The immediate goal was to “dramatically increase” America’s supply, but the extra doses could also be used to supply the world, a senior Biden official said: “Just connect the dots. The United States has a real capacity to become a “major supplier” of COVID vaccines.
The federal government began to think about what to do with its excess doses long before vaccines were even approved. At the end of last July, the Secretary of Health and Social Services Alex Azar convened a group to develop a global sharing strategy. The United States Agency for International Development (USAID) joined in the effort, but the Department of Defense, which negotiated the contracts with vaccine manufacturers, refused to commit. “The DOD gave us the middle finger,” said a source involved in the effort. “They literally wouldn’t attend meetings.” (A Defense Department spokesperson said, “The DoD and HHS have been working closely together to determine how to handle excessive doses” since the start of Operation Warp Speed.)
The National Security Council’s resilience leadership, which coordinated key aspects of the U.S. response to COVID, stepped in to help guide the debate. In a series of meetings in September and October, an interagency group comprising the State Department, the Department of Defense, and divisions of the Department of Health and Human Services, among others, assessed the range of obstacles that have stood in the way of US aid. around the world, from FDA regulations and export laws to chain-of-custody issues. Questions abounded: Should the United States sell its surplus? Make a donation ? Subsidize the cost?
At the heart of the debate was a battle over a critical question: how to define the point at which the United States could donate its excess vaccine. Was it when the United States achieved collective immunity? When should enough vaccines for each eligible American be produced under contract? Or when 70% of the population was vaccinated? “We used a lot of indicators,” said a former senior administration official who worked on the document. “What has become the driest is the amount produced and the population vaccinated.”
This effort led to the creation of The Framework for International Access, which says the United States intends to share its doses and will do so multilaterally. The document consisted of two versions: one of approximately four pages and one longer, as well as a spreadsheet that assessed the needs of each country likely to receive vaccines. Several countries have been ostensibly excluded from the list of potential beneficiaries, said the former senior administration official, due to their instability or human rights record.
In November, the document was cleared for elevation to the Board of Directors of the National Security Council. “We were told to prepare for a deployment,” the senior administration official said. On January 5, a four-page version of the framework reached the office of the Deputy National Security Advisor. Matthieu Pottinger. But the next day, MAGA insurgents stormed the Capitol. That afternoon Pottinger had resigned. The authors of the framework assumed that the document and the months of work that went into it were dead. “Just another draft sent to the circular saw,” said the former senior administration official.
Global-minded government officials braced for the fallout. “We are preparing for an extreme reaction from the world not to share,” the senior government official said. “When they say we are accumulating, we are.”
But the framework document has survived. One of Biden’s first memorandums, dated Jan.21, instructed Secretaries of State and Health and Human Services to “promptly provide the President” with a “framework for the donation of surplus vaccines.” And it looked like the document was getting closer to Biden’s office – until last Wednesday’s meeting.
Officials at the White House meeting found themselves deadlocked over the framework’s next steps. Several participants passionately argued that the document should be immediately elevated to the Board of Directors of the National Security Council, made up of the President’s senior advisers and Cabinet secretaries. The argument for doing so was obvious: the more the virus proliferates around the world, relatively unhindered by vaccines, the more likely it is to mutate and generate dangerous variants. “People who truly live and breathe global health understand how serious this is,” the senior official said. But those involved in the White House’s national COVID-19 response apparently made it clear to the group: This is not the moment.
Said the senior official with knowledge of the meeting, “They put the brakes on, until someone higher up could 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 global H5N1 bird flu epidemic in 2004 prompted Congress to pass the H5N1 law. public preparedness and emergency preparedness (PREP). The 2005 law offers manufacturers of vaccines and therapeutics developed in response to public health emergencies protection against liability, and makes the US government a guarantor of that protection.
The law provides for an “almost Star Trek-level ‘shields up’ ”, said Nicolas Pace, a senior social scientist at the RAND Corporation. But “the moment this vial crosses the border, PREP has no effect. The problem of cross-border liability is enormous.
According to a backgrounder prepared under the Trump administration for the National Security Council, part of which was obtained by Vanity Fair: “This type of liability protection is unique in the world; most other countries offer no protection and only in some cases some level of legal protection.
As a result of such unfortunate public health campaigns as the U.S. government’s mass swine flu vaccination in 1976, which resulted in numerous cases of paralysis from Guillain-Barré syndrome, exposure to liability has become the “third rail for these companies,” according to a senior Biden official. recognized. “They won’t do business if they are not protected.” Paul Mangue, one official in the Trump administration’s Operation Warp Speed put it another way: “If I’m a CEO of vaccine manufacturing, I haven’t signed up to do it so that I be responsible to Ethiopia. “
Operation Warp Speed appeared to bend over backwards to avoid this possibility, accepting a drastic restriction that prevents the United States from sharing its bounty and thus reaping diplomatic rewards.
Experts say the Trump administration – which, after all, was able to distribute billions of dollars in development funds – was under no law to fire vaccine makers. Sam Halabi, a researcher from the O’Neill Institute for National and Global Health Law at Georgetown University, which currently advises several international organizations involved in the global immunization effort, said the United States was “in very good position to call the manufacturers bluff: ‘if you want the billions of dollars to buy, then we want the flexibility to send’ doses abroad. But American negotiators “probably had no interest in sharing outside American territory.”
In contrast, during the H1N1 flu epidemic in 2009, a donation campaign in the United States was planned early and no geographic restrictions were imposed, said a former Obama administration official who had helped to plan donation of H1N1 vaccines. Given this story, “I am really surprised that the United States agrees to restrict its options,” the official said, after reading the text of the contract by Vanity Lounge.