.S., all eyes have been focused on the chaotic rollout of vaccinations. But if current trends continue, it will be months if not weeks before every adult who wants a shot is able to get one. Very soon, the U.S. will be in possession of a vast COVID vaccine surplus. And that, global-health experts within the government agree, could quickly turn into a P.R. nightmare. “Can you imagine the condemnation of the world if America has vaccines sitting on warehouse shelves expiring with the rest of the world dying?” said one senior government official with knowledge of the meeting.
Unfortunately, sending doses overseas is no simple matter. To even begin planning in earnest how to do so, an essential document entitled The Framework for International Access needed to be greenlit. That was a goal of several officials in attendance at the meeting at the White House last Wednesday.
Instead, those in attendance heard a stark and dismaying message: The pandemic was spiraling out of control here at home. There was no capacity to deal with global donations, meaning that planning would come to a “screeching halt,” said the senior government official.
Two days earlier, CDC director Rochelle Walensky had veered off script in a press briefing to express her feeling of “impending doom” in the face of a deadly uptick in cases. Now, those gathered for the White House meeting discussed the alarming reversal of recent U.S. gains, driven in part by reckless reopenings and spring break travel: a surge of more infectious variants, a rising rate of hospitalizations for patients under 40, and a staggeringly high nationwide positivity rate of more than 13%. Roughly 2.9 million Americans were being vaccinated each day, and deaths had dipped below 900 per day, but every other indicator was bad. “They are going into full hunker-down mode to figure out what’s going wrong,” said the senior official.
The domestic situation was “so severe,” said the official, that every federal entity that might work on overseas donations had instead been tasked with vaccinating more Americans. The rest of the world would have to wait.
For all the well-documented failures of its pandemic response, the Trump administration exceeded expectations when it came to developing COVID-19 vaccines. Thanks in part to Operation Warp Speed, a multibillion-dollar joint venture of the Pentagon, the Department of Health and Human Services, and private pharmaceutical companies, a handful of manufacturers were able to gain approval for new vaccines in record time, accomplishing in under a year what might normally have taken a decade.
Still, given the nature of the Trump administration, this signal accomplishment came with some substantial asterisks. Upon taking office, the Biden team discovered that the previous administration’s plans for the distribution of vaccinations to individual citizens were woefully inadequate. And the Trump team’s unwillingness to enact a national testing plan, or even to clearly advocate for basic protective measures, allowed the virus to run rampant, leading the U.S. to suffer more deaths than any other country on earth.
For officials hoping to finally pivot from domestic to international vaccination strategy, there was another major catch, reported here for the first time.
The contracts the Trump administration signed with the vaccine manufacturers prohibit the U.S. from sharing its surplus doses with the rest of the world. According to contract language Vanity Fair has obtained, the agreements with Pfizer, Moderna, AstraZeneca, and Janssen state: “The Government may not use, or authorize the use of, any products or materials provided under this Project Agreement, unless such use occurs in the United States” or U.S. territories.
The clauses in question are designed to ensure that the manufacturers retain liability protection, but they have had the effect of projecting the Trump administration’s America First agenda into the Biden era. “That is what has completely and totally prohibited the U.S. from donating or reselling, because it would be in breach of contract,” said a senior administration official involved in the global planning effort. “It is a complete and total ban. Those legal parameters must change before we do anything to help the rest of the world.”
In a statement to Vanity Fair, a Defense Department spokesperson acknowledged the contract restrictions, saying: “DoD did attempt to negotiate terms that would allow the use of vaccine doses outside the U.S., but in some cases, the vaccine manufacturers refused.” Given the imperative to produce 300 million doses for the American public, said the spokesperson, Operation Warp Speed officials agreed that it was “more important to contract with the vaccine manufacturers for doses that could be used” by U.S. citizens “than walk away from the negotiations based on this single term.”
The impasse is especially frustrating because the Biden team’s global ambitions go beyond donating money or surplus vaccines. Vanity Fair has learned that the administration is quietly considering plans to have the U.S. serve as a major manufacturer of affordable, high-quality COVID vaccines for the entire world—a role typically reserved for lower-cost countries such as India. The effort began in plain sight on March 2, when the administration announced that, under the Defense Production Act, Merck would repurpose two of its U.S. manufacturing plants to begin producing the Johnson & Johnson vaccine. The partnership, pairing two traditional rivals, could yield as many as one billion doses a year.
The immediate goal was to “vastly increase” America’s supply, but the extra doses could also be used to supply the world, said a senior Biden official: “Just connect the dots. There’s a real ability for the U.S. to become a major supplier” of COVID vaccines.
The federal government began thinking through what to do with its surplus doses long before any vaccines were even approved. At the end of last July, Secretary of Health and Human Services Alex Azar convened a group to develop a strategy for global sharing. The U.S. Agency for International Development (USAID) joined the effort, but the Defense Department, which negotiated the contracts with vaccine manufacturers, declined to engage. “DOD gave us the middle finger,” a source involved in the effort said. “They literally would not attend meetings.” (A Defense Department spokesperson said, “DoD and HHS have been working closely to determine how to handle excess doses” since the beginning of Operation Warp Speed.)
The National Security Council’s Resilience Directorate, which coordinated key aspects of the U.S. COVID response, stepped in to help guide the debate. In a series of meetings over September and October, an interagency group that included the State Department, the Defense Department, and divisions of the Health and Human Services Department, among others, assessed the array of obstacles that stood in the way of the U.S. helping the world, from FDA regulations and export laws to chain-of-custody issues. Questions abounded: Should the U.S. sell its surplus? Donate it? Subsidize the cost?
At the heart of the debate was a battle over an essential question: how to define the point at which the U.S. could donate its excess vaccine. Was it when the U.S. reached herd immunity? When enough vaccines for every eligible American were under contract to be produced? Or when 70% of the population was vaccinated? “We kicked around a lot of indicators,” said a former senior administration official who worked on the document. “The one that became the most cut and dry was the quantity produced and the population vaccinated.”
That effort led to the creation of The Framework for International Access, which affirms that the U.S. intends to share its doses and will do so multilaterally. The document had two versions: one that came to roughly four pages, and a longer one, as well as a spreadsheet that assessed the needs of each country that might receive vaccines. Several countries were pointedly excluded from the list of prospective recipients, said the former senior administration official, due to their instability or human rights records.
In November, the document was cleared to be elevated to the National Security Council’s Principals committee. “We were told to prepare for a rollout,” said the senior administration official. On January 5, a four-page version of the Framework made it to the desk of Deputy National Security Adviser Matthew Pottinger. But the next day, MAGA insurrectionists stormed the Capitol. By that afternoon, Pottinger had resigned. The Framework’s authors assumed that the document, and the months of work that went into it, were dead. “Just another project sent to the buzz saw,” said the former senior administration official.
Globally minded government officials braced for the fallout. “We are preparing for extreme backlash from the world for not sharing,” said the senior government official. “When they say we are hoarding, we are.”
But the Framework document lived on. One of Biden’s first memoranda, dated January 21, directed the Secretaries of State and Health and Human Services to “promptly deliver to the President” a “framework for donating surplus vaccines.” And it appeared that the document was moving closer to Biden’s desk—until the meeting last Wednesday.
The officials present at the White House meeting deadlocked over next steps for the Framework. Several attendees argued passionately that the document should be elevated immediately to the National Security Council’s Principals Committee, comprising the president’s top advisers and Cabinet secretaries. The argument for doing so was obvious: The longer the virus proliferates around the globe, relatively unimpeded by vaccines, the more likely it is to mutate and spawn dangerous variants. “The people who really live and breathe global health understand how dire it is,” said the senior official. But those involved in the White House’s domestic COVID-19 response apparently made clear to the group: Now is not the time.
Said the senior official with knowledge of the meeting, “They’ve put the brakes on, until someone higher can figure this out.”
A series of scares in the early 2000s, including the 2001 anthrax attacks on members of Congress and the press and the 2004 worldwide outbreak of H5N1 “bird flu,” prompted Congress to pass the Public Readiness and Emergency Preparedness (PREP) Act. The 2005 law gives manufacturers of vaccines and therapeutics developed in response to public health emergencies sweeping protection from liability, and makes the U.S. government a guarantor of that protection.
The law provides an “almost Star Trek–level ‘shields up,’” said Nicholas Pace, a senior social scientist at the RAND Corporation. But “the moment that vial walks across the border, PREP has no effect. The cross-border liability problem is a huge one.”
According to a briefing document prepared during the Trump administration for the National Security Council, a portion of which was obtained by Vanity Fair: “This type of liability protection is unique in the world; most other countries provide no protection at all and only in some cases provide some level of legal protection.”
In the wake of such woebegone public health campaigns as the U.S. government’s 1976 mass vaccination against swine flu, which led to numerous cases of paralysis from Guillain-Barré syndrome, liability exposure has become the “third rail for these companies,” a senior Biden official acknowledged. “They are not going to do business unless they’re protected.” Paul Mango, a Trump administration Operation Warp Speed official, put it another way: “If I am a vaccine manufacturing CEO, I did not sign up to do this so that I would be liable to Ethiopia.”
Operation Warp Speed seemed to bend over backward to avoid that possibility, agreeing to a sweeping restriction that prevents the United States from sharing its bounty and thereby reaping any diplomatic rewards.
Experts say the Trump administration—which, after all, was in the position of doling out billions of dollars in development funds—was not required by any law to roll over for the vaccine makers. Sam Halabi, a scholar at the O’Neill Institute for National and Global Health Law at Georgetown University, who is currently advising several international organizations involved in the global vaccination effort, said the U.S. had been in “a very good position to call the manufacturers’ bluff: ‘if you want the billions in procurement dollars then we want the flexibility to send’” doses overseas. But U.S. negotiators likely “didn’t have any interest in sharing outside of U.S. territory.”
By contrast, during the H1N1 flu outbreak in 2009, a U.S. donation campaign was planned early and geographic restrictions were not imposed, said a former Obama administration official who had helped plan H1N1 vaccine donations. Given that history, “I am really surprised the U.S. would agree to constrain its options,” said the official, after being read the contract language by Vanity Fair.
The result of Operation Warp Speed’s acquiescence is yet another manifestation of Trump’s nativist, “America First” agenda. The contracts, said one Biden health adviser, reflect the “whole ethos” of the Trump administration.
As to whether the Biden administration can overcome the Trump administration’s contractual restrictions against sharing globally, a senior White House official told Vanity Fair, “I am confident that we will overcome any obstacles, when we want to do something internationally.”
President Biden himself has made it clear that he intends to take a leadership role in the worldwide fight against COVID-19. On February 18, he pledged $4 billion to COVAX (short for COVID-19 Vaccine Global Access Facility), a collaborative international effort working to buy COVID-19 vaccines in bulk and distribute them to the world’s poorest countries. Biden’s pledge makes the United States COVAX’s biggest contributor. The administration is “walking the walk,” said Gian Gandhi, UNICEF’s COVAX coordinator for supply division.
Meanwhile, a Quad Alliance among Australia, India, Japan, and the U.S. is looking to boost COVID vaccine manufacturing in India, partly to counter China’s push to distribute its own vaccine to the developing world.
And then there is the Defense Production Act deal with Merck and Johnson & Johnson, which could lay the groundwork for an ambitious plan to make the U.S. a global supplier of COVID-19 vaccines.
On Sunday, March 28, the U.S. government took what appeared to be another small step toward that goal. A cargo plane touched down in Mexico City bearing 1.5 million doses of the AstraZeneca vaccine that is being manufactured here, but still has not been approved by U.S. drug regulators. Ten days earlier, the Biden administration had announced plans to “loan” 4 million AstraZeneca doses to Mexico and Canada, and this was the first installment.
Before the doses could be shipped, the two countries had to negotiate separate contracts to indemnify AstraZeneca. Even then, the use of the term “loan” was designed to end-run the language in the original Operation Warp Speed contracts.
Last Wednesday, when one attendee at the White House meeting referred to the AstraZeneca “donation,” several people immediately piped up, saying, “Don’t use that word.” Said the senior official with knowledge of what transpired, “If they use ‘donate,’ ‘sell,’ or ‘share,’ it would be a breach of contract.” The issue has made “a whole bunch of [government] lawyers very nervous,” said the official. “We, the United States government, have never broken contracts of that nature. This is not like DOD canceling an order for a plane.”
White House officials point to the AstraZeneca “loan” as an example of how they were able to overcome contractual obstacles to help global partners. “As we get increasing confidence that we have enough vaccine, we will explore options for sharing more broadly,” White House Press Secretary Jen Psaki said in a briefing on March 22.
Even with a vaccinated world seemingly close at hand, the international outlook remains grim. A deadly variant known as P1 is ravaging Brazil, leading to the collapse of that nation’s health system and the digging of mass graves. France, which had managed to keep its schools open throughout the pandemic, just closed them amid fast-spreading variants and a lag in vaccinations.
The AstraZeneca vaccine, which had promised to be a workhorse COVID inoculator for the developing world, due to its low price point and normal refrigeration requirements, faces a crisis of confidence. Last week, Germany suspended its use for those under 60, due to numerous cases of blood clots and some deaths that may be associated with its use. On Tuesday, a European Medicines Agency official said regulators now believe there is a definitive link.
Meanwhile, even as Biden has moved mountains to secure America’s COVID-19 vaccine supply, last week news broke that a manufacturing mix-up at a vaccine plant in Baltimore had contaminated 15 million doses of the Johnson & Johnson vaccine. The doses—enough to inoculate a small country—had to be destroyed.
Given these ongoing struggles, global sharing will continue to take a back seat. Hundreds of nations have now written to the U.S. government, requesting American-made vaccines, said the senior government official: “It’s sad, because we catalog all these requests. We answer them. But the answer is still, ‘No.’”
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